A stratified randomized single-blinded clinical trial.
To compare the efficacies of 2 active therapies for chronic low back pain (CLBP).
Summary of Background Data.
Both a multidisciplinary biopsychosocial rehabilitation program and an intensive individual therapist-assisted back muscle strengthening exercise program used in Denmark have been reported to be effective for the treatment of CLBP.
A total of 286 patients with CLBP were randomized to either a group-based 12-week program comprising 73 hours of therapist exposure (approximately 12 h/patient): 35 hours of hard physical exercise, 22 hours of light exercise/occupational therapy, and 16 hours of education (group A) or a 12-week program comprising 1 hour of personal training twice a week, i.e., therapist exposure 24 h/patient (group B). At baseline and at 3, 6, 12, and 24 months, patients filled out questionnaires on pain (visual analogue scale [VAS]-pain average, which was the primary outcome measure), Roland-Morris disability questionnaire, global perceived outcome, and 36-Item Short-Form General Health Survey. Data were analyzed using the intention-to-treat principle.
Of the 286 patients, 14 patients did not start treatment. Of the remaining patients, 25 (9%) dropped out of therapy. The 2 groups were comparable regarding baseline characteristic. After treatment, significant improvements were observed with regard to pain, disability, and most of the quality of life dimensions. These effects were sustained over the 24-month follow-up period. There were some statistically significant differences between the 2 groups relating to secondary end points, Roland-Morris disability questionnaire, and in the MOS 36-Item Short-Form Health Survey the “physical functioning” dimension and the “physical component summary.”
Both groups showed long-term improvements in pain and disability scores, with only minor statistically significant differences between the 2 groups. The minor outcome difference in favor of the group-based multidisciplinary rehabilitation program is hardly of clinical interest for individual patients.