The efficacy of jade moxibustion in knee osteoarthritis

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2020
INTERVENTION: Patients with knee osteoarthritis are randomly allocated into either jade moxibustion or traditional moxibustion groups. Patients will receive jade moxibustion or traditional moxibustion treatment on ST35, ST34, EX‐LE4, SP10 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. At 24 weeks, the questionnaire will be mailed to the subjects and they will be asked to post them back after filling them out. 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. CONDITION: Knee osteoarthritis ; Musculoskeletal Diseases ; Knee 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. Sensation measured by investigator question "What do you feel during the treatment?" (with possible answers of: heat, cold, pain, no feeling, or other which will be described); 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; 8. Dose of analgesic or non‐steroidal anti‐inflammatory drugs consumed, determined through daily participant reports from baseline to 24 weeks; 9. Any adverse events or side effects during the study are determined from the subject and investigator reports collected weekly from baseline to 24 weeks. Common side effects include redness and blisters by jade moxibustion and traditional moxibustion. Serious adverse events will also be reported to the Ethics Committee; INCLUSION CRITERIA: 1. Aged 50 to 75 years 2. Knee osteoarthritis according to the American College of Rheumatology Diagnostic Criteria 3. Radiologic confirmation of knee osteoarthritis (Kallgren‐Lawrence level =1) 4. Moderate to severe knee pain on most days of the past month (VAS score for arthritic pain =40) 5. Has a full understanding and gives informed consent to participate in the study
Epistemonikos ID: fc8e5bec31eaf76afaac2de42c4d422d5d5180a9
First added on: Aug 24, 2024