Osteoarthritis
Conditions
Interventions
Control Group:Intra-articular injection of normal saline plus hyaluronic acid once weekly for 5 consecutive weeks (2mL normal saline and 2.5mL [25mg] hyaluronic acid per injection)
Intervention Group:Intra-articular injection of arginine hydrochloride combined with hyaluronic acid once weekly for 5 consecutive weeks (2mL [500mg] arginine hydrochloride and 2.5mL [25mg] hyaluronic
Sponsors
Anhui Fuyang People's Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 40 and 80 years; 2. Meet the American College of Rheumatology (ACR) diagnostic criteria for symptomatic knee osteoarthritis; 3. Kellgren-Lawrecne knee osteoarthritis X-ray grade 1 to 3; 4. Willing and able to undergo knee radiographic examination; 5. Willing and able to undergo knee MRI examination; 6. Voluntarily participate in this study and provide written informed consent; 7. Able to complete follow-up visits by telephone or in person at the hospital.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding females, or females with a positive pregnancy test; 2. Diagnosis of rheumatoid arthritis, other autoimmune diseases or serious underlying illnesses (e.g., psoriatic arthritis, systemic lupus erythematosus, active malignancy, severe cardiovascular or renal diseases); 3. Bleeding tendency or coagulation disorders; 4. Severe hepatic or renal dysfunction; 5. Skin disease or infection at the injection site, or history of knee joint infection, surgery, or radiotherapy within the preceding 3 months; 6. Intra-articular, intramuscular or oral administration of corticosteroids, hyaluronic acid or L-arginine within the preceding 3 months; 7. Known hypersensitivity to any study medications; 8.MRI contraindications (e.g., cardiac pacemaker, artificial metal valve, history of clipped intracranial aneurysm, arterial dissection or claustrophobia); 9. Participation in other clinical trials that may confound the results within the preceding 12 months; 10. Other conditions deemed inappropriate for participation by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score;Knee cartilage volume loss (CVL); | — |
Secondary
| Measure | Time frame |
|---|---|
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness score;Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function score;Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score;Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score;Visual analogue scale (VAS) score;Clinical symptom score;Bone marrow lesions (BMLs);Effusion-synovitis;Timed Up and Go test (TUG); | — |
Countries
China
Contacts
Public ContactXiaochun Bai; Haiyang Yu
Southern Medical University; Anhui Fuyang People's Hospital
Outcome results
None listed