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| Name | Class |
|---|---|
| Korea Institute of Oriental Medicine | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pharmacopunture therapy | Experimental | The physicians will choose the type and volume of pharmacopuncture according to participants' conditions and inject it at the proper acupoints they choose. |
|
| physical therapy | Active Comparator | The physicians will choose the type and time of physical therapy according to participants' conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pharmacopuncture therapy | Procedure | This is a pragmatic RCT, so the physicians will choose the type and volume of pharmacopuncture according to participants' conditions. |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyoung Sun Park, Ph.D | Jaseng Hospital of Korean Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jaseng Korean Medicine Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39224580 | Derived | Kim D, Park KS, Kim SA, Seo JY, Cho HW, Lee YJ, Yang C, Ha IH, Han CH. Pharmacopuncture therapy for adhesive capsulitis: A pragmatic randomized controlled pilot study. Integr Med Res. 2024 Sep;13(3):101065. doi: 10.1016/j.imr.2024.101065. Epub 2024 Jun 21. |
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| ID | Term |
|---|---|
| D002062 | Bursitis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| physical therapy | Procedure | This is a pragmatic RCT, so the physicians will choose the type and time of physical therapy according to participants' conditions. |
|
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 |