Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-02-21 @ 11:18 PM
Study NCT ID:
NCT04409756
Status:
COMPLETED
Last Update Posted:
2020-06-01
First Post:
2020-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Shoulder Rating Questionnaire in Turkish
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020069', 'term': 'Shoulder Pain'}], 'ancestors': [{'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 122}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-29', 'studyFirstSubmitDate': '2020-05-25', 'studyFirstSubmitQcDate': '2020-05-29', 'lastUpdatePostDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'reliability of SRQ-T questionnaire', 'timeFrame': 'through study completion, an average of 1 month', '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Disability Evaluation', 'Shoulder Pain', 'Shoulder Validation Studies', 'Outcome measures'], 'conditions': ['Shoulder Pain']}, 'referencesModule': {'references': [{'pmid': '9160947', 'type': 'RESULT', '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."}, {'pmid': '15859531', 'type': 'RESULT', '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.'}, {'pmid': '15361390', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nSRQ-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.\n\nTo 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"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who were over 18 years with various shoulder pain complaints\n\nExclusion Criteria:\n\n* The patients with mixed-type pain, cancer pain, headache, substance abuse, severe depression and fibromyalgia syndrome'}, 'identificationModule': {'nctId': 'NCT04409756', 'briefTitle': 'Shoulder Rating Questionnaire in Turkish', 'organization': {'class': 'OTHER', 'fullName': 'Namik Kemal University'}, 'officialTitle': 'Validity and Reliability of the Turkish Version of the Shoulder Rating Questionnaire', 'orgStudyIdInfo': {'id': '20181106/4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'postassessment of the SRQ-T test', 'description': 'the SRQ -T will be obtained to all patients three days after the first assessment', 'interventionNames': ['Other: shoulder rating questionnaire']}], 'interventions': [{'name': 'shoulder rating questionnaire', 'type': 'OTHER', 'description': 'to investigate reliability of turkish version of shoulder rating questionnaire', 'armGroupLabels': ['postassessment of the SRQ-T test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '39750', 'city': 'Kırklareli', 'state': 'Lüleburgaz', 'country': 'Turkey (Türkiye)', 'facility': 'Betül Tepeli', 'geoPoint': {'lat': 41.73508, 'lon': 27.22521}}], 'overallOfficials': [{'name': 'Betül Tepeli', 'role': 'STUDY_DIRECTOR', 'affiliation': 'private balkan hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Betül Tepeli', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ufuk University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Department of Physical Medicine And Rehabilitation, Private Balkan Hospital,Principal Investigator,', 'investigatorFullName': 'Betül Tepeli', 'investigatorAffiliation': 'Namik Kemal University'}}}}