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

Jaseng Hospital of Korean Medicine

Status: Completed

Conditions: Adhesive Capsulitis

Treatments: Procedure: physical therapy; Procedure: pharmacopuncture therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05292482

JS-CT-2022-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 19 to 69 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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21 participants in 2 patient groups

pharmacopunture therapy

Experimental group

Description:

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

Treatment:

Procedure: pharmacopuncture therapy

physical therapy

Active Comparator group

Description:

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

Treatment:

Procedure: physical therapy