NCT07001228

Brief Summary

The goal of this study is to diagnose scapular dyskinesis-which can appear as a cause or result of various shoulder disorders-through screening tests in patients with shoulder impingement syndrome, the most common shoulder condition. By identifying scapular dyskinesis, the study aims to maximize treatment outcomes through appropriate rehabilitative exercise therapy.

Trial Health

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Monitor

Trial Health Score

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

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started May 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress47%
May 2025May 2027

First Submitted

Initial submission to the registry

May 23, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

May 29, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 3, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

June 6, 2025

Status Verified

June 1, 2025

Enrollment Period

2 years

First QC Date

May 23, 2025

Last Update Submit

June 4, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • visual analog pain scale (VAS)

    0-10, 0: not satisfied, 10: very much satisfied

    Initial, 3, 7, 13 weeks

Secondary Outcomes (2)

  • American Shoulder and Elbow Surgeons' (ASES) score

    Initial, 3, 7,13 weeks

  • Constant score

    Initial, 3, 7, 13 weeks

Study Arms (2)

Impinge c SD treatment

EXPERIMENTAL

In this experimental group, rehabilitation for scapular dyskinesis will begin at the second outpatient visit, which takes place three weeks after the subacromial steroid injection.

Behavioral: SD rehabilitation

Impinge s SD treatment

SHAM COMPARATOR

In this sham group, rehabilitation for scapular dyskinesis will not be begun at the second outpatient visit, which takes place three weeks after the subacromial steroid injection.

Behavioral: No SD rehabilitation

Interventions

For shoulder impingement syndrome, the standard rehabilitation protocol involves administering a subacromial steroid injection at the initial outpatient visit, followed by stick exercises to restore joint mobility starting three weeks later. Four weeks after initiating the stick exercises, rotator cuff strengthening exercises using therabands are introduced and maintained for a duration of six weeks. For SD rehabilitation, shoulder external rotation, push up plus, and shoulder rolls were performed. In the experimental group, rehabilitation for scapular dyskinesis will begin at the second outpatient visit, which takes place three weeks after the subacromial steroid injection.

Impinge c SD treatment

For shoulder impingement syndrome, the standard rehabilitation protocol involves administering a subacromial steroid injection at the initial outpatient visit, followed by stick exercises to restore joint mobility starting three weeks later. Four weeks after initiating the stick exercises, rotator cuff strengthening exercises using therabands are introduced and maintained for a duration of six weeks. In the sham group, rehabilitation for scapular dyskinesis will not begun at the second outpatient visit, which takes place three weeks after the subacromial steroid injection.

Impinge s SD treatment

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with unilateral shoulder impingement syndrome in the outpatient clinic (based on clinical symptoms and MRI) from the IRB approval date until March 1, 2027
  • Individuals who provided written informed consent after receiving a thorough explanation of the study prior to any procedures
  • Age 20 years or older

You may not qualify if:

  • Individuals who did not receive a subacromial steroid injection for shoulder impingement syndrome
  • Individuals with a history of surgical treatment or fracture in the affected shoulder
  • Individuals who refused to participate in the study
  • Individuals with neurological disorders affecting the ipsilateral upper extremity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hallym University Chuncheon Sacred Heart Hospital

Chuncheon, Gangwon-do, 24253, South Korea

Location

Related Publications (4)

  • Park JY, Hwang JT, Oh KS, Kim SJ, Kim NR, Cha MJ. Revisit to scapular dyskinesis: three-dimensional wing computed tomography in prone position. J Shoulder Elbow Surg. 2014 Jun;23(6):821-8. doi: 10.1016/j.jse.2013.08.016. Epub 2013 Nov 23.

    PMID: 24280352BACKGROUND
  • Park JY, Hwang JT, Kim KM, Makkar D, Moon SG, Han KJ. How to assess scapular dyskinesis precisely: 3-dimensional wing computer tomography--a new diagnostic modality. J Shoulder Elbow Surg. 2013 Aug;22(8):1084-91. doi: 10.1016/j.jse.2012.10.046. Epub 2013 Jan 24.

    PMID: 23352185BACKGROUND
  • Kibler WB, McMullen J. Scapular dyskinesis and its relation to shoulder pain. J Am Acad Orthop Surg. 2003 Mar-Apr;11(2):142-51. doi: 10.5435/00124635-200303000-00008.

    PMID: 12670140BACKGROUND
  • Kibler WB, Ludewig PM, McClure P, Uhl TL, Sciascia A. Scapular Summit 2009: introduction. July 16, 2009, Lexington, Kentucky. J Orthop Sports Phys Ther. 2009 Nov;39(11):A1-A13. doi: 10.2519/jospt.2009.0303.

    PMID: 19881011BACKGROUND

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Study Officials

  • Jung-Taek Hwang, MD, PhD

    Hallym University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jung-Taek Hwang, MD, PhD

CONTACT

Su-Jung Seo, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
The investigators plan to enroll patients who consent to participate in the study and allocate them into two groups using a random sequence generator. A random allocation table will be created and managed by a third party who is not involved in the study. When planning the treatment method, group assignment will be requested from this third party holding the allocation table, ensuring that the allocator is blinded to the upcoming group assignments in advance. Treatment in each group will be administered consistently according to a pre-agreed protocol, and follow-up will also be conducted using the same method in both groups.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: This study involves patients who visited the outpatient clinic with unilateral shoulder pain persisting for more than three months and were diagnosed with unilateral shoulder impingement syndrome based on MRI findings. Only patients who provided informed consent were enrolled in the study. A total of 320 patients with unilateral shoulder impingement syndrome from Chuncheon Sacred Heart Hospital were included. The participants were randomly assigned into two groups of 160 patients each. Both groups underwent rehabilitation for shoulder impingement syndrome; however, the control group (Group 1) did not receive rehabilitation for scapular dyskinesis, while the experimental group (Group 2) did receive rehabilitation targeting scapular dyskinesis.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 23, 2025

First Posted

June 3, 2025

Study Start

May 29, 2025

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2027

Last Updated

June 6, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

We can decide it after the termination of this study.

Locations