Study Shows New Therapy Against Disc Prolapse Is Effective - Orthokine Therapy Alleviates Severe Back Pain For Six Months

When a slipped disc is the source of severe back pain, a trapped or inflamed nerve is usually the cause. In the case of a slipped disc, the disc moves from its original position and presses on the nerve root. As a consequence, certain messenger substances of the immune system, such as Interleukin-1 or TNF-alpha, are released. These substances are responsible for inflammation, pain, and sensory disorders. However, therapy using the biological antagonists, especially Interleukin-1 receptor antagonist (IL-1Ra), can stop pain and inflammation.



"Based on an understanding of this disease mechanism, with the Orthokine therapy we have developed a completely new approach to the treatment of spinal disorders" explained Prof. Peter Wehling, M.D. and CEO of Orthogen AG, on Thursday in DГјsseldorf, Germany. In this procedure, developed by Wehling and the molecular biologist Dr. Julio Reinecke, these proteins are isolated from the blood of the patient. For this, physicians take blood using a special syringe. Within the syringe, the blood cells are stimulated to produce IL-1Ra and other cytokine antagonists and growth factors. After processing in the laboratory, this protein solution can be isolated and prepared as an injection.



In 1991, Wehling obtained his professorship at the Heinrich Heine University in DГјsseldorf with a study on the processes of the nerve root and the origin of pain. In 1997 the Orthokine therapy for treating osteoarthritis was developed. The procedure has been used for the treatment of disc prolapses and other back problems for several years and was the subject of an independent clinical study at the Ruhr University in Bochum.



Scientific study compares the effects of Orthokine and cortisone


84 patients suffering from nerve root disorders of the lumbar spine took part in the randomised, prospective, double-blinded clinical trial. In the trial, authorised by the ethics committee of the University of Bochum, 32 patients were treated with the Orthokine therapy, 27 patients received 5 mg cortisone, and a further 25 participants received 10 mg cortisone. All three drugs were injected into the affected nerve root, with the patients receiving three injections once a week. The participants were medically supervised over a period of six months. Check ups were made 6, 10, and 22 weeks after the first injection.



Orthokine is more effective than cortisone


The most important instrument for measuring the gravity of the disorder was the scientifically recognised visual analogue scale (VAS), on which patients rate the intensity of their pain on a scale of 0 to 100 (0 = no pain, 100 = most intense pain imaginable). At the beginning of the trial, all probands rated their pain as moderate to intense (VAS = 80) and had been suffering pain for at least six weeks. Four weeks after the treatment, all patients demonstrated a statistically significant reduction in symptoms (VAS = 30-34). As the trial progressed the pain level of the Orthokine-treated patients was further reduced (VAS = 15), whereas the pain level of the cortisone-treated patients fluctuated between VAS = 24 and VAS = 34. In total, the reduction of pain was greater with the Orthokine therapy than with the standard treatment.
















"This study has confirmed our results and shown for the first time that there is an effective, well tolerated alternative to cortisone treatment", said Wehling. The widespread standard therapy using cortisone is effective, but is however, associated with possible side effects. If cortisone treatment is repeated too often, in some cases it can lead to serious side effects, such as a weakening of the immune system, osteoporosis, oedema, or metabolic disorders. The treatment of patients with agents from their own body can therefore be recommended to every patient who wishes a natural and effective treatment that has few side effects.



Low back pain - a common disorder


Ten per cent of the population suffer from disc prolapses and low back pain. Lower-back problems can have different causes depending on age. In middle age, slipped discs are often the source of suffering. Men between the ages of 35 and 45 are especially susceptible. Older people are often afflicted with degeneration and stenosis of the spine. In addition, poor posture, genetic factors, or psychological problems play a role. The common factor of many back problems is discs or bones pressing on sensitive nerves, thus causing pain, restriction of movement or sensory disorders.Spine
Spine is the leading international specialist journal for spinal disorders. Only original work that has been qualified by peer review is published. spinejournal



Efficacy of Epidural Perineural Injections with Autologous Conditioned Serum for Lumbar Radicular Compression. An Investigator-Initiated, Prospective, Double-Blind, Reference-Controlled Study. Cordelia Becker, MD, et al., SPINE Volume 32, Number 17, pp 1803- 1808



Orthokine is used in Europe, but not yet approved in the United States by the FDA.


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