Efficacy and Safety Evaluation of Acupoint Application in the Treatment of Knee Osteoarthritis Joint Pain: a Randomized, Double-blind, Controlled Study
Overview
- Phase
- Phase 3
- Intervention
- acupoint application
- Conditions
- Knee Osteoarthritis
- Sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Changes in VAS pain score from baseline 4 weeks
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
To evaluate the efficacy and safety of acupoint application of Traditional Chinese medicine in the treatment of KOA joint pain through a prospective, randomized, double-blind, placebo-controlled clinical study.
Investigators
Quan Jiang
MD, PhD, Professor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Eligibility Criteria
Inclusion Criteria
- •Western medicine diagnosed as knee osteoarthritis, clinical classification is primary, and conforms to the TCM syndrome of cold and wet obstruction;
- •Guidelines for the diagnosis and treatment of osteoarthritis 2018 criteria and Kellgren -Lawrence\<Ⅲ;
- •VAS pain score ≥40mm (select the limb with the most obvious pain symptom);
- •For patients taking nonsteroidal drugs or other disease-improving drugs (such as cartilage protectants), the dose has been stable for at least 4 weeks;
- •Signed informed consent.
Exclusion Criteria
- •Patients who underwent intra-articular therapy within 3 months prior to the trial or required relevant surgical treatment within 1 year；
- •Glucocorticoid and joint cavity injection were used 4 weeks before treatment;
- •swelling and heat of knee joint;
- •other diseases causing knee pain; Such as acute joint injury, tuberculous arthritis, rheumatoid arthritis, rheumatoid arthritis, suppurative arthritis, osteomyelitis, psoriatic arthritis, gout, villi nodular synovitis.
- •History or evidence of any of the following diseases during the screening period: serious cardiovascular and cerebrovascular diseases, active or recurrent ulcer of digestive system or other diseases at risk of bleeding, other serious diseases of digestive system, combined with malignant tumor, serious or progressive diseases of blood system or other systems.
- •Patients with other mental diseases who are unable to cooperate or unwilling to cooperate.
- •Before screening, any of the laboratory test indicators met the following criteria: ALT and AST \> 1.5 times the upper limit of normal value, Cr \> 1.2 times the upper limit of normal value, and other clinically significant laboratory test abnormalities, which were determined by the investigator to be unsuitable for inclusion in the group.
- •allergic constitution or allergic to test drugs, excipients or similar ingredients.
- •Suspected or confirmed history of alcohol or drug abuse;
- •pregnant or lactating women or those who have planned pregnancy recently and do not want to use contraception;
Arms & Interventions
acupoint application
The acupoint application is applied each stick apply time 2h, once each day. Acupoints selected: Yanglingquan, Dubi, Neixiyan. The treatment lasted for 4 weeks.
Intervention: acupoint application
placebo
The placebo is applied the same acupuncture points, each stick apply time 2h, once each day. Acupoints selected: Yanglingquan, Dubi, Neixiyan. The treatment lasted for 4 weeks.
Intervention: placebo
Outcomes
Primary Outcomes
Changes in VAS pain score from baseline 4 weeks
Time Frame: 4 weeks
After treatment.researchers and investigators were assessed by VAS score (0-10cm) for the overall condition of the disease. Participants rated their current state of control from "very good" to "very poor." The researchers rated disease activity status from "no active rheumatism" to "most severe active rheumatism." The score is accurate to one decimal place.
Secondary Outcomes
- Number of Participants With Metabolic Abnormal Events at All Assessment Time Points.(4 weeks)
- Health Measurement Scale (SF-36)(4 weeks)
- Changes in WOMAC scale scores from baseline(4 weeks)