Knee osteoarthritis Musculoskeletal Diseases Knee osteoarthritis
Conditions
Interventions
Patients with knee osteoarthritis are randomly allocated into either jade moxibustion or traditional moxibustion groups.
Patients will receive jade moxibustion or traditional moxibustion treatment o
Sponsors
Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Knee pain caused by other diseases (such as rheumatoid arthritis, fibromyalgia syndrome, chronic fatigue syndrome, and ankylosing spondylitis) 2. Treatment with steroid drugs in the past 3 months 3. Received acupuncture or moxibustion treatment in the past 3 months 4. Intra-articular injection of hyaluronate in the past 6 months 5. Joint puncture or arthroscopy in the past year 6. Previous (or planned for during the trial) knee or hip replacement surgery 7. Use of other topical treatments for osteoarthritis of the knee 8. Diagnosis of any serious diseases including, but not limited to, heart disease, lung disease, kidney disease, liver disease, malignant tumor, systemic infection, infectious disease, and/or mental illness 9. Participation in another clinical study in the past month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
China
Contacts
Public ContactLusheng Chen
Outcome results
None listed