INTRODUCTION: Our objective was to compare the effectiveness and safety of traditional Chinese moxibustion to that of sham moxibustion in patients with chronic knee osteoarthritis (KOA) pain. METHODS: We conducted a randomized placebo-controlled trial involving 110 patients with KOA who met the inclusion criteria. These patients randomly received either active moxibustion (n = 55) or sham moxibustion control (n = 55) at acupoints Dubi (ST35), extra-point Neixiyan (EX-LE4), and an Ashi (tender) point three times a week for 6 weeks. Effects were evaluated with Western Ontario and McMaster Universities' Osteoarthritis Index (WOMAC VA 3.1) criteria at the end of the course of treatment and 3, 12, and 24 weeks after the initial treatment. RESULTS: The WOMAC pain scores showed greater improvement in the active treatment group than in control at weeks 3 (p = 0.012), 6 (p < 0.001), 12 (p = 0.002), and 24 (p = 0.002) as did WOMAC physical function scores of the active treatment group at week 3 (p = 0.002), 6 (p = 0.015), and 12 (p < 0.001) but not 24 (p = 0.058). Patients and practitioners were blinded successfully, and no significant adverse effects were found during the trial. CONCLUSIONS: A 6-week course of moxibustion seems to relieve pain effectively and improve function in patients with KOA for up to 18 weeks after the end of treatment. Moxibustion treatment appears to be safe, and the usefulness of the novel moxa device was validated. TRIAL REGISTRATION: Current Controlled Trial ISRCTN68475405. Registered 4 April 2014.

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