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Functional restoration versus outpatient physical training in chronic low back pain. A randomized comparative study [with consumer summary]
Bendix T, Bendix A, Labriola M, Haestrup C, Ebbehoj N
Spine 2000 Oct 1;25(19):2494-2500
clinical trial
4/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; 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*

STUDY DESIGN: A randomised parallel-group comparative trial with a 1-year follow-up period was performed. OBJECTIVE: To compare the effect of a comprehensive functional restoration program involving intensive physical training, ergonomic training, and behavioural support (39 hours per week for 3 weeks) with the effect of outpatient intensive physical training (1.5 hours three times per week for 8 weeks). SUMMARY OF BACKGROUND DATA: Nonrandomised studies conducted in the United States favor functional restoration for patients with chronic low back pain. Two previously reported randomised studies from the author's Back Centre in Copenhagen concur with this recommendation, although the positive effects in one of the studies had faded out after 2 years. Randomised functional restoration studies in Canada and Finland have failed to demonstrate any substantive effect. METHODS: Initially, 138 patients with chronic low back pain were included in the current study. They then were randomised to either functional restoration (n = 64) or outpatient intensive physical training (n = 74). Of the initial 138, 11 never started (5 and 6 respectively); 21 dropped out during treatment (8 and 13); and 7 of the graduates did not take part in the 1-year follow-up evaluation (3 and 4). The conclusions were drawn from the 99 patients (48 and 51, respectively) who graduated and participated in a 1-year follow-up evaluation. The median age of the patients was 42 years (range 21 to 55 years). The female-to-male ratio was 68 to 31, and the median sick leave days during the preceding 3 years was 180 (range 0 to 1080 days). The average back pain was rated 5.5 on a scale of 0 (no pain) to 10 (maximal pain). For theses variables, there were no important differences between the groups. However, the functional restoration group tended to be more capable of work at baseline (58% versus 42%; p = 0.09). RESULTS: At the one year follow-up evaluation, overall assessment favored functional restoration. Otherwise, no significant differences were observed regarding work capability, sick leave for those at work, health care contacts, back pain, leg pain, or self-reported activities of daily living. CONCLUSIONS: Only in terms of overall assessment, the functional restoration program was superior to a comparatively short time-consuming outpatient physical training program. DISCUSSION: It may be that lower economic benefits during sick leave in the United States lead to favorable results from both functional restoration programs, whereas greater benefits in Canada, Finland and Denmark result in different conclusions. Finally, it may be that the difference in results across studies points simply to whether the studies were randomised.
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