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

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ClinicalTrials.gov Identifier: NCT03658707
Recruitment Status : Recruiting
First Posted : September 5, 2018
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Damla Karabay, Izmir Katip Celebi University

Brief Summary:
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).

Condition or disease Intervention/treatment
Subacromial Impingement Syndrome Other: questionnaire

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.

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Study Type : Observational
Estimated Enrollment : 116 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Validity and Reliability of the Turkish Version of the Functional Shoulder Score in Patients With Subacromial Impingement Syndrome
Actual Study Start Date : November 23, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Intervention Details:
  • Other: questionnaire
    Shoulder questionnaire


Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. Global rating scale [ Time Frame: Baseline ]
    The global shoulder function is graded between 0 (no use) and 10 (normal function) on a scale.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03658707


Contacts
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Contact: Damla KARABAY 2323293535 ext +90 damla.gulpinar@ikc.edu.tr

Locations
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Turkey
Dokuz Eylul University, School of Physical Therapy and Rehabilitation Recruiting
İzmir, Turkey
Contact: Damla KARABAY, MS         
Sponsors and Collaborators
Dokuz Eylul University
Investigators
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Study Director: Sevgi Sevi YESILYAPRAK, PhD Dokuz Eylul University
Study Chair: Halime Ezgi TURKSAN Dokuz Eylul University
Study Chair: Mehmet ERDURAN, MD Dokuz Eylul University
Principal Investigator: Damla KARABAY, MSc Izmir Katip Celebi University

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Responsible Party: Damla Karabay, Principal investigator, Izmir Katip Celebi University
ClinicalTrials.gov Identifier: NCT03658707     History of Changes
Other Study ID Numbers: 3864-GOA
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Damla Karabay, Izmir Katip Celebi University:
Functional shoulder score
questionnaire
subacromial impingement syndrome
Additional relevant MeSH terms:
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Shoulder Impingement Syndrome
Syndrome
Rotator Cuff Injuries
Disease
Pathologic Processes
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Joint Diseases
Musculoskeletal Diseases