Pragmatic Randomized Controlled Trial of Pharmacopuncture Therapy for Chronic Knee Pain: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Knee pain numeric rating scale, NRS
研究概览
简要总结
This study is a pragmatic randomized controlled trial. Condition/disease: Chronic Knee Pain. Intervention: Pharmacopuncture
详细描述
Knee pain can have various causes. It may result from tears and injuries to structures or from inflammation due to various diseases. Chronic pain is often caused by overuse injuries, inflammation, or arthritis. Among these, osteoarthritis (OA) is the most common cause of chronic pain, affecting approximately 10% of Korean adults aged 20 to 89, either currently or in the past. In addition to OA, other conditions such as rheumatoid arthritis, post-traumatic degenerative arthritis, and chondromalacia can also lead to chronic pain. Therefore, it is evident that a significant number of patients suffer from chronic knee pain.
The purpose of this study is to conduct a pragmatic randomized controlled clinical trial involving 40 patients suffering from chronic knee pain. The trial will compare the effects of treatment strategies utilizing pharmacopuncture (20 patients) with those utilizing the standard Western medical treatment of physical therapy (20 patients) to verify the comparative efficacy of pharmacopuncture.
However, in this pragmatic clinical trial, patients will be randomly assigned to either the pharmacopuncture strategy or the physical therapy strategy. The specific methods of physical therapy and pharmacopuncture will not be predetermined but will be administered based on the clinical judgment of physicians and traditional Korean medicine practitioners according to the patient's condition. All applied treatment methods will be retrospectively reviewed through chart review and recorded in the Case Report Form (CRF) for comparison.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients whose NRS (Numeric Rating Scale) of knee pain is 5 or higher
- •Patients whose symptoms persist for more than 3 months
- •Patients who are between 19 and 70 years of age
- •Patients who, after receiving a detailed explanation of the clinical study and fully understanding it, voluntarily decide to participate and agree in writing to comply with the precautions.
排除标准
- •Patients who have been diagnosed with a specific serious disease that may cause knee pain (acute fracture, dislocation, traumatic damage to ligaments and cartilage, etc.)
- •If the cause of the pain is caused by a disease other than the knee (tumor, fibromyalgia, rheumatoid arthritis, gout, lumbar disc herniation, etc.)
- •Cases that occur due to a traumatic event and require surgical intervention due to suspected acute fracture, dislocation, ligament and cartilage damage
- •Patients who diagnosed other chronic diseases (stroke, myocardial infarction, kidney disease, diabetic neuropathy, dementia, epilepsy, etc.) that may interfere with the treatment effect or interpretation of results.
- •Patients who are currently taking steroids, immunosuppressants, drugs for mental illness, or other drugs that may affect the results of the study
- •Patients who acupuncture treatment is inappropriate or unsafe: Patients with bleeding disorders, those receiving anticoagulant treatment, and patients with severe diabetes at risk of infection.
- •Patients who have taken drugs that may affect pain, such as Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), or have received herbal acupuncture or physical therapy within the past week
- •Patients who are pregnant, planning to become pregnant, or are breastfeeding
- •Patients within 3 months after knee surgery or if knee replacement surgery was performed
- •Patients who has been less than 1 month since you finished participating in another clinical study, or if you are planning to participate in another clinical study during the study participation and follow-up period within 6 months from the date of selection
- •Patients who difficult to fill out the consent form for research participation
- •Other cases where participation in clinical research is difficult in the judgment of the researcher.
研究组 & 干预措施
Pharmacopuncture
20 patients with pharmacoacupuncture
干预措施: Pharmacopuncture (Procedure)
Physical therapy
20 patients with physical therapy
干预措施: Physical therapy (Procedure)
结局指标
主要结局
Knee pain numeric rating scale, NRS
时间窗: Screening day(W-1), Week 1, 2, 3, 4, 6
Joint pain will be assessed using the NRS. In the NRS, the patient chooses a number from 0 to 10 that best describes how comfortably they can relax (0 being no pain and 10 being the most comfortable they can imagine).
次要结局
- Knee pain visual analogue scale, VAS(Week 1, 2, 3, 4, 6)
- Korean Western Ontario & McMaster, K-WOMAC(Week 1, 4, 6)
- Short Form-12 Health Survey version 2, SF-12 v2(Week 1, 4, 6)
- Patient Global Impression of Change, PGIC(Week 4, 6)
- Economic evaluation question-Productivity loss(Week 1, 2, 3, 4, 6)
- Range of motion, ROM(Screening day(W-1), Week 1, 2, 3, 4, 6)
- Economic evaluation question-Medical costs(Week 1, 2, 3, 4, 6)
- EuroQol-5 Dimension, EQ-5D-5L(Week 1, 4, 6)
- Credibility and Expectancy(Screening day(W-1))
- Economic evaluation question-Time cost(Week 2)