- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04409756
Shoulder Rating Questionnaire in Turkish
Validity and Reliability of the Turkish Version of the Shoulder Rating Questionnaire
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Shoulder pain is one of the common musculoskeletal disorders. A self- administered patient-based questionnaire has an important role for evaluate shoulder disabilities and also it is helpful for assess the treatment success.The purpose of this study is to determine the Turkish version of the Shoulder Rating Questionnaire (SRQ) and assign reliability and validity in Turkish patients.The Turkish version of the Shoulder Rating Questionnaire (SRQ-T) will be applied to patients after translation from English into Turkish. 122 patients will be participate to the study. Patients who were over 18 years with various shoulder pain complaints will be included into the study. The patients with mixed-type pain, cancer pain, headache, substance abuse, severe depression and fibromyalgia syndrome will be excluded. The musculoskeletal and neurological examinations of the patients will be performed. The Turkish version of the Shoulder Rating Questionnaire (SRQ-T) and Disabilities of arm, shoulder, hands-T (DASH-T) will be applied to all patients.
SRQ-T and DASH-T will be collected in two sessions with at last three days between the sessions for pre-assessment and post-assessment. Reliability of SRQ-T questionnaire will be tested by internal consistency and test-retest reliability. Internal consistency will be evaluated by determining intraclass correlation coefficient (ICC) with 95% confidence interval, ranged between 0 and 1.
To determine the internal consistency of the five domains of SRQ-T, Cronbach's alfa coefficient will be computed for both pre- and post-assessment of the questionnaire. The test-retest method with Wilcoxon Signed Rank Test will be used to determine reliability of SRQ-T and its domains. Then, Spearman correlation coefficients will be used to assess the discriminant validity of SRQ-T for evaluation of shoulder pain. The Spearman correlation coefficient score more than 0.70 will be accepted for reliability
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Lüleburgaz
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Kırklareli, Lüleburgaz, Turkey, 39750
- Betül Tepeli
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients who were over 18 years with various shoulder pain complaints
Exclusion Criteria:
- The patients with mixed-type pain, cancer pain, headache, substance abuse, severe depression and fibromyalgia syndrome
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: postassessment of the SRQ-T test
the SRQ -T will be obtained to all patients three days after the first assessment
|
to investigate reliability of turkish version of shoulder rating questionnaire
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
reliability of SRQ-T questionnaire
Time Frame: through study completion, an average of 1 month
|
Reliability of SRQ-T questionnaire will be tested by internal consistency and test-retest reliability.
Internal consistency will be evaluated by determining intraclass correlation coefficient (ICC) with 95% confidence interval, ranged between 0 and 1.
|
through study completion, an average of 1 month
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Betül Tepeli, Private Balkan Hospital
Publications and helpful links
General Publications
- L'Insalata JC, Warren RF, Cohen SB, Altchek DW, Peterson MG. A self-administered questionnaire for assessment of symptoms and function of the shoulder. J Bone Joint Surg Am. 1997 May;79(5):738-48.
- Vermeulen HM, Boonman DC, Schuller HM, Obermann WR, van Houwelingen HC, Rozing PM, Vliet Vlieland TP. Translation, adaptation and validation of the Shoulder Rating Questionnaire (SRQ) into the Dutch language. Clin Rehabil. 2005 May;19(3):300-11. doi: 10.1191/0269215505cr811oa.
- Paul A, Lewis M, Shadforth MF, Croft PR, Van Der Windt DA, Hay EM. A comparison of four shoulder-specific questionnaires in primary care. Ann Rheum Dis. 2004 Oct;63(10):1293-9. doi: 10.1136/ard.2003.012088.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20181106/4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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