Clinical trial NCT05292482: 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
Overall status: COMPLETED
Phase: NA
Conditions: Adhesive Capsulitis
Lead sponsor: Jaseng Hospital of Korean Medicine
Sponsor class: OTHER
Collaborators: name: Korea Institute of Oriental Medicine
First posted: 2022-03-23
Enrollment: 21
Sex: ALL
Minimum age (years): 19
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Numeric rating scale (NRS) of shoulder pain
timeFrame: week 7
Secondary outcomes:
measure: Visual analogue scale (VAS) of shoulder pain
timeFrame: week 1, 2, 3, 4, 5, 6, 7, 13
measure: ROM(Range of motion)
timeFrame: week 1, 2, 3, 4, 5, 6, 7, 13
measure: SPADI
timeFrame: week 1, 7, 13
measure: PGIC
timeFrame: week 7, 13
measure: SF-12 v2
timeFrame: week 1, 7, 13
measure: EQ-5D-5L
timeFrame: week 1, 7, 13
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jaseng Korean Medicine Hospital
Study officials:
affiliation: Jaseng Hospital of Korean Medicine
name: Kyoung Sun Park, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: