Osteoarthritis (OA)
Conditions
Interventions
Treatment group:Glucocorticoid
Placebo group:Placebo
Sponsors
Guabgzhou First People‘s Hospital
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with symptomatic knee osteoarthritis (OA) meeting the American College of Rheumatology (ACR) diagnostic criteria; 2. Age >= 40 years; 3. Knee pain persisting for more than 6 months, with a visual analogue scale (VAS, 100 mm) pain score >= 40 mm in the past week; 4. Ultrasound imaging confirming synovitis with effusion in the knee joint; 5. MRI-assessed Hoffa's synovitis score >= 1 and effusive synovitis score >= 2, evaluated using the MRI Osteoarthritis Knee Score (MOAKS) system; 6. Ability to hear, speak, read, and understand Chinese, to comprehend the study requirements, cooperate with study personnel during the study procedures, and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Allergy to glucocorticoids; 2. Intra-articular glucocorticoid injection in the knee within the past 6 months; 3. History of severe trauma or surgery in the study knee; 4. Planned hip or knee surgery within the next 6 months (including arthroscopy, joint replacement, or other open joint procedures); 5. Contraindications to MRI (e.g., implanted cardiac pacemaker, artificial metal heart valve or cornea, history of aneurysm clipping, arterial dissection, intraocular metal foreign body, or claustrophobia); 6. Coexisting other types of arthritis, such as rheumatoid arthritis, psoriatic arthritis, or gout; 7. Other conditions causing pain exceeding that of knee OA; 8. Malignant tumors or other life-threatening diseases; 9. Infection, unstable or poorly controlled diabetes, coagulation disorders, osteonecrosis, or gastric/duodenal ulcers within the past 12 months; 10. Current use of glucocorticoids, nonsteroidal anti-inflammatory drugs, or immunosuppressants; 11. Pregnant or breastfeeding women; 12. Use of any investigational drugs or devices within the past 30 days. Note:If both knees of a participant meet the inclusion criteria, the knee with the higher VAS pain score will be selected as the study knee.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in WOMAC Pain Subscale Score at 6 Months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Quality of Life at 6 Months;Proportion of OARSI–OMERACT Responders at 6-Month Follow-up (0 = Non-responder, 1 = Responder);Change in WOMAC Physical Function Subscale Score at 6 Months;Change in Hoffa-Synovitis Score (MOAKS) at 6 Months;Change in WOMAC Pain Subscale Score at 3 Months;Change in Knee Pain VAS Score at 6 Months;Change in WOMAC Score at 6 Months;Incidence of adverse events reported during the 6-month follow-up period;Change in Tibiofemoral Cartilage Defects at 6 Months; | — |
Countries
China
Contacts
Public ContactGuangfeng Ruan
Guabgzhou First People‘s Hospital
Outcome results
None listed