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

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

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

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.
Observational

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.
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

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

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
rotator cuff related shoulder pain
Participants were assessed for SME, pain (rest, activity, night, measurement), and upper extremity function (FIT-HaNSA).
Device: Scapular muscle endurance test
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.
Other: Pain intensity
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.
Device: Upper Limb Functional Performance
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:
  • FIT-HaNSA
age gender matched healthy controls
Participants were assessed for SME, and upper extremity function (FIT-HaNSA).
Device: Scapular muscle endurance test
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.
Device: Upper Limb Functional Performance
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:
  • FIT-HaNSA

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
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gazi University

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.
  • 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)

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.
December 1, 2015

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.
December 1, 2017

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.
January 1, 2018

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).
August 26, 2018

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.
August 27, 2018

First Posted (Actual)

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.
August 29, 2018

Study Record Updates

Last Update Posted (Estimate)

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.
January 11, 2023

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.
January 10, 2023

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.
January 1, 2023

More Information

Terms related to this study

Keywords

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.
  • 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings