Knee Osteoarthritis
Conditions
Interventions
Waitlist control group:Delayed Treatment Intervention
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Diagnosed with primary unilateral knee osteoarthritis; (2) Symptoms persisting for at least one week; (3) Early to mid-stage disease (past six months) identified using the 2018 Chinese Medical Association's "Expert Consensus on Stepwise Treatment of Knee Osteoarthritis," incorporating imaging results (Kellgren-Lawrence Grade II-III) and symptom presentation; (4) Aged 40-75 years, irrespective of gender; (5) BMI < 28 kg/m²; (6) Visual Analog Scale (VAS) score between 40mm and 90mm; (7) Agrees not to use anti-inflammatory analgesics during the study (allowed when VAS = 80mm); (8) Spontaneous pain in the affected knee, palpable stiffness, nodules and cord-like structures in the vastus lateralis muscle on the affected side upon examination, or significant pain or discomfort compared to the healthy side as reported by the patient; (9) Willing and able to comply with the study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Acute inflammatory reaction in the affected knee, with symptoms of redness, swelling, heat, and pain; or severe deformity of the knee or poor lower limb alignment; (2) Secondary knee osteoarthritis, such as gouty arthritis, hemophilic arthritis, or knee joint structural damage due to severe trauma (e.g., car accidents, falls from heights); (3) Pregnant or lactating patients; (4) Use of osteoarthritis-related medications or traditional Chinese medicine (internal or external) within the past 3 months, or knee surgery within the past 6 months, potentially affecting study outcomes; (5) Concurrent lower limb pain due to other conditions, such as lumbar disc herniation, lumbar spinal stenosis; concomitant lower limb vascular disease; or multiple joint inflammations; (6) Engagement in professional sports or physical labor, or regular physical exercise habits (e.g., swimming, jogging, brisk walking); (7) Uncontrolled or undiagnosed internal medical conditions that may interfere with or affect the study treatment, such as severe liver, kidney, heart, or brain diseases; untreated or poorly controlled hypertension, or endocrine or immune system disorders; (8) Cognitive impairment or severe depression, anxiety; history of psychiatric illness; (9) Refusal to receive Fu’s subcutaneous needling therapy; (10) Tendency to bleed (e.g., leukemia, thrombocytopenia, irregular anticoagulant medication use); (11) Severe systemic or local skin diseases in the lower limbs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale;Western Ontario and McMaster Universities Osteoarthritis Index function subscale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale;Western Ontario and McMaster Universities Osteoarthritis Index;Range of motion of the affected knee;Assessment of Trust and Expectation Levels;30s chair-stand test;40 m (4×10 m) fast-paced walk test;9-step stair-climb test; | — |
Countries
China
Contacts
Public ContactJian Sun
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed