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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03658707
Other study ID # 3864-GOA
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 23, 2018
Est. completion date July 2023

Study information

Verified date July 2022
Source Dokuz Eylul University
Contact Damla KARABAY
Phone 2323293535
Email damla.gulpinar@ikc.edu.tr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 116
Est. completion date July 2023
Est. primary completion date July 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
questionnaire
Shoulder questionnaire

Locations

Country Name City State
Turkey Dokuz Eylul University, School of Physical Therapy and Rehabilitation Izmir

Sponsors (1)

Lead Sponsor Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Functional Shoulder Score 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 Modified Constant Murley Shoulder Score 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
Secondary American Shoulder and Elbow Surgeons (ASES) Society standardized shoulder assessment form 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
Secondary Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH) 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
Secondary Western Ontario Rotator Cuff (WORC) index 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
Secondary Global rating scale The global shoulder function is graded between 0 (no use) and 10 (normal function) on a scale. Baseline
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