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| Trunk muscle strength, cross-sectional area, and density in patients with chronic low back pain randomized to lumbar fusion or cognitive intervention and exercises [with consumer summary] |
| Keller A, Brox JI, Gunderson R, Holm I, Friis A, Reikeras O |
| Spine 2004 Jan 1;29(1):3-8 |
| clinical trial |
| 5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; 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: A randomised study. OBJECTIVES: To compare muscle strength, cross-sectional area, and density of the back muscles in two categories of patients with chronic low back pain, randomised to either lumbar or cognitive intervention and exercises. SUMMARY OF BACKGROUND DATA: In two clinical trials, patients with chronic low back pain plus disc degeneration and postlaminectomy syndrome, respectively, were randomised to either lumbar fusion or cognitive intervention and exercises. We have previously reported that results for the primary outcome were similar t the 1-year follow-up examination. METHODS: As the treatment alternatives and test procedures were identical, the two trials were merged into one. A total of 124 patients 25 to 60 years of age were included. Muscle strength, measured by isokinetic test device and by the Biering-Sorensen Test, was measured in 112 patients, and the cross-sectional area and density of the back muscles were measured in 61 patients at the inclusion and at the 1-year follow-up examination. RESULTS: The exercise group performed significantly better in muscle strength than did the lumbar fusion group, with the mean difference at 184 Nm (95% confidence interval 64 to 303 Nm; p = 0.003) and for the Biering-Sorensen Test 21 seconds (95% confidence interval 6 to 36 seconds; p = 0.006). The density at L3 to L4 decreased in the lumbar fusion group but remained unchanged in the exercise group. The mean difference was 5.3 HU (95% confidence interval 1.1 to 9.5 HU; p = 0.01). The cross-sectional area was unchanged in both groups. CONCLUSIONS: Patients with chronic low back pain who followed cognitive intervention and exercise programs improved significantly in muscle strength compared with patients who underwent lumbar fusion. In the lumbar fusion group, density decreased significantly at L3 to L4 compared with the exercise group.
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