NCT05292482

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 23, 2022

Completed
28 days until next milestone

Study Start

First participant enrolled

April 20, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2022

Completed
Last Updated

June 15, 2023

Status Verified

December 1, 2022

Enrollment Period

6 months

First QC Date

March 15, 2022

Last Update Submit

June 13, 2023

Conditions

Adhesive Capsulitis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Visual analogue scale (VAS) of shoulder pain

    week 1, 2, 3, 4, 5, 6, 7, 13

  • ROM(Range of motion)

    week 1, 2, 3, 4, 5, 6, 7, 13

  • SPADI

    week 1, 7, 13

  • PGIC

    week 7, 13

  • SF-12 v2

    week 1, 7, 13

  • +1 more secondary outcomes

Study Arms (2)

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.

Procedure: pharmacopuncture therapy

physical therapy

ACTIVE COMPARATOR

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

Procedure: physical therapy

Interventions

pharmacopuncture therapyPROCEDURE

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

pharmacopunture therapy
physical therapyPROCEDURE

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

physical therapy

Eligibility Criteria

Age19 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years old
  • participants who agreed and wrote informed consents

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jaseng Korean Medicine Hospital

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 39224580DERIVED

MeSH Terms

Conditions

Bursitis

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Kyoung Sun Park, Ph.D

    Jaseng Hospital of Korean Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2022

First Posted

March 23, 2022

Study Start

April 20, 2022

Primary Completion

October 25, 2022

Study Completion

December 6, 2022

Last Updated

June 15, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)