- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03651401
Scapular Muscle Endurance, Shoulder Pain, and Functionality
January 10, 2023 updated by: Ugur Sozlu, Gazi University
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
46
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
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
23 patients and 23 age-gender matched healthy subjects who met the inclusion criteria were included to the study
Description
Inclusion criteria:
- 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.
Exclusion criteria:
- 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.
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
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
rotator cuff related shoulder pain
Participants were assessed for SME, pain (rest, activity, night, measurement), and upper extremity function (FIT-HaNSA).
|
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 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.
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.
Other Names:
|
age gender matched healthy controls
Participants were assessed for SME, and upper extremity function (FIT-HaNSA).
|
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.
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Scapular muscle endurance
Time Frame: Baseline assessment, no follow-up
|
Unit of Measure:second
|
Baseline assessment, no follow-up
|
Pain intensity
Time Frame: Baseline assessment, no follow-up
|
Unit of Measure:visual analogue scale
|
Baseline assessment, no follow-up
|
Upper Limp Functional Performance
Time Frame: Baseline assessment, no follow-up
|
Protocol: FIT-HaNSA
|
Baseline assessment, no follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Selda BAŞAR, Gazi University
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)
December 1, 2015
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
January 1, 2018
Study Registration Dates
First Submitted
August 26, 2018
First Submitted That Met QC Criteria
August 27, 2018
First Posted (Actual)
August 29, 2018
Study Record Updates
Last Update Posted (Estimate)
January 11, 2023
Last Update Submitted That Met QC Criteria
January 10, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25901600-577
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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