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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Cyprus
      • Nicosia, Cyprus
        • Near East University Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Behavioral: Humeral Head Depressor Exercises
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.
Behavioral: Standard physical therapy
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Acromio-humeral Distance (Ultrasonography, USG)
Time Frame: Baseline and 6 weeks
Baseline and 6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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.
Baseline and 6 weeks
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
Kinesiophobia (Fear Avoidance Beliefs Questionnaire - FABQ, Work subscale)
Time Frame: Baseline and 6 weeks.
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).
Baseline and 6 weeks.
Upper Extremity Disability Through (DASH-T)
Time Frame: Baseline and 6 weeks
Baseline and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Near East University, Turkey

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 3, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 3, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 3, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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