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

Primary Purpose

Adhesive Capsulitis

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
pharmacopuncture therapy
physical therapy
Sponsored by
Jaseng Hospital of Korean Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adhesive Capsulitis

Eligibility Criteria

19 Years - 69 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Jaseng Korean Medicine Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

pharmacopunture therapy

physical therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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'.

Secondary Outcome Measures

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.
ROM(Range of motion)
The range of shoulder movement shows the function of the shoulder capsule.
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).
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.)
SF-12 v2
The SF-12 consists of 12 questions across 8 domains, and higher scores indicate better health-related quality of life.
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)

Full Information

First Posted
March 15, 2022
Last Updated
June 13, 2023
Sponsor
Jaseng Hospital of Korean Medicine
Collaborators
Korea Institute of Oriental Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05292482
Brief Title
Pragmatic Randomized Controlled Trial of Pharmacopuncture Therapy for Adhesive Capsulitis : A Pilot Study
Official Title
Pragmatic Randomized Controlled Trial of Pharmacopuncture Therapy for Adhesive Capsulitis : A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
April 20, 2022 (Actual)
Primary Completion Date
October 25, 2022 (Actual)
Study Completion Date
December 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jaseng Hospital of Korean Medicine
Collaborators
Korea Institute of Oriental Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pharmacopunture therapy
Arm Type
Experimental
Arm Description
The physicians will choose the type and volume of pharmacopuncture according to participants' conditions and inject it at the proper acupoints they choose.
Arm Title
physical therapy
Arm Type
Active Comparator
Arm Description
The physicians will choose the type and time of physical therapy according to participants' conditions.
Intervention Type
Procedure
Intervention Name(s)
pharmacopuncture therapy
Intervention Description
This is a pragmatic RCT, so the physicians will choose the type and volume of pharmacopuncture according to participants' conditions.
Intervention Type
Procedure
Intervention Name(s)
physical therapy
Intervention Description
This is a pragmatic RCT, so the physicians will choose the type and time of physical therapy according to participants' conditions.
Primary Outcome Measure Information:
Title
Numeric rating scale (NRS) of shoulder pain
Description
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'.
Time Frame
week 7
Secondary Outcome Measure Information:
Title
Visual analogue scale (VAS) of shoulder pain
Description
Visual analogue scale of shoulder pain, minimum 0 to maximum 100, which is a higher score means a worse outcome.
Time Frame
week 1, 2, 3, 4, 5, 6, 7, 13
Title
ROM(Range of motion)
Description
The range of shoulder movement shows the function of the shoulder capsule.
Time Frame
week 1, 2, 3, 4, 5, 6, 7, 13
Title
SPADI
Description
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).
Time Frame
week 1, 7, 13
Title
PGIC
Description
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.)
Time Frame
week 7, 13
Title
SF-12 v2
Description
The SF-12 consists of 12 questions across 8 domains, and higher scores indicate better health-related quality of life.
Time Frame
week 1, 7, 13
Title
EQ-5D-5L
Description
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)
Time Frame
week 1, 7, 13

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyoung Sun Park, Ph.D
Organizational Affiliation
Jaseng Hospital of Korean Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jaseng Korean Medicine Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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