Rotator Cuff Syndrome of Shoulder and Allied DisordersNCT03651401
Scapular Muscle Endurance, Shoulder Pain, and Functionality
An observational study of Rotator Cuff Syndrome of Shoulder and Allied Disorders, run by Gazi University.
Trial summary
The purpose of this study is to compare scapular muscle endurance (SME), shoulder pain, and functionality of patients with rotator cuff related shoulder pain (RCRSP) with those in the age-gender matched healthy controls and to evaluate the relationship between SME with shoulder pain, and functional impairments in… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rotator Cuff Syndrome of Shoulder and Allied Disorders
- What is being tested?
- Scapular muscle endurance test, Pain intensity and Upper Limb Functional Performance
- Type of treatment
- Medical device
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Jan 2018
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 65 years
- All sexes
- Adult, Older adult
Study population: 23 patients and 23 age-gender matched healthy subjects who met the inclusion criteria were included to the study
Who may be able to join
- Positive sign in two or more specific shoulder clinical tests;
- The presence of RCRSP in magnetic resonance imaging (MRI);
- At least 120° flexion, 25° abduction, and 30° external rotation movements of the shoulder;
- Being right arm dominant;
- No surgical history in the shoulder region.
Who cannot join
- Patients with shoulder pathology other than RCRSP such as glenohumeral instability (capsular and ligamentous lesions, labral lesions, or bone lesions), bicipital tendon lesions, acromioclavicular joint osteoarthritis, glenohumeral joint osteoarthritis, adhesive capsulitis, shoulder or cervical surgery history,
- Neurological and systemic inflammatory diseases,
- Bilateral shoulder complaints,
- Cardiovascular system diseases,
- Pregnancy,
- Underwent shoulder-related physical therapy within the past three months.
About this study
Official title: Scapular Muscle Endurance, Shoulder Pain, and Functionality in Patients With Rotator Cuff Related Shoulder Pain: A Matched, Case-Control Study
The purpose of this study is to compare scapular muscle endurance (SME), shoulder pain, and functionality of patients with rotator cuff related shoulder pain (RCRSP) with those in the age-gender matched healthy controls and to evaluate the relationship between SME with shoulder pain, and functional impairments in patients with RCRSP.
Read the detailed description
Patients with RCRSP (n:23), and age-gender matched healthy controls (n:23) were included in the study. SME were measured by a one-kilogram dynamometer while the shoulder and elbows are flexed 90°. Self-reported pain intensity (activity, night, after SME and FIT-HaNSA) was assessed visual analog scale (VAS). Functionality was also assessed using the Functional Impairment test-hand, neck, shoulder, and arm (FIT-HaNSA).
- Being tested
- Scapular muscle endurance test, Pain intensity, Upper Limb Functional Performance
- Keywords
- Scapula, Endurance, Disability, Rotator cuff lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scapular muscle endurance testDevice
The SME test, developed by Edmondston et al. 17, is based on an exercise used to improve the performance of the serratus anterior and trapezius muscles. The test was carried out while the subjects were facing the wall in standing position and with their shoulders and elbows flexed to 90 degrees. While both scapulae were in neutral position, an appropriate size of stick (18-36 cm) was selected and placed between the elbows, and they were asked to hold the dynamometer (Feta 137 F0202 1 kg/10 N) between their hands.
Pain intensityOther
Pain intensity assessment was performed by questioning rest, activity, night, and measuremant pain using a visual analogue scale (VAS) on a 10 cm line with marks at both ends to define the limits of the pain experience as "no pain" (0) and "maximum pain experienced" (10), with higher scores indicating greater pain 20.
Upper Limb Functional PerformanceDevice
Also called FIT-HaNSA
The Functional Impairment Test-Hand and Neck/Shoulder/Arm (FIT-HaNSA) protocol, which was developed by MacDermid et al. 21, was used to evaluate the functional performance of the upper extremity when performing 3 tasks.
| Study group | Role | What they receive |
|---|---|---|
| rotator cuff related shoulder pain | Participants were assessed for SME, pain (rest, activity, night, measurement), and upper extremity function (FIT-HaNSA). Receives: Device: Scapular muscle endurance test; Other: Pain intensity; Device: Upper Limb Functional Performance | |
| age gender matched healthy controls | Participants were assessed for SME, and upper extremity function (FIT-HaNSA). Receives: Device: Scapular muscle endurance test; Device: Upper Limb Functional Performance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scapular muscle endurance
Unit of Measure:second
Measured: Baseline assessment, no follow-up
Pain intensity
Unit of Measure:visual analogue scale
Measured: Baseline assessment, no follow-up
Upper Limp Functional Performance
Protocol: FIT-HaNSA
Measured: Baseline assessment, no follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study startDec 2015
- Primary completionDec 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff Syndrome of Shoulder and Allied DisordersStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ugur Sozlu, Gazi University
- Investigators
- Selda BAŞAR, Study chair, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03651401
- Sponsor's protocol ID
- 25901600-577
- Status last verified
- Jan 2023
- First submitted
- 26 Aug 2018
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scapular Muscle Endurance, Shoulder Pain, and Functionality in Patients With Rotator Cuff Related Shoulder Pain: A Matched, Case-Control Study
- ClinicalTrials.gov ID
- NCT03651401
- Acronym / sponsor ID
- 25901600-577
- Keywords
- Scapula, Endurance, Disability, Rotator cuff lesions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 29 Aug 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.
The purpose of this study is to compare scapular muscle endurance (SME), shoulder pain, and functionality of patients with rotator cuff related shoulder pain (RCRSP) with those in the age-gender matched healthy controls and to evaluate the relationship between SME with shoulder pain, and functional impairments in patients with RCRSP.
Detailed description
Patients with RCRSP (n:23), and age-gender matched healthy controls (n:23) were included in the study. SME were measured by a one-kilogram dynamometer while the shoulder and elbows are flexed 90°. Self-reported pain intensity (activity, night, after SME and FIT-HaNSA) was assessed visual analog scale (VAS). Functionality was also assessed using the Functional Impairment test-hand, neck, shoulder, and arm (FIT-HaNSA).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rotator cuff related shoulder pain | – | Device: Scapular muscle endurance test, Other: Pain intensity, Device: Upper Limb Functional PerformanceParticipants were assessed for SME, pain (rest, activity, night, measurement), and upper extremity function (FIT-HaNSA). |
| age gender matched healthy controls | – | Device: Scapular muscle endurance test, Device: Upper Limb Functional PerformanceParticipants were assessed for SME, and upper extremity function (FIT-HaNSA). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 23 patients and 23 age-gender matched healthy subjects who met the inclusion criteria were included to the study
Key inclusion criteria (5 listed)
- Positive sign in two or more specific shoulder clinical tests;
- The presence of RCRSP in magnetic resonance imaging (MRI);
- At least 120° flexion, 25° abduction, and 30° external rotation movements of the shoulder;
- Being right arm dominant;
- No surgical history in the shoulder region.
Key exclusion criteria (6 listed)
- Patients with shoulder pathology other than RCRSP such as glenohumeral instability (capsular and ligamentous lesions, labral lesions, or bone lesions), bicipital tendon lesions, acromioclavicular joint osteoarthritis, glenohumeral joint osteoarthritis, adhesive capsulitis, shoulder or cervical surgery history,
- Neurological and systemic inflammatory diseases,
- Bilateral shoulder complaints,
- Cardiovascular system diseases,
- Pregnancy,
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 |
|---|---|---|
| Scapular muscle endurance testThe SME test, developed by Edmondston et al. 17, is based on an exercise used to improve the performance of the serratus anterior and trapezius muscles. The test was carried out while the subjects were facing the wall in standing position and with their shoulders and elbows flexed to 90 degrees. While both scapulae were in neutral position, an appropriate size of stick (18-36 cm) was selected and placed between the elbows, and they were asked to hold the dynamometer (Feta 137 F0202 1 kg/10 N) between their hands. | Device | age gender matched healthy controls, rotator cuff related shoulder pain |
| Pain intensityPain intensity assessment was performed by questioning rest, activity, night, and measuremant pain using a visual analogue scale (VAS) on a 10 cm line with marks at both ends to define the limits of the pain experience as "no pain" (0) and "maximum pain experienced" (10), with higher scores indicating greater pain 20. | Other | rotator cuff related shoulder pain |
| Upper Limb Functional PerformanceAlso: FIT-HaNSAThe Functional Impairment Test-Hand and Neck/Shoulder/Arm (FIT-HaNSA) protocol, which was developed by MacDermid et al. 21, was used to evaluate the functional performance of the upper extremity when performing 3 tasks. | Device | age gender matched healthy controls, rotator cuff related shoulder pain |
Primary outcome
Scapular muscle endurance
Time frame: Baseline assessment, no follow-up
Unit of Measure:second
Pain intensity
Time frame: Baseline assessment, no follow-up
Unit of Measure:visual analogue scale
Upper Limp Functional Performance
Time frame: Baseline assessment, no follow-up
Protocol: FIT-HaNSA
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 11 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Selda BAŞAR study chair
Gazi University
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Syndrome of Shoulder and Allied Disorders, run by Gazi University.
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 5 inclusion and 6 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 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Scapular muscle endurance (time frame: Baseline assessment, no follow-up). The study lists 3 primary outcomes in all. 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 11 Jan 2023.