Objective: To estimate the effect of adding exercise classes, spinal manipulation delivered in NHS or private premises, or manipulation followed by exercise to "best care" in general practice for patients consulting with back pain. [See figure].
Design: Pragmatic randomised trial with factorial design.
Setting: 181 general practices in Medical Research Council General Practice Research Framework; 63 community settings around 14 centres across the United Kingdom.
Participants: 1334 patients consulting their general practices about low back pain.
Main outcome measures: Scores on the Roland Morris disability questionnaire at three and 12 months, adjusted for centre and baseline scores.
Results: All groups improved over time. Exercise improved mean disability questionnaire scores at three months by 1.4 (95% confidence interval 0.6 to 2.1) more than "best care." For manipulation the additional improvement was 1.6 (0.8 to 2.3) at three months and 1.0 (0.2 to 1.8) at 12 months. For manipulation followed by exercise the additional improvement was 1.9 (1.2 to 2.6) at three months and 1.3 (0.5 to 2.1) at 12 months. No significant differences in outcome occurred between manipulation in NHS premises and in private premises. No serious adverse events occurred.
Conclusions: Relative to "best care" in general practice, manipulation followed by exercise achieved a moderate benefit at three months and a small benefit at 12 months; spinal manipulation achieved a small to moderate benefit at three months and a small benefit at 12 months; and exercise achieved a small benefit at three months but not 12 months.