Shoulder Rating Questionnaire in Turkish
Primary Purpose
Shoulder Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
shoulder rating questionnaire
Sponsored by
About this trial
This is an interventional diagnostic trial for Shoulder Pain focused on measuring Disability Evaluation, Shoulder Pain, Shoulder Validation Studies, Outcome measures
Eligibility Criteria
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
Sites / Locations
- Betül Tepeli
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
postassessment of the SRQ-T test
Arm Description
the SRQ -T will be obtained to all patients three days after the first assessment
Outcomes
Primary Outcome Measures
reliability of SRQ-T questionnaire
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04409756
First Posted
May 25, 2020
Last Updated
May 29, 2020
Sponsor
Betül Tepeli
Collaborators
Ufuk University
1. Study Identification
Unique Protocol Identification Number
NCT04409756
Brief Title
Shoulder Rating Questionnaire in Turkish
Official Title
Validity and Reliability of the Turkish Version of the Shoulder Rating Questionnaire
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
March 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Betül Tepeli
Collaborators
Ufuk University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
Keywords
Disability Evaluation, Shoulder Pain, Shoulder Validation Studies, Outcome measures
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
122 (Actual)
8. Arms, Groups, and Interventions
Arm Title
postassessment of the SRQ-T test
Arm Type
Other
Arm Description
the SRQ -T will be obtained to all patients three days after the first assessment
Intervention Type
Other
Intervention Name(s)
shoulder rating questionnaire
Intervention Description
to investigate reliability of turkish version of shoulder rating questionnaire
Primary Outcome Measure Information:
Title
reliability of SRQ-T questionnaire
Description
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.
Time Frame
through study completion, an average of 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Betül Tepeli
Organizational Affiliation
private balkan hospital
Official's Role
Study Director
Facility Information:
Facility Name
Betül Tepeli
City
Kırklareli
State/Province
Lüleburgaz
ZIP/Postal Code
39750
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
9160947
Citation
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.
Results Reference
result
PubMed Identifier
15859531
Citation
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.
Results Reference
result
PubMed Identifier
15361390
Citation
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.
Results Reference
result
Learn more about this trial
Shoulder Rating Questionnaire in Turkish
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