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Four-year follow-up of surgical versus non-surgical therapy for chronic low back pain |
Brox JI, Nygaard OP, Holm I, Keller A, Ingebrigtsen T, Reikeras O |
Annals of the Rheumatic Diseases 2010 Sep;69(9):1643-1648 |
clinical trial |
7/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; 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* |
OBJECTIVES: To compare the long-term effectiveness of surgical and non-surgical treatment in patients with chronic low back pain. METHODS: Two merged randomised clinical trials compared instrumented transpedicular fusion with cognitive intervention and exercises in 124 patients with disc degeneration and at least 1 year of symptoms after or without previous surgery for disc herniation. The main outcome measure was the Oswestry disability index. RESULTS: At 4 years 14 (24%) patients randomly assigned to cognitive intervention and exercises had also undergone surgery. 15 (23%) patients assigned fusion had undergone re-surgery. The mean treatment effect for the primary outcome was 1.1; 95% CI -5.9 to 8.2, according to the intention-to-treat analysis and -1.6; 95% CI -8.9 to 5.6 in the as-treated analysis. There was no difference in return to work. CONCLUSIONS: Long-term improvement was not better after instrumented transpedicular fusion compared with cognitive intervention and exercises.
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