- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03658707
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
Conditions
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
- Name: Damla KARABAY
- Phone Number: +90 2323293535
- Email: damla.gulpinar@ikc.edu.tr
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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3864-GOA
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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