- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07228455
The Effect of Humeral Head Depressor Strengthening in Individuals With Subacromial Impingement Syndrome
November 13, 2025 updated by: Utku Kurtaran, Near East University, Turkey
Subacromial impingement syndrome is a common musculoskeletal disorder.
Therefore, to improve the shoulder biomechanics affected by the syndrome, an intervention group was compared with a control group.
The exercise program applied to the intervention group is expected to improve the function of the shoulder complex.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Subacromial Impingement Syndrome (SIS) is one of the most common musculoskeletal problems in the shoulder joint.
This study aimed to investigate the effectiveness of a rehabilitation program targeting humeral head depressor muscles on symptoms in individuals with SIS.Participants were randomly divided into study and control groups.Volunteers who complained of shoulder pain for more than a month, who had limitation in passive movement compared to the other side shoulder, who had Neer impingement test, Hawkins test, Jobe supraspinatus test, and who were able to com-municate were included in the study.
Individuals 1) Having any neurological condition affecting the upper extremity, 2) having neurological findings related to cervical disc herniation, 3) having a full-thickness rupture of one of the rotator cuff tendons, 4) having calcific tendonitis, 5) having undergone previous shoulder surgery and 6) Physical therapy-rehabilitation for the shoulder with the same complaints in the last 6 months, or 7) receiving corticosteroid injection were excluded from the study.
While the control group received standard physical therapy and rehabilitation, the study group underwent a progressive resistance exercise program to strengthen the humeral head depressors and peri-articular muscles, including the rotator cuff.
Acromio-humeral distance (AHD) and tendon thickness measurements were evaluated by ultrasonography, while pain intensity was measured through VAS and McGill Questionnaire, upper extremity disability through DASH-T, and kinesiophobia through Fear Avoidance Beliefs Questionnaire, respectively.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nicosia, Cyprus
- Near East University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Volunteers who complained of shoulder pain for more than a month,
- Who had limitation in passive movement compared to the other side shoulder,
- Who had Neer impingement test, Hawkins test, Jobe supraspinatus test, and -
- Who were able to com-municate were included in the study
Exclusion Criteria:
- Having any neurological condition affecting the upper extremity,
- Having neuro-logical findings related to cervical disc herniation,
- Having a full-thickness rupture of one of the rotator cuff tendons,
- Having calcific tendonitis,
- Having undergone previous shoulder surgery,
- Physical therapy-rehabilitation for the shoulder with the same complaints in the last 6 months,
- Receiving corticosteroid injection were excluded from the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: The Intervention Group
The Intervention group underwent a progressive resistance exercise program to strengthen the humeral head depressors and peri-articular muscles, including the rotator cuff.
The exercises were performed 3 times per week for 6 weeks, with each session lasting approximately 1 hour
|
The Intervention group underwent a progressive resistance exercise program to strengthen the humeral head depressors and peri-articular muscles, including the rotator cuff.
Exercises were performed 3 times per week for 6 weeks, each session lasting approximately 1 hour
|
|
Active Comparator: The Control Group
Participants in the control group received standard physical therapy and rehabilitation as usually applied in routine care.
Sessions were performed 3 times per week for 6 weeks, each lasting approximately 1 hour.
|
Participants in this group received standard physical therapy and rehabilitation as usually applied in routine care.
Exercises were performed 3 times per week for 6 weeks, each session lasting approximately 1 hour.
Outcomes were measured at the same time points as the intervention group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Acromio-humeral Distance (Ultrasonography, USG)
Time Frame: Baseline and 6 weeks
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Baseline and 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tendon Thickness Measurment
Time Frame: Baseline and 6 week
|
Supraspinatus Tendon, Infraspinatus Tendon, subscapularis Tendon, Teres Minor Tendon, Long Head Biceps Tendon, Rotator Cuff group Tendons General Thicknesses were evaluated in all planes, by USG using a GE LogiqP6 Pro device and a linear transducer.
Imaging was performed using standard shoulder sections while the patients were in a sitting position
|
Baseline and 6 week
|
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Pain (Visual Analog Scale, VAS)
Time Frame: Baseline and 6 weeks
|
Pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain).
Higher scores indicate greater pain intensity.
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Baseline and 6 weeks
|
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Pain (McGill Pain Questionnaire-Pain Rating Index)
Time Frame: Baseline and 6 weeks
|
Pain will be assessed using the McGill Pain Questionnaire, specifically the Pain Rating Index (PRI).
The total score ranges from 0 to 78, with higher scores indicating more severe pain.
|
Baseline and 6 weeks
|
|
Kinesiophobia (Fear Avoidance Beliefs Questionnaire - FABQ, Physical Activity subscale)
Time Frame: Baseline and 6 weeks
|
Kinesiophobia will be assessed using the Fear Avoidance Beliefs Questionnaire (FABQ) - Physical Activity subscale (items 2-5). Score range: 0 to 24 (higher scores indicate greater fear-avoidance beliefs related to physical activity). Time Frame: Baseline and 6 weeks. |
Baseline and 6 weeks
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Kinesiophobia (Fear Avoidance Beliefs Questionnaire - FABQ, Work subscale)
Time Frame: Baseline and 6 weeks.
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Kinesiophobia will also be assessed using the FABQ - Work subscale (items 6, 7, 9-12, 15).
Score range: 0 to 42 (higher scores indicate greater fear-avoidance beliefs related to work).
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Baseline and 6 weeks.
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Upper Extremity Disability Through (DASH-T)
Time Frame: Baseline and 6 weeks
|
Baseline and 6 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ahmet OZGUL, Prof., Department of Physical Medicine and Rehabilitation, Kyrenia University Hospital, Kyrenia, Cyprus
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 3, 2023
Primary Completion (Actual)
July 3, 2024
Study Completion (Actual)
July 3, 2024
Study Registration Dates
First Submitted
September 29, 2025
First Submitted That Met QC Criteria
November 13, 2025
First Posted (Estimated)
November 14, 2025
Study Record Updates
Last Update Posted (Estimated)
November 14, 2025
Last Update Submitted That Met QC Criteria
November 13, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/115-1751
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The individual participant data from this study will not be shared.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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