Validity and Reliability of the Turkish Version of the Functional Shoulder Score

July 26, 2022 updated by: Damla Karabay, Dokuz Eylul University

Validity and Reliability of the Turkish Version of the Functional Shoulder Score in Patients With Subacromial Impingement Syndrome

The aim of this study is to determine the validity and reliability of the Turkish version of the Functional Shoulder Score in Turkish patients with subacromial impingement syndrome (SIS).

Study Overview

Status

Recruiting

Intervention / Treatment

Detailed Description

The original form of the Functional Shoulder Score will be translated into Turkish by two Turkish mother tongue translators who also speak English in advanced level. Then these translations will be combined into one translation and translated back to English. The pre-final version will be composed and tested on a group of patients with SIS. If necessary, readjustments will be made, and the validity of the final version will be investigated in 116 patients with SIS. Additionally, for the test-retest reliability, 59 patients will fill out the questionnaire again after 3-7 days.

Study Type

Observational

Enrollment (Anticipated)

116

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • İzmir, Turkey
        • Recruiting
        • Dokuz Eylul University, School of Physical Therapy and Rehabilitation
        • Contact:
          • Damla KARABAY, MS

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with subacromial impingement syndrome from the outpatient clinic of the Dokuz Eylul University, Faculty of Medicine, Department of Orthopedics and Traumatology.

Description

Inclusion Criteria:

  • Diagnosis of subacromial impingement syndrome (Michener et al, 2009)
  • To read and understand Turkish

Exclusion Criteria:

  • 50% limitation of passive shoulder range of motion in ≥ 2 planes of motion
  • Glenohumeral instability
  • Fracture or surgery history in the shoulder
  • Another diagnosis that may affect shoulder function (frozen shoulder, primary shoulder arthritis, inflammatory/ neoplastic/neurological conditions, cervical spine induced pain)
  • Systemic musculoskeletal disease

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-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Shoulder Score
Time Frame: Baseline - within 3-7 days after the baseline
The questionnaire includes 11 items: One is about shoulder pain intensity and 10 is about the shoulder function. The minimum score is 0 (worst) and the maximum score is 100 (best).
Baseline - within 3-7 days after the baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Constant Murley Shoulder Score
Time Frame: Baseline
100 points total score of this score consists of 15 points of pain, 20 points of daily activities, 40 points of the active range of motion, and 25 points of strength. The minimum score is 0 (worst) and the maximum score is 100 (best).
Baseline
American Shoulder and Elbow Surgeons (ASES) Society standardized shoulder assessment form
Time Frame: Baseline
The patient self-evaluation questionnaire includes 11 item; one is about shoulder pain intensity and 10 are about the shoulder function.The minimum score is 0 (worst) and the maximum score is 100 (best).
Baseline
Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH)
Time Frame: Baseline
The disability level of the upper extremity is determined by 30 questions; 21 questions are about physical function, 3 questions are about social/role function and 6 questions are about the symptoms of the patient. The minimum score is 0 (best) and the maximum score is 100 (worst).
Baseline
Western Ontario Rotator Cuff (WORC) index
Time Frame: Baseline
The disease-specific questionnaire includes 21 items, 4 about physical symptoms, 4 about sport/recreation, 4 about work, 4 about lifestyle and 4 about emotions. The minimum score is 0 (worst) and the maximum score is 100 (best).
Baseline
Global rating scale
Time Frame: Baseline
The global shoulder function is graded between 0 (no use) and 10 (normal function) on a scale.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Damla KARABAY, MSc, Izmir Katip Çelebi University
  • Study Chair: Halime Ezgi TURKSAN, Dokuz Eylül University
  • Study Chair: Mehmet ERDURAN, MD, Dokuz Eylül 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)

November 23, 2018

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

September 2, 2018

First Submitted That Met QC Criteria

September 4, 2018

First Posted (Actual)

September 5, 2018

Study Record Updates

Last Update Posted (Actual)

July 27, 2022

Last Update Submitted That Met QC Criteria

July 26, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

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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