Ling Zhao1, Ke Cheng2, Fan Wu1, Jiong Du3, Yue Chen4, Ming T Tan5, Lixing Lao6, Xueyong Shen7. 1. L. Zhao, PhD, F. Wu, PhD, School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, and Shanghai Research Center of Acupuncture & Meridian, Shanghai, China Shanghai, China. 2. K. Cheng, PhD, X. Shen, MD, School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, and School of Shanghai Research Center of Acupuncture & Meridian, Shanghai, China. 3. J. Du, PhD, Department of Orthopedics and Traumatology department Shuguang Hospital, Shanghai, China. 4. Y. Chen, PhD, Department of Traditional Chinese Medicine, Shanghai Tongren Traditional Chinese Medicine Hospital, Shanghai, China. 5. M.T. Tan, PhD, Department of Biostatistics, Bioinformatics & Biomathematics Georgetown University Medical Center, Washington, USA. 6. L. Lao, PhD, Virginia University of Integrative Medicine, Fairfax, Virginia, USA, and School Of Chinese Medicine, University of Hong Kong, Hong Kong, China. 7. K. Cheng, PhD, X. Shen, MD, School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, and School of Shanghai Research Center of Acupuncture & Meridian, Shanghai, China; sxy1@shutcm.edu.cn llao@vuim.edu.
Abstract
OBJECTIVE: To examine the effects of laser moxibustion on pain and function in patients with knee osteoarthritis (OA). METHODS: A double-blind randomized clinical trial (4-week treatment, 20-week follow-up) was conducted. A total of 392 symptomatic knee OA patients with moderate to severe clinically significant knee pain were randomly assigned to laser treatment or sham laser control group (1:1). Twelve sessions of laser moxibustion or sham laser treatments on the acupuncture points at the affected knee(s) were performed 3 times a week for 4 weeks. The primary outcome measurement was change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score from baseline to Week 4. RESULTS: Among the 392 randomized participants, 364 (92.86%) completed the trial. The median WOMAC pain score decreased significantly at Week 4 in the active group than in the sham group (2.1, 95% CI 1.6-2.6, P < 0.01). At Week 24, compared to the sham laser, active laser treatment resulted in significant pain reduction and function improvement (3.0, 95% CI 2.5-3.6, P < 0.01, and 14.8, 95% CI 11.9-17.6, P < 0.01, respectively). The physical component of the quality of life significantly improved in the active group vs the sham controls at Week 4 (3.2, 95% CI 1.3-5.0, P = 0.001) up to Week 24 (5.1, 95% CI 3.3-7.0, P < 0.001). No serious adverse effects were reported. CONCLUSION:Laser moxibustion resulted in statistically and clinically significant pain reduction and function improvement following a 4-week treatment in patients with knee OA.
RCT Entities:
OBJECTIVE: To examine the effects of laser moxibustion on pain and function in patients with knee osteoarthritis (OA). METHODS: A double-blind randomized clinical trial (4-week treatment, 20-week follow-up) was conducted. A total of 392 symptomatic knee OA patients with moderate to severe clinically significant knee pain were randomly assigned to laser treatment or sham laser control group (1:1). Twelve sessions of laser moxibustion or sham laser treatments on the acupuncture points at the affected knee(s) were performed 3 times a week for 4 weeks. The primary outcome measurement was change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score from baseline to Week 4. RESULTS: Among the 392 randomized participants, 364 (92.86%) completed the trial. The median WOMAC pain score decreased significantly at Week 4 in the active group than in the sham group (2.1, 95% CI 1.6-2.6, P < 0.01). At Week 24, compared to the sham laser, active laser treatment resulted in significant pain reduction and function improvement (3.0, 95% CI 2.5-3.6, P < 0.01, and 14.8, 95% CI 11.9-17.6, P < 0.01, respectively). The physical component of the quality of life significantly improved in the active group vs the sham controls at Week 4 (3.2, 95% CI 1.3-5.0, P = 0.001) up to Week 24 (5.1, 95% CI 3.3-7.0, P < 0.001). No serious adverse effects were reported. CONCLUSION: Laser moxibustion resulted in statistically and clinically significant pain reduction and function improvement following a 4-week treatment in patients with knee OA.