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Completed

NCT Number: NCT05292482

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.

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Key information

Conditions

Adhesive Capsulitis Bursitis Joint Diseases Musculoskeletal Diseases

Age range

19 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jaseng Korean Medicine Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pharmacopuncture therapy

Procedure

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

physical therapy

Procedure

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

Primary outcomes

  1. Numeric rating scale (NRS) of shoulder pain

    Time frame: week 7

    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 outcomes

  1. Visual analogue scale (VAS) of shoulder pain

    Time frame: week 1, 2, 3, 4, 5, 6, 7, 13

    Visual analogue scale of shoulder pain, minimum 0 to maximum 100, which is a higher score means a worse outcome.

  2. ROM(Range of motion)

    Time frame: week 1, 2, 3, 4, 5, 6, 7, 13

    The range of shoulder movement shows the function of the shoulder capsule.

  3. SPADI

    Time frame: week 1, 7, 13

    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).

  4. PGIC

    Time frame: week 7, 13

    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.)

  5. SF-12 v2

    Time frame: week 1, 7, 13

    The SF-12 consists of 12 questions across 8 domains, and higher scores indicate better health-related quality of life.

  6. EQ-5D-5L

    Time frame: week 1, 7, 13

    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)

Sponsors and collaborators

Lead sponsor

Jaseng Hospital of Korean Medicine

Other

Collaborators

  • Korea Institute of Oriental Medicine

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 23, 2022
Registry last updated
Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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