Effectiveness and Safety of Pharmacopuncture Treatment for Rotator Cuff Disease
- Conditions
- Diseases of the musculoskeletal system and connective tissue
- Registration Number
- KCT0007416
- Lead Sponsor
- Korea Institute of Oriental Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
1) 19-75 years old
2) Those diagnosed with rotator cuff disease by other medical institutions or this researcher
3) Visual Analogue Scale(VAS) of shoulder pain is more than 40mm
4) Those who voluntarily decide to participate and consent in writing after hearing a sufficient explanation of the research purpose and process
1) Participants who had undergone shoulder surgery within 3 months
2) Participants who diagnosed with specific serious disease that may cause shoulder pain(bone metastasis of tumor, vertebral fracture, etc.)
3) Participants who are scheduled for shoulder surgery within the study period
4) Participants who have underlying disease (stroke, myocardial infarction, kidney disease, severe diabetes, dementia, epilepsy, severe hemorrhagic disease, etc.) that may interfere with treatment effect or interpretation of results
5) Participants taking steroid, immunosuppressant, psychotropic medication, or taking other drugs within the last 3 months that may affect outcomes
6) Participants with severe abnormalities in blood tests (AST or ALT is 3 times the upper limit of normal range, blood creatinine is 2 times the upper limit of normal range, etc.)
7) Participants who took NSAIDs or pharmacopuncture, acupuncture, physical therapy within 1 week
8) Pregnant, planning to get pregnant or lactating women
9) Participants who had participated in other clinical trial within 1 month, or have plan for participation in other trial during follow up period of this trial
10) Participants who are difficult to participate in the trial according to investigator's decision
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Visual analogue scale(VAS)
- Secondary Outcome Measures
Name Time Method Shoulder Pain And Disability Index(SPADI);Range of Motion of the shoulder(ROM);EuroQol-5D(EQ-5D);Patient Global Impression of change (PGIC) ;no worse than mild pain;Safety assessment(Adverse effect);pain medicine consumption