Rotator Cuff Impingement SyndromeNCT04956757
Scapula Retraction Exercises in Subacromial Pain Syndrome
A study testing Exercise Intervention in people with Rotator Cuff Impingement Syndrome, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Scapula retraction exercises are often recommended as a part of the exercise programs. The primary aim of this study is to investigate the initial effect of the scapula retraction exercises on acromiohumeral distance (AHD) at varying shoulder abduction angles and to compare asymptomatic subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Impingement Syndrome
- What is being tested?
- Exercise Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jul 2021to 17 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- aged between 18-45
- painful arc of movement during flexion or abduction;
- positive Neer or Kennedy-Hawkins impingement signs
- pain on resisted lateral rotation, abduction or empty can test.
Who cannot join
- previous shoulder surgery;
- shoulder pain reproduced by neck movement;
- clinical signs of full-thickness RC tears; or
- adhesive capsulitis.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University, Faculty of Physical Therapy and Rehabilitation
Ankara, 06100
About this study
Official title: Investigating the Effect of Scapula Retraction Exercises on Acromiohumeral Distance Values and Symptoms (Pain and Disability) in Patients With SPS
Scapula retraction exercises are often recommended as a part of the exercise programs. The primary aim of this study is to investigate the initial effect of the scapula retraction exercises on acromiohumeral distance (AHD) at varying shoulder abduction angles and to compare asymptomatic subjects. The secondary aim of this study is to investigate the effect of scapula retraction exercises on AHD values and symptoms (pain and disability) in patients with SPS.
Read the detailed description
Subacmial pain syndrome (SPS) is a common cause of shoulder pain and dysfunction in the general population. Exercise interventions is thought as a primary choice in clinical settings. Scapula retraction exercises are commonly recommended as a part of the exercise programs. Applying scapula retraction exercises at varying shoulder abduction angles could restore balance between the scapulothoracic muscles. Since the scapulothoracic muscles dynamically control subacromial space, scapula retraction exercises could further help to maintain AHD during arm elevation.
The primary aim of this study is to investigate the initial effect of the scapula retraction exercises on acromiohumeral distance (AHD) at varying shoulder abduction angles and to compare asymptomatic subjects. The secondary aim of this study is to investigate the effect of scapula retraction exercises on AHD values and symptoms (pain and disability) in patients with SPS.
- Conditions
- Rotator Cuff Impingement Syndrome
- Being tested
- Exercise Intervention
- Keywords
- pain severity, functional status, acromiohumeral distance, shoulder pain
- Medical subject headings
- Shoulder Impingement Syndrome, Pain, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scapula retraction exercises at varying shoulder abduction angles will be applied
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | exercise program consists of progressive scapula retraction exercises will be applied three times a week total 24 sessions.
Home exercise program will also advised two times a day. Receives: Other: Exercise Intervention |
| Control Group | No intervention | Control group will not perform scapula retraction exercises. AHD values of the control group will be compared to intervention groups both retracted and non-retracted conditions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acromiohumeral Distance (AHD) measurement
Acromiohumeral Distance will be recorded at 0°, 30°, 45°, 60° and 90° of shoulder abduction, and while they are doing scapular retraction with resistive elastic band at each shoulder position. All assessment will be recorded at baseline and at the end of the eight week rehabilitation sessions
Measured: Acromiohumeral distance values will be recorded at baseline and 8-week follow-up
Secondary outcomes (2)
pain severity
pain severity will be assessed by using 100 millimeters Visual Analogue Scale at rest, at night and during activity.
All patients were asked to mark their pain level that corresponds to their pain intensity on the line between "0=no pain" and "100=the worst pain imaginable".
Measured: pain severity will be recorded at baseline and 8-week follow-up
disability status
disability status will be assessed by using Shoulder Pain and Disability Index (SPADİ). All assessment will be recorded at baseline and at the end of the eight week treatment sessions.
The questionnaire is scored on a 100-point scale, where 0 represents "no disabilities" and 100 represents "extreme disabilities"
Measured: PADI Score will be recorded at baseline and 8-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start30 Jul 2021
- Primary completion30 Oct 2022
- Study completion17 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff Impingement SyndromeStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leyla Eraslan, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956757
- Sponsor's protocol ID
- GO18/55
- Status last verified
- Feb 2024
- First submitted
- 29 Jun 2021
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effect of Scapula Retraction Exercises on Acromiohumeral Distance Values and Symptoms (Pain and Disability) in Patients With SPS
- ClinicalTrials.gov ID
- NCT04956757
- Acronym / sponsor ID
- GO18/55
- Conditions
- Rotator Cuff Impingement Syndrome
- Keywords
- pain severity, functional status, acromiohumeral distance, shoulder pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 30 Jul 2021 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 17 Jun 2023 (actual)
- First posted
- 9 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Scapula retraction exercises are often recommended as a part of the exercise programs. The primary aim of this study is to investigate the initial effect of the scapula retraction exercises on acromiohumeral distance (AHD) at varying shoulder abduction angles and to compare asymptomatic subjects. The secondary aim of this study is to investigate the effect of scapula retraction exercises on AHD values and symptoms (pain and disability) in patients with SPS.
Detailed description
Subacmial pain syndrome (SPS) is a common cause of shoulder pain and dysfunction in the general population. Exercise interventions is thought as a primary choice in clinical settings. Scapula retraction exercises are commonly recommended as a part of the exercise programs. Applying scapula retraction exercises at varying shoulder abduction angles could restore balance between the scapulothoracic muscles. Since the scapulothoracic muscles dynamically control subacromial space, scapula retraction exercises could further help to maintain AHD during arm elevation.
The primary aim of this study is to investigate the initial effect of the scapula retraction exercises on acromiohumeral distance (AHD) at varying shoulder abduction angles and to compare asymptomatic subjects. The secondary aim of this study is to investigate the effect of scapula retraction exercises on AHD values and symptoms (pain and disability) in patients with SPS.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Exercise Interventionexercise program consists of progressive scapula retraction exercises will be applied three times a week total 24 sessions. Home exercise program will also advised two times a day. |
| Control Group | No intervention | –Control group will not perform scapula retraction exercises. AHD values of the control group will be compared to intervention groups both retracted and non-retracted conditions. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- aged between 18-45
- painful arc of movement during flexion or abduction;
- positive Neer or Kennedy-Hawkins impingement signs
- pain on resisted lateral rotation, abduction or empty can test.
Key exclusion criteria (4 listed)
- previous shoulder surgery;
- shoulder pain reproduced by neck movement;
- clinical signs of full-thickness RC tears; or
- adhesive capsulitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise InterventionScapula retraction exercises at varying shoulder abduction angles will be applied | Other | Intervention Group |
Primary outcome
Acromiohumeral Distance (AHD) measurement
Time frame: Acromiohumeral distance values will be recorded at baseline and 8-week follow-up
Acromiohumeral Distance will be recorded at 0°, 30°, 45°, 60° and 90° of shoulder abduction, and while they are doing scapular retraction with resistive elastic band at each shoulder position. All assessment will be recorded at baseline and at the end of the eight week rehabilitation sessions
2 secondary outcomes
pain severity
Time frame: pain severity will be recorded at baseline and 8-week follow-up
disability status
Time frame: PADI Score will be recorded at baseline and 8-week follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Rotator Cuff Impingement Syndrome
Not yet recruiting
TECAR With Shoulder Chronic Shoulder Impingement Syndrome
Shoulder Impingement Syndrome
Recruiting
Device-Assisted Balance Training for People With Shoulder Impingement
Shoulder
Not yet recruiting
"Effectiveness of a Telerehabilitation Program Versus a Conventional Rehabilitation Program in Patients With Subacromial Pain"
Subacromial Impingement Syndrome
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Not yet recruiting
Spencer vs Positional Release Techniques for Chronic Subacromial Impingement
Chronic Subacromial Impingement Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention in people with Rotator Cuff Impingement Syndrome, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acromiohumeral Distance (AHD) measurement (time frame: Acromiohumeral distance values will be recorded at baseline and 8-week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.