Subacromial Impingement SyndromeNCT03494192
Effects of Exercise Trainings on Pain, Function and AHD in Patients With SPS
A study testing Scapula Retraction Exercise Group and Scapula Retraction +Glenohumeral Rotational Exercise Group in people with Subacromial Impingement Syndrome, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Abnormal reduction of the AHD has been considered as one of the possible mechanisms in the aetiology of subacromial pain syndrome. Maintenance of the AHD is crucial for prevention and rehabilitation of rotator cuff related disorders. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Subacromial Impingement Syndrome
- What is being tested?
- Scapula Retraction Exercise Group and Scapula Retraction +Glenohumeral Rotational Exercise Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2018to 15 Feb 2021
- 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
- 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
- shoulder capsulitis.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University, Faculty of Health Sciences, Dept. of Physiotherapy and Rehabilitation
Ankara, 06100
About this study
Official title: Utilizing Scapula Retraction Exercises With or Without Glenohumeral Rotational Exercises With a Gradual Progression: A Double-Blind Randomized Controlled Trial for Subacromial Pain Syndrome
Abnormal reduction of the AHD has been considered as one of the possible mechanisms in the aetiology of subacromial pain syndrome. Maintenance of the AHD is crucial for prevention and rehabilitation of rotator cuff related disorders.
The development of a rehabilitation treatment plan is based in part on the assessment of scapular motion and muscle deficits in patients with shoulder pain. Rehabilitation should be based on the identified impairments.
The aim of this study is to investigate the effect of utilizing scapula retraction exercises with or without glenohumeral rotational exercises at gradual shoulder elevation angles into a scapular stabilization program on functionality, pain and AHD in patients with SPS and compare with health population.
Read the detailed description
Coordinated motion between the humerus and scapula is required for pain-free arm movement. Rotator cuff and scapulothoracic muscles dynamically control the subacromial space or acromiohumeral distance (AHD).Scapulothoracic muscles need to provide stability and control in a synchronized fashion to facilitate normal scapulohumeral movement. Scapular upward rotation and posterior tilt is essential to maintain the AHD.Therefore, the force couple function of the rotator cuff muscles play an critical role in opposing the superior migration force that is generated by deltoid muscle and, to maintenance the subacromial space.
Abnormal reduction of the AHD has been considered as one of the possible mechanisms in the aetiology of subacromial impingement syndrome. Maintenance of the AHD is crucial for prevention and rehabilitation of rotator cuff related disorders.
The development of a rehabilitation treatment plan is based in part on the assessment of scapular motion and muscle deficits in patients with shoulder pain. Rehabilitation should be based on the identified impairments.
he aim of this study is to investigate the effect of utilizing scapula retraction exercises with or without glenohumeral rotational exercises at gradual shoulder elevation angles into a scapular stabilization program on functionality, pain and AHD in patients with SPS and compare with health population.
- Conditions
- Subacromial Impingement Syndrome
- Being tested
- Scapula Retraction Exercise Group, Scapula Retraction +Glenohumeral Rotational Exercise Group
- Keywords
- acromiohumeral distance, pain, functional level, Subacromial Impingement Syndrome
- Medical subject headings
- Shoulder Impingement Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scapula Retraction Exercise GroupOther
Also called scapula stabilization exercises
physiotherapy program consists of manual therapy, supervised stretching and scapulothoracic muscles strengthening exercises and home exercise programme including stretching and strengthening exercises will be applied two times a week total 24 sessions.
After 24 sessions completed, patients will proceed to reduced exercise program until the 6-month follow-up.
Scapula Retraction +Glenohumeral Rotational Exercise GroupOther
Also called Scapula stabilization +Glenohumeral Rotational Exercise Group
physiotherapy program consists of manual therapy, supervised stretching and scapulothoracic and also rotator cuff muscles strengthening exercises and home exercise programme including stretching and strengthening exercises will be applied two times a week total 24 sessions.
After 24 sessions completed, patients will proceed to reduced exercise program until the 6-month follow-up
| Study group | Role | What they receive |
|---|---|---|
| scapula retraction exercise group | Experimental | * Manual Therapy
* Stretching Exercises
* Exercise training focus on scapulothoracic muscles will be applied two times per week total 12 week After 12 week follow-up, patients will proceed to reduced exercise program until the 6-month follow-up. Receives: Other: Scapula Retraction Exercise Group |
| Scapula Retraction +Glenohumeral Rotational Exercise Group | Experimental | * Manual Therapy
* Stretching Exercises
* Exercise training focus on scapulothoracic muscles
* Exercise training focus on rotator cuff muscles will be applied two times per week total 12 week After 12 week follow-up, patients will proceed to reduced exercise program until the 6-month follow-up. Receives: Other: Scapula Retraction +Glenohumeral Rotational Exercise Group |
| Control Group | No intervention | Age-sex and hand-dominancy matched healthy controls will be included as a control group (CG) for acromiohumeral distance (AHD) normative data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Level
Functional level will be assessed by using Shoulder Pain and Disability Index (SPADİ). All assessment will be recorded at baseline, at the end of the 12-week treatment sessions and 6-month follow-up.
Measured: ffrom baseline to twelve week after treatment sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start1 Aug 2018
- Primary completion15 Aug 2020
- Study completion15 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacromial Impingement SyndromeStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 49 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
- NCT03494192
- Sponsor's protocol ID
- KA-180018
- Status last verified
- Jan 2022
- First submitted
- 27 Mar 2018
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will share IPD when we recruiting the patients
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Scapula Retraction Exercises With or Without Glenohumeral Rotational Exercises With a Gradual Progression: A Double-Blind Randomized Controlled Trial for Subacromial Pain Syndrome
- ClinicalTrials.gov ID
- NCT03494192
- Acronym / sponsor ID
- KA-180018
- Conditions
- Subacromial Impingement Syndrome
- Keywords
- acromiohumeral distance, pain, functional level, Subacromial Impingement Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 15 Aug 2020 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 11 Apr 2018 (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.
Abnormal reduction of the AHD has been considered as one of the possible mechanisms in the aetiology of subacromial pain syndrome. Maintenance of the AHD is crucial for prevention and rehabilitation of rotator cuff related disorders.
The development of a rehabilitation treatment plan is based in part on the assessment of scapular motion and muscle deficits in patients with shoulder pain. Rehabilitation should be based on the identified impairments.
The aim of this study is to investigate the effect of utilizing scapula retraction exercises with or without glenohumeral rotational exercises at gradual shoulder elevation angles into a scapular stabilization program on functionality, pain and AHD in patients with SPS and compare with health population.
Detailed description
Coordinated motion between the humerus and scapula is required for pain-free arm movement. Rotator cuff and scapulothoracic muscles dynamically control the subacromial space or acromiohumeral distance (AHD).Scapulothoracic muscles need to provide stability and control in a synchronized fashion to facilitate normal scapulohumeral movement. Scapular upward rotation and posterior tilt is essential to maintain the AHD.Therefore, the force couple function of the rotator cuff muscles play an critical role in opposing the superior migration force that is generated by deltoid muscle and, to maintenance the subacromial space.
Abnormal reduction of the AHD has been considered as one of the possible mechanisms in the aetiology of subacromial impingement syndrome. Maintenance of the AHD is crucial for prevention and rehabilitation of rotator cuff related disorders.
The development of a rehabilitation treatment plan is based in part on the assessment of scapular motion and muscle deficits in patients with shoulder pain. Rehabilitation should be based on the identified impairments.
he aim of this study is to investigate the effect of utilizing scapula retraction exercises with or without glenohumeral rotational exercises at gradual shoulder elevation angles into a scapular stabilization program on functionality, pain and AHD in patients with SPS and compare with health population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| scapula retraction exercise group | Experimental | Other: Scapula Retraction Exercise Group* Manual Therapy * Stretching Exercises * Exercise training focus on scapulothoracic muscles will be applied two times per week total 12 week After 12 week follow-up, patients will proceed to reduced exercise program until the 6-month follow-up. |
| Scapula Retraction +Glenohumeral Rotational Exercise Group | Experimental | Other: Scapula Retraction +Glenohumeral Rotational Exercise Group* Manual Therapy * Stretching Exercises * Exercise training focus on scapulothoracic muscles * Exercise training focus on rotator cuff muscles will be applied two times per week total 12 week After 12 week follow-up, patients will proceed to reduced exercise program until the 6-month follow-up. |
| Control Group | No intervention | –Age-sex and hand-dominancy matched healthy controls will be included as a control group (CG) for acromiohumeral distance (AHD) normative data |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
- shoulder 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 |
|---|---|---|
| Scapula Retraction Exercise GroupAlso: scapula stabilization exercisesphysiotherapy program consists of manual therapy, supervised stretching and scapulothoracic muscles strengthening exercises and home exercise programme including stretching and strengthening exercises will be applied two times a week total 24 sessions. After 24 sessions completed, patients will proceed to reduced exercise program until the 6-month follow-up. | Other | scapula retraction exercise group |
| Scapula Retraction +Glenohumeral Rotational Exercise GroupAlso: Scapula stabilization +Glenohumeral Rotational Exercise Groupphysiotherapy program consists of manual therapy, supervised stretching and scapulothoracic and also rotator cuff muscles strengthening exercises and home exercise programme including stretching and strengthening exercises will be applied two times a week total 24 sessions. After 24 sessions completed, patients will proceed to reduced exercise program until the 6-month follow-up | Other | Scapula Retraction +Glenohumeral Rotational Exercise Group |
Primary outcome
Functional Level
Time frame: ffrom baseline to twelve week after treatment sessions
Functional level will be assessed by using Shoulder Pain and Disability Index (SPADİ). All assessment will be recorded at baseline, at the end of the 12-week treatment sessions and 6-month 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 3 Feb 2022.
- Individual participant dataSharing planned: Undecided. We will share IPD when we recruiting the patients
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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 Scapula Retraction Exercise Group and Scapula Retraction +Glenohumeral Rotational Exercise Group in people with Subacromial 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 3 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 3 Feb 2022. 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?
Functional Level (time frame: ffrom baseline to twelve week after treatment sessions). 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 3 Feb 2022; AzTrials last refreshed its copy on 1 Nov 2026.