BACKGROUND: Acupuncture is widely used by patients with low back pain, although its effectiveness is unclear. We investigated the efficacy of acupuncture compared with minimal acupuncture and with no acupuncture in patients with chronic low back pain. METHODS: Patients were randomized to treatment with acupuncture, minimal acupuncture (superficial needling at nonacupuncture points), or a waiting list control. Acupuncture and minimal acupuncture were administered by specialized acupuncture physicians in 30 outpatient centers, and consisted of 12 sessions per patient over 8 weeks. Patients completed standardized questionnaires at baseline and at 8, 26, and 52 weeks after randomization. The primary outcome variable was the change in low back pain intensity from baseline to the end of week 8, as determined on a visual analog scale (range, 0-100 mm). RESULTS: A total of 298 patients (67.8% female; mean +/- SD age, 59 +/- 9 years) were included. Between baseline and week 8, pain intensity decreased by a mean +/- SD of 28.7 +/- 30.3 mm in the acupuncture group, 23.6 +/- 31.0 mm in the minimal acupuncture group, and 6.9 +/- 22.0 mm in the waiting list group. The difference for the acupuncture vs minimal acupuncture group was 5.1 mm (95% confidence interval, -3.7 to 13.9 mm; P = .26), and the difference for the acupuncture vs waiting list group was 21.7 mm (95% confidence interval, 13.9-30.0 mm; P<.001). Also, at 26 (P=.96) and 52 (P=.61) weeks, pain did not differ significantly between the acupuncture and the minimal acupuncture groups. CONCLUSION: Acupuncture was more effective in improving pain than no acupuncture treatment in patients with chronic low back pain, whereas there were no significant differences between acupuncture and minimal acupuncture.