Knee Osteoarthritis
Conditions
Interventions
test group:Basic treatment + Bone paste plaster
Control group:Basic treatment + Diclofenac sodium patch
Sponsors
Zhejiang Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Consistent with the diagnosis of knee osteoarthritis; (2) TCM differentiation is cold and wet paralysis; (3) Determined by the investigator or the radiologist of the research center during the screening period, the imaging grade of Kellgren-Lawrence on the study side of the knee joint is grade 1-3 (imaging results within 3 months before screening can be accepted), and the grade of the contralateral knee joint is not higher than the target side; (4) The clinical stage at the time of screening was the remission period, and the pain VAS score was 4-7 points (including 4 points and 7 points); (5) Age 40-75 years old (including 40 years old and 75 years old); (6) Voluntarily participate in the trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) The participant's knee joint was considered to be deformable osteitis (Paget's bone disease), joint fracture, severe dysplasia or congenital abnormality, tautosis, lupus, acromegaly, hemochromatosis, hepatolenticular degeneration, primary chondromatosis, or lower limb joint OA other than the knee joint, which may affect knee pain and functional evaluation; (2) A history of chronic inflammatory diseases (e.g., rheumatoid arthritis, psoriatic arthritis, gouty arthritis, fibromyalgia), or other causes that may affect the target joint or its function and pain assessment (e.g., osteonecrosis, cartilage calcification); (3) Body mass index (BMI) >35 kg/m2; (4) Abnormal limb function caused by abnormal nerve function; (5) Acupuncture and moxibustion were performed within 1 week before treatment, and intervention and local closure were performed within 3 weeks before treatment; (6) Use of NSaids within 7 days before randomization or plan to use them during the study period (except for acetaminophen tablets with a dose of less than 2000mg daily); (7) Participants who used opioids or corticosteroids within 30 days prior to screening or planned to use them during the study period (but only inhaled corticosteroids for asthma treatment were included); (8) Intra - cavity steroid injection, viscoelastic supplement or arthroscopy were performed on the study side of the knee within 3 months before screening; (9) The knee joint on the study side was injured or underwent surgery within 6 months before screening; (10) Abnormal liver and kidney function (AST and ALT > 2 times of normal upper limit, serum creatinine > normal upper limit); (11) lactating or pregnant women; (12) Allergic constitution or broken skin in the affected area; (13) Known alcohol or drug abuse; (14) Participated in any interventional clinical trials within the past 1 month; (15)Any other circumstances that compromised the subject's safety, affected the investigator's assessment, or poor adherence to the protocol were considered by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain VAS score;WOMAC score;TCM Syndrome Points;Imaging evaluation (MRI);Concise Health Status Questionnaire (SF-12) Score;interleukin-6?tumor necrosis factor a; | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse events ;vital signs;physical examination ;blood routine examination;routine urine and urine sediment microscopy ;liver function ;renal function ;12-lead ECG examination ; | — |
Countries
China
Contacts
Public ContactPeijian Tong
Zhejiang Hospital of Traditional Chinese Medicine
Outcome results
None listed