Pragmatic Randomized Controlled Trial of Pharmacopuncture Therapy for Adhesive Capsulitis : A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Numeric rating scale (NRS) of shoulder pain
研究概览
简要总结
This is a 2-arm parallel pragmatic randomized controlled trial that will compare pharmacopuncture therapy with physical therapy for adhesive capsulitis.
详细描述
Participants who voluntarily signed informed consent form and eligible for the study were randomly assigned in a 1:1 ratio (25:25) for pharmacopuncture therapy and physical therapy group. Participants of each group will receive twice a week for total 6 weeks of intervention. This is a pragmatic randomized controlled trial, so physicians will have medical decision making according to each participant's conditions.
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 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Limitation of the shoulder movement (active or passive)
- •Numeric Rating Scale (NRS) of neck pain is more than 5
- •Symptoms of adhesive capsulitis for more than 1 month
- •Discrimination findings which can explain clinical symptoms on shoulder MRI or CT
- •19-69 years old
- •participants who agreed and wrote informed consents
排除标准
- •Case of being diagnosed with a specific serious disease that may cause shoulder pain(Fracture, Dislocation, etc.)
- •Cause of pain due to soft tissue disease, not the spine(Cancer, fibromyalgia, RA, goat, or etc.) Other chronic diseases(stroke, MI, kidney disease, diabetic neuropathy, dimentia, epilepsy, or etc.) that may interfere with the interpretation of therapeutic effects or outcomes
- •Participants taking steroid, immunosuppressant, psychotropic medication, or taking other drugs that may affect outcomes
- •Inappropriate or unsafe pharmacopuncture therapy; hemorrhagic disease, taking anticoagulant drug, or severe diabetes patients who are likely to be infected
- •Participants who took NSAIDs or pharmacopuncture, acupuncture, physical therapy within 1 week
- •Pregnant, planning to get pregnant or lactating women
- •Participants who had undergone shoulder surgery within 3 months
- •Participants who had participated in other clinical trial within 1 month, had participated in other study within 6 months from the date of selection, or have plan for participation in other trial during follow up period of this trial
- •Participants who can not write informed consent
- •Participants who is difficult to participate in the trial according to investigator's decision
结局指标
主要结局
Numeric rating scale (NRS) of shoulder pain
时间窗: week 7
NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.
次要结局
- Visual analogue scale (VAS) of shoulder pain(week 1, 2, 3, 4, 5, 6, 7, 13)
- SPADI(week 1, 7, 13)
- SF-12 v2(week 1, 7, 13)
- EQ-5D-5L(week 1, 7, 13)
- ROM(Range of motion)(week 1, 2, 3, 4, 5, 6, 7, 13)
- PGIC(week 7, 13)