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

Jaseng Hospital of Korean Medicine1 site in 1 country21 target enrollmentApril 20, 2022

ConditionsAdhesive Capsulitis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Adhesive Capsulitis
Sponsor: Jaseng Hospital of Korean Medicine
Enrollment: 21
Locations: 1
Primary Endpoint: Numeric rating scale (NRS) of shoulder pain
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 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.

Registry

clinicaltrials.gov

Start Date

April 20, 2022

End Date

December 6, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Jaseng Hospital of Korean Medicine

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Numeric rating scale (NRS) of shoulder pain

Time Frame: 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'.