OBJECTIVE: To compare the effectiveness of manual therapy, physiotherapy, treatment by the general practitioner, and a placebo therapy for patients with persistent non-specific back and neck complaints. DESIGN: Randomised clinical trial. SETTING: Manual therapy practice physiotherapy practice, and general practice in primary health care. PATIENTS: 256 patients with non-specific back and neck complaints with a present attack duration of at least six weeks, who have not been treated with physiotherapy or manual therapy in the previous two years. INTERVENTIONS: At the discretion of the manual therapist, physiotherapists and general practitioners. Physiotherapy consisted of exercises, massage and/or physical therapy modalities (heat, electrotherapy, ultrasound, shortwave diathermy). Manual therapy consisted of manipulation and mobilisation of the spine. Treatment by the general practitioner consisted of prescription medication (eg, analgesics, NSAIDs), advice about posture, home exercises and (bed)rest. Placebo treatment consisted of a protocol of detuned shortwave diathermy (ten minutes) and detuned ultrasound (ten minutes). MAIN OUTCOME MEASURES: Changes in severity of the main complaint and limitation of physical functioning measured on a ten-point scale by a blinded research assistant, and global perceived effect measured on a 6-point scale by the patients themselves. RESULTS: A large number of the patients who had been originally assigned to treatment by their general practitioner or to placebo treatment changed from the assigned therapy to another therapy during the one year of follow-up. Manual therapy showed a larger improvement of the main complaint compared to physiotherapy. The difference on a 10-point scale was 0.9 and its 95% confidence interval was 0.1 to 1.7 after 12 months of follow-up. Manual therapy also showed a larger improvement in physical functioning. The global perceived effect after 6 and 12 months of follow-up was similar for both treatments. The original number of treatment sessions was much fewer for manual therapy (mean 5.4) than for physiotherapy (mean 14.7). CONCLUSIONS: Manual therapy and physiotherapy are clearly superior compared to treatment by the general practitioner and placebo therapy. Futhermore, the findings indicate slightly better results for manual therapy compared to physiotherapy after 12 months follow-up.

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