Scapular Muscle Endurance, Shoulder Pain, and Functionality

Rotator Cuff Syndrome of Shoulder and Allied Disorders Clinical Trial

Official title:

Scapular Muscle Endurance, Shoulder Pain, and Functionality in Patients With Rotator Cuff Related Shoulder Pain: A Matched, Case-Control Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03651401
• Other study ID #: 25901600-577
• Status: Completed
• Start date: December 2015
• Est. completion date: January 2018

Study information

• Verified date: January 2023
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 patients with RCRSP.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rotator Cuff Syndrome of Shoulder and Allied Disorders
• Shoulder Pain

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scapular muscle endurance	Unit of Measure:second	Baseline assessment, no follow-up
Primary	Pain intensity	Unit of Measure:visual analogue scale	Baseline assessment, no follow-up
Primary	Upper Limp Functional Performance	Protocol: FIT-HaNSA	Baseline assessment, no follow-up