The effect of infrared heating or traditional moxibustion in osteoarthritis of the knee

INTERVENTION: Patients with knee osteoarthritis are randomly allocated into either CO2 laser moxibustion or traditional moxibustion groups. Patients will receive CO2 laser moxibustion or traditional moxibustion treatment on ST35, EX‐LE4 and Ashi points in the area of the affected knee(s). Patients in both groups receive 20 minutes of treatment, 3 times per week for 4 weeks. The effects of treatment on the most painful joint (which is identified through participant report at baseline and is the joint assessed throughout the study) are assessed at the hospital at baseline, 2 (mid‐term), 4 (the end of treatment), 8, and 12 weeks after baseline. During the follow‐up period (5 to 24 weeks), the subject report on adverse events and side effects will be sought via telephone call weekly. Participants will be allowed to take any analgesic or non‐steroidal anti‐inflammatory drugs that they used before the study. They will be asked to record the daily dose during the entire clinical trial, and then the investigators will analyze the changes in the dose. Laser moxibustion: The wavelength of laser irradiation was 10.6 µm, and the output power was adjusted in the range of 160‐180 mW. Energy density ranged from 61.2 to 68.8 J/cm2 for one treatment. Traditional moxibustion:We used a commercially available moxibustion device (Nanyang Hanyi Moxa Company, Ltd., Nanyang, Henan, China). It has a cylindrical opening to hold a pillar of moxa; at its base is an adhesive membrane. During treatment, the device is placed at an acupoint, and the moxa is burned about 8 mm above the skin. Both groups have 20 minutes of treatment. CONDITION: Knee osteoarthritis ; Musculoskeletal Diseases ; Osteoarthritis PRIMARY OUTCOME: Knee pain, measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score at baseline and 2, 4, 8, 12, and 24 weeks SECONDARY OUTCOME: ; 1. Knee function measured using the WOMAC function score at baseline, weeks 2, 4, 8, 12, and 24 weeks; 2. Knee stiffness measured using the WOMAC stiffness score at baseline, weeks 2, 4, 8, 12, and 24 weeks; 3.Knee osteoarthritis symptoms measured using the WOMAC total score at baseline, weeks 2, 4, 8, 12, and 24 weeks; 4. Knee pain measured using the Visual Analogue Scale (VAS) pain score at baseline, weeks 2,4, 8, 12, and 24 weeks; 5. The 50‐yard walking time was assessed and recorded among the participants at baseline, weeks 4 and 12weeks to observe improvements in walking.; 6. Quality of life measured using the 36‐Item Short Form Health Survey (SF‐36) at 4, 12 and 24 weeks and the Quality of Life Scale (QOLS) at 4 weeks; 7. Participant perception of the safety of the treatment measured by investigator question (with possible answers of: safe, less safe, safety problem, or serious safety problem) at 4 weeks; INCLUSION CRITERIA: Patients aged 50 to 75 undergoing conventional knee osteoarthritis treatment