Efficacy and Safety Evaluation of Acupoint Application in the Treatment of Knee Osteoarthritis Joint Pain: a Randomized, Double-blind, Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Changes in VAS pain score from baseline 4 weeks
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
- •Participants in other clinical trials within 3 months prior to enrollment;
- •The investigator considered that the patients should not participate in the clinical trial.Other requirements for inclusion are willingness to participate for the duration of the trial. All patients will receive verbal and written information about the trial and sign a consent form before inclusion. The researcher obtains written consent before inclusion and randomisation.
研究组 & 干预措施
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.
干预措施: acupoint application (Drug)
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.
干预措施: placebo (Other)
结局指标
主要结局
Changes in VAS pain score from baseline 4 weeks
时间窗: 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.
次要结局
- 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)
研究者
Quan Jiang
MD, PhD, Professor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences