Functional restoration for XXXX . Two-year follow-up of two randomized clinical trials.

@entity1 @entity1643 @entity158
STUDY DESIGN: Two randomized, prospective clinical trials involving 238 chronic @entity1643 @entity1 were carried out. Results at 2-year follow-up are presented. OBJECTIVES: To compare the clinical outcomes of a multidisciplinary functional restoration program with a nontreated control group (Project A) and with two less intensive but different training programs (Project B). SUMMARY OF BACKGROUND DATA: The effectiveness of functional restoration programs has not been firmly established. Results from trials carried out in the United States differ from those in trials conducted in other countries. Only a few of these studies have been carried out as prospective and randomized clinical studies. METHODS: Two hundred thirty-eight @entity1 with chronic @entity1643 of at least 6 months' duration were included. There were 106 @entity1 in project A and 132 @entity1 in project B. Two years after completion of treatment @entity1 were mailed a questionnaire that included questions regarding their work status, @entity158 and disability levels, number of sick leave days, number of medical care contacts, medication use, physical activity levels, and subjective overall assessment of their "back life situation." RESULTS: @entity1 in both studies were comparable at inclusion, except that @entity1 in Project A were recruited from all of Denmark, whereas those in Project B were from the greater Copenhagen area. Thirteen @entity1 did not report for treatment after randomization. Of the remaining 225 @entity1 , 20 (9%) did not complete treatment. The questionnaire response rate was 94%. In Project A, those @entity1 receiving treatment (functional restoration) reported significantly less contact with the health care system, fewer sick leave days, and a less disabled life style during the follow-up period, compared with reports of @entity1 in the control group. Other effect parameters did not demonstrate a significant difference between the two groups. In Project B, all effect parameters reported, except leg @entity158 and medication usage, were significantly in favor of functional restoration, compared with reports from the less intensively treated groups. CONCLUSIONS: The functional restoration program seems effective in various parameters compared with the less intensive programs, but the differences in outcome in the two parallel studies indicate the necessity of testing a treatment program in different settings, in that the statistical variation may be a major factor in results of different studies.
