Cymbalta(R) Significantly Reduced Chronic Low Back Pain In New Study

In a new study, 60 mg of Cymbalta(R) (duloxetine HCl) taken once daily significantly reduced chronic low back pain, as measured by the Brief Pain Inventory (BPI) average pain rating, compared with placebo.(1) The data were presented at the annual meeting of the American Academy of Pain Medicine (AAPM) in San Antonio, Texas.


A total of 401 patients participated in the 12-week, double-blind, placebo-controlled study, designed to assess the efficacy of duloxetine 60 mg once daily on the reduction of pain severity in patients with chronic low back pain. In the study, duloxetine-treated patients experienced a statistically significantly greater improvement on BPI average pain scale compared with placebo in chronic low back pain (p







Cymbalta is approved in the United States for the treatment of major depressive disorder, the treatment of generalized anxiety disorder, the management of diabetic peripheral neuropathic pain and the management of fibromyalgia, all in adults (18+). Cymbalta is not approved for use in pediatric patients.


Indications and Important Safety Information for Cymbalta


Indications


Cymbalta is approved to treat major depressive disorder and generalized anxiety disorder, and to manage diabetic peripheral neuropathic pain and fibromyalgia.


Important Safety Information


Antidepressants can increase suicidal thoughts and behaviors in children, adolescents, and young adults. Suicide is a known risk of depression and some other psychiatric disorders. Patients should call their doctor right away if they experience new or worsening depression symptoms, unusual changes in behavior, or thoughts of suicide. Be especially observant within the first few months of treatment or after a change in dose. Cymbalta is approved only for adults 18 and over.


Cymbalta is not for everyone. Patients should not take Cymbalta if they have recently taken a type of antidepressant called a monoamine oxidase inhibitor (MAOI), are taking Mellaril(R) (thioridazine), or have uncontrolled glaucoma (increased eye pressure). Patients should speak with their doctor about all their medical conditions including kidney or liver problems, glaucoma, diabetes, seizures, or if they have bipolar disorder. Cymbalta may worsen a type of glaucoma or diabetes. Patients should talk to their doctor if they have itching, right upper belly pain, dark urine, yellow skin or eyes, or unexplained flu-like symptoms, which may be signs of liver problems. Severe liver problems, sometimes fatal, have been reported. They should also talk to their doctor about alcohol consumption. Patients should tell their doctor about all their medicines, including those for migraine, to avoid a potentially life-threatening condition. Symptoms may include high fever, confusion, and stiff muscles. Taking Cymbalta with NSAID pain relievers, aspirin, or blood thinners may increase bleeding risk. Patients should consult with their doctor before stopping Cymbalta or changing the dose. If after starting Cymbalta, patients experience dizziness or fainting upon standing, they should contact their doctor. Cymbalta can increase blood pressure. Healthcare providers should check patients' blood pressure prior to and while taking Cymbalta. Patients should tell their doctor if they experience headache, weakness, confusion, problems concentrating, memory problems, or feel unsteady while taking Cymbalta as this may be signs of low sodium levels. Patients should consult their doctor if they develop problems with urine flow while taking Cymbalta or if they are pregnant or nursing.


The most common side effects of Cymbalta include nausea, dry mouth, sleepiness, and constipation. This is not a complete list of side effects. Cymbalta may cause sleepiness and dizziness. Until patients know how Cymbalta affects them, they should not drive a car or operate hazardous machinery.


About Eli Lilly and Company (NYSE: LLY)


Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs.


This press release contains forward-looking statements about the potential of Cymbalta for the management of chronic low back pain, and reflects Lilly's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. There is no guarantee that the product will continue to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.


References


(1) Skljarevski, et al. "Effect of Duloxetine 60 mg Once-daily Versus Placebo in Patients With Chronic Low Back Pain: A 12-week, Randomized, Double-blind Trial." Presented at 2010 American Academy of Pain Medicine Annual Meeting, Feb. 3, 2010.


(2) Thomas E, et al. BMJ. 1999;318:1662-1667.


(3) International Association for the Study of Pain. "IASP Pain Terminology"


(4) American Pain Society. "Pain Control in the Primary Care Setting." 2006:15.


Source: Eli Lilly and Company



View drug information on Cymbalta.

Patients With Back Pain Recover Without Surgery

If you suffer from a ruptured disk in your lower back your will recover whether you have surgery or not. However, your pain will be eased earlier if you have surgery. US researchers, in two new studies suggest there is no harm in waiting if you don't want to undergo surgery.


You can read about this in the Journal of the American Medical Association (JAMA).


There was some resistance to the trial from surgeons who felt it would be wrong to ask patients in pain to forfeit surgery just to see whether they would recover. However, the trial went ahead and the researchers concluded that both surgery and waiting are effective - neither one is better than the other. In other words, the patient can safely decide whether he/she wants to wait or undergo surgery. In the USA, surgery costs about $6,000.


One study involved 472 patients, with an average age of 42. They were all followed up for two years after being randomly assigned either surgery or non-invasive treatment. The non-invasive treatment included education, physiotherapy (physical therapy) and painkilling drugs. Surgery meant taking out part of the swollen disk (outpatient basis). The researchers found that both groups experienced similar improvements and relief of pain over the two year period. 4% of patients who had surgery needed another operation within 12 months.
(North America - Physical Therapy. UK/Ireland/Australasia - Physiotherapy)


The other study involved 743 patients. In this study the patients chose whether they wanted surgery or not. The researchers found that the surgery patients experienced earlier pain relief. After three months 82% of surgery patients felt better, compared to 48% of non-surgery patients. By the end of two years the difference between the two groups was insignificant.


In neither study did any patient develop Cauda Equina Syndrome - a disabling condition - a fear many doctors and patients have if they do not have surgery. These two studies show compelling evidence that the fear is perhaps unnecessary. In other words, a patient can safely decide whether or not to have surgery.


The researchers believe these two studies will have a major impact on how lower back pain is treated in future. In the USA about 300,000 patients undergo surgery to relieve back pain each year. Patients are often told that if they do not have the operation they risk serious complications - the two studies showed the complications do not happen.


Surgeons' fears of complications if patients did not have an operation were real - before these two studies there was no way of knowing.





From what I can gather after reading the studies, surgery is more likely to get rid of the pain earlier. If you can tolerate the pain and are willing to wait (not have surgery), you most likely will get better without complications.


Surgical vs Nonoperative Treatment for Lumbar Disk Herniation


1. "The Spine Patient Outcomes Research Trial (SPORT): A Randomized Trial"

James N. Weinstein, DO, MSc; Tor D. Tosteson, ScD; Jon D. Lurie, MD, MS; Anna N. A. Tosteson, ScD; Brett Hanscom, MS; Jonathan S. Skinner, PhD; William A. Abdu, MD, MS; Alan S. Hilibrand, MD; Scott D. Boden, MD; Richard A. Deyo, MD, MPH

JAMA. 2006;296:2441-2450.

Click here to see abstract online


2. "The Spine Patient Outcomes Research Trial (SPORT) Observational Cohort"

James N. Weinstein, DO, MSc; Jon D. Lurie, MD, MS; Tor D. Tosteson, ScD; Jonathan S. Skinner, PhD; Brett Hanscom, MS; Anna N. A. Tosteson, ScD; Harry Herkowitz, MD; Jeffrey Fischgrund, MD; Frank P. Cammisa, MD; Todd Albert, MD; Richard A. Deyo, MD, MPH

JAMA. 2006;296:2451-2459.

Click here to see abstract online


Another article that may be of interest:


"Surgical Treatment of Lumbar Disk Disorders"

Eugene Carragee, MD

JAMA. 2006;296:2485-2487

Click here to see editorial


Written by:

Chronic Pain Relieved By Strength Training Of Neck Muscles

Neck pain has been steadily increasing over the past two decades and is now second to back pain, the most common musculoskeletal disorder. Women are more likely than men to suffer from persistent neck pain, in particular those who engage in repetitive tasks such as working at a computer keyboard. Previous studies have shown conflicting results as to whether or not exercise can effectively treat neck pain, but there has not been enough high-quality research in this area to draw firm conclusions. A new study on women with neck pain published in the January issue of Arthritis Care & Research found that specific strength training exercises led to significant prolonged relief of neck muscle pain, while general fitness training resulted in only a small amount of pain reduction.



Led by Gisela SjГёgaard and Lars L. Andersen of the National Research Centre for the Working Environment in Copenhagen, Denmark, researchers conducted a randomized controlled trial for which they recruited 94 women from seven workplaces in Copenhagen between September 2005 and March 2006. The work tasks performed by the women consisted of assembly line work and office work, with 79 percent of the participants using a keyboard for more than three-quarters of their working time. Participants first answered a questionnaire about their pain and then underwent a clinical exam to confirm a diagnosis of trapezius myalgia (muscle pain in the trapezius muscle, which extends along the back of the neck). Participants were assigned to three intervention groups: those who did supervised specific strength training (SST) exercises for the neck and shoulder muscles, those who did high-intensity general fitness training (GFT) on a bicycle ergometer, and a control group that received health counseling but no physical training. Both exercise groups worked out for 20 minutes three times a week for 10 weeks.



The results showed that the GFT group showed a small decrease in neck muscle pain only immediately after exercise, while the SST group showed a marked decrease in pain over a prolonged training period and with a lasting effect after the training ended. "Thus specific strength training locally of the neck and shoulder muscles is the most beneficial treatment in women with chronic neck muscle pain," the authors state.



The study also showed that the reduction in pain occurred gradually in the SST group, with trapezius muscle pain gradually decreasing as muscle strength increased. Although the GFT decreased the pain only temporarily, the authors note that even minor decreases in pain may be enough motivation to overcome barriers to exercise, and the resulting increase in fitness may benefit overall long-term health.



The authors state that the marked reduction in pain in the SST group is of "major clinical importance." They conclude: "Based on the present results, supervised high-intensity dynamic strength training of the painful muscle 3 times a week for 20 minutes should be recommended in the treatment of trapezius myalgia."







Article: "Effect of Two Contrasting Types of Physical Exercise on Chronic Neck Muscle Pain," Lars L. Andersen, Michael Kjær, Karen Søgaard, Lone Hansen, Ann I. Kryger, Gisela Sjøgaard, Arthritis Care & Research , January 2008; 59:1; pp. 84-91.



Source: Amy Molnar


Wiley-Blackwell

MRI Abundance May Lead To Excess In Back Surgeries, Stanford Study Shows

Patients reporting new low-back pain are more likely to undergo surgery if treated in an area with a higher-than-average concentration of magnetic resonance imaging machines, according to research from the Stanford University School of Medicine.



This may be bad news for patients, since previous studies have found that increased surgery rates don't improve patient outcomes. "The worry is that many people will not benefit from the surgery, so heading in this direction is concerning," said senior author Laurence Baker, PhD, professor of health research and policy.



In their new study, to be published online Oct. 14 in Health Affairs, Baker and first author Jacqueline Baras correlate areas with high numbers of MRI machines to an increased likelihood that MRIs will be performed on new low-back pain patients. In turn, high local MRI availability correlates with increased rates of low-back surgery.



"It is important that policymakers recognize that infrastructure matters, and that the number of MRI machines in any particular area may affect the volume and quality of health care that patients receive," said Baras, a Stanford medical student with a master's degree in health services research.



Low-back pain was the fifth-most common reason for physician visits in the United States, with 26.4 percent of adults reporting low-back pain for a day or more during a three-month period in 2002. More than 80 percent of low-back pain was diagnosed as nonspecific, a category that includes lumbar strains and sprains, degenerative disk disease and spinal instability.



MRIs visualize the body's internal structure and allow doctors to rule out some specific causes of back pain. However, MRIs may also detect anomalies unrelated to back pain, prompting doctors to perform surgery that may not benefit the patient, the authors noted.



To determine how MRI technology influences patient treatment, the researchers collected data on traditional Medicare patients who received care for nonspecific low-back pain from 1998 through 2005. Patient data were linked with the number of MRI machines in the area. The areas of MRI availability were then divided into four groups, from high to low, and the incidence of MRI scans and surgeries were determined in each group.



Researchers projected that in 2004 there would have been 5.4 percent fewer low-back MRIs and 9 percent fewer back surgeries if all Medicare patients reporting new-onset low-back pain had been living in the areas of lowest MRI availability.



Two-thirds of the MRI scans that appear to result from increased availability happened within the first month of onset. Clinical guidelines recommend delaying MRI use until four weeks after onset, during which time most low-back pain patients show spontaneous improvement. "Not only are patients in high-availability areas getting more MRIs, but they are getting them earlier," said Baras.



Between 2000 and 2005, the MRI availability in the United States more than tripled, from 7.6 machines per 1 million persons to 26.6 machines. Each machine costs more than $2 million and one low-back scan costs $1,500. Increased rates of scans and surgeries are increasing the cost to treat low-back pain, the authors said.



Doctors and patients face difficult decisions when using high-tech medical equipment, such as MRIs. "The big issue is how we handle new and exciting technologies in ways that allow us to reap the benefits of medical advances, without letting all of our new things generate waste or, worse, actual reductions in patient well-being," said Baker.



John Birkmeyer, MD, professor of surgery and a health policy researcher at the University of Michigan, who was not involved in the Stanford study, said the research confirms fears that greater access to MRI technology leads to more back surgeries. "The net result is increased risks of unnecessary surgery for patients and increased costs for everybody else," Birkmeyer said.



This research was funded by the California Healthcare Foundation and the Stanford Medical Scholars Research Program.



Source:
Michelle Brandt


Stanford University Medical Center

BrainStorm's NurOwn™ Stem Cell Technology Shows Promise For Treating Sciatic Nerve Injury

BrainStorm Cell Therapeutics Inc. (OTCBB: BCLI), a leading developer of adult stem cell technologies and therapeutics, announced that intramuscular transplantation of autologous, astrocyte-like cells that produce and secrete neurotrophic factors (NTFs), representing the company's NuOwn™ technology platform, preserved motor function, significantly inhibited the degeneration of the neuromuscular junctions (NMJs), and preserved the myelinated motor axons in an animal sciatic nerve injury model. Results of the study appear in the online edition of the journal Stem Cell Reviews and Reports.


"The findings from this study demonstrating that BrainStorm's autologous NurOwn™ stem cell therapy can alleviate signs of sciatic nerve injury is an important milestone for the company," said Chaim Lebovits, President of BrainStorm. "One of the major caveats of stem cell transplantation is the fate of the transplanted cells. In the current study, we show that our transplanted cells can integrate and survive in the host muscles of animals after sciatic nerve crush for at least 3 weeks. This preclinical work provides additional support for the upcoming Phase 1 clinical trial of NurOwn™ for patients with amyotrophic lateral sclerosis (ALS) and other neurological disorders."


In a study conducted at Tel Aviv University, mesenchymal stem cells (MSCs) isolated from the femurs and tibias of adult rats were developed into NurOwn™ using a two-step medium based differentiating protocol to induce the MSCs into NTF secreting cells. These cells produce and release high amounts of NTFs, such as glial derived neurotrophic factor (GDNF) and brain derived neurotrophic factor (BDNF). The NTF secreting cells (NurOwn™) were labeled with superparamagnetic iron oxide (SPIO) to enable tracking of surviving cells following injection into the muscles of the right hind limb 24-hours after sciatic nerve crush.


Four days after transplantation, there was a statistically significant beneficial effect on the motor function in the NurOwn™ treated animals compared to the control rats, which did not receive cell transplants, or rats transplanted with non-differentiated MSCs. The high compound muscle action potential and low latency indices recorded in the hind limb muscles of NurOwn™ treated animals provided evidence that NurOwn™ preserved the myelinated motor axons and innervated peripheral muscles. Histology of the animal's hind limb muscles 3-weeks after transplantation revealed significant amount of pre-labeled NurOwn™ cells and high levels of BDNF in the muscles.


About Sciatica


One of the most common peripheral neuropathy is sciatica, damage to the sciatic nerve, with a high reported prevalence. Sciatica is characterized by muscle weakness, reflex changes and numbness. Tumors, cysts or other extraspinal insults can cause sciatica. The majority of sciatica patients suffer from persistent and severe types of pain, motor dysfunctions and prolonged disability.















About Amyotrophic Lateral Sclerosis


Amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's Disease, is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord. According to the ALS Association, approximately 5,600 people in the U.S. are diagnosed with ALS each year and it is estimated that as many as 30,000 Americans may have the disease at any given time. The financial cost to families of patients is exceedingly high, and it is estimated that in the advanced stage, care can cost an average of $200,000 per year, which represents more than a $6 billion cost to the healthcare system.


About NurOwn™


BrainStorm's core technology, NurOwn™, is based on the scientific achievements of Professor Eldad Melamed, former Head of Neurology, Rabin Medical Center, and Tel-Aviv University, and a member of the Scientific Committee of the Michael J. Fox Foundation for Parkinson's Research, and Professor Daniel Offen, Head of the Neuroscience Laboratory, Felsenstein Medical Research Center (FMRC) at the Tel-Aviv University.


The NurOwn™ technology processes adult human mesenchymal stem cells that are present in bone marrow and are capable of self-renewal as well as differentiation into many other cell types. The research team is among the first to have successfully achieved the in vitro differentiation of adult bone marrow cells (animal and human) into astrocyte-like cells capable of releasing neurotrophic factors, including glial-derived neurotrophic factor (GDNF). The ability to induce differentiation into astrocyte-like cells along with intramuscular or intrathecal (or other) delivery makes NurOwn™ technology highly attractive for treating ALS and Parkinson's disease as well as MS and spinal cord injury.


BrainStorm's stem cell therapy contains human mesenchymal stromal cells induced to differentiate into astrocyte-like cells secreting neurotrophic factors by means of a specific differentiation-inducing culture medium.


Source:

BrainStorm Cell Therapeutics, Inc.

Rat Model Provides Insights Into Sciatica

A newly developed animal model for the painful nerve condition known as sciatica should help researchers diagnose and treat it, according to Duke University bioengineers and surgeons.



Sciatica is not a single disorder, but rather a diverse range of symptoms, such as numbness or pain from the lower back to the feet, radiating leg pain or difficulty in controlling the leg. It is often caused by compression, or pinching, of any of the five nerve roots that combine to make up the sciatic nerve. These roots are the parts of the nerve that pass through openings in the spine to the spinal cord.



Surgical simulation of nerve compression in rats was led by Mohammed Shamji, a neurosurgery resident and recent Ph.D. graduate working in the laboratory of senior researcher Lori Setton, professor of biomedical engineering and surgery at Duke's Pratt School of Engineering. Shamji and post-doctoral research fellow Kyle Allen observed that the animals' gait became asymmetric, and that they over-responded to temperature changes and touch in their limbs after the surgery.



They also found, for the first time, that the physical symptoms experienced by the affected animals seemed to be linked to an increase in levels of interleukin-17 (IL-17), a protein involved in regulating the inflammatory response. Elevated levels of IL-17 have already been implicated in such autoimmune diseases as rheumatoid arthritis and asthma.



"This finding suggests a possible role for immune system activation in contributing to symptoms of sciatica," said Shamji, now completing his neurosurgical residency at the Ottawa Hospital in Canada. "This offers new insight into the pathophysiology of the disease, and may also identify novel therapeutic targets to treat it."



The results of Shamji's and Allen's experiments were published online in the journal Spine.



"If immune system activation is involved, and it turns out to be an important part of the condition, it is possible that existing or new drugs that can block this immune response could offer relief to patients," Setton said. "This new model should help us find answers for a disorder that has few good treatments."



For their experiments, the researchers compressed a specific nerve root known as the dorsal root ganglia in the lumbar region of the spine, which simulated sciatica in one of the rear legs. They performed numerous tests on the animals' ability to move as well as their reaction to pain and temperature. Throughout this process, they took blood samples to measure any changes in the levels of specific immune system molecules.



One of the more novel tests, developed by Allen, involved taking high-speed videotapes of the animals - those that received the procedure and those that did not - and analyzing step by step the particulars of the animals' gait. Specifically, they measured how the animals responded to the pressure of walking with an affected leg and how they shifted their weight in response.



"Following surgery, we noticed some novel signs of limping, characterized by changes in gait symmetry and the placement of more weight on the non-affected limb," Allen explained. "While some of our findings confirmed what others have suggested, our results were able to quantify the extent of the gait asymmetry, or limping, which could prove important as we evaluate different treatments."



Further studies are planned to test the effects of different IL-17 blockers on the mechanics of the animals' movement.



The research was support by funds from Zimmer Orthopedics, National Institutes of Health and a Pratt-Gardner Predoctoral Research Fellowship.



Other Duke members of the research team were Stephen So, Liufang Jing, Samuel Adams, Reinhard Schuh, Janet Huebner, Virginia Kraus, Allan Friedman and William Richardson.



Source:
Richard Merritt


Duke University

Do UK GPs Need Educating On The Psychosocial Management Of Back Pain

Researchers from Bournemouth, UK set out to identify whether there were any inconsistencies or deficits in the knowledge and understanding of local general practitioners (GPs) about the management of lower back pain - both physically and psychosocially. The intent was to inform the development of new and improved educational tools and interventions designed to improve confidence and clinical effectiveness in treating this group of patients.


Twenty-one general practitioners from the Somerset area in the UK initially took part in a short semi-structured telephone interview about the management of back pain. The responses from these first phase interviews helped develop the structure of more in-depth focus groups that took place two months later with the same group. Both discussions were transcribed, coded and quantitatively analysed for consistent themes and specific issues.


On review of the information provided by this group, five consistent areas of discussion evolved: the patient-practitioner relationship; feelings of the patient; time; education (of both patients and professionals) and resources. Psychosocial issues were rarely mentioned.


The researchers conclude by recognising how complicated and frustrating lower back pain consultations can be for physicians, but they also emphasise the value of improved GP education regarding the psychosocial aspects of lower back pain and how a better understanding of these complications might substantially improve quality of care.


paineuropenewswire

Live Webcast Of A Minimally Invasive Lumbar Discectomy To Correct Severe Lower Back Pain

Sergio Gonzalez-Arias,
M.D., chief of neurological surgery and medical director of Baptist
Hospital's Neuroscience Center, will perform a minimally invasive
lumbar discectomy on Wednesday, January 28, at 4 p.m. The webcast
will be moderated by Dr. Sean Kenniff, former healthcare reporter for
WFOR-CBS Channel 4. Viewers can also choose to watch the procedure in
Spanish.



A minimally invasive lumbar discectomy is performed to correct a
herniated disc in the lower back. The surgery involves delicate
instrumentation that allows the surgeon to operate through a small
incision, spreading muscles rather than cutting them. Compared to
open surgical procedures, minimally invasive spine surgery has many
advantages, including less blood loss, less pain, smaller incisions
and a faster recovery. Most patients can go home the day of surgery.



Baptist Hospital's Neuroscience Center provides the most
comprehensive and innovative techniques to diagnose and treat the
brain, spine and nervous system. The Center's staff includes
neurosurgeons and other specialists acclaimed for clinical and
educational leadership, as well as specialty-trained nurses and
clinical professionals.



Dr. Gonzalez-Arias has served as chief of the Baptist Hospital's
Department of Surgery and is past president of the medical staff. He
has lectured nationally and internationally on minimally invasive
spine surgery and stereotactic radiosurgery. He is currently involved
in multicenter clinical research in minimally invasive spine surgery.



About Baptist Hospital



Baptist Hospital is part of Baptist Health South Florida, the largest
faith-based, not-for-profit healthcare organization in the region. It
also includes Baptist Children's Hospital, South Miami Hospital,
Doctors Hospital, Homestead Hospital, Mariners Hospital in the Upper
Keys, Baptist Cardiac & Vascular Institute and Baptist Outpatient
Services. Baptist Health Foundation, the organization's fundraising
arm, supports services at all hospitals and facilities affiliated
with Baptist Health.



About OR-Live



OR-Live is the world's leading surgical broadcasting company,
providing communication solutions to hospitals, device manufacturers,
and pharmaceutical companies that demonstrate, communicate, and
educate the latest clinical and technological advances in surgery to
surgeons, physicians, allied health professionals, and consumers. The
OR-Live broadcasting network provides an intimate look at over 600
live and on-demand surgeries to a global audience, streaming over
23,000 hours of programming each month.

OR-Live

Interventional Spine's Compression Technology Has Now Been Used To Treat More Than 6,000 Patients

Interventional Spine Inc. announced that medical devices using its proprietary compression technology have now been implanted in more than 6,000 patients.


In making the announcement, Walter A. Cuevas, Interventional Spine's CEO, emphasized that the patented technology is unique to all of the products in the Company's portfolio.


Interventional Spine is a co-sponsor and exhibitor at Spineweek 2008, currently underway in Geneva, Switzerland. "Here at Spineweek 2008," Mr. Cuevas commented, "spine surgeons from around the world have come together to share their experiences with the newest techniques and products available Worldwide. This exchange of ideas will result in improving the outcomes of their patients seeking relief from chronic, often debilitating, back pain."


"In addition to being an exhibitor at this important conference, Interventional Spine, as a major sponsor, will conduct a panel discussion today on 'The Growing Continuum of Treatment Options,' during which five distinguished surgeons will present case histories and the biomechanical features of Interventional Spine's PercuDyn™ and PERPOS™ PLS Systems."


Mr. Cuevas concluded, "This is a truly exciting time for spine-patients in need of new approaches to old problems, and an exciting time for our Company in that we believe that the approaches we have pioneered at Interventional Spine hold so much promise for improved outcomes today. Our percutaneous product options are revolutionary, affording physicians the means to treat back pain without major surgery, thus reducing complications, the time required to return patients to normal activity, and accordingly, the costs of treatment."


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, providing benefits to patients, surgeons, and hospitals.

Interventional Spine Inc

New Treatment For Back Pain

From the 1 of March the Osteopathy and Manual Medicine Service at the PoliclпїЅnica San JosпїЅ in Vitoria-Gasteiz, administrative capital of the Basque Autonomous Community, will have the very first Vertebral Axial Decompression Table in Spain. Patented by the North American firm, Vax-D, this will be the third Table in Europe (they have just acquired two more in Great Britain).



The new table enables the treatment of problems of the spinal column, in the lumbar region, where there is acute and/or chronic pain caused by disc hernias, degeneration of the discs, posterior facet syndrome, discoarthrosis and sciaticas.



The treatment uses an exclusive system for the decompression of the intervertebral discs and the vertebral articulations, thus enabling the introduction of the herniated disc apart from separating the vertebrae to improve their functioning and to produce a stretching of the contacted muscles.



This system for vertebral decompression is what differentiates this treatment from any other system used for complaints of this kind.



The treatment has been successfully carried out in the USA for more than ten years and the equipment to arrive in Vitoria-Gasteiz in March will be the first in Spain. The technique has an efficacy rate of about 80%, depending on the pathology.



Over the last few years, Dr. J.C. Vicente, Director of the Osteopathy and Manual Medicine Service, has undertaken a thorough-going monitoring of the operation of the Vax-D in the USA, sending patients to be treated there with this method and, thus, confirming its efficacy and positive results. The experience was the motive for bringing the treatment technique to Vitoria-Gasteiz. It will be, in many cases, an alternative to surgery, thus reducing the risks inherent in the operation theatre as well as cutting the recovery time for patients with these complaints.



The treatment is painless and involves daily sessions of 30 minutes over a period of 20 days.







Contact: Irati Kortabitarte

iratikelhuyar

Elhuyar Fundazioa

MRC Study Reinforces Effectiveness Of Spinal Manipulation

The American Chiropractic Association (ACA) is applauding a new study from the Medical Research Council (MRC) that shows
that spinal manipulation - the primary form of care performed by doctors of chiropractic - combined with an exercise program
offers effective treatment for those suffering from back pain. The study, published in the Nov. 19 issue of the British
Medical Journal, found that a collective approach to back pain treatment provided "significant relief of symptoms and
improvements in general health."


Specifically, the study found that the greatest reduction of pain and the greatest improvement in back function was
experienced by patients who received a treatment approach consisting of spinal manipulation and exercise in addition to care
from their general practitioner.


The MRC is based in the United Kingdom where its research is funded by the country's taxpayers. The council promotes medical
and related science research with the aims of improving the health and quality of life of the general public. The MRC is
independent in its choice of which research to support.


"The costs of back pain and other musculoskeletal conditions on the country's economy and workforce productivity are
staggering - conservatively estimated at about $50 billion per year," commented ACA President Donald J. Krippendorf, DC. "The
ACA is pleased that research such as this is being conducted and brought to the attention of the public through journals such
as the British Medical Journal. With reports such as these, we can offer our patients the best care possible."


The MRC trial included more than 1,300 patients from across the United Kingdom, whose back pain had not improved after
receiving care from a general practitioner. Treatment options were:


-- A physical exercise program

-- Spinal manipulation alone

-- A combined package of spinal manipulation followed by a exercise regimen


The results showed that patients in all treatment groups reported improved back function and reduced pain over time, but to
varying degrees. However, the greatest improvement was found in the patients assigned to combined manipulation and exercise.



According to the ACA, the MRC study is one of a number of recent studies regarding chiropractic's effectiveness for back pain
over traditional medical care.


A March 2004 study in the Journal of Manipulative and Physiological Therapeutics found that chiropractic care is more
effective than medical care at treating chronic low-back pain in patients' first year of symptoms. And a study published in
the July 15, 2003, edition of the medical journal Spine found that manual manipulation provides better short-term relief of
chronic spinal pain than does a variety of medications.


Contact: Angela Kargus

akargusamerchiro

703-276-8800

American Chiropractic Association< /a>

Research Into Inflammation, Sensory Neurons And Low Back Pain Receives $1.7 Million

The National Institute of Neurological Disorders and Stroke has awarded $1.7 million to University of Cincinnati (UC) anesthesiology researchers to study a condition that costs Americans $50 billion a year - low back pain.



Back pain is the leading cause of disability in Americans younger than 45 years old and is experienced by 50 to 80 percent of adults at some point in their lives. Back pain becomes chronic if it persists for more than three months and the cause can sometimes be difficult to determine.



The UC researchers are focusing their five-year study on inflammation and how its effects on sensory neurons in the low back cause persistent chronic pain.



The team, led by Jun-Ming Zhang, MD, director of UC's Pain Research Center, believes small molecules called chemokines are key factors in the development of pain. Chemokines are a family of small cytokines - chemical "messenger" molecules used by immune and nerve cells to communicate with other cells.



"If we can determine the role these chemokines play in the development of back pain we can hopefully develop better medications to treat the problem," says Zhang.



Zhang says acute (short-term) pain can actually be beneficial. "Acute pain responses to potentially dangerous stimuli - like the neural circuitry that tells you to pull your hand away from a hot stove - are essential for survival," says Zhang.



But when pain becomes chronic, it "serves no useful purpose," he says, and often affects a person's quality of life.



Back pain can be caused by physical trauma such as a sports injury, lifting heavy items or from a car accident, Zhang explains. For others, medical conditions such as a herniated disc cause pain. But many people experience back pain for no apparent reason.



"When a patient goes to the doctor for low back pain, they may undergo an MRI or an X-ray. Sometimes these tests show anatomical reasons for the pain such as a herniated disc. But for some patients, tests don't show any physical evidence for why they are experiencing low back pain," he says.



Zhang adds that the lack of physical evidence can be very frustrating for patients and make it more difficult for doctors to help a patient effectively manage their pain through medication and other treatment therapies.



"That's why we hope to identify specific molecules that contribute to low back pain development. Our goal is to develop a non-opiod analgesic targeting those molecules to alleviate pain," says Zhang.



In previous research, Zhang and his team, including Judith Strong, PhD, co-investigator for the new study, found that pain-sensing neurons can become abnormally sensitive or "fire" spontaneously in the absence of stimuli. This early spontaneous activity plays a key role in setting up the pathological pain state.



"We found that by blocking the early spontaneous activity of an injured nerve we can completely prevent the development of chronic pain. This technique could be extremely useful for combat nerve injuries and amputations that often lead chronic pain," he says.



In the new study, the team will explore how inflammation may contribute to the development of low back pain by intentionally causing this abnormal neuronal firing.







Source: Jamie Kaun


University of Cincinnati

Minimally Invasive Surgery Corrects Scoliosis And Relieves Retired Teacher's Chronic Pain

Carole Riggs, a retired teacher and school principal, points to her work during one Christmas vacation bending, twisting and sitting on the floor to create games and teaching aids as the primary culprit behind many years of back pain.


Burak M. Ozgur, M.D., the neurosurgeon at Cedars-Sinai Medical Center who performed the minimally invasive procedures that relieved the pain, attributes the problem to adult degenerative scoliosis affecting the disks and structures between five vertebrae (thoracic 12 to lumbar 5) in Riggs' lower back. The operations took place in Oct. 2008, and Riggs, 71, has celebrated a year without back pain for the first time in about three decades.


Riggs and her husband, Charles, recently moved to Los Angeles from Springfield, Va., where they lived when the once-tolerable pain became severe. They were at a conference in San Diego in early 2008 when she discussed the pain with her son, Richard V. Riggs, M.D., medical director and chairman of the Department of Physical Medicine and Rehabilitation at Cedars-Sinai Medical Center. He suggested she consult Ozgur, a specialist in minimally invasive spine surgery in the Department of Neurosurgery, who recommended the minimally invasive, two-stage operation to correct her spine.


"At the time, it was all too new to me to just say, yeah, let's go with it. So I said, 'Let me wait and see.' Well, it didn't get any better. It just got worse," said Riggs, who has a doctorate in education and has taught at all levels up to graduate school.


She sought a second opinion from a local surgeon in Virginia who recommended a more conventional surgical approach that would have required months of painful recuperation. She also received injections of pain medications which did not help and eventually decided that the minimally invasive neurosurgical approach was her best option.


"For adult degenerative scoliosis, in which the spine is twisted and curved, minimally invasive procedures enable us to straighten the spine in a more natural way than traditional surgery allows," Ozgur said. "The traditional approach requires a large incision and the placement of screws that are used as handles to force the spine straight, typically causing significant pain and blood loss.


"In certain patients, like Carole Riggs, spinal correction can be accomplished without using force. If we re-expand the collapsed disks at each level, one by one, the spine will straighten up. It's like pumping up tires on a car. The ligaments will become taut and the spine will correct itself in a more natural way."


In the first operation, Ozgur inserted specially designed tools through small incisions in the side to remove the five damaged disks and insert "cages" that contain bone graft materials and a protein that accelerates the fusion process. This lateral approach allows surgeons to reach the intervertebral disks with less risk to organs, nerves and blood vessels of the abdomen or the major muscle groups in the back.


In the second procedure, two days later, he placed titanium screws and custom-shaped titanium rods along the spine to provide strength and stability. Instead of opening a large area of the back, the minimally invasive approach uses small, muscle-sparing incisions and an imaging guidance system to place the screws into the bones of the spine and slide the rods into position.


"Specialized tools make it possible to insert even long rods and screws without making large incisions, avoiding the muscle injury, blood loss, and months of recuperation associated with traditional spine surgery," Ozgur said.


Riggs was out of bed and walking the second day after surgery, and she, her husband and family members were celebrating the couple's 50th anniversary in Hawaii during the holidays a little more than two months later.


When October arrived this year, she marked the first anniversary of the procedures that brought an end to her ongoing pain. "I told my husband how well I was feeling. It's just unbelievable compared to what I experienced before surgery," said Riggs, who is planning another week in Hawaii during this holiday season.


"It's going to be fun," she said. "I was doing well last year but I certainly feel more like myself now with the surgery a year behind me."


Source: Cedars-Sinai Medical Center

UK Health Services Failing 20 Million+ Joint Pain Sufferers

UK health services are failing to meet the needs of millions of chronic joint pain sufferers. More than 80 per cent of chronic back and knee pain sufferers still suffer from pain following treatments recommended by a healthcare professional, according to new research for Bupa.


Despite the scale of chronic joint pain in the UK (22 million back pain; 13 million knee pain) and its debilitating effect on sufferers, sufferers say their treatment options are limited - and in many cases ineffective[1].


- More than one in three chronic joint pain sufferers say their condition significantly impacts their quality of life (41 per cent back pain; 39 per cent knee pain)

- Around one in three chronic joint pain sufferers is disappointed by their treatment (33 per cent back pain; 29 per cent knee pain)

- Around half of sufferers say their treatment options are limited (55 per cent back pain, 47 per cent knee pain)


The research, carried out among 4,000+ UK adults, reveals that sufferers are seeking to fill the current gap in treatment options between pain relievers and surgery:


- More than 80 per cent of sufferers do not believe pain killers to be a very effective form of treatment (84 per cent back pain; 85 per cent knee pain)

- More than three quarters (82 per cent back, 77 per cent knee) are seeking a non-surgical solution to their chronic joint pain.


Today, Bupa launches a breakthrough new treatment for chronic knee and lower back pain, which aims to help address this growing need. The APOS Treatment (which stands for All Phases of Step Cycle) combines two simple principles for treating lower back and knee pain: realigning the body as it walks and introducing a mild instability, which encourages the retraining of the systems that stabilise the joints.


It is a non-pharmaceutical, non-surgical solution which heals as you walk and fits easily into people's everyday lives. The APOS Treatment:


- can eliminate the need for prescription pain relief for seven out of 10 people[2].


- can reduce the intensity of knee pain by an average of 66 percent after just eight weeks[3]


- can eliminate the need for pain relief for lower back pain sufferers in seven out of 10 cases[4]


- can significantly improve joint function and enhances patients' quality of life and


- has a high success rate: 86 percent of people who have experienced the APOS Treatment would recommend it to a friend or relative[5].


The APOS Treatment has two key elements: The APOS WalkrightTM, high-tech footwear which is individually adjusted to address patients' specific pain needs, and a six-month programme of care that provides ongoing clinical and computerised assessment of your walking pattern and readjustments as your needs change.



The APOS Treatment was first invented in Israel in 2005 at the acclaimed Assaf Harofeh Medical Centre. Since then, 12,000 people have undergone the APOS Treatment.















This month Bupa is bringing the APOS Treatment to the UK for the first time. The first step for anyone interested in the APOS Treatment is to undergo a free hour-and-a-half assessment at a Bupa centre to see whether APOS is suitable for them. This includes an in-depth consultation with a clinician and a computerised gait analysis which assesses the way they walk.


If the APOS Treatment is appropriate, patients will receive a six-month programme of care, including a series of follow-up assessments with a clinician, where the Walkrights are adjusted to meet their changing pain needs, as well as on-call telephone support from the Bupa team. The cost of APOS Treatment is ВЈ2,925 when paid up front or ВЈ3,250 when spread over six-months: an initial payment of ВЈ1,750 followed by five monthly payments of ВЈ300.


Laura Samuels, a school librarian and mum of two from Bushey Heath, Hertfordshire, was one of the first to trial the APOS Treatment in the UK. Laura said: "I had split the anterior cruciate ligament in both knees and suffered from arthritis and constant pain before trying the APOS Treatment. Now, I no longer feel any pain in my knees and don't have to face the prospect of surgery. This treatment has completely changed my life."



Dr Peter Mace, deputy medical director, Bupa said: "By bringing this innovative treatment to the UK for the first time, Bupa is providing an additional treatment option for people with knee and back pain. It helps plug the gap between simple pain relievers and surgery."


Dr Amit Mor, chairman and co-founder of APOS, said: "People are best placed to treat their joint problems if they have good alignment and feel less pain, features which APOS provides. We're delighted to be working with Bupa to bring the benefits of the treatment to back and knee pain sufferers in the UK."


[1] Source: Research Now- online survey of a representative sample of 4,008 UK adults (aged 16 +) between 4th and 11th June 2009.


[2] Source: Communications Centre of the Brandman Institute in Tel Aviv. Telephone interviews conducted in March, 2008 among 200 people, aged 35 +,using the APOSTreatment. Seventy percent of those taking prescription pain relief before their APOS Treatment reported no longer needing pain relief afterwards. Eighty percent of the sample were being treated with APOS for knee pain, and 20 percent for back pain.


[3] Source for this emerging evidence is: Department of Orthopaedic Surgery, Assaf Harofeh Medical Center. Zerifin, Israel. A medical study of 57 people with knee osteoarthritis was carried out in Israel between September 2005 and February 2006. The study has been registered with Clinicaltrials clinicaltrials/ct2/show/record/NCT00457132


[4] Source: As footnote 2 - above


[5] Source: As footnote 2 - above

Source
UK Health Services

This School Year, Avoid Injuries From Backpacks

According to the U.S. Consumer Product Safety Commission, more than 7,000 children were injured last year due to overloaded backpacks, some weighing as much as 45 pounds. Experts recommend that backpacks weigh no more than 10 percent to 15 percent of a child's weight, but the average backpack weighs in at 20 percent.


"In fact, 10 percent to 19 percent of children miss school or sports activities every year because of pain caused by heavy backpacks," says Matthew Dobbs, M.D., orthopaedic surgeon at Washington University School of Medicine and St. Louis Children's Hospital. "And 30 to 50 percent of adolescents complain of pain related to backpack use."


Dobbs says pediatricians can help their patients avoid injuries from using backpacks by stressing to them the following:


-- Limit personal items.


-- Don't carry the pack by hand or sling it over one shoulder. Use both straps over the shoulders to distribute the weight evenly.


-- Wear backpacks over the strongest muscles, located in the midback.


"Adolescent girls ages 11 to 16 are most at risk, which may be attributed to the rapid growth spurt they experience during this age range and the susceptibility of rapidly growing spines to back pain. In addition, girls often weigh less than boys, but still carry the same amount of backpack weight," Dobbs says. "Kids who walk to and from school are also more likely to suffer back pain from heavy packs because duration of use increases the risk of injury."


Treatment for backpack pain usually involves prescribing anti-inflammatory medicine for 10 days. Physical therapy is sometimes recommended.


"These types of injury are usually temporary, and pediatricians can reassure parents that the extra weight doesn't cause structural or long-term damage to the spine, nor does it cause scoliosis," Dobbs says. "But since backpacks are a fun and popular way for kids to express their own sense of style, it's important that physicians stress safety precautions to patients and their parents."


Washington University School of Medicine's 2,100 employed and volunteer faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Children's hospitals. The School of Medicine is one of the leading medical research, teaching and patient care institutions in the nation, currently ranked third in the nation by U.S. News & World Report. Through its affiliations with Barnes-Jewish and St. Louis Children's hospitals, the School of Medicine is linked to BJC HealthCare.


Washington University in St. Louis

One Brookings Dr., Campus Box 1070

St. Louis, MO 63130

United States

wustl

Northeastern Professor Warns Big Backpacks Cause Big Back Pains

Beyond the obvious academic stress that September brings, heading back to school may literally be a pain in the neck for students. The burden of a heavy backpack can eventually lead to the more serious problems of chronic back pain and scoliosis, according to NU physical therapy professor Mary Hickey. According to the American Physical Therapy Association, backpacks should weigh no more than 15 percent of the carriers' total body weight. However, Hickey recommends that backpacks weigh in at no more than a tenth of a child's body weight.


"Kids who use backpacks often use them incorrectly and to their physical detriment," she says. "Big bags can have a lasting physical impact on developing skeletal systems and posture."


Hickey conducted a research study on the physically damaging affects of heavy backpacks after witnessing her own children strain under the weight of their schoolbooks. About 70 percent of the middle school students in her experiment were lugging around a backpack that was harmful to their growing bodies. While small kids hauling around 25-pound backpacks is a common sight in elementary, middle and high school hallways, according to Hickey's computation, only a 200-pound person can safely carry a bag of this size.


"The most important thing for parents to know is that there are simple ways to prevent kids from permanently damaging their backs," Hickey explains. Hickey offers some advice for parents to keep in mind, especially while shopping for back-to-school gear:


-- As a rule, kids should never carry a bag that weighs more than 10% of their body weight. This rule applies to all students, no matter what age. "If your child is unable to stand up straight with the pack on, the load is too heavy," explains Hickey.


-- Remind your kids about the value of lockers. Reducing backpack poundage will prevent any serious back pain in the future.


-- The bigger the bag, the more stuff kids will cram into it. Purchase a smaller backpack that will only fit the bare necessities. This will prevent kids from lugging around those leftovers from lunch, notes passed in math class, or half-melted chapsticks.


-- Periodically remind your child to clean out trash and remove old papers and homework.


School nurses can also lend a hand by encouraging kids to keep their bags light and warn them of the potential danger heavy backpack may cause their growing bodies. Librarians can also protect young spines by keeping a set of school textbooks on reserve to lighten the backpack load on the way to and from school.


Northeastern University, a private research institution located in Boston, Massachusetts, is a world leader in practice-oriented education. Building on its flagship cooperative education program, Northeastern links classroom learning with workplace experience and integrates professional preparation with study in the liberal arts and sciences. U.S. News & World Report, in its annual guide America's Best Colleges, 2003, ranked Northeastern University number one in the country among programs that "require or encourage students to apply what they're learning in the classroom out in the real world." In addition, Northeastern's career services was top ranked by Kaplan Newsweek's "Unofficial Insiders Guide to the 320 Most Interesting Colleges and Universities," 2003 edition. For more information, please visit northeastern.


Contact: Emily Robbins

prco-opur.neu

617-373-5739

Northeastern University

Utah Company Has Solution To Chronic Foot, Leg, And Back Pain

Leonardo da Vinci said, "The foot is a masterpiece of engineering and a work of art." Unfortunately, despite his genius, he missed a piece. What he could not appreciate in his time is that many people are born with hidden congenital defects that cause their feet and legs to function incorrectly throughout the whole of their lives.(1)


Oblivious to their own poor foot function, huge numbers of people continue to expose their feet to an incredible amount of stress. They'll jog 5-miles a day on them, walk the mall for 6-hours on them, dance until 2:00 AM on them, kick footballs with them, and cram them into all sorts of shoe some too short, some too narrow, and some with very high heels! Perhaps it shouldn't come as a surprise to us to discover that up to 45% of the adult population may be suffering with foot pain at any given time.(2)


But now, using Varifit Orthotic's breakthrough technology, today's foot health care professionals can examine foot function in a completely new and technologically-advanced way, which enables them to expose the previously hidden structural and mechanical causes of chronic lower-limb pain. At the core of the VF-300™ system is a unique foot scanner that captures true 3-D images of the feet held in special pre-determined positions. The images are uploaded to a software program called 3-D Analytics™, which uses complex algorithms to identify the mechanical defects in the patient's foot structure and function. Using this information, and by employing patent-pending robot technology, the system can then quickly and easily manufacture custom-made foot supports to correct the mechanical defects and relieve the associated symptoms of pain and disability.


VF-300™ systems are now being distributed to foot health care professionals all over the continental USA and Canada.


It's incredible to think that the average person takes 8,000-10,000 steps a day, and walks over 115,000 miles in a lifetime the equivalent of over four times the circumference of the earth. It's also amazing to think that up to 138-million Americans may be doing it in pain! Using the latest foot analysis technology from Varifit Orthotics™, foot health care professionals can help foot pain sufferers identify the mechanical reasons for their pains, and provide a solution to make their journeys more comfortable.


If Leonardo had had a VF-300™ system for his studies of the human foot, he would have likely concluded: "Many feet are a tragedy of engineering but still a work of art."


About Varifit Orthotics:


Varifit Orthotics is a custom orthotics equipment manufacturer focused on 3D foot analysis and efficient orthotic fabrication technologies. Varifit's patent-pending 3D Foot Analytics facilitates biomechanical foot assessments and functional grouping of feet. The VF-300 Fabrication System, which debuted in 2008, is capable of producing a pair of custom orthotics in less than 20 minutes.


References:



1. Wood BC, Warfield CA: Foot Pain from bad shoes to aberrant genes, Hosp Pract (Off Ed). 1987, Sept 30:22)9A): 107-9, 112, 116-22.



2. Garrow AP, Silman AJ, Macfarlane GJ. The Cheshire foot pain and disability survey: a population survey assessing prevalence and associations. Pain. 2004;110:378 - 384.


Source: Varifit Orthotics

Four Out Of 10 Back Pain Sufferers Will Recover Within A Year

Over a third (35%) of patients will recover from chronic low back pain within nine months and four out of 10 (41%) will do so within a year, according to research published on BMJ.


This is the first study of its kind and the results go against the common view that recovery from an episode of chronic low back pain is unlikely.


The lead author, Dr Luciola Menezes Costa, from the University of Sydney, says individuals with previous sick leave due to low back pain, high disability levels, low levels of education and being born overseas were more likely to have delayed recovery.


Chronic low back pain is a major health problem, say the authors, and places a huge social and economic burden on society. They also argue that there is currently considerable uncertainty associated with recovery rates.


The participants were drawn from a larger group of 973 patients who attended primary care clinics in Sydney with a new episode of low back pain. These patients had visited their health care provider with acute low back pain (ie. the episode had lasted for more than 24 hours but less than two weeks). Patients with serious spinal health problems such as cancer, infection, fractures or inflammatory arthritis were excluded from the study. Those who had not recovered by 90 days were considered to have chronic non-specific low back pain and joined the current study.


The researchers followed up 400 patients with chronic non-specific low back pain with a telephone interview assessing pain and disability levels and work status nine and 12 months later. The results reveal that a reasonable number of participants had complete recovery within a year of first developing chronic low back pain (35% by nine months, 41% by one year).



In conclusion, Dr Menezes Costa says that this study is important as it demonstrates that the rate of recovery from chronic low back pain is higher than previously reported and that the findings suggest that the prognosis is not uniformly poor for patients with chronic low back pain.


The authors add that the results should be reassuring for patients as they show that recovery from a new episode of chronic non-specific low back pain is possible.


However, in an accompanying editorial, two senior researchers from Keele University point out that, for a condition like low back pain, which for many people lasts a lifetime, research on what happens to patients over much longer time scales is needed.


Only then can we improve our understanding about how different patterns emerge and in what order, why some people recover whereas others have episodic pain for years or develop long term constant pain, they write.


Link to paper

Link to editorial


Source
British Medical Journal

International Osteoporosis Foundation Campaign Puts Spotlight On Vastly Under-Diagnosed And Under-Treated Spinal Fractures

At a press conference held in Brussels, the International Osteoporosis Foundation (IOF), the Belgian Bone Club and the European Parliament Osteoporosis Interest Group called on health care professionals and health policy officials in Europe to take action to prevent spinal fractures. The call to action was made at the launch of a unique photographic essay, 'snap! the breaking spine', leading up to World Osteoporosis Day on October 20, 2010.



Taking viewers across the globe to Brazil, Canada, India, Jordan and Switzerland, the photographic essay captures a typical day in the lives of six people with spinal osteoporotic fractures. At times touching and sad, at times hopeful, the photographs provide an intimate portrait of the daily challenges of living with osteoporosis.



Spinal fractures caused by osteoporosis are all too often dismissed as simple back pain or arthritis and so often do not come to clinical attention, thereby remaining undiagnosed and untreated. Even when referred to a doctor, only about 40% of older women with spinal fractures visible on X-ray are tested for osteoporosis and the figure is even lower in men (less than 20%). Speaking at the event, Prof. Steven Boonen of the University of Leuven, Belgium, said, "It is essential that spinal fractures are identified and treated before further fractures occur. Unless treated, as many as one in five women with a spinal fracture will sustain another within twelve months."



The repercussions of spinal fractures can be severe. Spinal fractures can result in stooped back, acute and chronic back pain, loss of height, immobility, depression, increased number of bed days, reduced pulmonary function and even premature death.



Spinal fractures also represent a significant socio-economic burden. It is estimated that around the world one spinal fracture occurs every 22 seconds. "In Europe, new cases of spinal osteoporotic fractures were estimated to cost 719 million EUR in year 2000," said Professor Jean-Yves Reginster, University of LiГЁge, Belgium. Despite only a minority of spinal fractures coming to clinical attention, in the UK alone, they account for around 2,188 hospital admissions each year in patients 45 years and over. These direct costs do not take into account indirect costs such as lost working days, need for caregivers, and the long-term impact on the patients' quality of life or ability to work.



Costs associated with all osteoporotic fractures are predicted to rise markedly over the next 40 years as the population ages. In Europe the population aged 80 years or more will increase by 160% in women and by 239% in men between 2000 and 2050. As a result, the total direct costs of osteoporotic fractures in Europe are projected to increase from a current 36 billion EUR annually, to 54 billion and 77 billion EUR in 2025 and 2050 respectively.



Opening speakers at the launch event held in the Bavarian Representation of the European Parliament included Wolfgang H. Caselmann, M.D. Head of Division, Medical Affairs and Prevention, Bavarian State Ministry of the Environment and Public Health, MГјnich, Germany, as well as Dr. Anja Weisgerber MEP, Germany and Mary Honeyball MEP, UK, co-chairs of the European Parliament Osteoporosis Interest Group.



"Prevention of all osteoporotic fractures, including spinal fractures, must be a key public health goal. Diagnosis and early intervention would advance this goal, leading to a reduced burden of disease, along with dramatic improvements in the quality of life of those who suffer from osteoporotic fractures," said IOF CEO Patrice McKenney.



About World Osteoporosis Day



World Osteoporosis Day, marked on October 20th each year, is a focal point for raising awareness of osteoporosis around the world. The International Osteoporosis Foundation has focused its World Osteoporosis Day 2010 campaign on the theme of spinal bone health and the motto "Don't miss the signs of a breaking spine"



About snap! The breaking spine



This unique photographic journey, available as a book, exhibition and online multimedia experience, provides a personal look at the lives of six people living with osteoporosis and spinal fractures in five countries around the world. The concept and photographs are the work of IOF photographer and multimedia specialist Gilberto Lontro Domingues.



Source:

L. Misteli

International Osteoporosis Foundation

Chiropractic Is Cost-Effective In Treating Chronic Back Pain, Study

A new study finds that chiropractic and medical care have comparable costs for treating chronic low-back pain, with chiropractic care producing significantly better outcomes. A group of chronic low-back patients who underwent chiropractic treatment showed higher pain relief and satisfaction with the care and lower disability scores than a group that underwent medical care, according to an October 2005 study in the Journal of Manipulative and Physiological Therapeutics (JMPT).


Although several cost-effectiveness studies outside the United States have favorably compared chiropractic to medical care, this new study is one of the first to compare low-back treatment costs and outcomes within the structure of the American health care system. In the United States alone, back pain associated costs are estimated to reach $48 billion this year, and, at any given time, 80 percent of the U.S. population suffers from back pain - statistics that make this study especially pertinent, according to the authors.


Specifics of the study:


The study involved 2780 patients with mechanical low-back pain who referred themselves to 60 doctors of chiropractic and 111 medical doctors in 64 general practice community clinics in Oregon and one in Vancouver, Wa. Chiropractic care included spinal manipulation, physical therapies, an exercise plan, and self-care patient education. Medical care consisted of prescription drugs, an exercise plan, self-care advice, and a referral to a physical therapist (in approximately 25 percent of cases). The costs of treatment and patients' pain, disability, and satisfaction with their health care were assessed at 3 and 12 months after the initial visit to the doctor.


The office costs alone for chiropractic treatment of low-back pain were higher than for medical care. However, when costs of advanced imaging and referral to physical therapists and other providers were added, chiropractic care costs for chronic patients were 16 percent lower than medical care costs. The differences between medical and chiropractic total costs were not statistically significant for acute or chronic patients. The study did not include over-the-counter drug, hospitalization, or surgical costs.


Both acute and chronic patients showed better outcomes in pain and disability reduction and higher satisfaction with their care after undergoing chiropractic treatment. The advantage of chiropractic care was clinically significant in the chronic patient group at 3 months' follow-up, but smaller in the acute group. Improvements in patients' physical and mental health were comparable in both the chiropractic and the medical group, with the exception of physical health scores in the acute patients in the chiropractic group, which showed an advantage over the medical group.


"With their mission to increase value and respond to patient preferences, health care organizations and policy makers need to reevaluate the appropriateness of chiropractic as a treatment option for low-back pain," concluded the study authors.


The Journal of Manipulative and Physiological Therapeutics, the premier biomedical publication in the chiropractic profession and the official scientific journal of the American Chiropractic Association, provides the latest information on current research developments, as well as clinically oriented research and practical information for use in clinical settings. The journal's editorial board includes some of the world's leading clinical researchers from chiropractic, medicine, and post-secondary education.


Angela Kargus / Felicity Feather

akargusamerchiro / ffeatheramerchiro

800-986-4636

American Chiropractic Association

amerchiro

NHS Institute Launches Focus On: Musculoskeletal Interface Services

The NHS Institute for Innovation and Improvement has launched a new publication to support the NHS in improving community-based access to specialist services for patients suffering from musculoskeletal (MSK) conditions such as chronic back pain, osteoporosis and other bone, joint, spinal and muscular diseases.



The publication, Focus On: Musculoskeletal Interface Services, highlights the key characteristics of best practice for MSK interface services and is aimed at commissioner and provider organisations aiming to set up an MSK interface service or develop an existing service.



The improvements in MSK interface services detailed in the document have the potential to allow services to be redesigned to provide more care in the community and free up significant capacity in secondary care.



Sophie Cowley, the lead Associate from the NHS Institute said: "Musculoskeletal conditions frequently have an adverse influence on health and quality of life for many individuals and can limit daily activities. Recent statistics show that they are the most commonly reported type of work-related illness and take up more than 30 per cent of all GP consultations. They also result in the loss of an estimated 10.7 million working days in England."



MSK disorders are extremely common and healthcare experts recognise that these services could be better managed across NHS. Traditionally access to good care in the community has been limited and access to secondary care restricted by long waiting times. In this context, multidisciplinary interface services are being developed to provide community-based access to specialist MSK services. These new models mean that patients can often avoid secondary care waits by being managed in the community and at the same time benefiting from a full range of physiological and psychological support.



Focus On: Musculoskeletal Interface Services was developed following months of research by the NHS Institute's Delivering Quality and Value team. The team observed a selection of musculoskeletal interface services across England to identify characteristics of high quality care.



Robin Evans, NHS Institute's Lead Clinician for the project and a Consultant Radiologist at Mayday Healthcare NHS Trust, Croydon explains: "The future of the modern NHS depends on redesigning cost effective pathways around the patient while maintaining high quality provision. These interface services are an excellent example of how this can be achieved for common musculoskeletal conditions. By sharing these key characteristics we aim to provide a roadmap for local development, but at the same time recognising that the detail of the changes will be dependant upon varying local circumstance and priorities."



The document has been sent to every Primary Care Trust and every Orthopaedic Department in England. It can also be downloaded at institute.nhs.uk/msk






Notes


Focus on: Musculoskeletal Interface Services has been developed by the NHS Institute's Delivering Quality and Value team. Visit institute.nhs.uk/msk for further information.



- The NHS Institute for Innovation and Improvement supports the NHS to transform healthcare for patients and the public by rapidly developing and spreading new ways of working, new technology and world-class leadership.



- Please visit institute.nhs.uk for further information on the NHS Institute and its work.

Source
NHS Institute for Innovation and Improvement

Dr. Alfred Bonati Comments On Study That Reveals Traditional Open Back Surgery Fails 74% Of The Time

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

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

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.

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

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

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