Alfred O. Bonati, M.D., internationally known orthopedic surgeon and founder of The Bonati Spine Institute, reports that, in his experience, the failure rates for open back surgery, as recently reported by the Ohio Bureau of Workers' Compensation, are not out of line.
Researchers reviewed records from 1,450 patients in the Ohio Bureau database who had diagnoses of disc degeneration, disc herniation or radiculopathy, a nerve condition that causes tingling and weakness of the limbs. Half of the patients had surgery to fuse two or more vertebrae in hopes of curing low back pain. The other half had no surgery, even though they had comparable diagnoses.
After two years, just 25 percent of those who had surgery had actually returned to work. That's compared to 67 percent of patients who didn't have surgery. In what might be the most troubling study finding, researchers determined that there was a 41 percent increase in the use of painkillers, specifically opiates, in those who had surgery.
"This study provides clear evidence that for many patients, fusion surgeries designed to alleviate pain from degenerating discs don't work," says the study's lead author, Dr. Nguyen, a researcher at the University of Cincinnati College of Medicine.
"It is alarming that over 40% of the patients that we see at The Bonati Spine Institute are individuals who are suffering from Failed Back Surgery Syndrome due to traditional open back surgery performed at another medical facility," commented Dr. Bonati. "This study provides clear evidence that for many patients, fusion surgeries designed to alleviate pain from degenerating discs do not work," continued Dr. Bonati.
The Bonati Spine Procedures, utilizing patented methods and instrumentation, are a proven technique for the treatment of spinal disorders. The minimally invasive endoscopic laser spine surgery involves smaller incisions and less blood loss, and no general anesthesia, resulting in faster recovery. Dr. Bonati is a pioneer in introducing these techniques,
Source:
The Bonati Spine Institute
вторник, 31 мая 2011 г.
понедельник, 30 мая 2011 г.
National Athletic Trainers' Association Recommends 10 Steps To Combat Low Back Pain
To celebrate Allied Health Professions Week, the National Athletic Trainers' Association has prepared a 10-step guide that people of all ages can use to reduce body stress, prevent back pain and thereby improve quality of life - especially with holiday plans and travel just around the corner. Along with the season comes the lifting of heavy suitcases and holiday gifts that can put additional pressure on the back. NATA represents certified athletic trainers who are among the more than 80 professions being honored during Allied Health Professions Week (Nov. 4-10, 2007).
"The human body is an incredible machine that adapts to the stresses we give it every day," said certified athletic trainer Darrell Barnes, LAT, ATC, CSCS, performance center coordinator, St. Vincent Sports Performance Center in Indianapolis, Ind. "Stresses such as poor posture, unusual movement or activities or even a sedentary lifestyle can lead to poor mechanics and pain. Disability from back pain is second only to the common cold as a cause of lost work time."
According to the Arthritis Foundation, back pain affects 80 percent of the adult population at some point in their lives. In fact, back pain, limited mobility and stiffness end up costing American consumers $24 billion in treatment costs annually.
Following are recommendations to prevent and reduce back pain now and year-round:
1. Identify negative stresses that may be exacerbated by the holidays - Everybody has physical limitations that can lead to body imbalances, so it's important to identify problematic areas and correct these imbalances. Look at your sitting/standing posture. Do you complain that your muscles "feel tight" or weak? Do you use poor mechanics when lifting heavy items? Are you putting unusual stress on the back with certain activities and lifting during the holiday season? Learning correct lifting techniques and strengthening your back can help to alleviate pain. Use a luggage cart or lighten your load when lifting heavy packages or luggage.
2. Make yourself mobile - Poor posture and muscle stiffness decrease the body's ability to move freely, which can lead to injury or pain. There are many ways to increase mobility including daily stretches or activities that increase flexibility and get the body moving in different directions. Try yoga, tai chi, swimming or pilates to keep you limber.
3. Increase strength - It's important to get strong to improve overall balance and flexibility to reduce stress on the back. Exercises should involve the whole body, especially the core muscles of the stomach, back, hips and pelvis. At the same time, strengthening of the legs and shoulders can help you more easily squat, lift and carry even heavy items without overworking or injuring your back.
4. Add aerobic exercise - Physical activities like walking, swimming and running for at least 20 minutes three times a week increases muscular endurance and cardiovascular fitness. Aerobic activities also improve blood flow to the spine and help decrease daily stress.
5. Pay attention to posture - Try not to sit or drive for long periods of time. Get up every 15 to 30 minutes and move around or stretch to increase your mobility. When seated always remember to keep your hips and knees at right angles to one another and find a chair with adequate lumbar (lower back) support.
6. Stand up straight - When engaged in activities while standing, be sure to stand with your head up, shoulders straight, chest forward and stomach tight. Avoid standing in the same position for too long, though, and use your legs - rather than your back - when pushing or pulling heavy doors and other items.
7. Use proper lifting mechanics - When lifting objects from a position below your waist, stand with a wide stance and a slight bend at your hips and knees. Tighten your stomach as you lift and keep your back as flat as possible - do not arch or bend. When carrying heavy objects, keep them as close to your body as you can. Avoid carrying objects on only one side of your body.
8. Get a good night's sleep - Select a firm mattress and box spring that does not sag. Try to sleep in a position that allows you to maintain the natural curve in your back.
9. Warm-up before physical activity - Engage in a low impact activity prior to playing sports or exercising. Increasing muscle temperature and mobility will decrease the chance of injury.
10. Improve your healthy lifestyle - Obesity and smoking have been found to increase the incidence of back pain. Taking steps to improve your health will decrease the chance of back pain and improve your overall quality of life.
Barnes also urges people to always listen to their bodies: "If you are participating in any fitness routines or general activity and feel any twinges of back pain, you should stop immediately and consult your physician. Identifying the cause of the pain and treating it safely and appropriately will help you gain back mobility and range of motion and feel your physical best."
About the National Athletic Trainers' Association (NATA)
Athletic trainers are unique health care providers who specialize in the prevention, assessment, treatment and rehabilitation of injuries and illnesses. The National Athletic Trainers' Association represents and supports 30,000 members of the athletic training profession through education and research. Only 42 percent of high schools have access to athletic trainers. NATA advocates for equal access to athletic trainers for athletes and patients of all ages, and supports H.R. 1846.
National Athletic Trainers' Association
"The human body is an incredible machine that adapts to the stresses we give it every day," said certified athletic trainer Darrell Barnes, LAT, ATC, CSCS, performance center coordinator, St. Vincent Sports Performance Center in Indianapolis, Ind. "Stresses such as poor posture, unusual movement or activities or even a sedentary lifestyle can lead to poor mechanics and pain. Disability from back pain is second only to the common cold as a cause of lost work time."
According to the Arthritis Foundation, back pain affects 80 percent of the adult population at some point in their lives. In fact, back pain, limited mobility and stiffness end up costing American consumers $24 billion in treatment costs annually.
Following are recommendations to prevent and reduce back pain now and year-round:
1. Identify negative stresses that may be exacerbated by the holidays - Everybody has physical limitations that can lead to body imbalances, so it's important to identify problematic areas and correct these imbalances. Look at your sitting/standing posture. Do you complain that your muscles "feel tight" or weak? Do you use poor mechanics when lifting heavy items? Are you putting unusual stress on the back with certain activities and lifting during the holiday season? Learning correct lifting techniques and strengthening your back can help to alleviate pain. Use a luggage cart or lighten your load when lifting heavy packages or luggage.
2. Make yourself mobile - Poor posture and muscle stiffness decrease the body's ability to move freely, which can lead to injury or pain. There are many ways to increase mobility including daily stretches or activities that increase flexibility and get the body moving in different directions. Try yoga, tai chi, swimming or pilates to keep you limber.
3. Increase strength - It's important to get strong to improve overall balance and flexibility to reduce stress on the back. Exercises should involve the whole body, especially the core muscles of the stomach, back, hips and pelvis. At the same time, strengthening of the legs and shoulders can help you more easily squat, lift and carry even heavy items without overworking or injuring your back.
4. Add aerobic exercise - Physical activities like walking, swimming and running for at least 20 minutes three times a week increases muscular endurance and cardiovascular fitness. Aerobic activities also improve blood flow to the spine and help decrease daily stress.
5. Pay attention to posture - Try not to sit or drive for long periods of time. Get up every 15 to 30 minutes and move around or stretch to increase your mobility. When seated always remember to keep your hips and knees at right angles to one another and find a chair with adequate lumbar (lower back) support.
6. Stand up straight - When engaged in activities while standing, be sure to stand with your head up, shoulders straight, chest forward and stomach tight. Avoid standing in the same position for too long, though, and use your legs - rather than your back - when pushing or pulling heavy doors and other items.
7. Use proper lifting mechanics - When lifting objects from a position below your waist, stand with a wide stance and a slight bend at your hips and knees. Tighten your stomach as you lift and keep your back as flat as possible - do not arch or bend. When carrying heavy objects, keep them as close to your body as you can. Avoid carrying objects on only one side of your body.
8. Get a good night's sleep - Select a firm mattress and box spring that does not sag. Try to sleep in a position that allows you to maintain the natural curve in your back.
9. Warm-up before physical activity - Engage in a low impact activity prior to playing sports or exercising. Increasing muscle temperature and mobility will decrease the chance of injury.
10. Improve your healthy lifestyle - Obesity and smoking have been found to increase the incidence of back pain. Taking steps to improve your health will decrease the chance of back pain and improve your overall quality of life.
Barnes also urges people to always listen to their bodies: "If you are participating in any fitness routines or general activity and feel any twinges of back pain, you should stop immediately and consult your physician. Identifying the cause of the pain and treating it safely and appropriately will help you gain back mobility and range of motion and feel your physical best."
About the National Athletic Trainers' Association (NATA)
Athletic trainers are unique health care providers who specialize in the prevention, assessment, treatment and rehabilitation of injuries and illnesses. The National Athletic Trainers' Association represents and supports 30,000 members of the athletic training profession through education and research. Only 42 percent of high schools have access to athletic trainers. NATA advocates for equal access to athletic trainers for athletes and patients of all ages, and supports H.R. 1846.
National Athletic Trainers' Association
воскресенье, 29 мая 2011 г.
Cephalon Announces Positive Results For FENTORA(TM) (Fentanyl Buccal Tablet) For Breakthrough Pain In Patients With Chronic Low Back Pain
Cephalon, Inc. (Nasdaq: CEPH) today announced that data from a Phase 3 clinical trial of
FENTORA(TM) (fentanyl buccal tablet) [C-II] demonstrate efficacy in the
management of breakthrough pain in opioid-tolerant patients with chronic
low back pain.
In the double-blind, placebo-controlled study, statistically
significant differences in pain intensity were apparent within 10 minutes
(p
Breakthrough Pain
Breakthrough pain - a component of chronic pain - is a transitory flare
of moderate-to-severe pain in patients with otherwise stable persistent
pain. Breakthrough pain can reach peak intensity in as little as three
minutes and typically lasts for 30 to 60 minutes. An estimated 64 percent
of all cancer patients treated for persistent pain - and an estimated 74
percent of patients treated for persistent pain from other chronic pain
conditions - will experience breakthrough pain.
IMPORTANT WARNINGS AND SAFETY INFORMATION
FENTORA contains fentanyl, an opioid agonist and a Schedule II
controlled substance, with an abuse liability similar to other opioid
analgesics. FENTORA can be abused in a manner similar to other opioid
agonists, legal or illicit. This should be considered when prescribing or
dispensing FENTORA in situations where the physician or pharmacist is
concerned about an increased risk of misuse, abuse or diversion. Schedule
II opioid substances which include morphine, oxycodone, hydromorphone,
oxymorphone, and methadone have the highest potential for abuse and risk of
fatal overdose due to respiratory depression.
FENTORA is indicated for the management of breakthrough pain in
patients with cancer who are already receiving and who are tolerant to
opioid therapy for their underlying persistent cancer pain. Patients
considered opioid tolerant are those who are taking at least 60 mg of oral
morphine/day, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg
of oxycodone daily, at least 8 mg of oral hydromorphone daily or an
equianalgesic dose of another opioid for a week or longer.
Because life-threatening respiratory depression could occur at any dose
in opioid non-tolerant patients, FENTORA is contraindicated in the
management of acute or postoperative pain. This product is not indicated
for use in opioid non-tolerant patients.
Patients and their caregivers must be instructed that FENTORA contains
a medicine in an amount which can be fatal to a child. Patients and their
caregivers must be instructed to keep all tablets out of the reach of
children (see Information for Patients and Their Caregivers contained
within the prescribing information for disposal instructions).
Due to the higher bioavailability of fentanyl in FENTORA, when
converting patients from other oral fentanyl products, including oral
transmucosal fentanyl citrate (OTFC and Actiq(R)), to FENTORA, do not
substitute FENTORA on a mcg per mcg basis and adjust doses as appropriate
(see DOSAGE AND ADMINISTRATION contained within the prescribing
information).
FENTORA is intended to be used only in the care of opioid tolerant
cancer patients and only by healthcare professionals who are knowledgeable
of and skilled in the use of Schedule II opioids to treat cancer pain.What are Opioids?
For more information on what opioids are, and opioid-induced constipation (OIC), please see:
All About Opioids and Opioid-Induced Constipation (OIC)
Cephalon, Inc.
Founded in 1987, Cephalon, Inc. is an international biopharmaceutical
company dedicated to the discovery, development and marketing of innovative
products in four core therapeutic areas: central nervous system, pain,
oncology and addiction. Cephalon currently employs approximately 3,000
people in the United States and Europe. U.S. sites include the company's
headquarters in Frazer, Pennsylvania, and offices, laboratories or
manufacturing facilities in West Chester, Pennsylvania, Salt Lake City,
Utah, and suburban Minneapolis, Minnesota. Cephalon's European headquarters
are located in Maisons-Alfort, France.
The company currently markets six proprietary products in the United
States: PROVIGIL(R) (modafinil) Tablets [C-IV], FENTORA, TRISENOX(R)
(arsenic trioxide) injection, VIVITROL(R) (naltrexone for extended-release
injectable suspension), GABITRIL(R) (tiagabine hydrochloride), ACTIQ(R)
(oral transmucosal fentanyl citrate) [C-II], and numerous products
internationally. Full prescribing information on its U.S. products is
available at cephalon or by calling 1-800-896-5855.
In addition to historical facts or statements of current condition,
this press release may contain forward-looking statements. Forward-looking
statements provide Cephalon's current expectations or forecasts of future
events. These may include statements regarding anticipated scientific
progress on its research programs; development of potential pharmaceutical
products, including any future indications for FENTORA; interpretation of
clinical results, including the results of the clinical trials of FENTORA
in patients with chronic low back pain; prospects for regulatory approval;
market prospects for its product; sales and earnings guidance; and other
statements regarding matters that are not historical facts. You may
identify some of these forward-looking statements by the use of words in
the statements such as "anticipate," "estimate," "expect," "project,"
"intend," "plan," "believe" or other words and terms of similar meaning.
Cephalon's performance and financial results could differ materially from
those reflected in these forward-looking statements due to general
financial, economic, regulatory and political conditions affecting the
biotechnology and pharmaceutical industries as well as more specific risks
and uncertainties facing Cephalon such as those set forth in its reports on
Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange
Commission. Given these risks and uncertainties, any or all of these
forward-looking statements may prove to be incorrect. Therefore, you should
not rely on any such factors or forward-looking statements. Furthermore,
Cephalon does not intend to update publicly any forward-looking statement,
except as required by law. The Private Securities Litigation Reform Act of
1995 permits this discussion.
Cephalon, Inc
FENTORA
View drug information on Naltrexone Hydrochloride Tablets; Oxycodone and Aspirin.
FENTORA(TM) (fentanyl buccal tablet) [C-II] demonstrate efficacy in the
management of breakthrough pain in opioid-tolerant patients with chronic
low back pain.
In the double-blind, placebo-controlled study, statistically
significant differences in pain intensity were apparent within 10 minutes
(p
Breakthrough Pain
Breakthrough pain - a component of chronic pain - is a transitory flare
of moderate-to-severe pain in patients with otherwise stable persistent
pain. Breakthrough pain can reach peak intensity in as little as three
minutes and typically lasts for 30 to 60 minutes. An estimated 64 percent
of all cancer patients treated for persistent pain - and an estimated 74
percent of patients treated for persistent pain from other chronic pain
conditions - will experience breakthrough pain.
IMPORTANT WARNINGS AND SAFETY INFORMATION
FENTORA contains fentanyl, an opioid agonist and a Schedule II
controlled substance, with an abuse liability similar to other opioid
analgesics. FENTORA can be abused in a manner similar to other opioid
agonists, legal or illicit. This should be considered when prescribing or
dispensing FENTORA in situations where the physician or pharmacist is
concerned about an increased risk of misuse, abuse or diversion. Schedule
II opioid substances which include morphine, oxycodone, hydromorphone,
oxymorphone, and methadone have the highest potential for abuse and risk of
fatal overdose due to respiratory depression.
FENTORA is indicated for the management of breakthrough pain in
patients with cancer who are already receiving and who are tolerant to
opioid therapy for their underlying persistent cancer pain. Patients
considered opioid tolerant are those who are taking at least 60 mg of oral
morphine/day, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg
of oxycodone daily, at least 8 mg of oral hydromorphone daily or an
equianalgesic dose of another opioid for a week or longer.
Because life-threatening respiratory depression could occur at any dose
in opioid non-tolerant patients, FENTORA is contraindicated in the
management of acute or postoperative pain. This product is not indicated
for use in opioid non-tolerant patients.
Patients and their caregivers must be instructed that FENTORA contains
a medicine in an amount which can be fatal to a child. Patients and their
caregivers must be instructed to keep all tablets out of the reach of
children (see Information for Patients and Their Caregivers contained
within the prescribing information for disposal instructions).
Due to the higher bioavailability of fentanyl in FENTORA, when
converting patients from other oral fentanyl products, including oral
transmucosal fentanyl citrate (OTFC and Actiq(R)), to FENTORA, do not
substitute FENTORA on a mcg per mcg basis and adjust doses as appropriate
(see DOSAGE AND ADMINISTRATION contained within the prescribing
information).
FENTORA is intended to be used only in the care of opioid tolerant
cancer patients and only by healthcare professionals who are knowledgeable
of and skilled in the use of Schedule II opioids to treat cancer pain.What are Opioids?
For more information on what opioids are, and opioid-induced constipation (OIC), please see:
All About Opioids and Opioid-Induced Constipation (OIC)
Cephalon, Inc.
Founded in 1987, Cephalon, Inc. is an international biopharmaceutical
company dedicated to the discovery, development and marketing of innovative
products in four core therapeutic areas: central nervous system, pain,
oncology and addiction. Cephalon currently employs approximately 3,000
people in the United States and Europe. U.S. sites include the company's
headquarters in Frazer, Pennsylvania, and offices, laboratories or
manufacturing facilities in West Chester, Pennsylvania, Salt Lake City,
Utah, and suburban Minneapolis, Minnesota. Cephalon's European headquarters
are located in Maisons-Alfort, France.
The company currently markets six proprietary products in the United
States: PROVIGIL(R) (modafinil) Tablets [C-IV], FENTORA, TRISENOX(R)
(arsenic trioxide) injection, VIVITROL(R) (naltrexone for extended-release
injectable suspension), GABITRIL(R) (tiagabine hydrochloride), ACTIQ(R)
(oral transmucosal fentanyl citrate) [C-II], and numerous products
internationally. Full prescribing information on its U.S. products is
available at cephalon or by calling 1-800-896-5855.
In addition to historical facts or statements of current condition,
this press release may contain forward-looking statements. Forward-looking
statements provide Cephalon's current expectations or forecasts of future
events. These may include statements regarding anticipated scientific
progress on its research programs; development of potential pharmaceutical
products, including any future indications for FENTORA; interpretation of
clinical results, including the results of the clinical trials of FENTORA
in patients with chronic low back pain; prospects for regulatory approval;
market prospects for its product; sales and earnings guidance; and other
statements regarding matters that are not historical facts. You may
identify some of these forward-looking statements by the use of words in
the statements such as "anticipate," "estimate," "expect," "project,"
"intend," "plan," "believe" or other words and terms of similar meaning.
Cephalon's performance and financial results could differ materially from
those reflected in these forward-looking statements due to general
financial, economic, regulatory and political conditions affecting the
biotechnology and pharmaceutical industries as well as more specific risks
and uncertainties facing Cephalon such as those set forth in its reports on
Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange
Commission. Given these risks and uncertainties, any or all of these
forward-looking statements may prove to be incorrect. Therefore, you should
not rely on any such factors or forward-looking statements. Furthermore,
Cephalon does not intend to update publicly any forward-looking statement,
except as required by law. The Private Securities Litigation Reform Act of
1995 permits this discussion.
Cephalon, Inc
FENTORA
View drug information on Naltrexone Hydrochloride Tablets; Oxycodone and Aspirin.
суббота, 28 мая 2011 г.
Back Pain A Common Problem For Nurses
Nurses offer care and comfort, but they often end up with a pain in the back for their efforts, the results of a new study show.
"Nurses suffer from work-related low back pain more often than workers in other professions," said Edgar Vieira, a doctoral student in the University of Alberta Faculty of Rehabilitation Medicine and lead author of the study.
Most often, nurses hurt their backs while turning bed-ridden patients or transferring them among stretchers, beds and chairs, Vieira said, adding that orthopedic and intensive care unit (ICU) nurses have the highest rates of low back pain among all nurses. According to the study, 65 per cent of orthopedic nurses and 58 per cent of ICU nurses develop debilitating low back pain at some point in their careers.
"If a patient is unconscious, nurses will try to turn him every two hours or so to prevent him from getting bed sores. If you consider that nurses often work 12 hours shifts, the amount of lifting in one shift adds up a lot, and you can see how the job could be very hard to manage physically," said Vieira.
However, Vieira believes a few simple changes may prevent nurses from sustaining injuries. For example, providing nursing with access to more mechanical lifting devices would help reduce the risks, he said, adding that mechanical lifting devices are currently used only about 15 per cent of the time.
"Also, hospital rooms are often small, and nurses have to move furniture around so that they can do their jobs--most of the time lifting devices wouldn't even fit in these rooms," added Vieira, whose study appeared this month in the Journal of Advanced Nursing.
Providing bigger, uncluttered rooms to work in would help nurses, as would hiring more staff to share the workload, Vieira said.
Preventing work related low back pain is a humanitarian issue, and efforts to address the controllable risk factors are essential, Vieira said. He also noted that such injuries incur a great expense to taxpayers.
"Most individuals that suffer low back pain carry on with their normal activities after a few days, but in about seven per cent of cases, the pain persists and worsens, limiting daily activity and work. About 70 per cent of worker compensation costs are generated by the cases in which the absence from work lasts six months or longer. So, the best thing for everyone is to prevent disabilities, and the best way to do this is to prevent causation of the injuries.
"We hope we can raise awareness of this problem by improving working conditions and educating nurses about how to reduce the number of work-related low back pain injuries that they suffer, because right now the incidences of it are way too high," Vieira said.
Edgar Vieira can be reached at evieiraualberta.ca.
Contact: Ryan Smith
University of Alberta
"Nurses suffer from work-related low back pain more often than workers in other professions," said Edgar Vieira, a doctoral student in the University of Alberta Faculty of Rehabilitation Medicine and lead author of the study.
Most often, nurses hurt their backs while turning bed-ridden patients or transferring them among stretchers, beds and chairs, Vieira said, adding that orthopedic and intensive care unit (ICU) nurses have the highest rates of low back pain among all nurses. According to the study, 65 per cent of orthopedic nurses and 58 per cent of ICU nurses develop debilitating low back pain at some point in their careers.
"If a patient is unconscious, nurses will try to turn him every two hours or so to prevent him from getting bed sores. If you consider that nurses often work 12 hours shifts, the amount of lifting in one shift adds up a lot, and you can see how the job could be very hard to manage physically," said Vieira.
However, Vieira believes a few simple changes may prevent nurses from sustaining injuries. For example, providing nursing with access to more mechanical lifting devices would help reduce the risks, he said, adding that mechanical lifting devices are currently used only about 15 per cent of the time.
"Also, hospital rooms are often small, and nurses have to move furniture around so that they can do their jobs--most of the time lifting devices wouldn't even fit in these rooms," added Vieira, whose study appeared this month in the Journal of Advanced Nursing.
Providing bigger, uncluttered rooms to work in would help nurses, as would hiring more staff to share the workload, Vieira said.
Preventing work related low back pain is a humanitarian issue, and efforts to address the controllable risk factors are essential, Vieira said. He also noted that such injuries incur a great expense to taxpayers.
"Most individuals that suffer low back pain carry on with their normal activities after a few days, but in about seven per cent of cases, the pain persists and worsens, limiting daily activity and work. About 70 per cent of worker compensation costs are generated by the cases in which the absence from work lasts six months or longer. So, the best thing for everyone is to prevent disabilities, and the best way to do this is to prevent causation of the injuries.
"We hope we can raise awareness of this problem by improving working conditions and educating nurses about how to reduce the number of work-related low back pain injuries that they suffer, because right now the incidences of it are way too high," Vieira said.
Edgar Vieira can be reached at evieiraualberta.ca.
Contact: Ryan Smith
University of Alberta
пятница, 27 мая 2011 г.
Replication Medical Receives Grant Of Nearly $250,000.00 On The Heels Of Successful Clinical Results With Its Innovative GelStix(TM) Treatment
Replication Medical, Inc., a developer of proprietary, hydrogel based products for spine and other surgical applications, reported that it has been awarded a Qualifying Therapeutic Discovery Project (QTDP) grant from the U.S. government in the amount of $244,479 based on Replication Medical's 2009 GelStix related research expenditures. The GelStix product is intended to treat chronic lower back pain which impacts nearly 10-15% of adults and is associated with a condition known as degenerative disc disease.
Early stage treatments for degenerative disc disease (DDD) include non-surgical pain management such as anti-inflammatory medications and exercise programs. Traditional surgical interventions include spinal fusion and disc replacement, which can be debilitating and risky for patients, especially the elderly. The Replication Medical Inc. GelStix™ device is a matchstick-sized implant placed into the intradiscal space using a small needle and doesn't require surgery. Once implanted, GelStix absorbs bodily fluids and expands many times in volume to rehydrate and repressurize the disc. The product represents an important step in filling the continuum of care gap for DDD. "There are few suitable treatment options for older patients dealing with chronic back pain," commented Dr. James Yue, Co-Chief of Spine and Orthopedic Medicine at Yale University. "Often we have little to offer these patients other than repetitive injections that provide only short term pain-relief. Alongside Dr. R. Morgenstern (Barcelona, Spain), I treated the first 59 year old patient to receive the device. Based upon personal experience, I am impressed with GelStix ease-of-use and the near complete elimination of back pain symptoms. GelStix has the potential to provide real hope for this large, underserved patient population."
GelStix received the CE Mark in early 2010 and is now available for sale and distribution within the European Union. As the population ages there is increasing pressure to develop a non-surgical treatment for chronic back pain which provides lasting clinical benefit and attendant reduced costs. "This cash infusion following promising clinical results in Europe will enable us to continue the commercialization of GelStix outside of the United States and fund the clinical development needed for FDA approval, stated Ann Prewett, PhD, President & CEO of Replication Medical.
Source: Replication Medical, Inc
Early stage treatments for degenerative disc disease (DDD) include non-surgical pain management such as anti-inflammatory medications and exercise programs. Traditional surgical interventions include spinal fusion and disc replacement, which can be debilitating and risky for patients, especially the elderly. The Replication Medical Inc. GelStix™ device is a matchstick-sized implant placed into the intradiscal space using a small needle and doesn't require surgery. Once implanted, GelStix absorbs bodily fluids and expands many times in volume to rehydrate and repressurize the disc. The product represents an important step in filling the continuum of care gap for DDD. "There are few suitable treatment options for older patients dealing with chronic back pain," commented Dr. James Yue, Co-Chief of Spine and Orthopedic Medicine at Yale University. "Often we have little to offer these patients other than repetitive injections that provide only short term pain-relief. Alongside Dr. R. Morgenstern (Barcelona, Spain), I treated the first 59 year old patient to receive the device. Based upon personal experience, I am impressed with GelStix ease-of-use and the near complete elimination of back pain symptoms. GelStix has the potential to provide real hope for this large, underserved patient population."
GelStix received the CE Mark in early 2010 and is now available for sale and distribution within the European Union. As the population ages there is increasing pressure to develop a non-surgical treatment for chronic back pain which provides lasting clinical benefit and attendant reduced costs. "This cash infusion following promising clinical results in Europe will enable us to continue the commercialization of GelStix outside of the United States and fund the clinical development needed for FDA approval, stated Ann Prewett, PhD, President & CEO of Replication Medical.
Source: Replication Medical, Inc
четверг, 26 мая 2011 г.
Chronic Back Pain Linked To Changes In The Brain
A German research team using a specialized imaging technique revealed that individuals suffering from chronic low back pain also had microstructural changes in their brains. The findings were presented at the annual meeting of the Radiological Society of North America (RSNA).
The researchers, led by Jurgen Lutz, M.D., a radiology resident at University Hospital, Ludwig-Maximilians University in Munich, Germany, used a technique called diffusion tensor imaging (DTI) to track the movement of water molecules in the brain's gray and white matter.
"A major problem for patients with chronic pain is making their condition believable to doctors, relatives and insurance carriers. DTI could play an important role in this regard," Dr. Lutz said. "With these objective and reproducible correlates in brain imaging, chronic pain may no longer be a subjective experience. For pain diagnosis and treatment, the consequences could be enormous."
Individual water molecules are constantly in motion, colliding with each other and other nearby molecules, causing them to spread out, or diffuse. DTI allows scientists to analyze water diffusion in the tissues of the brain that indicate changes in brain cell organization.
"In normal white matter, water diffuses in one main direction," Dr. Lutz explained. "But when fiber pathways are developing during childhood or are extensively used, their microstructural organization becomes more organized and complex with measurable changes in diffusion."
Dr. Lutz and colleagues studied 20 patients experiencing chronic back pain with no precisely identifiable cause and 20 age- and gender-matched healthy control patients. DTI was performed to measure the diffusion in several areas of each patient's brain.
Compared to the healthy volunteers, the patients with chronic low back pain had a significantly more directed diffusion in the three pain-processing regions of the brain, including the cingulate gyrus, postcentral gyrus and superior frontal gyrus.
"Our results reveal that in chronic pain sufferers, the organization of cerebral microstructure is much more complex and active in the areas of the brain involved in pain processing, emotion and the stress response," said co-author Gustav Schelling, M.D., Ph.D. from the Department of Anaesthesiology at Munich University.
The researchers said the findings may help explain the extreme resistance to treatment for chronic low back pain and provide much-needed evidence for individual sufferers. However, it is unclear which occurs first, the chronic back pain or the microstructural changes in the brain.
"It's difficult to know whether these are pre-existing changes in the brain that predispose an individual to developing chronic pain, whether ongoing pain creates the hyperactivity that actually changes the brain organization, or if it is some mixture of both," Dr. Schelling said. "DTI may help explain what's happening for some of these patients, and direct therapeutic attention from the spine to the brain," he added.
Co-authors are Maximilian F. Reiser, M.D., Olaf Dietrich, Ph.D., Lorenz Jaeger, M.D. and Robert Stahl, M.D.
RSNA is an association of more than 40,000 radiologists, radiation oncologists, medical physicists and related scientists committed to promoting excellence in radiology through education and by fostering research, with the ultimate goal of improving patient care. The Society is based in Oak Brook, Ill.
The data in these releases may differ from those in the printed abstract and those actually presented at the meeting, as researchers continue to update their data right up until the meeting.
Contact: Maureen Morley
Radiological Society of North America
The researchers, led by Jurgen Lutz, M.D., a radiology resident at University Hospital, Ludwig-Maximilians University in Munich, Germany, used a technique called diffusion tensor imaging (DTI) to track the movement of water molecules in the brain's gray and white matter.
"A major problem for patients with chronic pain is making their condition believable to doctors, relatives and insurance carriers. DTI could play an important role in this regard," Dr. Lutz said. "With these objective and reproducible correlates in brain imaging, chronic pain may no longer be a subjective experience. For pain diagnosis and treatment, the consequences could be enormous."
Individual water molecules are constantly in motion, colliding with each other and other nearby molecules, causing them to spread out, or diffuse. DTI allows scientists to analyze water diffusion in the tissues of the brain that indicate changes in brain cell organization.
"In normal white matter, water diffuses in one main direction," Dr. Lutz explained. "But when fiber pathways are developing during childhood or are extensively used, their microstructural organization becomes more organized and complex with measurable changes in diffusion."
Dr. Lutz and colleagues studied 20 patients experiencing chronic back pain with no precisely identifiable cause and 20 age- and gender-matched healthy control patients. DTI was performed to measure the diffusion in several areas of each patient's brain.
Compared to the healthy volunteers, the patients with chronic low back pain had a significantly more directed diffusion in the three pain-processing regions of the brain, including the cingulate gyrus, postcentral gyrus and superior frontal gyrus.
"Our results reveal that in chronic pain sufferers, the organization of cerebral microstructure is much more complex and active in the areas of the brain involved in pain processing, emotion and the stress response," said co-author Gustav Schelling, M.D., Ph.D. from the Department of Anaesthesiology at Munich University.
The researchers said the findings may help explain the extreme resistance to treatment for chronic low back pain and provide much-needed evidence for individual sufferers. However, it is unclear which occurs first, the chronic back pain or the microstructural changes in the brain.
"It's difficult to know whether these are pre-existing changes in the brain that predispose an individual to developing chronic pain, whether ongoing pain creates the hyperactivity that actually changes the brain organization, or if it is some mixture of both," Dr. Schelling said. "DTI may help explain what's happening for some of these patients, and direct therapeutic attention from the spine to the brain," he added.
Co-authors are Maximilian F. Reiser, M.D., Olaf Dietrich, Ph.D., Lorenz Jaeger, M.D. and Robert Stahl, M.D.
RSNA is an association of more than 40,000 radiologists, radiation oncologists, medical physicists and related scientists committed to promoting excellence in radiology through education and by fostering research, with the ultimate goal of improving patient care. The Society is based in Oak Brook, Ill.
The data in these releases may differ from those in the printed abstract and those actually presented at the meeting, as researchers continue to update their data right up until the meeting.
Contact: Maureen Morley
Radiological Society of North America
среда, 25 мая 2011 г.
Javelin Pharmaceuticals Launches Dyloject(R) In UK
Javelin Pharmaceuticals, Inc. (AMEX:JAV) announced that it has received and published its UK pricing for Dyloject® (diclofenac sodium solution for injection). Pricing was received from the Department of Health Pharmaceutical Price Regulation Scheme ("PPRS"). PPRS accepted Javelin's proposal that the National Health Service (NHS) Tariff Price for Dyloject be GBP 48.00 per pack (10 x 75mg/2ml vials).
"Today is a watershed in Javelin's evolution from a development company to a revenue-generating organization," said Dr. Daniel Carr, CEO/CMO. "Pricing publication marks the UK launch of Dyloject, our proprietary injectable NSAID for the treatment of acute moderate-to-severe pain. The Javelin sales force is now fully engaging hospital formulary decision makers in making the product available to prescribers within the hospital setting."
"This decision is a very positive outcome for Javelin in the UK, coming as it does at a time of increasing price pressures. Based upon such pricing, we believe that Dyloject provides significant clinical and cost savings benefits to patients, healthcare providers and the National Health Service," said Derek Gallacher, Javelin's European Managing Director.
Javelin intends to file additional marketing applications through the mutual recognition process in a number of European Union ("EU") member countries, including Germany, Europe's largest market for prescription injectable pain medications.
About Dyloject
In its pivotal UK registration trial, Dyloject's efficacy and safety were superior to those of the currently marketed IV formulation of diclofenac. Each dose of the latter product requires buffering, dilution and slow infusion. Dyloject comes ready to use for immediate IV bolus administration, works faster, and according to a recent study, has potential to save the UK NHS up to GBP 50 per postoperative patient compared to the currently marketed formulation. This pharmacoeconomic benefit coupled with Dyloject's superior clinical attributes differentiates Dyloject from the currently marketed IV formulation of diclofenac sodium, which holds approximately 60 (sixty) percent of the market for UK injectable nonsteroidal anti-inflammatory drugs (NSAIDs). Dyloject employs a proprietary solubilizing agent that is significantly less irritating to veins than the organic solvents used in the currently marketed IV diclofenac formulation.
According to IMS Health, a well-known pharmaceutical market intelligence provider, the original formulation of diclofenac sodium is the most widely prescribed injectable NSAID in the UK and is sold in numerous countries throughout the world. IMS estimates over seventy million injectable NSAID units are prescribed annually in the G5 countries alone.
Dyloject's UK label includes two routes of administration, intramuscular (IM) injection and rapid (IV bolus) injection. IM is effective for acute forms of pain, including renal colic, exacerbations of osteo- and rheumatoid arthritis, and acute flare-ups of back pain or gout. Dyloject's IV bolus application is for the treatment or prevention of post-operative pain in supervised healthcare settings. With Dyloject, Javelin Pharmaceuticals is the first company to create a formulation for rapid IV bolus or low volume IM diclofenac injections. Javelin was recently awarded European Patent 1,574,221, extending patent protection on Dyloject through 2024. A corresponding patent application is pending in the United States.
In the United States, Javelin has completed patient accrual in the first of its two Phase 3 pivotal trials, and is now enrolling patients in the second of two Phase 3 pivotal trials for Dyloject. Javelin plans to file a New Drug Application (NDA) for FDA approval in the first half of 2009.
NSAIDs such as Dyloject can be used postoperatively with opioids, e.g., morphine, to reduce opioid doses by as much as thirty to fifty percent, and thereby decrease morphine-related side effects. Combining different types of pain medicines (called "multimodal analgesia") is the most commonly advocated approach to acute postoperative pain management worldwide. A number of studies of multimodal analgesia have shown that when patients are given an NSAID along with an opioid, dose requirements and adverse effects of the latter are reduced. Opioid side effects that are reduced by this dose-sparing approach include nausea, vomiting, and inadequate breathing.
About Javelin Pharmaceuticals, Inc.
Javelin is a specialty pharmaceutical company that applies proprietary technologies to develop new drugs and improved formulations of existing drugs for pain management. Specialty pharmaceutical analysts from six investment firms cover Javelin Pharmaceuticals, Inc. Javelin's headquarters are located in Cambridge, Massachusetts with European offices in Cambridge, England and Cologne, Germany. For additional information, visit javelinpharmaceuticals.
Forward Looking Statement
This news release contains forward-looking statements. Such statements are valid only as of today, and we disclaim any obligation to update this information. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other governmental regulation, our ability to obtain working capital, our ability to successfully develop and commercialize drug candidates, and competition from other pharmaceutical companies.
Javelin Pharmaceuticals
"Today is a watershed in Javelin's evolution from a development company to a revenue-generating organization," said Dr. Daniel Carr, CEO/CMO. "Pricing publication marks the UK launch of Dyloject, our proprietary injectable NSAID for the treatment of acute moderate-to-severe pain. The Javelin sales force is now fully engaging hospital formulary decision makers in making the product available to prescribers within the hospital setting."
"This decision is a very positive outcome for Javelin in the UK, coming as it does at a time of increasing price pressures. Based upon such pricing, we believe that Dyloject provides significant clinical and cost savings benefits to patients, healthcare providers and the National Health Service," said Derek Gallacher, Javelin's European Managing Director.
Javelin intends to file additional marketing applications through the mutual recognition process in a number of European Union ("EU") member countries, including Germany, Europe's largest market for prescription injectable pain medications.
About Dyloject
In its pivotal UK registration trial, Dyloject's efficacy and safety were superior to those of the currently marketed IV formulation of diclofenac. Each dose of the latter product requires buffering, dilution and slow infusion. Dyloject comes ready to use for immediate IV bolus administration, works faster, and according to a recent study, has potential to save the UK NHS up to GBP 50 per postoperative patient compared to the currently marketed formulation. This pharmacoeconomic benefit coupled with Dyloject's superior clinical attributes differentiates Dyloject from the currently marketed IV formulation of diclofenac sodium, which holds approximately 60 (sixty) percent of the market for UK injectable nonsteroidal anti-inflammatory drugs (NSAIDs). Dyloject employs a proprietary solubilizing agent that is significantly less irritating to veins than the organic solvents used in the currently marketed IV diclofenac formulation.
According to IMS Health, a well-known pharmaceutical market intelligence provider, the original formulation of diclofenac sodium is the most widely prescribed injectable NSAID in the UK and is sold in numerous countries throughout the world. IMS estimates over seventy million injectable NSAID units are prescribed annually in the G5 countries alone.
Dyloject's UK label includes two routes of administration, intramuscular (IM) injection and rapid (IV bolus) injection. IM is effective for acute forms of pain, including renal colic, exacerbations of osteo- and rheumatoid arthritis, and acute flare-ups of back pain or gout. Dyloject's IV bolus application is for the treatment or prevention of post-operative pain in supervised healthcare settings. With Dyloject, Javelin Pharmaceuticals is the first company to create a formulation for rapid IV bolus or low volume IM diclofenac injections. Javelin was recently awarded European Patent 1,574,221, extending patent protection on Dyloject through 2024. A corresponding patent application is pending in the United States.
In the United States, Javelin has completed patient accrual in the first of its two Phase 3 pivotal trials, and is now enrolling patients in the second of two Phase 3 pivotal trials for Dyloject. Javelin plans to file a New Drug Application (NDA) for FDA approval in the first half of 2009.
NSAIDs such as Dyloject can be used postoperatively with opioids, e.g., morphine, to reduce opioid doses by as much as thirty to fifty percent, and thereby decrease morphine-related side effects. Combining different types of pain medicines (called "multimodal analgesia") is the most commonly advocated approach to acute postoperative pain management worldwide. A number of studies of multimodal analgesia have shown that when patients are given an NSAID along with an opioid, dose requirements and adverse effects of the latter are reduced. Opioid side effects that are reduced by this dose-sparing approach include nausea, vomiting, and inadequate breathing.
About Javelin Pharmaceuticals, Inc.
Javelin is a specialty pharmaceutical company that applies proprietary technologies to develop new drugs and improved formulations of existing drugs for pain management. Specialty pharmaceutical analysts from six investment firms cover Javelin Pharmaceuticals, Inc. Javelin's headquarters are located in Cambridge, Massachusetts with European offices in Cambridge, England and Cologne, Germany. For additional information, visit javelinpharmaceuticals.
Forward Looking Statement
This news release contains forward-looking statements. Such statements are valid only as of today, and we disclaim any obligation to update this information. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other governmental regulation, our ability to obtain working capital, our ability to successfully develop and commercialize drug candidates, and competition from other pharmaceutical companies.
Javelin Pharmaceuticals
вторник, 24 мая 2011 г.
Labopharm Reports Results For Phase III Study On Twice-daily Tramadol-acetaminophen Formulation
Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) announced the results of its recently completed North American Phase III clinical trial for its twice-daily formulation of tramadol and acetaminophen (study 06CCL3-001).
Study 06CCL3-001 was a multi-centre, randomized, double-blind, parallel-arm study that compared the efficacy and safety of Labopharm's twice-daily tramadol-acetaminophen formulation to placebo in the treatment of moderate to severe acute low back pain. A total of 277 patients were included in the study. Thirteen percent (13%) of patients in the active treatment group discontinued early (12% due to adverse events) and 5% of patients in the placebo group discontinued early (2% due to adverse events).
Results of the efficacy measures in the study demonstrated a statistically significant difference from placebo in some cases but not in others. An analysis of covariance demonstrated a statistically significant difference from placebo on the Sum of Pain Intensity Differences (SPID) over 50 hours using LOCF (last observation carried-forward) as the imputation method, however, the results were not statistically significant using LOCF/BOCF (baseline observation carried-forward), the primary endpoint. A non-parametric analysis, however, demonstrated statistical significance using both LOCF and LOCF/BOCF as imputation methods. The difference from placebo on the Total Pain Relief (TOTPAR) score was also statistically significant using both LOCF and LOCF/BOCF imputation methods and the patients' global impression of the effectiveness of the study medication was statistically different from placebo. Statistical significance reflects a p-value of less than 0.05 in each of the analyses.
Regulatory authorities throughout the world have different requirements for the analysis and demonstration of efficacy in clinical trials. Labopharm believes that it is likely that the results of this trial are insufficient to support the acceptance of a New Drug Application (NDA) by the Food and Drug Administration (FDA) in the United States. The Company intends to discuss the matter with the FDA's Division of Anesthesia, Analgesia & Rheumatology Products (DAARP) to determine the path forward. The results of this study are however statistically significant under analyses that the Company believes may be accepted for the evaluation of analgesics in Europe, Canada and other jurisdictions. Accordingly, the Company intends to meet with the regulatory authorities for these jurisdictions at the earliest available opportunity in pursuit of regulatory approval. Should the authorities be in agreement, the Company expects that it would submit a regulatory application in those jurisdictions.
The Company will provide additional information following discussions with the various regulatory authorities.
The results of the study have no bearing on the upcoming launch of the Company's once-daily tramadol product in the United States.
About Tramadol-Acetaminophen Combination Products
Tramadol-acetaminophen products leverage the unique but complementary modes of action of each of the active ingredients to provide the analgesic strength of a mild opioid (tramadol) and the rapid pain relief of acetaminophen. Tramadol-acetaminophen combination products were first launched in 2001 in the United States and in 2003 in other major markets and are indicated for the short-term (five days or less) management of acute pain in the U.S. and the symptomatic treatment of moderate to severe pain in the rest of the world.
About Labopharm Inc.
Labopharm is an emerging leader in optimizing the performance of existing small molecule drugs using its proprietary controlled-release technologies. The Company's lead product, a unique once-daily formulation of tramadol, is being commercially launched in key markets globally and its second product, a novel formulation of trazodone for the treatment of major depressive disorder, is under regulatory review by the FDA. The Company also has a robust pipeline of follow-on products in both pre-clinical and clinical development. Labopharm's vision is to become an integrated, international, specialty pharmaceutical company with the capability to internally develop and commercialize its own products. For more information, please visit labopharm.
This press release contains forward-looking statements, which reflect the Company's current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including the price of the Company's shares, the uncertainties related to the regulatory process for drug approval and the commercialization of the Company's products, if they are approved. Investors should consult the Company's ongoing quarterly filings and annual reports for additional information on risks and uncertainties relating to these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. The Company disclaims any obligation to update these forward-looking statements.
Labopharm Inc.
labopharm
Study 06CCL3-001 was a multi-centre, randomized, double-blind, parallel-arm study that compared the efficacy and safety of Labopharm's twice-daily tramadol-acetaminophen formulation to placebo in the treatment of moderate to severe acute low back pain. A total of 277 patients were included in the study. Thirteen percent (13%) of patients in the active treatment group discontinued early (12% due to adverse events) and 5% of patients in the placebo group discontinued early (2% due to adverse events).
Results of the efficacy measures in the study demonstrated a statistically significant difference from placebo in some cases but not in others. An analysis of covariance demonstrated a statistically significant difference from placebo on the Sum of Pain Intensity Differences (SPID) over 50 hours using LOCF (last observation carried-forward) as the imputation method, however, the results were not statistically significant using LOCF/BOCF (baseline observation carried-forward), the primary endpoint. A non-parametric analysis, however, demonstrated statistical significance using both LOCF and LOCF/BOCF as imputation methods. The difference from placebo on the Total Pain Relief (TOTPAR) score was also statistically significant using both LOCF and LOCF/BOCF imputation methods and the patients' global impression of the effectiveness of the study medication was statistically different from placebo. Statistical significance reflects a p-value of less than 0.05 in each of the analyses.
Regulatory authorities throughout the world have different requirements for the analysis and demonstration of efficacy in clinical trials. Labopharm believes that it is likely that the results of this trial are insufficient to support the acceptance of a New Drug Application (NDA) by the Food and Drug Administration (FDA) in the United States. The Company intends to discuss the matter with the FDA's Division of Anesthesia, Analgesia & Rheumatology Products (DAARP) to determine the path forward. The results of this study are however statistically significant under analyses that the Company believes may be accepted for the evaluation of analgesics in Europe, Canada and other jurisdictions. Accordingly, the Company intends to meet with the regulatory authorities for these jurisdictions at the earliest available opportunity in pursuit of regulatory approval. Should the authorities be in agreement, the Company expects that it would submit a regulatory application in those jurisdictions.
The Company will provide additional information following discussions with the various regulatory authorities.
The results of the study have no bearing on the upcoming launch of the Company's once-daily tramadol product in the United States.
About Tramadol-Acetaminophen Combination Products
Tramadol-acetaminophen products leverage the unique but complementary modes of action of each of the active ingredients to provide the analgesic strength of a mild opioid (tramadol) and the rapid pain relief of acetaminophen. Tramadol-acetaminophen combination products were first launched in 2001 in the United States and in 2003 in other major markets and are indicated for the short-term (five days or less) management of acute pain in the U.S. and the symptomatic treatment of moderate to severe pain in the rest of the world.
About Labopharm Inc.
Labopharm is an emerging leader in optimizing the performance of existing small molecule drugs using its proprietary controlled-release technologies. The Company's lead product, a unique once-daily formulation of tramadol, is being commercially launched in key markets globally and its second product, a novel formulation of trazodone for the treatment of major depressive disorder, is under regulatory review by the FDA. The Company also has a robust pipeline of follow-on products in both pre-clinical and clinical development. Labopharm's vision is to become an integrated, international, specialty pharmaceutical company with the capability to internally develop and commercialize its own products. For more information, please visit labopharm.
This press release contains forward-looking statements, which reflect the Company's current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including the price of the Company's shares, the uncertainties related to the regulatory process for drug approval and the commercialization of the Company's products, if they are approved. Investors should consult the Company's ongoing quarterly filings and annual reports for additional information on risks and uncertainties relating to these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. The Company disclaims any obligation to update these forward-looking statements.
Labopharm Inc.
labopharm
понедельник, 23 мая 2011 г.
Heavy Packs Endanger Kids' Health, UCR Study Shows
A joint study by University of California Riverside researchers and the Inland Empire Spine Center has found that parents would be wise to pay attention to their child's backpack, as a significant percentage of local middle school students suffer lasting pain related to the weight on their backs.
The pain could be a harbinger of longstanding back problems or even permanent injury, said Dr. David Siambanes (pronounced SIGH-am-BAN-ess), chief investigator for the study, published recently in the Journal of Pediatric Orthopedics.
"This is truly alarming," said Siambanes, a physician and partner in the spine center, in Riverside. "Research has shown that adults with severe back problems often had pain as kids. You can suffer all your life from this kind of injury."
The UCR study focused on 3,498 middle school students in Riverside and San Bernardino counties. Also on the research team were UC Riverside sociologists Jason W. Martinez and emeritus Professor Edgar W. Butler and spine center founder Thomas Haider (pronounced HY-der), a UCR donor who also is an assistant clinical professor in the university's biomedical sciences program. Haider concluded that rolling backpacks might be one possible way to deal with the substantial weight of school textbooks, since students don't really have a choice about whether to carry them or not.
Funding for the research came from the Children's Spine Foundation, Siambanes said.
Studying local 11- through 15-year-olds and their backpack habits, the team found that the main predictor of pain was how much a backpack weighed compared with the student carrying it. Long-term effects have not been assessed, Siambanes said, but the team plans to follow up on its research to learn more. Plans for doing a study took shape as the number of young patients at the spine center increased, he said.
"We got calls from families," he said. "Kids were complaining about pain, about their backpacks. Kids complain all the time and nobody pays much attention, but this seemed like too much of the same thing. We decided to get a real study, and not just blow the kids off."
The team weighed the students and their backpacks and asked the students how they used their packs and how much pain they had, if any. Sixty-four percent of the students surveyed by the UCR team reported pain, and 21 percent reported pain that lasted more than six months.
The team found an increase in reports of pain as the weight of backpacks rose compared with their owners' body weights. The increase was so gradual that the team was unable to specify a "safe" relative backpack weight for protecting students. It found that a student whose backpack weighed five percent of what he or she weighed was much less likely to report back pain than a student whose pack weighed 20 percent of what he or she weighed.
One concern researchers cited is that most schools have removed lockers because of vandalism and concerns about safety, so many students carry a whole day's worth of books and supplies at all times.
Four middle schools were included in the study. At two, a majority of students came from lower-income families, based on the percentage of students participating in a free lunch program. Two of the schools made some use of extra sets of textbooks -- one for the classroom and one for students' use at home -- so students did not have to carry all their books home. None of the schools had lockers for book storage.
The researchers calculated the relative weights of the students' packs as a percentage of their body weights. They also assessed the influence of how the students carried their packs -- in the hands, over one shoulder or over both shoulders -- and for how long they carried the packs.
More than 64 percent of the middle school students surveyed reported pain, and more than 41 percent said they felt pain while carrying their packs. Almost all said they were relieved when they could take their packs off. Of those with pain, more than 12 percent called it "not bad," more than 75 percent called it "bad" and more than 12 percent called it "very bad."
The backpacks weighed from half a pound to 37 pounds, with a mean average weight of 10.6 pounds. The ratio of backpack weight to student weight, expressed as a percentage, ranged from less than 1 percent to 43 percent. Over forty percent of the students walked to and from school carrying their packs. The team found a significant link between that and pain. How the students carried their packs did not seem significant, the team concluded.
Some Tips to Lighten the Load
These are general guidelines for school backpacks, gleaned from a variety of sources:
-- Encourage use of rolling backpacks.
-- Don't just choose a color -- try the backpack on your child. The backpack should end above the waist. Choose one with padded shoulder straps and a belt to distribute the weight evenly.
-- Wear the backpack on both shoulders, not slung over one.
-- Pull the shoulder straps snug, so the weight is on the upper back, not hanging down.
-- Load the heaviest books closest to the back.
-- Lift the backpack from the ground by bending at the knees, not at the waist.
-- Encourage school officials to provide classroom sets of textbooks so students can keep their copies at home.
-- Keep the backpack cleaned out so your child carries only the books needed for the day. Store old assignments at home. Leave home extras such as video games and inline skates.
-- Provide a ride to and from school as much as possible.
-- Try to keep the weight of the loaded backpack less than 15 percent of your child's body weight.
Contact: Kris Lovekin
kris.lovekinucr
951-827-2495
University of California - Riverside
The pain could be a harbinger of longstanding back problems or even permanent injury, said Dr. David Siambanes (pronounced SIGH-am-BAN-ess), chief investigator for the study, published recently in the Journal of Pediatric Orthopedics.
"This is truly alarming," said Siambanes, a physician and partner in the spine center, in Riverside. "Research has shown that adults with severe back problems often had pain as kids. You can suffer all your life from this kind of injury."
The UCR study focused on 3,498 middle school students in Riverside and San Bernardino counties. Also on the research team were UC Riverside sociologists Jason W. Martinez and emeritus Professor Edgar W. Butler and spine center founder Thomas Haider (pronounced HY-der), a UCR donor who also is an assistant clinical professor in the university's biomedical sciences program. Haider concluded that rolling backpacks might be one possible way to deal with the substantial weight of school textbooks, since students don't really have a choice about whether to carry them or not.
Funding for the research came from the Children's Spine Foundation, Siambanes said.
Studying local 11- through 15-year-olds and their backpack habits, the team found that the main predictor of pain was how much a backpack weighed compared with the student carrying it. Long-term effects have not been assessed, Siambanes said, but the team plans to follow up on its research to learn more. Plans for doing a study took shape as the number of young patients at the spine center increased, he said.
"We got calls from families," he said. "Kids were complaining about pain, about their backpacks. Kids complain all the time and nobody pays much attention, but this seemed like too much of the same thing. We decided to get a real study, and not just blow the kids off."
The team weighed the students and their backpacks and asked the students how they used their packs and how much pain they had, if any. Sixty-four percent of the students surveyed by the UCR team reported pain, and 21 percent reported pain that lasted more than six months.
The team found an increase in reports of pain as the weight of backpacks rose compared with their owners' body weights. The increase was so gradual that the team was unable to specify a "safe" relative backpack weight for protecting students. It found that a student whose backpack weighed five percent of what he or she weighed was much less likely to report back pain than a student whose pack weighed 20 percent of what he or she weighed.
One concern researchers cited is that most schools have removed lockers because of vandalism and concerns about safety, so many students carry a whole day's worth of books and supplies at all times.
Four middle schools were included in the study. At two, a majority of students came from lower-income families, based on the percentage of students participating in a free lunch program. Two of the schools made some use of extra sets of textbooks -- one for the classroom and one for students' use at home -- so students did not have to carry all their books home. None of the schools had lockers for book storage.
The researchers calculated the relative weights of the students' packs as a percentage of their body weights. They also assessed the influence of how the students carried their packs -- in the hands, over one shoulder or over both shoulders -- and for how long they carried the packs.
More than 64 percent of the middle school students surveyed reported pain, and more than 41 percent said they felt pain while carrying their packs. Almost all said they were relieved when they could take their packs off. Of those with pain, more than 12 percent called it "not bad," more than 75 percent called it "bad" and more than 12 percent called it "very bad."
The backpacks weighed from half a pound to 37 pounds, with a mean average weight of 10.6 pounds. The ratio of backpack weight to student weight, expressed as a percentage, ranged from less than 1 percent to 43 percent. Over forty percent of the students walked to and from school carrying their packs. The team found a significant link between that and pain. How the students carried their packs did not seem significant, the team concluded.
Some Tips to Lighten the Load
These are general guidelines for school backpacks, gleaned from a variety of sources:
-- Encourage use of rolling backpacks.
-- Don't just choose a color -- try the backpack on your child. The backpack should end above the waist. Choose one with padded shoulder straps and a belt to distribute the weight evenly.
-- Wear the backpack on both shoulders, not slung over one.
-- Pull the shoulder straps snug, so the weight is on the upper back, not hanging down.
-- Load the heaviest books closest to the back.
-- Lift the backpack from the ground by bending at the knees, not at the waist.
-- Encourage school officials to provide classroom sets of textbooks so students can keep their copies at home.
-- Keep the backpack cleaned out so your child carries only the books needed for the day. Store old assignments at home. Leave home extras such as video games and inline skates.
-- Provide a ride to and from school as much as possible.
-- Try to keep the weight of the loaded backpack less than 15 percent of your child's body weight.
Contact: Kris Lovekin
kris.lovekinucr
951-827-2495
University of California - Riverside
воскресенье, 22 мая 2011 г.
Before And After Percutaneous Vertebroplasty, Cone-Beam CT Is Just As Useful As MDCT
Cone-beam CT which is believed to deliver less radiation than MDCT is just as useful when evaluating patients before and after percutaneous vertebroplasty according to a study performed at the Department of Clinical Radiology, Kyushu University, Fukoka, Japan. Percutaneous vertebroplasty is a minimally invasive cement augmentation technique to relieve pain in the back that is non-responsive to conservative treatment.
The study included 22 patients who had osteoporotic compression fractures and underwent percutaneous vertebroplasty for treatment. During the study cone-beam CT and MDCT were performed on all patients before and after percutaneous vertebroplasty. Before vertebroplasty, all 75 cortical defects seen on MDCT were also observed on cone-beam CT with 100% sensitivity and specificity. After vertebroplasty, MDCT found cement leakages in 17 disk spaces, 15 paravertebral soft tissues and 12 veins; cone-beam CT identified all cement leakages.
"While there is no gross difference between MDCT and cone-beam CT, cone-beam CT is believed to deliver less radiation," said Akio Hiwatashi, MD, lead author of the study.
Percutaneous vertebroplasty is common throughout the United States and European countries. It is often used when conservative treatments like pain medication, activity limitation, physical therapy and bracing is not enough.
"Patients can be safely evaluated before and after vertebroplasty using the cone-beam CT system. It is a technical advance in image guided intervention," said Dr. Hiwatashi.
This study appears in the November issue of the American Journal of Roentgenology.
About ARRS
The American Roentgen Ray Society (ARRS) was founded in 1900 and is the oldest radiology society in the United States. Its monthly journal, the American Journal of Roentgenology, began publication in 1906. Radiologists from all over the world attend the ARRS annual meeting to participate in instructional courses, scientific paper presentations and scientific and commercial exhibits related to the field of radiology. The Society is named after the first Nobel Laureate in Physics, Wilhelm Röentgen, who discovered the x-ray in 1895.
Source: Heather Curry
American Roentgen Ray Society
The study included 22 patients who had osteoporotic compression fractures and underwent percutaneous vertebroplasty for treatment. During the study cone-beam CT and MDCT were performed on all patients before and after percutaneous vertebroplasty. Before vertebroplasty, all 75 cortical defects seen on MDCT were also observed on cone-beam CT with 100% sensitivity and specificity. After vertebroplasty, MDCT found cement leakages in 17 disk spaces, 15 paravertebral soft tissues and 12 veins; cone-beam CT identified all cement leakages.
"While there is no gross difference between MDCT and cone-beam CT, cone-beam CT is believed to deliver less radiation," said Akio Hiwatashi, MD, lead author of the study.
Percutaneous vertebroplasty is common throughout the United States and European countries. It is often used when conservative treatments like pain medication, activity limitation, physical therapy and bracing is not enough.
"Patients can be safely evaluated before and after vertebroplasty using the cone-beam CT system. It is a technical advance in image guided intervention," said Dr. Hiwatashi.
This study appears in the November issue of the American Journal of Roentgenology.
About ARRS
The American Roentgen Ray Society (ARRS) was founded in 1900 and is the oldest radiology society in the United States. Its monthly journal, the American Journal of Roentgenology, began publication in 1906. Radiologists from all over the world attend the ARRS annual meeting to participate in instructional courses, scientific paper presentations and scientific and commercial exhibits related to the field of radiology. The Society is named after the first Nobel Laureate in Physics, Wilhelm Röentgen, who discovered the x-ray in 1895.
Source: Heather Curry
American Roentgen Ray Society
суббота, 21 мая 2011 г.
Depression Overtakes Back Pain for Incapacity Benefit Claims, UK
Common mental disorders, such as depression and anxiety, now account for more incapacity benefit claims than
musculoskeletal conditions like low back pain, say researchers in this week's BMJ.
Long term sickness absence is a major public health and economic problem. In 2003, 176 million working days were lost; up 10
million on the previous year. Each year, пїЅ13bn are spent on benefits, and the reduction of long term sick leave is now a top
government priority.
Until recently, the most common causes of long term sickness absence were musculoskeletal disorders, in particular low back
pain, but over the last decade, the contribution of psychiatric disorders has increased markedly. Since 1995, the number of
people reporting stress that was caused or made worse by their work has doubled, and common mental disorders are now the
leading cause of sickness absence.
These disorders are managed almost entirely in primary care, but with limited capacity for psychological therapies, waiting
times are often long. The United Kingdom also has very poor provision of occupational physicians (one specialist for every
43,000 workers) compared with the rest of Europe.
Both employers and patients require a speedier response than is currently delivered, as the longer an individual remains off
work, the more difficult a return becomes.
If the government is serious about tackling the consequences of common mental disorders then innovative policies, including a
major expansion in occupational health and psychological therapy services in primary care, will be required alongside
research into the most effective and cost effective methods of delivering service, say the authors.
This would be a wise investment given the substantial economic and social costs engendered by the current service framework,
they conclude.
(Editorial: Long term sickness absence)
bmj/cgi/content/full/330/7495/802
British Medical
Journal
musculoskeletal conditions like low back pain, say researchers in this week's BMJ.
Long term sickness absence is a major public health and economic problem. In 2003, 176 million working days were lost; up 10
million on the previous year. Each year, пїЅ13bn are spent on benefits, and the reduction of long term sick leave is now a top
government priority.
Until recently, the most common causes of long term sickness absence were musculoskeletal disorders, in particular low back
pain, but over the last decade, the contribution of psychiatric disorders has increased markedly. Since 1995, the number of
people reporting stress that was caused or made worse by their work has doubled, and common mental disorders are now the
leading cause of sickness absence.
These disorders are managed almost entirely in primary care, but with limited capacity for psychological therapies, waiting
times are often long. The United Kingdom also has very poor provision of occupational physicians (one specialist for every
43,000 workers) compared with the rest of Europe.
Both employers and patients require a speedier response than is currently delivered, as the longer an individual remains off
work, the more difficult a return becomes.
If the government is serious about tackling the consequences of common mental disorders then innovative policies, including a
major expansion in occupational health and psychological therapy services in primary care, will be required alongside
research into the most effective and cost effective methods of delivering service, say the authors.
This would be a wise investment given the substantial economic and social costs engendered by the current service framework,
they conclude.
(Editorial: Long term sickness absence)
bmj/cgi/content/full/330/7495/802
British Medical
Journal
пятница, 20 мая 2011 г.
5 Ways You Can Beat Lower Back Pain
Most adults will experience lower back pain sometime during their lifetime. The good news is you can usually prevent or reduce the pain yourself.
Lower back pain is something that almost everyone will experience at some time in their lives. In fact, the National Institutes of Health estimates that eight out of ten people will suffer from back pain, making it one of the most common medical problems today. It affects women and men equally, and can happen at any age, according to The Cleveland Clinic's Arthritis Advisor.
That's the bad news. The good news is that you can treat it, minimize it, and even prevent it by following some back-friendly guidelines.
"The better physical condition you're in, the less likely you'll injure your back," says Santhosh Thomas, D.O., medical director of Cleveland Clinic's Westlake Spine Center. "That's why everybody can benefit from strong abdominal and back muscles."
Many factors can cause lower back pain. Thankfully, most cases are not serious and respond to simple, non-invasive treatments. Trauma and injuries from sprains and strains are common culprits, but pain can also stem from degenerative conditions such as arthritis and osteoporosis. Bone disease, viral infections, irritation to joints, disc herniation, and congenital abnormalities in the spine can also cause an achy back.
Poor body mechanics can cause problems, too. If you've overdone it playing golf or pulling up weeds, the result is likely to be a sore back.
"You can just sleep awkwardly and get a stiff back," says Dr. Thomas.
Age also plays a part. As you get older, bone strength and muscle elasticity decrease while your spinal discs begin to lose fluid and flexibility, which decreases their ability to cushion the spine's vertebrae. Certain health-related conditions and habits such as obesity, stress, poor posture, and smoking can also aggravate your back.
Because it's such a common problem, it might be tempting to treat back pain as a minor matter. But Dr. Thomas says it's important to seek medical care if you experience severe pain particularly pain that wakes you at night pain that radiates from your back into your legs, or pain that doesn't go away in a reasonable amount of time. These symptoms could indicate more serious conditions than just a strained muscle.
Fortunately, most cases of lower back pain can be treated at home. Ice or a cold pack can ease soreness, Dr. Thomas says, although some people find more relief from applying heat or taking a hot shower or bath. Over-the-counter anti-inflammatory medications such as ibuprofen (Advil, Motrin) or acetaminophen (Tylenol), are also helpful.
If you find such remedies don't help, muscle relaxants or prescription-strength pain medicine may be pre-scribed. Your doctor may also refer you to a specialist for physical therapy targeted at easing the pain as well as strengthening your back muscles. Surgery, Dr. Thomas says, is the last resort for most conditions.
Once your pain has subsided enough to allow you to comfortably move about, exercise is recommended. "Anything that keeps your joints moving and maintains flexibility is good for you," says Dr. Thomas. "Walking, biking, and swimming are particularly beneficial if you suffer from back pain."
Meanwhile, consider the exercises shown here to keep back pain at bay. As with any exercise program, check with your doctor before you begin.
Belvoir Media Group, LLC.
7820 Holiday Drive So., Suite 315
Sarasota, FL 34231
United States
belvoir
Lower back pain is something that almost everyone will experience at some time in their lives. In fact, the National Institutes of Health estimates that eight out of ten people will suffer from back pain, making it one of the most common medical problems today. It affects women and men equally, and can happen at any age, according to The Cleveland Clinic's Arthritis Advisor.
That's the bad news. The good news is that you can treat it, minimize it, and even prevent it by following some back-friendly guidelines.
"The better physical condition you're in, the less likely you'll injure your back," says Santhosh Thomas, D.O., medical director of Cleveland Clinic's Westlake Spine Center. "That's why everybody can benefit from strong abdominal and back muscles."
Many factors can cause lower back pain. Thankfully, most cases are not serious and respond to simple, non-invasive treatments. Trauma and injuries from sprains and strains are common culprits, but pain can also stem from degenerative conditions such as arthritis and osteoporosis. Bone disease, viral infections, irritation to joints, disc herniation, and congenital abnormalities in the spine can also cause an achy back.
Poor body mechanics can cause problems, too. If you've overdone it playing golf or pulling up weeds, the result is likely to be a sore back.
"You can just sleep awkwardly and get a stiff back," says Dr. Thomas.
Age also plays a part. As you get older, bone strength and muscle elasticity decrease while your spinal discs begin to lose fluid and flexibility, which decreases their ability to cushion the spine's vertebrae. Certain health-related conditions and habits such as obesity, stress, poor posture, and smoking can also aggravate your back.
Because it's such a common problem, it might be tempting to treat back pain as a minor matter. But Dr. Thomas says it's important to seek medical care if you experience severe pain particularly pain that wakes you at night pain that radiates from your back into your legs, or pain that doesn't go away in a reasonable amount of time. These symptoms could indicate more serious conditions than just a strained muscle.
Fortunately, most cases of lower back pain can be treated at home. Ice or a cold pack can ease soreness, Dr. Thomas says, although some people find more relief from applying heat or taking a hot shower or bath. Over-the-counter anti-inflammatory medications such as ibuprofen (Advil, Motrin) or acetaminophen (Tylenol), are also helpful.
If you find such remedies don't help, muscle relaxants or prescription-strength pain medicine may be pre-scribed. Your doctor may also refer you to a specialist for physical therapy targeted at easing the pain as well as strengthening your back muscles. Surgery, Dr. Thomas says, is the last resort for most conditions.
Once your pain has subsided enough to allow you to comfortably move about, exercise is recommended. "Anything that keeps your joints moving and maintains flexibility is good for you," says Dr. Thomas. "Walking, biking, and swimming are particularly beneficial if you suffer from back pain."
Meanwhile, consider the exercises shown here to keep back pain at bay. As with any exercise program, check with your doctor before you begin.
Belvoir Media Group, LLC.
7820 Holiday Drive So., Suite 315
Sarasota, FL 34231
United States
belvoir
четверг, 19 мая 2011 г.
Overweight Children May Develop Back Pain And Spinal Abnormalities
Being overweight as a child could lead to early degeneration in the spine, according to a study presented today at the annual meeting of the Radiological Society of North America (RSNA).
"This is the first study to show an association between increased body mass index (BMI) and disc abnormalities in children," said the study's lead author, Judah G. Burns, M.D., fellow in diagnostic neuroradiology at The Children's Hospital at Montefiore in New York City.
In this retrospective study, Dr. Burns and colleagues reviewed MR images of the spines of 188 adolescents between the ages of 12 and 20 who complained of back pain and were imaged at the hospital over a four-year period. Trauma and other conditions that would predispose children to back pain were eliminated from the study.
The images revealed that 98 (52.1 percent) of the patients had some abnormality in the lower, or lumbar, spine. Most of those abnormalities occurred within the discs, which are sponge-like cushions in between the bones of the spine. Disc disease occurs when a bulging or ruptured disc presses on nerves, causing pain or weakness.
"In children, back pain is usually attributed to muscle spasm or sprain," Dr. Burns said. "It is assumed that disc disease does not occur in children, but my experience says otherwise."
According to the Centers for Disease Control and Prevention, 15 percent of U.S. children (age 6 - 11) and 18 percent of U.S. adolescents (age 12 -19) are overweight. BMI, a mathematical ratio of body weight and height, is a widely used measurement for obesity. Lower BMI is associated with being underweight or a healthy body size; higher BMI scores are associated with being overweight or obese. Children above the 85th percentile are generally classified as overweight or at risk of being overweight.
The researchers were able to determine an age-adjusted BMI for 106 of the total 188 patients. Fifty-four had BMI greater than the 75th percentile for age. Thirty-seven (68.5 percent) of these children showed abnormal findings on their spine MRI. Fifty-two patients fell into the lowest three quartiles. Only 18 (34.6 percent) of the children at or below a healthy weight had an abnormal MRI of the spine.
"We observed a trend toward increased spine abnormality with higher BMI," Dr. Burns said. "These results demonstrate a strong relationship between increased BMI in the pediatric population and the incidence of lumbar disc disease."
According to Dr. Burns, data revealed in the study could signal a significant public health problem given the health costs of back pain in the U.S.
"Back pain causes significant morbidity in adults, affecting quality of life and the ability to be productive," he said.
Co-authors are Amichai J. Erdfarb, M.D., Jordana Schneider, David Ginsburg, B.A., Benjamin Taragin, M.D., and Michael L. Lipton, M.D., Ph.D.
Source
Radiological Society of North America
"This is the first study to show an association between increased body mass index (BMI) and disc abnormalities in children," said the study's lead author, Judah G. Burns, M.D., fellow in diagnostic neuroradiology at The Children's Hospital at Montefiore in New York City.
In this retrospective study, Dr. Burns and colleagues reviewed MR images of the spines of 188 adolescents between the ages of 12 and 20 who complained of back pain and were imaged at the hospital over a four-year period. Trauma and other conditions that would predispose children to back pain were eliminated from the study.
The images revealed that 98 (52.1 percent) of the patients had some abnormality in the lower, or lumbar, spine. Most of those abnormalities occurred within the discs, which are sponge-like cushions in between the bones of the spine. Disc disease occurs when a bulging or ruptured disc presses on nerves, causing pain or weakness.
"In children, back pain is usually attributed to muscle spasm or sprain," Dr. Burns said. "It is assumed that disc disease does not occur in children, but my experience says otherwise."
According to the Centers for Disease Control and Prevention, 15 percent of U.S. children (age 6 - 11) and 18 percent of U.S. adolescents (age 12 -19) are overweight. BMI, a mathematical ratio of body weight and height, is a widely used measurement for obesity. Lower BMI is associated with being underweight or a healthy body size; higher BMI scores are associated with being overweight or obese. Children above the 85th percentile are generally classified as overweight or at risk of being overweight.
The researchers were able to determine an age-adjusted BMI for 106 of the total 188 patients. Fifty-four had BMI greater than the 75th percentile for age. Thirty-seven (68.5 percent) of these children showed abnormal findings on their spine MRI. Fifty-two patients fell into the lowest three quartiles. Only 18 (34.6 percent) of the children at or below a healthy weight had an abnormal MRI of the spine.
"We observed a trend toward increased spine abnormality with higher BMI," Dr. Burns said. "These results demonstrate a strong relationship between increased BMI in the pediatric population and the incidence of lumbar disc disease."
According to Dr. Burns, data revealed in the study could signal a significant public health problem given the health costs of back pain in the U.S.
"Back pain causes significant morbidity in adults, affecting quality of life and the ability to be productive," he said.
Co-authors are Amichai J. Erdfarb, M.D., Jordana Schneider, David Ginsburg, B.A., Benjamin Taragin, M.D., and Michael L. Lipton, M.D., Ph.D.
Source
Radiological Society of North America
среда, 18 мая 2011 г.
Hope For Back Pain Sufferers Offered By Award Winning Research
A University of Manchester engineering student has scooped a top industry prize for research that could bring relief to thousands of back pain sufferers.
Rachael Ambury scooped The Morgan Crucible prize for the Best Materials Student in the annual Science, Engineering and Technology (SET) Student of the Year Awards.
Her final year project, which focused on tissue engineering and examined how special braces or 'scaffolds' could be used to treat slipped discs and other back problems, received glowing praise from the panel of judges.
The spark of inspiration for Rachael's work came from a PhD student, who was working on a project on back pain. The condition is reported to affect two out of three adults at some time in their lives and it is estimated UK industry loses billions of pounds as a result.
Employing an engineering process known as electro spinning, Rachael produced a series of 'bioresorbable' polymer scaffolds, which can be surgically implanted to hold tissue together, helping cells repair and re-grow.
Using these bioresorbable scaffolds, which dissolve naturally over time, reduces the cost of treatment and allows the patient to recover quicker.
As part of her work, 22-year-old Rachael looked into the physical and biological impact of using different types of scaffold.
She was nominated for the prestigious Morgan Crucible award by her tutors in June 2006. After making the three-strong shortlist, Rachael was invited down to London at the end of September, to discuss her project with the judges.
Rachael collected her prize at a swish black-tie ceremony at the Royal Courts of Justice.
Although her research has not yet reached the clinical stage, she hopes that other University of Manchester students will pick up the gauntlet and take her award-winning work further.
"It's fantastic to have my final year project recognised at a national level and to be supported by the University," said Rachael. "I would like to thank the World Leadership Forum and Morgan Crucible for supporting engineering and science with this award."
Professor Bob Young, head of The University of Manchester's School of Materials said: "We are delighted that Rachael has won the prize. She has been an enthusiastic and hard-working student throughout her course and deserves the success.
"This is the third time in the last five years that one of our graduates has won the SET award in the face of strong competition from students at Oxford, Cambridge and Imperial College in London.
"We are also very pleased that Rachael has decided to stay on with us to continue her studies and undertake a PhD in the important area of biomedical materials science."
In awarding Rachael the accolade, judges from the Institute of Materials, Minerals and Mining commented: "Rachael presented a project containing high quality technical which is highly relevant and valuable to current medical practices.
"Rachael showed a maturity of approach in both her scientific work and her dealing with colleagues.
"We feel Rachael will make a great ambassador for materials science and will influence all whom she meets."
While at the University of Manchester, Rachael has been awarded Institute of Materials Course Prize, the Court Medal from the Senate, the School of Materials course prize and the Morgan Ceramics Prize for the best final year project in the School of Materials. She has also been nominated for the Institute of Materials RH Craven Award.s:
The SET Awards (Science, Engineering & Technology Student of the Year) are Britain's most important awards for science and technology undergraduates. Supported by British Industry, and Britain's leading scientific and technical institutions, the SET awards are multidisciplinary to reflect the wide range of degrees our universities have to offer. The SET awards provide a showcase for educational excellence by publicly recognising the exceptional achievements of both students and universities. They are presented at a spectacular ceremony bringing together hundreds of technology students and academics, as well as senior figures from industry, government, science and the media. The awards are organised by the World Leadership Forum. For more information, see setawards/.
Rachael's project, entitled 'Novel bioresorbable electrospun synthetic polymer scaffolds for tissue-engineered intervertebral disc repairs' was part of her MEng in Biomedical Materials Science with Industrial Experience. She is now studying for a PhD within the biomaterials group at The University of Manchester.
The School of Materials is part of the University of Manchester's Faculty of Engineering and Physical Sciences.
Contact: Alex Waddington
University of Manchester
Rachael Ambury scooped The Morgan Crucible prize for the Best Materials Student in the annual Science, Engineering and Technology (SET) Student of the Year Awards.
Her final year project, which focused on tissue engineering and examined how special braces or 'scaffolds' could be used to treat slipped discs and other back problems, received glowing praise from the panel of judges.
The spark of inspiration for Rachael's work came from a PhD student, who was working on a project on back pain. The condition is reported to affect two out of three adults at some time in their lives and it is estimated UK industry loses billions of pounds as a result.
Employing an engineering process known as electro spinning, Rachael produced a series of 'bioresorbable' polymer scaffolds, which can be surgically implanted to hold tissue together, helping cells repair and re-grow.
Using these bioresorbable scaffolds, which dissolve naturally over time, reduces the cost of treatment and allows the patient to recover quicker.
As part of her work, 22-year-old Rachael looked into the physical and biological impact of using different types of scaffold.
She was nominated for the prestigious Morgan Crucible award by her tutors in June 2006. After making the three-strong shortlist, Rachael was invited down to London at the end of September, to discuss her project with the judges.
Rachael collected her prize at a swish black-tie ceremony at the Royal Courts of Justice.
Although her research has not yet reached the clinical stage, she hopes that other University of Manchester students will pick up the gauntlet and take her award-winning work further.
"It's fantastic to have my final year project recognised at a national level and to be supported by the University," said Rachael. "I would like to thank the World Leadership Forum and Morgan Crucible for supporting engineering and science with this award."
Professor Bob Young, head of The University of Manchester's School of Materials said: "We are delighted that Rachael has won the prize. She has been an enthusiastic and hard-working student throughout her course and deserves the success.
"This is the third time in the last five years that one of our graduates has won the SET award in the face of strong competition from students at Oxford, Cambridge and Imperial College in London.
"We are also very pleased that Rachael has decided to stay on with us to continue her studies and undertake a PhD in the important area of biomedical materials science."
In awarding Rachael the accolade, judges from the Institute of Materials, Minerals and Mining commented: "Rachael presented a project containing high quality technical which is highly relevant and valuable to current medical practices.
"Rachael showed a maturity of approach in both her scientific work and her dealing with colleagues.
"We feel Rachael will make a great ambassador for materials science and will influence all whom she meets."
While at the University of Manchester, Rachael has been awarded Institute of Materials Course Prize, the Court Medal from the Senate, the School of Materials course prize and the Morgan Ceramics Prize for the best final year project in the School of Materials. She has also been nominated for the Institute of Materials RH Craven Award.s:
The SET Awards (Science, Engineering & Technology Student of the Year) are Britain's most important awards for science and technology undergraduates. Supported by British Industry, and Britain's leading scientific and technical institutions, the SET awards are multidisciplinary to reflect the wide range of degrees our universities have to offer. The SET awards provide a showcase for educational excellence by publicly recognising the exceptional achievements of both students and universities. They are presented at a spectacular ceremony bringing together hundreds of technology students and academics, as well as senior figures from industry, government, science and the media. The awards are organised by the World Leadership Forum. For more information, see setawards/.
Rachael's project, entitled 'Novel bioresorbable electrospun synthetic polymer scaffolds for tissue-engineered intervertebral disc repairs' was part of her MEng in Biomedical Materials Science with Industrial Experience. She is now studying for a PhD within the biomaterials group at The University of Manchester.
The School of Materials is part of the University of Manchester's Faculty of Engineering and Physical Sciences.
Contact: Alex Waddington
University of Manchester
вторник, 17 мая 2011 г.
Interventional Spine®, Inc. Announces The Completion Of Another Successful Cervical Surgery, With Its PERPOS® Percutaneous Cervical System
Interventional Spine, Inc. announced the completion of another successful surgery with the unique PERPOS Percutaneous Cervical System for the treatment of neck pain.
To the Company's knowledge, the PERPOS Percutaneous Cervical System is the only product that can stabilize the posterior cervical spine with a truly percutaneous procedure. Designed based on the experience gained with the use of its PERPOS lumbar system, in use in the United States since 2005, the company believes that its percutaneous approach to the cervical spine will minimize intra and post-operative patient morbidity, reduce procedure time and provide cost efficiencies to hospitals and surgeons alike.
The PERPOS Percutaneous Cervical System includes a 3.8mm CS Facet Compression Device which is indicated for the treatment of Spondylolisthesis, Spondylolysis, Degenerative Disc Disease (DDD), degeneration of the facets with instability and fracture, Pseudoarthrosis, and also for patients that have failed previous fusion of the cervical spine. Its intended use is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints via bilateral facet fixation, with or without bone graft, at single or multiple levels from C2 to S1. Currently, there are approximately 125,000 cervical spine procedures completed each year in the United States and an equal number performed internationally. The Company estimates that the market for the PERPOS Percutaneous Cervical System is over $450 million annually on a worldwide basis.
The surgery was performed at the Mercy Medical Center in Redding, CA, by Dr. David Bradley Jones, MD. Upon completing the procedure, Dr. Jones commented: "For the true percutaneous approach, it is a huge benefit for the patient in post op recovery less pain and less risk of wound complications. From a hospital standpoint, the percutaneous application in a posterior cervical fusion case allows for a much reduced length of stay therefore higher contribution to margin compared to an open procedure. I was able to successfully accomplish my desired goal of allowing a decompression and fusion in this posterior cervical fusion (PCF) revision case."
Walter A. Cuevas, Chief Executive Officer of Interventional Spine commented: "The PERPOS Percutaneous Cervical System has some key patented attributes which make it unique among other posterior cervical systems in the market." The product was officially launched at the International Society for the Advancement of Spine Surgery meeting in New Orleans on April 27 - 30, 2010.
Interventional Spine, Inc. is a privately held company based in Irvine, California that designs, develops and markets patented implantable devices for the spine that can be deployed via percutaneous techniques. Supported by the Company's unique product introduction systems, Interventional Spine's products provide benefits to patients, surgeons and hospitals.
Source: Interventional Spine, Inc
To the Company's knowledge, the PERPOS Percutaneous Cervical System is the only product that can stabilize the posterior cervical spine with a truly percutaneous procedure. Designed based on the experience gained with the use of its PERPOS lumbar system, in use in the United States since 2005, the company believes that its percutaneous approach to the cervical spine will minimize intra and post-operative patient morbidity, reduce procedure time and provide cost efficiencies to hospitals and surgeons alike.
The PERPOS Percutaneous Cervical System includes a 3.8mm CS Facet Compression Device which is indicated for the treatment of Spondylolisthesis, Spondylolysis, Degenerative Disc Disease (DDD), degeneration of the facets with instability and fracture, Pseudoarthrosis, and also for patients that have failed previous fusion of the cervical spine. Its intended use is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints via bilateral facet fixation, with or without bone graft, at single or multiple levels from C2 to S1. Currently, there are approximately 125,000 cervical spine procedures completed each year in the United States and an equal number performed internationally. The Company estimates that the market for the PERPOS Percutaneous Cervical System is over $450 million annually on a worldwide basis.
The surgery was performed at the Mercy Medical Center in Redding, CA, by Dr. David Bradley Jones, MD. Upon completing the procedure, Dr. Jones commented: "For the true percutaneous approach, it is a huge benefit for the patient in post op recovery less pain and less risk of wound complications. From a hospital standpoint, the percutaneous application in a posterior cervical fusion case allows for a much reduced length of stay therefore higher contribution to margin compared to an open procedure. I was able to successfully accomplish my desired goal of allowing a decompression and fusion in this posterior cervical fusion (PCF) revision case."
Walter A. Cuevas, Chief Executive Officer of Interventional Spine commented: "The PERPOS Percutaneous Cervical System has some key patented attributes which make it unique among other posterior cervical systems in the market." The product was officially launched at the International Society for the Advancement of Spine Surgery meeting in New Orleans on April 27 - 30, 2010.
Interventional Spine, Inc. is a privately held company based in Irvine, California that designs, develops and markets patented implantable devices for the spine that can be deployed via percutaneous techniques. Supported by the Company's unique product introduction systems, Interventional Spine's products provide benefits to patients, surgeons and hospitals.
Source: Interventional Spine, Inc
понедельник, 16 мая 2011 г.
Clinical Data Utilizing The DRX9000™ Will Be Presented At The 2008 PainWeek Conference In Las Vegas
Clinical data utilizing the DRX9000 True Non-Surgical Spinal Decompression System™ will be presented at the PainWeek Conference in Las Vegas, September 4-6, 2008. The first, is an IRB-approved, prospective multi-center phase II, non-randomized pilot study authored by Dr. John Leslie of the Mayo Clinic and others. This study was designed to evaluate the effectiveness and safety of the DRX9000 in treating chronic lower back pain. A greater than 50% reduction in pain score was observed after two weeks of treatment, and upon completion of the entire six week protocol an amazing success rate of 88.9% was documented. Improvement of Oswestry scores and a decreased consumption of adjunctive pain medication was also noted. The second, is retrospective data which included lumbar spine CT scans before and after patients were treated on the DRX9000 that demonstrates possible morphological changes associated with treatment. Dr. Christian Apfel, MD, Associate Professor of Anesthesiology and Perioperative Care at the University of California at San Francisco, will present this data at the PainWeek Conference. Dr. Apfel, lead author and his colleagues conclude, "A significant reduction in chronic LBP [lower back pain] after non-invasive spinal decompression correlated with an increase in disc height." Abstracts of both studies will be available during the 2008 PainWeek Conference.
Non-treatment or control groups were not included making efficacy outcome versus placebo or spontaneous recovery difficult to determine. Randomized double-blinded or comparative long-term outcome trials are needed to further prove the efficacy of non-surgical spinal decompression systems such as the DRX9000™ for the routine treatment of chronic LBP. This study was partially funded by Axiom Worldwide.
A randomized controlled trial is needed to prove that restoration in disc height is the mechanism through which non-surgical spinal decompression systems such as the DRX9000™ leads to these impressive reductions in pain.
Axiom Worldwide manufactures and distributes its flagship products, the DRX9000 True Non-Surgical Spinal Decompression System™, DRX9000C™, and DRX9500™ in medical markets around the globe. Axiom also manufactures a digital electroceutical device, the EPS8000™, for use in relieving pain and for use in muscular rehabilitation. Axiom prides itself on providing safe, non-surgical alternatives that patients should consider prior to undergoing surgery.
Axiom Worldwide
Non-treatment or control groups were not included making efficacy outcome versus placebo or spontaneous recovery difficult to determine. Randomized double-blinded or comparative long-term outcome trials are needed to further prove the efficacy of non-surgical spinal decompression systems such as the DRX9000™ for the routine treatment of chronic LBP. This study was partially funded by Axiom Worldwide.
A randomized controlled trial is needed to prove that restoration in disc height is the mechanism through which non-surgical spinal decompression systems such as the DRX9000™ leads to these impressive reductions in pain.
Axiom Worldwide manufactures and distributes its flagship products, the DRX9000 True Non-Surgical Spinal Decompression System™, DRX9000C™, and DRX9500™ in medical markets around the globe. Axiom also manufactures a digital electroceutical device, the EPS8000™, for use in relieving pain and for use in muscular rehabilitation. Axiom prides itself on providing safe, non-surgical alternatives that patients should consider prior to undergoing surgery.
Axiom Worldwide
воскресенье, 15 мая 2011 г.
Manipulated Neural Stem Cells To Repair Spinal Cord Injury
One of the most common causes of disability in young adults is spinal cord injury. Currently, there is no proven reparative treatment. Hope that neural stem cells (NSCs) might be of benefit to individuals with severe spinal cord injury has now been provided by the work of a team of researchers, led by Kinichi Nakashima, at Nara Institute of Science and Technology, Japan, in a mouse model of this devastating condition.
In the study, mice with severe spinal cord injury were transplanted with NSCs and administered a drug known as valproic acid, which is used in the treatment of epilepsy. The valproic acid promoted the transplanted NSCs to generate nerve cells, rather than other brain cell types, and the combination therapy resulted in impressive restoration of hind limb function. The authors hope that this approach, whereby the fate of transplanted NSCs is manipulated, for example by administration of valproic acid, could be developed as an effective treatment for severe spinal cord injury.
In an accompanying commentary, Tamir Ben-Hur, at Hadassah Hebrew University Medical School, Israel, highlights the impressive functional recovery attained using this approach but cautions that further work is needed before it can be determined whether this approach will work in human patients.
Title:
Neurons derived from transplanted neural stem cells restore disrupted neuronal circuitry in a mouse model of spinal cord injury
Source:
Karen Honey
Journal of Clinical Investigation
In the study, mice with severe spinal cord injury were transplanted with NSCs and administered a drug known as valproic acid, which is used in the treatment of epilepsy. The valproic acid promoted the transplanted NSCs to generate nerve cells, rather than other brain cell types, and the combination therapy resulted in impressive restoration of hind limb function. The authors hope that this approach, whereby the fate of transplanted NSCs is manipulated, for example by administration of valproic acid, could be developed as an effective treatment for severe spinal cord injury.
In an accompanying commentary, Tamir Ben-Hur, at Hadassah Hebrew University Medical School, Israel, highlights the impressive functional recovery attained using this approach but cautions that further work is needed before it can be determined whether this approach will work in human patients.
Title:
Neurons derived from transplanted neural stem cells restore disrupted neuronal circuitry in a mouse model of spinal cord injury
Source:
Karen Honey
Journal of Clinical Investigation
суббота, 14 мая 2011 г.
CPPC Calls For A National Framework In England To Help Millions Suffering From Long Term Chronic Pain
The Chronic Pain Policy Coalition (CPPC), established to promote better treatment for the 7.8 million
who suffer from long-term chronic pain such as severe back pain or depression, is calling for a national
chronic pain treatment framework for England in the light of the Darzi review into the future of the
NHS.
Despite Lord Darzi outlining the use of personal budgets for 5,000 patients suffering from complex longterm
conditions and personal care plans for all 15 million patients with a long-term condition, the CPPC
believes a national strategy specifically targeted at chronic pain patients in England would be a vital
step towards improving patient care. Wales has already outlined a national strategy for the management
of chronic pain and Scotland published the 'Getting to GRIPS' report into the issue as far back as 2003.
Chronic pain, defined as pain that persists beyond the normal healing process, affects more people than
coronary heart disease and diabetes combined yet there is still no proposed national framework for
England to help primary care trusts or strategic health authorities to systematically promote more
effective treatment.
All too often specific signs that acute pain can lead to long-term chronic pain are missed, leading to a
lifetime of physically and mentally debilitating symptoms. Early intervention, diagnosis and treatment
for patients regardless of where they live, would massively improve patients quality of life and enable
many to get back to work and to get on with their lives.
Not only is the lack of a strategic treatment framework in England bad news for patients who are forced
to learn to live with discomfort on a daily basis, but it's also bad for businesses and the economy with
50% of all people living with chronic pain going on to lose their jobs as a result. It has been estimated
that the cost of back pain alone to the UK economy was ВЈ 12.3 billion in 2000 with 119 million working
days lost as a result.
The CPPC believes a national framework in England could also help challenge popular misconceptions
over chronic pain that are hampering effective treatment. It would allow for resources to be better
targeted on educating patients as to when, where and how to access treatments and to help better
inform doctors to ensure they can give patients appropriate information and treatments wherever they
happen to live in the UK.
Popular misconceptions include
- 'Chronic pain only affects the elderly and is just a natural part of the ageing process'
Of those living with chronic pain in the UK, about 75 % are of working age between18-65.
- 'There is nothing doctors can do to treat my pain.'
Thankfully there is! From self management courses that help people manage their own
pain to supporting lifestyle changes to the use of analgesic drugs doctors, have a
combination of approaches at their disposal to choose from which they can adapt to the
individual patients needs.
Responding in the wake of the Darzi report, Dr Beverly Collett, Chair of the CPPC said:
'Lord Darzis's proposals on the future of the NHS could pave the way for significant change in
healthcare in this country but the CPPC strongly urges Government to adopt a national chronic
pain framework for England to help the many millions of people who are suffering from this
silent epidemic. England should not be allowed to fall further behind Wales or Scotland who
already recognise that we need to try and ensure that those who need treatment can access it
regardless of where they happen to live.
At the moment, taxpayers as well as patients may be losing out because we have a system that
would rather compensate people for not working when we need to look at ways we can improve
patients wellbeing, helping them manage their pain better and getting them back to work -
which is what many patients are desperate to be able to do.'
Melanie Jones, Manager of the CPPC said:
'In half of all cases, the patient experiences chronic pain for more than a decade; a fifth suffer
for more than twenty years. Because most patients believe there is little that doctors can do
for them, and because most doctors don't know how they can help patients to better manage
and deal with their pain, most end up suffering in dignified silence for years.
At the moment, treatment services are variable and relatively under resourced and can depend
on where you live in the country. A national framework would allow for patients across England
to expect minimum standards for the treatment of chronic pain when they visit their GP. I hope
the Government, in the light of the Darzi report, recognise the importance of offering all those
with chronic pain the chance to regain control over their condition.'
Visit paincoalition.uk for further information.
The CPPC has recently launched a Five Point Pain Manifesto that calls for:
1. Education - so that pain is an integral part of all professional medial training. Undergraduate
doctors currently only receive about 4 hours training on pain.
2. Empowerment - to support patients to make decisions about their own condition
3. Collaboration - so that all stakeholders share in a joined-up patient strategy
4. Early Access - to prevent acute pain becoming debilitating chronic pain
5. Measurement - of pain as the 5th Vital Sign
A range of case studies of chronic pain sufferers is available to interested media. If you wish to receive
details, or to be made aware of forthcoming releases by the CPPC, please e-mail
daniel.goldingpolicyconnect.uk.
About the Chronic Pain policy Coalition
The CPPC was established in 2006 to improve the lives of people who live with chronic pain by
developing and sharing ideas for more effective prevention, treatment and management of chronic pain
throughout the UK.
The CPPC brings together patients alongside healthcare professionals and parliamentarians who are
committed to advancing the management and treatment of chronic pain by identifying examples of best
practice, promoting joined-up thinking across Government departments and seeking patient-centered
services that allow patients to manage their own condition.
The CPPC's President is Baroness Rennie Frichtie of Gloucester and the Chair is Dr Beverley Collett, a
Consultant in Pain Management at University Hospitals of Leicester.
Chronic Pain policy Coalition
who suffer from long-term chronic pain such as severe back pain or depression, is calling for a national
chronic pain treatment framework for England in the light of the Darzi review into the future of the
NHS.
Despite Lord Darzi outlining the use of personal budgets for 5,000 patients suffering from complex longterm
conditions and personal care plans for all 15 million patients with a long-term condition, the CPPC
believes a national strategy specifically targeted at chronic pain patients in England would be a vital
step towards improving patient care. Wales has already outlined a national strategy for the management
of chronic pain and Scotland published the 'Getting to GRIPS' report into the issue as far back as 2003.
Chronic pain, defined as pain that persists beyond the normal healing process, affects more people than
coronary heart disease and diabetes combined yet there is still no proposed national framework for
England to help primary care trusts or strategic health authorities to systematically promote more
effective treatment.
All too often specific signs that acute pain can lead to long-term chronic pain are missed, leading to a
lifetime of physically and mentally debilitating symptoms. Early intervention, diagnosis and treatment
for patients regardless of where they live, would massively improve patients quality of life and enable
many to get back to work and to get on with their lives.
Not only is the lack of a strategic treatment framework in England bad news for patients who are forced
to learn to live with discomfort on a daily basis, but it's also bad for businesses and the economy with
50% of all people living with chronic pain going on to lose their jobs as a result. It has been estimated
that the cost of back pain alone to the UK economy was ВЈ 12.3 billion in 2000 with 119 million working
days lost as a result.
The CPPC believes a national framework in England could also help challenge popular misconceptions
over chronic pain that are hampering effective treatment. It would allow for resources to be better
targeted on educating patients as to when, where and how to access treatments and to help better
inform doctors to ensure they can give patients appropriate information and treatments wherever they
happen to live in the UK.
Popular misconceptions include
- 'Chronic pain only affects the elderly and is just a natural part of the ageing process'
Of those living with chronic pain in the UK, about 75 % are of working age between18-65.
- 'There is nothing doctors can do to treat my pain.'
Thankfully there is! From self management courses that help people manage their own
pain to supporting lifestyle changes to the use of analgesic drugs doctors, have a
combination of approaches at their disposal to choose from which they can adapt to the
individual patients needs.
Responding in the wake of the Darzi report, Dr Beverly Collett, Chair of the CPPC said:
'Lord Darzis's proposals on the future of the NHS could pave the way for significant change in
healthcare in this country but the CPPC strongly urges Government to adopt a national chronic
pain framework for England to help the many millions of people who are suffering from this
silent epidemic. England should not be allowed to fall further behind Wales or Scotland who
already recognise that we need to try and ensure that those who need treatment can access it
regardless of where they happen to live.
At the moment, taxpayers as well as patients may be losing out because we have a system that
would rather compensate people for not working when we need to look at ways we can improve
patients wellbeing, helping them manage their pain better and getting them back to work -
which is what many patients are desperate to be able to do.'
Melanie Jones, Manager of the CPPC said:
'In half of all cases, the patient experiences chronic pain for more than a decade; a fifth suffer
for more than twenty years. Because most patients believe there is little that doctors can do
for them, and because most doctors don't know how they can help patients to better manage
and deal with their pain, most end up suffering in dignified silence for years.
At the moment, treatment services are variable and relatively under resourced and can depend
on where you live in the country. A national framework would allow for patients across England
to expect minimum standards for the treatment of chronic pain when they visit their GP. I hope
the Government, in the light of the Darzi report, recognise the importance of offering all those
with chronic pain the chance to regain control over their condition.'
Visit paincoalition.uk for further information.
The CPPC has recently launched a Five Point Pain Manifesto that calls for:
1. Education - so that pain is an integral part of all professional medial training. Undergraduate
doctors currently only receive about 4 hours training on pain.
2. Empowerment - to support patients to make decisions about their own condition
3. Collaboration - so that all stakeholders share in a joined-up patient strategy
4. Early Access - to prevent acute pain becoming debilitating chronic pain
5. Measurement - of pain as the 5th Vital Sign
A range of case studies of chronic pain sufferers is available to interested media. If you wish to receive
details, or to be made aware of forthcoming releases by the CPPC, please e-mail
daniel.goldingpolicyconnect.uk.
About the Chronic Pain policy Coalition
The CPPC was established in 2006 to improve the lives of people who live with chronic pain by
developing and sharing ideas for more effective prevention, treatment and management of chronic pain
throughout the UK.
The CPPC brings together patients alongside healthcare professionals and parliamentarians who are
committed to advancing the management and treatment of chronic pain by identifying examples of best
practice, promoting joined-up thinking across Government departments and seeking patient-centered
services that allow patients to manage their own condition.
The CPPC's President is Baroness Rennie Frichtie of Gloucester and the Chair is Dr Beverley Collett, a
Consultant in Pain Management at University Hospitals of Leicester.
Chronic Pain policy Coalition
пятница, 13 мая 2011 г.
African-Americans Need Equal Treatment For Pain, SLU Study Finds
They're not getting it, and it's costing us all money in the long term -
As if doing the right thing isn't enough, Saint Louis University researchers have found another reason African-Americans and
the poor should receive equal medical treatment and compensation for occupational back pain.
It's actually cheaper in the long run, concludes study author John T. Chibnall, Ph.D., associate professor of psychiatry at
Saint Louis University School of Medicine.
Research by Chibnall and Raymond C. Tait, Ph.D., professor of psychiatry at Saint Louis University School of Medicine, in
Pain Medicine finds that the cheaper treatment and smaller settlements typically given to African-Americans and the poor lead
to greater dissatisfaction with the Workers' Compensation system, which in turn creates more long-term disability and costs.
The study is a companion to recent work by the authors, which found that African-Americans and poor people with work-related
back injuries receive less medical care and smaller compensation packages than Caucasians.
"We looked at the relationship between their satisfaction with the process and their self-reported disability nearly two
years after their claims were settled," Chibnall says.
"African-Americans got less treatment and compensation for their pain, all other things being equal. This made them more
dissatisfied, and more likely to report higher rates of disability later. That also held for poor people."
The study examined 1,475 Missouri Workers' Compensation back pain cases, which were settled between Jan. 1, 2001, and June 1,
2002. Researchers used Workers' Compensation archives and patient interviews as sources of data.
"As an insurance system that provides uniform coverage for workers injured in the course of their employment in the United
States, Workers' Compensation should be equitable with regard to case management of persons with low back injuries,
regardless of race or socioeconomic status. Similarly, outcomes of treatment, all other things being equal, should be roughly
equivalent," Chibnall says.
"The current data suggest that these expectations may not apply for African-American and lower social economic claimants in
Missouri. Not only were these groups less compensated with respect to medical treatment, temporary disability, case
settlement and disability rating, they were also less satisfied with the Workers' Compensation process and reported higher
levels of post-settlement disability."
Higher disability carries a cost, he notes, which is disproportionately borne by African Americans and those who are poor.
In addition to the work by Chibnall and Tait, other recent studies have agreed that dissatisfaction with the Workers'
Compensation process stimulates continued legal activity and prolongs disability, including failure to return to work.
Claimants with unresolved disability may turn to the Social Security Disability Insurance (SSDI) system and never return to
work, Chibnall says. In fact, Chibnall and Tait found that African-Americans were one-and-a-half times more likely than
Caucasians to have applied for SSDI within two years of case settlement.
"Some level of the system will bear the cost," Chibnall says. "If treatment and compensation for work-related back pain
injuries were more equitable, particularly along racial and socioeconomic lines, claimants would be more satisfied with their
experience and better off in the long run. The point of the system is to return people to work and to give them a fresh start
after their injury, not to encourage costly legal wrangling and disability applications."
This month's issue of Pain Medicine is devoted to addressing disparities in pain care for racial and ethnic minorities.
Established in 1836, Saint Louis University School of Medicine has the distinction of awarding the first M.D. degree west of
the Mississippi River. Saint Louis University School of Medicine is a pioneer in geriatric medicine, organ transplantation,
chronic disease prevention, cardiovascular disease, neurosciences and vaccine research, among others. The School of Medicine
trains physicians and biomedical scientists, conducts medical research, and provides health services on a local, national and
international level.
Nancy Solomon - solomonnslu
Saint Louis University
As if doing the right thing isn't enough, Saint Louis University researchers have found another reason African-Americans and
the poor should receive equal medical treatment and compensation for occupational back pain.
It's actually cheaper in the long run, concludes study author John T. Chibnall, Ph.D., associate professor of psychiatry at
Saint Louis University School of Medicine.
Research by Chibnall and Raymond C. Tait, Ph.D., professor of psychiatry at Saint Louis University School of Medicine, in
Pain Medicine finds that the cheaper treatment and smaller settlements typically given to African-Americans and the poor lead
to greater dissatisfaction with the Workers' Compensation system, which in turn creates more long-term disability and costs.
The study is a companion to recent work by the authors, which found that African-Americans and poor people with work-related
back injuries receive less medical care and smaller compensation packages than Caucasians.
"We looked at the relationship between their satisfaction with the process and their self-reported disability nearly two
years after their claims were settled," Chibnall says.
"African-Americans got less treatment and compensation for their pain, all other things being equal. This made them more
dissatisfied, and more likely to report higher rates of disability later. That also held for poor people."
The study examined 1,475 Missouri Workers' Compensation back pain cases, which were settled between Jan. 1, 2001, and June 1,
2002. Researchers used Workers' Compensation archives and patient interviews as sources of data.
"As an insurance system that provides uniform coverage for workers injured in the course of their employment in the United
States, Workers' Compensation should be equitable with regard to case management of persons with low back injuries,
regardless of race or socioeconomic status. Similarly, outcomes of treatment, all other things being equal, should be roughly
equivalent," Chibnall says.
"The current data suggest that these expectations may not apply for African-American and lower social economic claimants in
Missouri. Not only were these groups less compensated with respect to medical treatment, temporary disability, case
settlement and disability rating, they were also less satisfied with the Workers' Compensation process and reported higher
levels of post-settlement disability."
Higher disability carries a cost, he notes, which is disproportionately borne by African Americans and those who are poor.
In addition to the work by Chibnall and Tait, other recent studies have agreed that dissatisfaction with the Workers'
Compensation process stimulates continued legal activity and prolongs disability, including failure to return to work.
Claimants with unresolved disability may turn to the Social Security Disability Insurance (SSDI) system and never return to
work, Chibnall says. In fact, Chibnall and Tait found that African-Americans were one-and-a-half times more likely than
Caucasians to have applied for SSDI within two years of case settlement.
"Some level of the system will bear the cost," Chibnall says. "If treatment and compensation for work-related back pain
injuries were more equitable, particularly along racial and socioeconomic lines, claimants would be more satisfied with their
experience and better off in the long run. The point of the system is to return people to work and to give them a fresh start
after their injury, not to encourage costly legal wrangling and disability applications."
This month's issue of Pain Medicine is devoted to addressing disparities in pain care for racial and ethnic minorities.
Established in 1836, Saint Louis University School of Medicine has the distinction of awarding the first M.D. degree west of
the Mississippi River. Saint Louis University School of Medicine is a pioneer in geriatric medicine, organ transplantation,
chronic disease prevention, cardiovascular disease, neurosciences and vaccine research, among others. The School of Medicine
trains physicians and biomedical scientists, conducts medical research, and provides health services on a local, national and
international level.
Nancy Solomon - solomonnslu
Saint Louis University
среда, 11 мая 2011 г.
Axiom Worldwide To Present Prospective And Retrospective Clinical Data On Non-Surgical Spinal Decompression At Las Vegas Seminar
The clinical results of an IRB-approved prospective, multi-center phase II, non-randomized pilot study utilizing the DRX9000(TM) will be presented by two of its authors at the Parker Seminars Las Vegas February 7 - 9, 2008. The study, authored by Dr. John Leslie of The Mayo Clinic and others, was designed to evaluate the effectiveness and safety of the DRX9000 in the treatment of chronic lower back pain. Patients enrolled in the study had suffered an overall average of ten years of chronic back pain. After two weeks of treatment on the DRX9000 there was an average 50% reduction in pain scores and upon completion of the entire six week protocol an amazing success rate of 88.9% was documented. The investigators also noted an improvement in Oswestry Disability score.
A second study will also be presented in Las Vegas. This study titled, "Treatment of 94 Outpatients With Chronic Discogenic Low Back Pain with the DRX9000: A Retrospective Chart Review," reports that patients with a mean pain duration of 535 weeks reported a mean verbal numerical pain intensity rating equal to 6.05 on a 0 to 10 scale prior to treatment with the DRX9000. This decreased to a statistically and clinically significant mean rating of 0.89 after the last treatment on the DRX9000. Patients also reported a decrease in analgesic use and improvement in activities of daily living. In addition, the authors were able to follow-up at a mean 31 weeks with 29 patients and reveal mean values of 83% improvement in back pain and satisfaction of 8.55 on a 10-point scale. None of these patients reported requiring surgery. The authors also acknowledge that there are other spinal decompression systems available commercially. However, they suggest that the design difference between these devices, "…may lead to differing physical responses to therapy, so studies of one type of apparatus should not readily be applied across all machines." The study will be released in print in the March 2008 issue of Pain Practice. Copies of both poster presentations will be available.
Non-treatment or control groups were not included making efficacy outcome versus placebo or spontaneous recovery difficult to determine. Randomized double-blinded or comparative long-term outcome trials are needed to further prove the efficacy of non-surgical spinal decompression systems such as the DRX9000™ for the routine treatment of chronic LBP.
Axiom Worldwide manufactures and distributes its flagship products, the DRX9000 True Non-surgical Spinal Decompression System™, DRX9000C™, and DRX9500™ in medical markets around the globe. Axiom also manufactures a digital electroceutical device, the EPS8000™, for use in relieving pain and for use in muscular rehabilitation. Axiom prides itself on providing safe, non-surgical alternatives that patients should consider prior to undergoing surgery. For additional information or to receive a copy of the data presented at Parker Seminars Las Vegas please visit: AxiomWorldwide.
Axiom Worldwide
A second study will also be presented in Las Vegas. This study titled, "Treatment of 94 Outpatients With Chronic Discogenic Low Back Pain with the DRX9000: A Retrospective Chart Review," reports that patients with a mean pain duration of 535 weeks reported a mean verbal numerical pain intensity rating equal to 6.05 on a 0 to 10 scale prior to treatment with the DRX9000. This decreased to a statistically and clinically significant mean rating of 0.89 after the last treatment on the DRX9000. Patients also reported a decrease in analgesic use and improvement in activities of daily living. In addition, the authors were able to follow-up at a mean 31 weeks with 29 patients and reveal mean values of 83% improvement in back pain and satisfaction of 8.55 on a 10-point scale. None of these patients reported requiring surgery. The authors also acknowledge that there are other spinal decompression systems available commercially. However, they suggest that the design difference between these devices, "…may lead to differing physical responses to therapy, so studies of one type of apparatus should not readily be applied across all machines." The study will be released in print in the March 2008 issue of Pain Practice. Copies of both poster presentations will be available.
Non-treatment or control groups were not included making efficacy outcome versus placebo or spontaneous recovery difficult to determine. Randomized double-blinded or comparative long-term outcome trials are needed to further prove the efficacy of non-surgical spinal decompression systems such as the DRX9000™ for the routine treatment of chronic LBP.
Axiom Worldwide manufactures and distributes its flagship products, the DRX9000 True Non-surgical Spinal Decompression System™, DRX9000C™, and DRX9500™ in medical markets around the globe. Axiom also manufactures a digital electroceutical device, the EPS8000™, for use in relieving pain and for use in muscular rehabilitation. Axiom prides itself on providing safe, non-surgical alternatives that patients should consider prior to undergoing surgery. For additional information or to receive a copy of the data presented at Parker Seminars Las Vegas please visit: AxiomWorldwide.
Axiom Worldwide
вторник, 10 мая 2011 г.
Only Exercise Prevents Low-Back Problems: Clinical Trials' Review
Low-back pain continues to impose a huge burden on industrialized societies, in terms of symptoms, medical costs, productivity, and work absence. Annual costs related to back pain in the United States alone may run as high as $100 billion per year.
But a systematic review of the literature for high-quality scientific trials published in the February issue of The Spine Journal finds exercise in workplace and community settings effective in preventing new episodes of low-back problems. "Strong and consistent evidence finds many popular prevention methods to fail while exercise has a significant impact, both in terms of preventing symptoms and reducing back pain-related work loss," said Dr. Stanley J. Bigos, University of Washington professor emeritus of orthopaedic surgery and environmental health.
Bigos and his colleagues assessed methodological quality and potential for bias of clinical trials in preventing episodes of back problems. The researchers found 20 controlled trials to be high-quality according to Cochrane Collaboration Back Review Group criteria. Seven of the eight high-quality trials promoting various exercise programs were found effective, but other common and popular methods failed including: reduced lifting programs, back or ergonomic educational interventions, lumbar supports, shoe inserts and stress management.
"Passive interventions such as lumbar belts and shoe inserts do not appear to work," Bigos said. "And eight trials found ergonomic interventions, of either reducing lifting, or back or ergonomic training sessions to be ineffective in preventing back problems."
The new review does not, however, discredit popular ergonomic innovations, said Dr. John Holland, a co-author and UW clinical professor of environmental and occupational health sciences. "Ergonomic interventions may increase productivity, product quality, and work comfort. There are many reasons why such research should continue," said Holland.
The authors suggest that due to the varied and unreliable results of lower quality studies, resources for prevention of back problems should be devoted to interventions already found to be effective in high-quality trials, or to support well-designed research to investigate promising new approaches.
"The new review also supports one additional important conclusion. Ten years ago, some critics suggested we rely upon lower level studies. They maintained that it was not possible to perform high-quality clinical trials on preventive interventions for low-back problems in the workplace. However, our review demonstrates the viability of the growing number of high-quality trials providing more reliable evidence to guide back problem prevention efforts," said Bigos.
Bigos chaired the Acute Low Problems in Adults, the world's first major set of evidence-based clinical guidelines on the management of low-back problems, published by the U.S. Department of Health and Human Services' Agency for Healthcare Policy and Research, now known as the Agency for Healthcare Research and Quality.
Source: Mary Guiden
University of Washington
But a systematic review of the literature for high-quality scientific trials published in the February issue of The Spine Journal finds exercise in workplace and community settings effective in preventing new episodes of low-back problems. "Strong and consistent evidence finds many popular prevention methods to fail while exercise has a significant impact, both in terms of preventing symptoms and reducing back pain-related work loss," said Dr. Stanley J. Bigos, University of Washington professor emeritus of orthopaedic surgery and environmental health.
Bigos and his colleagues assessed methodological quality and potential for bias of clinical trials in preventing episodes of back problems. The researchers found 20 controlled trials to be high-quality according to Cochrane Collaboration Back Review Group criteria. Seven of the eight high-quality trials promoting various exercise programs were found effective, but other common and popular methods failed including: reduced lifting programs, back or ergonomic educational interventions, lumbar supports, shoe inserts and stress management.
"Passive interventions such as lumbar belts and shoe inserts do not appear to work," Bigos said. "And eight trials found ergonomic interventions, of either reducing lifting, or back or ergonomic training sessions to be ineffective in preventing back problems."
The new review does not, however, discredit popular ergonomic innovations, said Dr. John Holland, a co-author and UW clinical professor of environmental and occupational health sciences. "Ergonomic interventions may increase productivity, product quality, and work comfort. There are many reasons why such research should continue," said Holland.
The authors suggest that due to the varied and unreliable results of lower quality studies, resources for prevention of back problems should be devoted to interventions already found to be effective in high-quality trials, or to support well-designed research to investigate promising new approaches.
"The new review also supports one additional important conclusion. Ten years ago, some critics suggested we rely upon lower level studies. They maintained that it was not possible to perform high-quality clinical trials on preventive interventions for low-back problems in the workplace. However, our review demonstrates the viability of the growing number of high-quality trials providing more reliable evidence to guide back problem prevention efforts," said Bigos.
Bigos chaired the Acute Low Problems in Adults, the world's first major set of evidence-based clinical guidelines on the management of low-back problems, published by the U.S. Department of Health and Human Services' Agency for Healthcare Policy and Research, now known as the Agency for Healthcare Research and Quality.
Source: Mary Guiden
University of Washington
понедельник, 9 мая 2011 г.
Higher Survival Rate Shown In Patient Group Receiving Minimally Invasive Surgery For Spinal Fractures Than In Group Treated Non-Surgically
Medtronic, Inc. announced yesterday the results of a retrospective claims-based data analysis suggesting that a patient group of those over 65 in the U.S. whose spinal fractures were treated with minimally invasive surgery had a higher survival rate up to four years after treatment than a patient group that did not have surgery. The evaluation is pending U.S. Food and Drug Administration (FDA) review of the claims.
The data further suggested that of the patient group treated with one of the two minimally invasive surgical procedures available, a sub-group treated with balloon kyphoplasty had higher survival rate up to four years after treatment than a sub-group that was treated with vertebroplasty. During the evaluation period, Kyphon® Balloon
Kyphoplasty was the only balloon kyphoplasty treatment for spinal fractures cleared by the FDA in the U.S.
This first longitudinal, population-based comparison of mortality risk between operated and non-operated patient groups with spinal fractures and between balloon kyphoplasty and vertebroplasty patient sub-groups was published online recently in The Journal of Bone and Mineral Research.i
In the evaluation, researchers looked at data from the U.S. Medicare dataset including a population of 1 million patients that suffered vertebral compression fractures from 2005 through 2008. After inclusion criteria were applied, a population of 858,978 spinal fracture patients was analyzed. The population included 119,253 or 13.9% treated with balloon kyphoplasty, 63,693 or 7.4% treated with vertebroplasty and the remaining treated only with non-surgical care such as pain medication, bed rest, physiotherapy or bracing.
While an estimated 1.4 millionii debilitating and painful spinal fractures are suffered annually worldwide, prior to this evaluation the association between surgical treatment for these painful fractures and survivorship was unknown.
The evaluation was jointly carried out by Exponent, Inc., a scientific and engineering consulting firm and Medtronic, the balloon kyphoplasty market leader with over 900,000 spinal fractures worldwide treated with Kyphon Balloon Kyphoplasty.
Among the findings of the evaluation at up to four years follow-up were:
The patient group whose spinal fractures were treated surgically with either balloon kyphoplasty or vertebroplasty had a statistically significant higher adjusted survival rate of 60.8% compared to 50.0% for the patient group
undergoing conservative or non-surgical care (p
The improved survivor rate of the group treated with minimally invasive surgery was confirmed by an analysis of a sub-group of these patients who were alive one year after their initial diagnosis of a spinal fracture. This group was 18% less likely to die by the end of the study than those in the non-surgical group (p
The data further suggested that of the patient group treated with one of the two minimally invasive surgical procedures available, a sub-group treated with balloon kyphoplasty had higher survival rate up to four years after treatment than a sub-group that was treated with vertebroplasty. During the evaluation period, Kyphon® Balloon
Kyphoplasty was the only balloon kyphoplasty treatment for spinal fractures cleared by the FDA in the U.S.
This first longitudinal, population-based comparison of mortality risk between operated and non-operated patient groups with spinal fractures and between balloon kyphoplasty and vertebroplasty patient sub-groups was published online recently in The Journal of Bone and Mineral Research.i
In the evaluation, researchers looked at data from the U.S. Medicare dataset including a population of 1 million patients that suffered vertebral compression fractures from 2005 through 2008. After inclusion criteria were applied, a population of 858,978 spinal fracture patients was analyzed. The population included 119,253 or 13.9% treated with balloon kyphoplasty, 63,693 or 7.4% treated with vertebroplasty and the remaining treated only with non-surgical care such as pain medication, bed rest, physiotherapy or bracing.
While an estimated 1.4 millionii debilitating and painful spinal fractures are suffered annually worldwide, prior to this evaluation the association between surgical treatment for these painful fractures and survivorship was unknown.
The evaluation was jointly carried out by Exponent, Inc., a scientific and engineering consulting firm and Medtronic, the balloon kyphoplasty market leader with over 900,000 spinal fractures worldwide treated with Kyphon Balloon Kyphoplasty.
Among the findings of the evaluation at up to four years follow-up were:
The patient group whose spinal fractures were treated surgically with either balloon kyphoplasty or vertebroplasty had a statistically significant higher adjusted survival rate of 60.8% compared to 50.0% for the patient group
undergoing conservative or non-surgical care (p
The improved survivor rate of the group treated with minimally invasive surgery was confirmed by an analysis of a sub-group of these patients who were alive one year after their initial diagnosis of a spinal fracture. This group was 18% less likely to die by the end of the study than those in the non-surgical group (p
воскресенье, 8 мая 2011 г.
Mesoblast Limited (ASX:MSB) Proprietary Stem Cells Successfully Repair/Regenerate Damaged Intervertebral Disc Cartilage
Australia's regenerative medicine company, Mesoblast Limited (ASX:MSB)(PINK:MBLTY), today announced highly successful preclinical trial results of its adult stem cells in the treatment of degenerative intervertebral disc disease, the leading cause of low back pain.
A single low-dose injection of Mesoblast's allogeneic or "off-the-shelf' adult stem cells into severely damaged intervertebral discs resulted in dramatic reversal of the degenerative process, regrowth of disc cartilage, and sustained normalization of disc pathology, anatomy and function. The results of a placebo-controlled, randomised trial of Mesoblast's cells for the treatment of degenerative disc disease in 36 sheep is being presented and highlighted at the World Congress on Osteoarthritis, OsteoArthritis Research Society International (OARSI), being held in Montreal, Canada from 10-12 September.
Six months after a single direct intra-discal injection of Mesoblast's cells, discs that were initially severely damaged and degenerated were found to have become indistinguishable from healthy non-degenerated discs in their histopathology, cartilage content, height, and structure. In contrast, severely degenerated discs which served as controls and were either not injected or were injected with hyaluronic acid, continued to demonstrate significantly reduced disc height (p
A single low-dose injection of Mesoblast's allogeneic or "off-the-shelf' adult stem cells into severely damaged intervertebral discs resulted in dramatic reversal of the degenerative process, regrowth of disc cartilage, and sustained normalization of disc pathology, anatomy and function. The results of a placebo-controlled, randomised trial of Mesoblast's cells for the treatment of degenerative disc disease in 36 sheep is being presented and highlighted at the World Congress on Osteoarthritis, OsteoArthritis Research Society International (OARSI), being held in Montreal, Canada from 10-12 September.
Six months after a single direct intra-discal injection of Mesoblast's cells, discs that were initially severely damaged and degenerated were found to have become indistinguishable from healthy non-degenerated discs in their histopathology, cartilage content, height, and structure. In contrast, severely degenerated discs which served as controls and were either not injected or were injected with hyaluronic acid, continued to demonstrate significantly reduced disc height (p
суббота, 7 мая 2011 г.
$1.7 Million Grant To Study Stem Cells In Intervertebral Discs Of The Spine Received By Jefferson
Scientists at Jefferson Medical College have received a five-year, $1.7 million National Institutes of Health grant funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases to study mechanisms regulating stem cell self-renewal and differentiation with the aim of regenerating diseased and painful intervertebral discs. A previous study by the same group showed that stem cells exist in both animal and human intervertebral discs. This grant will enable the researchers to continue studying the disc cells and determine factors which govern their activities in health and disease.
"Disc degeneration and the associated back pain that goes with it costs the U.S. healthcare industry approximately $100 billion annually," said Irving M. Shapiro, Ph.D., associate director of Orthopedic Research and the director of the Cell and Tissue Engineering Graduate Program at Jefferson Medical College of Thomas Jefferson
University. "As a major cause of lost productivity worldwide it is critical that we develop a treatment that will regenerate intervertebral disc structure and function."
A variety of factors contribute to the degeneration of the intervertebral disc including age, genetics and biomechanical factors. Several surgical procedures are available to pacify the pain associated with the degenerative disc, but the most common procedures often only provide symptomatic relief. No current therapy can completely restore the function of a degenerated disc nor prevent its further deterioration. Historically, investigations of the intervertebral disc have been limited in scope, leading to a lack of understanding of the biology and function of both healthy and diseased tissues.
"Researchers have tried repairing the discs by injecting them with agents that are thought to have beneficial effects on cell function," said Makarand Risbud, Ph.D, associate professor of Orthopedic Surgery at Jefferson Medical College of Thomas Jefferson University. "However, these treatments are limited in their effectiveness in restoring disc structure and function. Our ongoing studies suggest that a group of proteins that compromise the notch signaling pathway in the intervertebral discs are central to this process. These proteins regulate a variety of activities of stem cells including proliferation, self-renewal and differentiation. Our goal is to harness the body's own regenerative potential and activate endogenous cells."
Drs. Risbud and Shapiro are collaborating with Drs. Todd Albert and D. Greg Anderson, their clinical colleagues at the Rothman Institute at Jefferson, as well as Dr. Ernestina Schipani, an expert in molecular genetics at Harvard University. The investigators plan to develop a genetically engineered mouse model that lacks selected proteins of the notch signaling pathway in the intervertebral disc. This model will provide important mechanistic insights into the role of the notch signaling pathway in controlling disc cell activities.
"Eventually, we hope to be able to regulate the activities of the disc cells including fostering their inherent regenerative potential," said Risbud. "If we are able to do this it could lead to development of new therapies to treat degenerative disc disease providing relief to millions of back pain suffers."
Source:
Rick Cushman
Thomas Jefferson University
"Disc degeneration and the associated back pain that goes with it costs the U.S. healthcare industry approximately $100 billion annually," said Irving M. Shapiro, Ph.D., associate director of Orthopedic Research and the director of the Cell and Tissue Engineering Graduate Program at Jefferson Medical College of Thomas Jefferson
University. "As a major cause of lost productivity worldwide it is critical that we develop a treatment that will regenerate intervertebral disc structure and function."
A variety of factors contribute to the degeneration of the intervertebral disc including age, genetics and biomechanical factors. Several surgical procedures are available to pacify the pain associated with the degenerative disc, but the most common procedures often only provide symptomatic relief. No current therapy can completely restore the function of a degenerated disc nor prevent its further deterioration. Historically, investigations of the intervertebral disc have been limited in scope, leading to a lack of understanding of the biology and function of both healthy and diseased tissues.
"Researchers have tried repairing the discs by injecting them with agents that are thought to have beneficial effects on cell function," said Makarand Risbud, Ph.D, associate professor of Orthopedic Surgery at Jefferson Medical College of Thomas Jefferson University. "However, these treatments are limited in their effectiveness in restoring disc structure and function. Our ongoing studies suggest that a group of proteins that compromise the notch signaling pathway in the intervertebral discs are central to this process. These proteins regulate a variety of activities of stem cells including proliferation, self-renewal and differentiation. Our goal is to harness the body's own regenerative potential and activate endogenous cells."
Drs. Risbud and Shapiro are collaborating with Drs. Todd Albert and D. Greg Anderson, their clinical colleagues at the Rothman Institute at Jefferson, as well as Dr. Ernestina Schipani, an expert in molecular genetics at Harvard University. The investigators plan to develop a genetically engineered mouse model that lacks selected proteins of the notch signaling pathway in the intervertebral disc. This model will provide important mechanistic insights into the role of the notch signaling pathway in controlling disc cell activities.
"Eventually, we hope to be able to regulate the activities of the disc cells including fostering their inherent regenerative potential," said Risbud. "If we are able to do this it could lead to development of new therapies to treat degenerative disc disease providing relief to millions of back pain suffers."
Source:
Rick Cushman
Thomas Jefferson University
пятница, 6 мая 2011 г.
Lower Back Pain Cause: New Procedure Allows Diagnosis
Functional anesthetic discography (FAD), a new diagnostic procedure involving injecting anesthetic directly into a spinal disc, can be used to confirm the presence of injured discs as the source of a patient's lower back pain symptoms, according to a new study by researchers from Winthrop-University Hospital in Mineola, NY.
For the study, the researchers performed FAD in 19 consecutive patients who underwent lumbar discography for suspected disc-caused lower back pain. A total of 29 discs were injected with anesthetic and then studied afterward using MDCT and patient response. The researchers found that 19 out of the 29 discs showed a favorable response to the injection in the form of pain relief of the patient.
"We hoped that by using FAD in our practice we could isolate patients that would likely benefit from disc surgery. FAD is a functional examination; it relies on the patient's induction of pain during active patient movement, which is far different than the typical discogram. When the patient performs the movement or position that causes pain, we then inject anesthetic into the disc in hopes of relieving the pain. If the pain is or is not alleviated, then this either confirms the discogram results or proves a false negative or positive discogram, respectfully," said Jonathan Luchs, MD, lead author of the study.
The authors do caution that even though FAD seemed to work in some cases, it often actually raised more questions as to diagnosis. "Many of our patients - although a small number at this time - did have pain relief after FAD, and some even had complete pain relief. This pain relief reveals that these anesthetized discs were the source of the problem, so we view that as beneficial information for the surgeon and patient, confirming that disc surgery is in order. However, the surprising information was that not all patients had the same amount of pain relief with the anesthetic during functional motion. This led us to believe that not all of our patients suffered from merely disc disease, but their pain may be from various spinal contributors. Therefore although this is a new helpful exam that does in many cases add to the localization of back pain, it is not the final answer to diagnosing back pain," said Dr. Luchs.
The full results of the study will be presented on Tuesday, May 8, 2007 during the American Roentgen Ray Society Annual Meeting in Orlando, FL.
Contact: Necoya Lightsey
American Roentgen Ray Society
For the study, the researchers performed FAD in 19 consecutive patients who underwent lumbar discography for suspected disc-caused lower back pain. A total of 29 discs were injected with anesthetic and then studied afterward using MDCT and patient response. The researchers found that 19 out of the 29 discs showed a favorable response to the injection in the form of pain relief of the patient.
"We hoped that by using FAD in our practice we could isolate patients that would likely benefit from disc surgery. FAD is a functional examination; it relies on the patient's induction of pain during active patient movement, which is far different than the typical discogram. When the patient performs the movement or position that causes pain, we then inject anesthetic into the disc in hopes of relieving the pain. If the pain is or is not alleviated, then this either confirms the discogram results or proves a false negative or positive discogram, respectfully," said Jonathan Luchs, MD, lead author of the study.
The authors do caution that even though FAD seemed to work in some cases, it often actually raised more questions as to diagnosis. "Many of our patients - although a small number at this time - did have pain relief after FAD, and some even had complete pain relief. This pain relief reveals that these anesthetized discs were the source of the problem, so we view that as beneficial information for the surgeon and patient, confirming that disc surgery is in order. However, the surprising information was that not all patients had the same amount of pain relief with the anesthetic during functional motion. This led us to believe that not all of our patients suffered from merely disc disease, but their pain may be from various spinal contributors. Therefore although this is a new helpful exam that does in many cases add to the localization of back pain, it is not the final answer to diagnosing back pain," said Dr. Luchs.
The full results of the study will be presented on Tuesday, May 8, 2007 during the American Roentgen Ray Society Annual Meeting in Orlando, FL.
Contact: Necoya Lightsey
American Roentgen Ray Society
четверг, 5 мая 2011 г.
Study Shows New Therapy Against Disc Prolapse Is Effective - Orthokine Therapy Alleviates Severe Back Pain For Six Months
When a slipped disc is the source of severe back pain, a trapped or inflamed nerve is usually the cause. In the case of a slipped disc, the disc moves from its original position and presses on the nerve root. As a consequence, certain messenger substances of the immune system, such as Interleukin-1 or TNF-alpha, are released. These substances are responsible for inflammation, pain, and sensory disorders. However, therapy using the biological antagonists, especially Interleukin-1 receptor antagonist (IL-1Ra), can stop pain and inflammation.
"Based on an understanding of this disease mechanism, with the Orthokine therapy we have developed a completely new approach to the treatment of spinal disorders" explained Prof. Peter Wehling, M.D. and CEO of Orthogen AG, on Thursday in DГјsseldorf, Germany. In this procedure, developed by Wehling and the molecular biologist Dr. Julio Reinecke, these proteins are isolated from the blood of the patient. For this, physicians take blood using a special syringe. Within the syringe, the blood cells are stimulated to produce IL-1Ra and other cytokine antagonists and growth factors. After processing in the laboratory, this protein solution can be isolated and prepared as an injection.
In 1991, Wehling obtained his professorship at the Heinrich Heine University in DГјsseldorf with a study on the processes of the nerve root and the origin of pain. In 1997 the Orthokine therapy for treating osteoarthritis was developed. The procedure has been used for the treatment of disc prolapses and other back problems for several years and was the subject of an independent clinical study at the Ruhr University in Bochum.
Scientific study compares the effects of Orthokine and cortisone
84 patients suffering from nerve root disorders of the lumbar spine took part in the randomised, prospective, double-blinded clinical trial. In the trial, authorised by the ethics committee of the University of Bochum, 32 patients were treated with the Orthokine therapy, 27 patients received 5 mg cortisone, and a further 25 participants received 10 mg cortisone. All three drugs were injected into the affected nerve root, with the patients receiving three injections once a week. The participants were medically supervised over a period of six months. Check ups were made 6, 10, and 22 weeks after the first injection.
Orthokine is more effective than cortisone
The most important instrument for measuring the gravity of the disorder was the scientifically recognised visual analogue scale (VAS), on which patients rate the intensity of their pain on a scale of 0 to 100 (0 = no pain, 100 = most intense pain imaginable). At the beginning of the trial, all probands rated their pain as moderate to intense (VAS = 80) and had been suffering pain for at least six weeks. Four weeks after the treatment, all patients demonstrated a statistically significant reduction in symptoms (VAS = 30-34). As the trial progressed the pain level of the Orthokine-treated patients was further reduced (VAS = 15), whereas the pain level of the cortisone-treated patients fluctuated between VAS = 24 and VAS = 34. In total, the reduction of pain was greater with the Orthokine therapy than with the standard treatment.
"This study has confirmed our results and shown for the first time that there is an effective, well tolerated alternative to cortisone treatment", said Wehling. The widespread standard therapy using cortisone is effective, but is however, associated with possible side effects. If cortisone treatment is repeated too often, in some cases it can lead to serious side effects, such as a weakening of the immune system, osteoporosis, oedema, or metabolic disorders. The treatment of patients with agents from their own body can therefore be recommended to every patient who wishes a natural and effective treatment that has few side effects.
Low back pain - a common disorder
Ten per cent of the population suffer from disc prolapses and low back pain. Lower-back problems can have different causes depending on age. In middle age, slipped discs are often the source of suffering. Men between the ages of 35 and 45 are especially susceptible. Older people are often afflicted with degeneration and stenosis of the spine. In addition, poor posture, genetic factors, or psychological problems play a role. The common factor of many back problems is discs or bones pressing on sensitive nerves, thus causing pain, restriction of movement or sensory disorders.Spine
Spine is the leading international specialist journal for spinal disorders. Only original work that has been qualified by peer review is published. spinejournal
Efficacy of Epidural Perineural Injections with Autologous Conditioned Serum for Lumbar Radicular Compression. An Investigator-Initiated, Prospective, Double-Blind, Reference-Controlled Study. Cordelia Becker, MD, et al., SPINE Volume 32, Number 17, pp 1803- 1808
Orthokine is used in Europe, but not yet approved in the United States by the FDA.
orthokine
"Based on an understanding of this disease mechanism, with the Orthokine therapy we have developed a completely new approach to the treatment of spinal disorders" explained Prof. Peter Wehling, M.D. and CEO of Orthogen AG, on Thursday in DГјsseldorf, Germany. In this procedure, developed by Wehling and the molecular biologist Dr. Julio Reinecke, these proteins are isolated from the blood of the patient. For this, physicians take blood using a special syringe. Within the syringe, the blood cells are stimulated to produce IL-1Ra and other cytokine antagonists and growth factors. After processing in the laboratory, this protein solution can be isolated and prepared as an injection.
In 1991, Wehling obtained his professorship at the Heinrich Heine University in DГјsseldorf with a study on the processes of the nerve root and the origin of pain. In 1997 the Orthokine therapy for treating osteoarthritis was developed. The procedure has been used for the treatment of disc prolapses and other back problems for several years and was the subject of an independent clinical study at the Ruhr University in Bochum.
Scientific study compares the effects of Orthokine and cortisone
84 patients suffering from nerve root disorders of the lumbar spine took part in the randomised, prospective, double-blinded clinical trial. In the trial, authorised by the ethics committee of the University of Bochum, 32 patients were treated with the Orthokine therapy, 27 patients received 5 mg cortisone, and a further 25 participants received 10 mg cortisone. All three drugs were injected into the affected nerve root, with the patients receiving three injections once a week. The participants were medically supervised over a period of six months. Check ups were made 6, 10, and 22 weeks after the first injection.
Orthokine is more effective than cortisone
The most important instrument for measuring the gravity of the disorder was the scientifically recognised visual analogue scale (VAS), on which patients rate the intensity of their pain on a scale of 0 to 100 (0 = no pain, 100 = most intense pain imaginable). At the beginning of the trial, all probands rated their pain as moderate to intense (VAS = 80) and had been suffering pain for at least six weeks. Four weeks after the treatment, all patients demonstrated a statistically significant reduction in symptoms (VAS = 30-34). As the trial progressed the pain level of the Orthokine-treated patients was further reduced (VAS = 15), whereas the pain level of the cortisone-treated patients fluctuated between VAS = 24 and VAS = 34. In total, the reduction of pain was greater with the Orthokine therapy than with the standard treatment.
"This study has confirmed our results and shown for the first time that there is an effective, well tolerated alternative to cortisone treatment", said Wehling. The widespread standard therapy using cortisone is effective, but is however, associated with possible side effects. If cortisone treatment is repeated too often, in some cases it can lead to serious side effects, such as a weakening of the immune system, osteoporosis, oedema, or metabolic disorders. The treatment of patients with agents from their own body can therefore be recommended to every patient who wishes a natural and effective treatment that has few side effects.
Low back pain - a common disorder
Ten per cent of the population suffer from disc prolapses and low back pain. Lower-back problems can have different causes depending on age. In middle age, slipped discs are often the source of suffering. Men between the ages of 35 and 45 are especially susceptible. Older people are often afflicted with degeneration and stenosis of the spine. In addition, poor posture, genetic factors, or psychological problems play a role. The common factor of many back problems is discs or bones pressing on sensitive nerves, thus causing pain, restriction of movement or sensory disorders.Spine
Spine is the leading international specialist journal for spinal disorders. Only original work that has been qualified by peer review is published. spinejournal
Efficacy of Epidural Perineural Injections with Autologous Conditioned Serum for Lumbar Radicular Compression. An Investigator-Initiated, Prospective, Double-Blind, Reference-Controlled Study. Cordelia Becker, MD, et al., SPINE Volume 32, Number 17, pp 1803- 1808
Orthokine is used in Europe, but not yet approved in the United States by the FDA.
orthokine
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