Patients with primary knee osteoarthritis of Kellgren-Lawrence grade II or III Knee Osteoarthritis Acupuncture
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosed with primary knee osteoarthritis according to the American College of Rheumatology (ACR) diagnostic criteria. 2. Radiographic severity of knee osteoarthritis classified as Kellgren-Lawrence grade II or III. 3. Bilateral knee involvement. 4. Knee pain intensity of 40 mm or higher on a 100-mm Visual Analog Scale (VAS) at baseline. 5. Presence of knee pain symptoms for a minimum duration of three months prior to enrollment. 6. No history of acute knee injury within the three months prior to enrollment. 7. Able to ambulate independently, with or without the use of assistive devices. 8. Willing and able to participate in the study and having provided written informed consent.
Exclusion criteria
Exclusion criteria: 1. Currently experiencing an acute flare of knee symptoms. 2. Presence of systemic inflammatory joint diseases, including but not limited to rheumatoid arthritis, gout, ankylosing spondylitis, or osteoarticular tuberculosis. 3. History of knee surgery, including total knee replacement or arthroscopic surgery. 4. Receipt of intra-articular corticosteroid injection within the past three months, or hyaluronic acid or platelet-rich plasma (PRP) injection within the past six months. 5. Treatment with acupoint catgut embedding or auricular acupuncture within the past three months. 6. History of keloid formation or hypertrophic scarring. 7. Coagulation disorders or current use of anticoagulant therapy. 8. Allergy to absorbable surgical sutures, local infection or skin lesions at the acupoint area, or any contraindication to acupoint catgut embedding or auricular acupuncture according to the Vietnam Ministry of Health guidelines. 9. Auricular deformities that obscure anatomical landmarks required for accurate identification of auricular acupuncture points. 10. Participation in another clinical trial or completion of an interventional study within the previous three months. 11. Presence of severe or unstable comorbidities that, in the investigator's opinion, could pose a safety risk or interfere with the evaluation of treatment efficacy (for example: NYHA class IV heart failure, severe hepatic impairment, end-stage renal disease, respiratory failure, uncontrolled diabetes mellitus, progressive malignancy, neuropsychiatric disorders, severe active infection, or a high risk of infection due to immunosuppression or immunosuppressive therapy). 12. Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in knee pain intensity at baseline and every two weeks over four weeks 100mm Visual Analog Scale (VAS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Requirement for analgesic medication during four weeks Medical records,Change in physical function and joint stiffness at baseline and every two weeks over four weeks Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC),Change in constant pain, intermittent pain, and pain-related impact on daily activities at baseline and every two weeks over four weeks Intermittent and Constant Osteoarthritis Pain (ICOAP) questionnaire,Patient satisfaction after four weeks 100mm Visual Analog Scale (VAS),Adverse events related to the procedures during four weeks Patient interviews, medical records, and clinical observations | — |
Countries
Vietnam
Contacts
University of Medicine and Pharmacy at Ho Chi Minh City