Objective: To determine whether a short course of traditional acupuncture improves longer term outcomes for patients with persistent non-specific low back pain in primary care.

Design: Pragmatic, open, randomised controlled trial.

Setting: Three private acupuncture clinics and 18 general practices in York, England.

Participants: 241 adults aged 18-65 with non-specific low back pain of 4-52 weeks' duration.

Interventions: 10 individualised acupuncture treatments from one of six qualified acupuncturists (160 patients) or usual care only (81 patients).

Main outcome measures: The primary outcome was SF-36 bodily pain, measured at 12 and 24 months. Other outcomes included reported use of analgesics, scores on the Oswestry pain disability index, safety, and patient satisfaction.

Results: 39 general practitioners referred 289 patients of whom 241 were randomised. At 12 months average SF-36 pain scores increased by 33.2 to 64.0 in the acupuncture group and by 27.9 to 58.3 in the control group. Adjusting for baseline score and for any clustering by acupuncturist, the estimated intervention effect was 5.6 points (95% confidence interval -0.2 to 11.4) at 12 months (n = 213) and 8.0 points (2.8 to 13.2) at 24 months (n = 182). The magnitude of the difference between the groups was about 10%-15% of the final pain score in the control group. Functional disability was not improved. No serious or life threatening events were reported.

Conclusions: Weak evidence was found of an effect of acupuncture on persistent non-specific low back pain at 12 months, but stronger evidence of a small benefit at 24 months. Referral to a qualified traditional acupuncturist for a short course of treatment seems safe and acceptable to patients with low back pain.

Trial registration: ISRCTN80764175 [controlled-trials.com].