NCT03651401

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2015

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2018

Completed
Last Updated

January 11, 2023

Status Verified

January 1, 2023

Enrollment Period

2 years

First QC Date

August 26, 2018

Last Update Submit

January 10, 2023

Conditions

Keywords

ScapulaEnduranceDisabilityRotator cuff lesions

Outcome Measures

Primary Outcomes (3)

  • Scapular muscle endurance

    Unit of Measure:second

    Baseline assessment, no follow-up

  • Pain intensity

    Unit of Measure:visual analogue scale

    Baseline assessment, no follow-up

  • Upper Limp Functional Performance

    Protocol: FIT-HaNSA

    Baseline assessment, no follow-up

Study Arms (2)

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 testOther: Pain intensityDevice: Upper Limb Functional Performance

age gender matched healthy controls

Participants were assessed for SME, and upper extremity function (FIT-HaNSA).

Device: Scapular muscle endurance testDevice: Upper Limb Functional Performance

Interventions

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.

age gender matched healthy controlsrotator cuff related shoulder pain

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.

rotator cuff related shoulder pain

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.

Also known as: FIT-HaNSA
age gender matched healthy controlsrotator cuff related shoulder pain

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

23 patients and 23 age-gender matched healthy subjects who met the inclusion criteria were included to the study

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Selda BAŞAR

    Gazi University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistant

Study Record Dates

First Submitted

August 26, 2018

First Posted

August 29, 2018

Study Start

December 1, 2015

Primary Completion

December 1, 2017

Study Completion

January 1, 2018

Last Updated

January 11, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share