M de Sèze1, L Saliba, J-M Mazaux. 1. EA 4136 handicap et système nerveux, service de MPR, unité de médecine orthopédique, hôpital Tastet-Girard, CHU de Bordeaux, université de Bordeaux Segalen, place Amélie-Raba-Léon, 33076 Bordeaux cedex, France. mathieu.de-seze@chu-bordeaux.fr
Abstract
OBJECTIVES: Sciatica is a common disease; between 13% and 40% of the general population will experience at least one episode of sciatica due to spinal disc herniation and nerve root irritation. In some specialist centres, percutaneous intradiscal techniques can be applied as an intermediate measure between conservative treatment and surgery, with a view to avoiding the adverse events associated with surgical discectomy. Discogel(®) is a percutaneously implanted medical device for the treatment of lumbar sciatica due to a herniated disc. We performed an open, prospective, observational study in order to (a) determine whether the prior use of air disc manometry could limit the risk of nerve root irritation reportedly associated with nucleolysis and administration of Discogel(®) and (b) investigate the technique's efficacy and safety. METHOD: A total of 79 Discogel(®)-treated patients were systematically reviewed. A nurse anaesthetist evaluated each patient's pain levels during the procedure itself. The therapist assessed the patient on inclusion and 8weeks after the Discogel(®) procedure. A third assessment was based on a telephone interview (by an independent assessor) at least 4months after the procedure. RESULTS: Pain levels immediately after the Discogel(®) procedure (1.7±2.0) were markedly lower than before the procedure (5.5±2.3). There were no complications. Two months after Discogel(®) administration, the initial pain level had fallen by an average of 74±34%. The outcome was quite stable over time (mean follow-up: 8months). At the end of the follow-up period, 60.7% of the patients were free of pain, 76% considered the treatment outcome to be good or very good, 74% had returned to work and 76% would recommend the treatment to a friend. CONCLUSION: The favourable outcomes associated with the procedure should now be confirmed in a controlled trial.
OBJECTIVES: Sciatica is a common disease; between 13% and 40% of the general population will experience at least one episode of sciatica due to spinal disc herniation and nerve root irritation. In some specialist centres, percutaneous intradiscal techniques can be applied as an intermediate measure between conservative treatment and surgery, with a view to avoiding the adverse events associated with surgical discectomy. Discogel(®) is a percutaneously implanted medical device for the treatment of lumbar sciatica due to a herniated disc. We performed an open, prospective, observational study in order to (a) determine whether the prior use of air disc manometry could limit the risk of nerve root irritation reportedly associated with nucleolysis and administration of Discogel(®) and (b) investigate the technique's efficacy and safety. METHOD: A total of 79 Discogel(®)-treated patients were systematically reviewed. A nurse anaesthetist evaluated each patient's pain levels during the procedure itself. The therapist assessed the patient on inclusion and 8weeks after the Discogel(®) procedure. A third assessment was based on a telephone interview (by an independent assessor) at least 4months after the procedure. RESULTS:Pain levels immediately after the Discogel(®) procedure (1.7±2.0) were markedly lower than before the procedure (5.5±2.3). There were no complications. Two months after Discogel(®) administration, the initial pain level had fallen by an average of 74±34%. The outcome was quite stable over time (mean follow-up: 8months). At the end of the follow-up period, 60.7% of the patients were free of pain, 76% considered the treatment outcome to be good or very good, 74% had returned to work and 76% would recommend the treatment to a friend. CONCLUSION: The favourable outcomes associated with the procedure should now be confirmed in a controlled trial.
Authors: M Bellini; D G Romano; S Leonini; I Grazzini; C Tabano; M Ferrara; P Piu; L Monti; A Cerase Journal: AJNR Am J Neuroradiol Date: 2014-11-13 Impact factor: 3.825