Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2025-12-26 @ 2:18 AM
Study NCT ID:
NCT06833359
Status:
COMPLETED
Last Update Posted:
2025-04-18
First Post:
2025-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validity, Reliability of Neck Disability Index in Albanian
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D009209', 'term': 'Myofascial Pain Syndromes'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 582}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-04-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-15', 'studyFirstSubmitDate': '2025-02-12', 'studyFirstSubmitQcDate': '2025-02-12', 'lastUpdatePostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Albanian Neck Disability Index', 'timeFrame': '7 days', 'description': "An online questionnaire used to assess the impact of neck pain on patients' activities of daily living and quality of life which consists of 10 items, each addressing a specific dimension of functionality or symptoms related to neck disorders.Each item includes five response options ranging from 0 to 5 points, where 0 indicates the absence of problems or limitations and 5 represents the maximum inability or restriction to perform the evaluated activity. The total score is calculated by adding the values of the 10 items, with a maximum of 50 points."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Validity', 'cross-cultural adaptation', 'Albanian Neck Disability index', 'Translation'], 'conditions': ['Myofascial Pain Dysfunction Syndrome', 'Trigger Point Pain, Myofascial']}, 'descriptionModule': {'briefSummary': 'To translate and validate the Cervical Disability Index (NDI) into Albanian for use in the Albanian-speaking population', 'detailedDescription': 'The cross-cultural adaptation will be carried out according to the internationally recommended methodology, following the guidelines: translation, back-translation; dissemination of questionnaires and data collection and analysis.\n\nPsychometric properties will be assessed by administering the questionnaire to approximately 400 participants. Reliability will be estimated by assessing stability and homogeneity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'adults with cervical pain', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Myofascial syndrome\n* Headache\n* muscular pain\n* articular pain\n* arthirtis\n\nExclusion Criteria:\n\n* contraindications to manual therapy\n* severe trauma\n* tumor\n* metabolic disease'}, 'identificationModule': {'nctId': 'NCT06833359', 'acronym': 'NDI', 'briefTitle': 'Validity, Reliability of Neck Disability Index in Albanian', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Católica San Antonio de Murcia'}, 'officialTitle': 'Adaptation, Translation, and Cross-cultural Validation of the Cervical Disability Index (NDI) for Use in the Albanian-speaking Population', 'orgStudyIdInfo': {'id': '208/9'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Observation', 'type': 'OTHER', 'description': 'The Cervical Disability Index will be taught individually online through the Google questionnaire.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '30107', 'city': 'Murcia', 'country': 'Spain', 'facility': 'Jasemin Todri', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}], 'overallOfficials': [{'name': 'Jasemin Todri', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCAM Universidad Catolica San Antonio de Murcia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Católica San Antonio de Murcia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jasemin Todri', 'investigatorAffiliation': 'Universidad Católica San Antonio de Murcia'}}}}