Spine stabilisation trial

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2000
INTERVENTION: 1. Surgical stabilisation (spinal fusion) 2. Special non‐operative rehabilitation Follow‐up: 6,12 months, 2 years post randomisation CONDITION: Chronic low back pain ; Musculoskeletal Diseases ; Chronic low back pain PRIMARY OUTCOME: The two primary measures at 24 months included a back pain specific questionnaire and a standardised walking test. The Oswestry low back pain disability index is scored from 0% (no disability) to 100% (totally disabled or bedridden) and designed to assess limitations of various activities of daily living. The shuttle walking test is a standardised, progressive, maximal test of walking speed and endurance. SECONDARY OUTCOME: 1. The short form 36 general health questionnaire (SF‐36) includes 35 items summarised in two measures related to physical and mental health. Each scale ranges from 0 (worst health state) to 100 (best health state). The summary measures are transformed to give a population mean of 50 (SD 10). The SF‐36 is recommended as an outcome assessment for spinal disorders because it provides strong psychometric support and extensive normative data.; 2. Psychological assessment: we used the distress and risk assessment method (DRAM), which includes the modified Zung depression index and somatic perception questionnaire, to assess anxiety and depression.; 3. Complications: we recorded the intraoperative use of anaesthetic agents, implants; radiological investigations; complications of surgery and any adverse effects of rehabilitation; postoperative complications, implant failure and repeat surgery and personal items and devices purchased by the patient because of lower back pain. Work status was monitored. We recorded 'obvious pseudoarthrosis' only where it was clear to the treating surgeon that fusion had failed and that this was a problem to the patient. INCLUSION CRITERIA: 1. Patients who were candidates for surgical stabilisation of the spine were eligible if the clinician and patient were uncertain which of the study treatment strategies was best. 2. Patients had to be aged between 18 and 55, with more than a 12 month history of chronic low back pain (with or without referred pain) and irrespective of whether they had had previous root decompression or discectomy.
Epistemonikos ID: 65670315c02039acfe61179c850949c331a8a626
First added on: Aug 21, 2024