Osteoarthritis
Conditions
Interventions
Control group:Under ultrasound guidance, PRP injection is administered into the diseased joint, with 2-3ml per injection, once a week, for a continuous 3-week period, constituting one course of treatm
Experimental group:PRP Combined Spectral Therapy Device
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years, any gender; 2. Meets the American College of Rheumatology (ACR) diagnostic criteria for osteoarthritis; 3. Has not received intra-articular injections, physical therapy, or anti-inflammatory systemic treatments in the past month; 4. Visual Analog Scale (VAS) pain score >=4 (out of 10) at rest within a week; 5. Kellgren–Lawrence grade II-III; 6. Adequate organ function with baseline laboratory values within the following limits: - Hemoglobin >=90 g/L; - Platelet count >=100×10^9/L; - Neutrophil count >=1.5×10^9/L; - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =40 mL/min; - Creatine kinase (CK) <=2×ULN; - Glycated hemoglobin A1c (HbA1c) <=10.0%; 7. The patient or their legal guardian voluntarily agrees to participate and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Combined non-degenerative joint diseases such as rheumatoid arthritis and gouty arthritis; 2. Known history of the following immunodeficiencies: Human Immunodeficiency Virus (HIV) or active Hepatitis C Virus (HCV: PCR positive for RNA) or active Hepatitis B Virus (HBV: PCR positive for DNA) infection; 3. Have active autoimmune diseases or a history of autoimmune diseases with potential relapse (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), excluding patients with clinically stable autoimmune thyroid diseases or type 1 diabetes; 4. The affected limb has fractures, severe deformities, infections, tumors, or a history of surgery; 5. Accompanied by severe coagulation disorders or abnormal platelet counts; 6. Pregnant or breastfeeding women; 7. Allergic to PRP components or unable to tolerate spectrum quality; 8. Patient or their legal guardian refuses to sign for treatment; 9. Any life-threatening diseases, physical conditions, or organ system dysfunctions regarded by the investigator as potentially endangering the subject's safety or unnecessarily risking the study results; known alcohol or drug dependence; uncontrolled psychiatric disorders; cognitive impairment; 10. Subjects whom the investigator considers to have other systemic disease histories or who are otherwise unsuitable for participation in this clinical trial for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in effective rates between groups at 3 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficiency differences between groups at other time points;Improvement of joint function; | — |
Countries
China
Contacts
Public ContactCheng Weinan
Shanghai Sixth People's Hospital
Outcome results
None listed