Pragmatic Randomized Controlled Trial of Pharmacopuncture Therapy for Adhesive Capsulitis: A Pilot Study

Not Applicable

Completed

• Conditions: Diseases of the musculoskeletal system and connective tissue

• Registration Number: KCT0007198
• Lead Sponsor: Jaseng Hospital of Korean Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-12-06
• Last Update Posted: 2 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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 Criteria

-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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umeric rating scale (NRS) of shoulder pain

Secondary Outcome Measures

Name	Time	Method
Visual analogue scale (VAS) of shoulder pain;ROM(Range of motion;SF-12 v2;EQ-5D-5