Status:
COMPLETED
Pragmatic Randomized Controlled Trial of Pharmacopuncture Therapy for Adhesive Capsulitis : A Pilot Study
Lead Sponsor:
Jaseng Hospital of Korean Medicine
Collaborating Sponsors:
Korea Institute of Oriental Medicine
Conditions:
Adhesive Capsulitis
Eligibility:
All Genders
19-69 years
Phase:
NA
Brief Summary
This is a 2-arm parallel pragmatic randomized controlled trial that will compare pharmacopuncture therapy with physical therapy for adhesive capsulitis.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2022
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT05292482
Start Date
April 20 2022
End Date
December 6 2022
Last Update
June 15 2023
Active Locations (1)
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1
Jaseng Korean Medicine Hospital
Seoul, South Korea