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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-20

Study Completion Date

2022-12-06

Brief Summary

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This is a 2-arm parallel pragmatic randomized controlled trial that will compare pharmacopuncture therapy with physical therapy for adhesive capsulitis.

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Detailed Description

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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.

Conditions

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Adhesive Capsulitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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pharmacopunture therapy

The physicians will choose the type and volume of pharmacopuncture according to participants' conditions and inject it at the proper acupoints they choose.

Group Type EXPERIMENTAL

pharmacopuncture therapy

Intervention Type PROCEDURE

This is a pragmatic RCT, so the physicians will choose the type and volume of pharmacopuncture according to participants' conditions.

physical therapy

The physicians will choose the type and time of physical therapy according to participants' conditions.

Group Type ACTIVE_COMPARATOR

physical therapy

Intervention Type PROCEDURE

This is a pragmatic RCT, so the physicians will choose the type and time of physical therapy according to participants' conditions.

Interventions

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pharmacopuncture therapy

This is a pragmatic RCT, so the physicians will choose the type and volume of pharmacopuncture according to participants' conditions.

Intervention Type PROCEDURE

physical therapy

This is a pragmatic RCT, so the physicians will choose the type and time of physical therapy according to participants' conditions.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes