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| Randomized clinical trial of lumbar instrumented fusion and cognitive intervention and exercises in patients with chronic low back pain and disc degeneration [with consumer summary] |
| Brox JI, Sorensen R, Friis A, Nygaard O, Indahl A, Keller A, Ingebrigtsen T, Eriksen HR, Holm I, Koller AK, Riise R, Reikeras O |
| Spine 2003 Sep 1;28(17):1913-1921 |
| clinical trial |
| 8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
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STUDY DESIGN: Simple blind randomised study. OBJECTIVES: To compare the effectiveness of lumbar instrumented fusion with cognitive intervention and exercises in patients with chronic low back pain and disc degeneration. SUMMARY OF BACKGROUND DATA: To the author's best knowledge, only one randomised study has evaluated the effectiveness of lumbar fusion. The Swedish Lumbar Spine Study reported that lumbar fusion was better than continuing physiotherapy and care by the family physician. PATIENTS AND METHODS: Sixty-four patients aged 25 to 60 years with low back pain lasting longer than 1 year and evidence of disc degeneration at L4 to L5 and/or L5 to S1 at radiographic examination were randomised to either lumbar fusion with posterior transpedicular screws and post-operative physiotherapy, or cognitive intervention and exercises. The cognitive intervention consisted of a lecture to give the patient an understanding that ordinary physical activity would not harm the disc and a recommendation to use the back and bend it. This was reinforced by three daily physical exercises sessions for 13 weeks. The main outcome measure was the Oswestry Disability Index. RESULTS: At the 1-year follow-up, 97% of the patients, including 6 patients who had either not attended treatment or changed groups, were examined. The Oswestry Disability Index was significantly reduced from 41 to 26 after surgery, compared with 42 to 30 after cognitive intervention and exercises. The mean difference between groups was 2.3 (-6.7 to 11.4) (p = 0.33). Improvements in back pain, use of analgesics, emotional distress, life satisfaction, and return to work were not different. Fear-avoidance beliefs and fingertip-floor distance were reduced more after non-operative treatment, and lower limb pain was reduced more after surgery. The success rate according to an independent observer was 70% after surgery and 76% after cognitive intervention and exercises. The early complication rate in the surgical group was 18%. CONCLUSION: The main outcome measure showed equal improvement in patients with chronic low back pain and disc degeneration randomised to cognitive intervention and exercises, or lumbar fusion.
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