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

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

Study Overview

• Status: Completed
• Conditions: Adhesive Capsulitis
• Intervention / Treatment: Procedure: pharmacopuncture therapy; Procedure: physical therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Jaseng Korean Medicine Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: physical therapy; The physicians will choose the type and time of physical therapy according to participants' conditions.	Procedure: physical therapy; This is a pragmatic RCT, so the physicians will choose the type and time of physical therapy according to participants' conditions.
Experimental: 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.	Procedure: pharmacopuncture therapy; This is a pragmatic RCT, so the physicians will choose the type and volume of pharmacopuncture according to participants' conditions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric rating scale (NRS) of shoulder pain	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'.	week 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue scale (VAS) of shoulder pain	Visual analogue scale of shoulder pain, minimum 0 to maximum 100, which is a higher score means a worse outcome.	week 1, 2, 3, 4, 5, 6, 7, 13
ROM(Range of motion)	The range of shoulder movement shows the function of the shoulder capsule.	week 1, 2, 3, 4, 5, 6, 7, 13
SPADI	SPADI is a functional disability questionnaire. The possible range of each item score is 0 to 10. Total score range is 0 (better outcome) to 100 (worse outcome).	week 1, 7, 13
PGIC	Participants rate the improvement after treatment on a 7-point Likert scale (1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.)	week 7, 13
SF-12 v2	The SF-12 consists of 12 questions across 8 domains, and higher scores indicate better health-related quality of life.	week 1, 7, 13
EQ-5D-5L	The EQ-5D-5L consists of 5 questions (mobility, self-care, usual activities, pain, anxiety/depression) that ask about the current state of health, and answers each question with 5 likert. (1=I have no problems about, 2=I have slight problems about, 3=I have moderate problems about, 4=I have severe problems about, 5=I am unable to about)	week 1, 7, 13

Collaborators and Investigators

• Sponsor: Jaseng Hospital of Korean Medicine
• Collaborators: Korea Institute of Oriental Medicine
• Investigators: Principal Investigator: Kyoung Sun Park, Ph.D, Jaseng Hospital of Korean Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2022
• Primary Completion (Actual): October 25, 2022
• Study Completion (Actual): December 6, 2022

Study Registration Dates

• First Submitted: March 15, 2022
• First Submitted That Met QC Criteria: March 15, 2022
• First Posted (Actual): March 23, 2022

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Bursitis
• Other Study ID Numbers: JS-CT-2022-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No