Effectiveness of percutaneous laser disc decompression versus conventional open discectomy in the treatment of lumbar disc herniation; Design of a prospective randomized controlled trial
Background. The usual surgical treatment of refractory sciatica caused by lumbar disc herniation, is open discectomy. Minimally invasive procedures, including percutaneous therapies under local anesthesia, are increasingly gaining attention. One of these treatments is Percutaneous Laser Disc Decompression (PLDD). This treatment can be carried out in an outpatient setting and swift recovery and return to daily routine are suggested. Thus far, no randomized trial into cost-effectiveness of PLDD versus standard surgical procedure has been performed. We present the design of a randomized controlled trial, studying the cost-effectiveness of PLDD versus conventional open discectomy in patients with sciatica from lumbar disc herniation. Methods/design. The study is a randomized prospective multi-center trial, in which two treatment strategies are compared in a parallel group design. Patients (age 18-70 years) visiting the neurosurgery department of the participating hospitals, are considered for inclusion in the trial when sciatica due to lumbar disc herniation has lasted more than 8 weeks. Patients with disc herniation smaller than 1/3 of the spinal canal diameter, without concomitant lateral recess stenosis or sequestration, are eligible for participation, and are randomized into one of two treatment arms; either Percutaneous Laser Disc Decompression or conventional discectomy. The functional outcome of the patient, as assessed by the Roland Disability Questionnaire for Sciatica at 8 weeks and 1 year after treatment, is the primary outcome measure. The secondary outcome parameters are recovery as perceived by the patient, leg and back pain, incidence of re-intervention, complications, quality of life, medical consumption, absence of work and secondary costs. Discussion. Open discectomy is still considered to be the golden standard in the surgical treatment of lumbar disc herniation. Whether Percutaneous Laser Disc Decompression has at least as much efficacy as the standard surgical procedure, and is more cost-effective, will be determined by this trial. Trial registration. Current Controlled Trials ISRCTN25884790.
|Keywords||absenteeism, adolescent, adult, aged, article, backache, case report, clinical trial, controlled clinical trial, controlled study, cost benefit analysis, cost effectiveness analysis, decompression surgery, deep vein thrombosis, disease duration, economics, female, functional assessment, health care cost, health care utilization, hematoma, hernia, hospital department, human, instrumentation, intermethod comparison, intervertebral disk, intervertebral disk hernia, intervertebral diskectomy, ischialgia, leg pain, low level laser therapy, lumbar disk, lumbar vertebra, male, methodology, middle aged, multicenter study, neurological complication, outcome assessment, pain assessment, pathology, pathophysiology, percutaneous laser disc decompression, postoperative infection, postoperative thrombosis, prospective study, quality of life, questionnaire, randomized controlled trial, reoperation, surgical patient, surgical ward, therapy effect, treatment outcome, urinary tract infection, vertebral canal|
|Persistent URL||dx.doi.org/10.1186/1471-2474-10-49, hdl.handle.net/1765/17109|
Brouwer, P.A, Peul, W.C, Brand, R, Arts, M.P, Koes, B.W, van den Berg, A.A, & van Buchem, M.A. (2009). Effectiveness of percutaneous laser disc decompression versus conventional open discectomy in the treatment of lumbar disc herniation; Design of a prospective randomized controlled trial. BMC Musculoskeletal Disorders, 10(1). doi:10.1186/1471-2474-10-49