Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2026-03-03 @ 5:04 PM
Study NCT ID:
NCT02754934
Status:
COMPLETED
Last Update Posted:
2016-11-04
First Post:
2016-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of a Self-administered Neck Mobility Assessment Tool in Chronic Neck Pain Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019547', 'term': 'Neck Pain'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-03', 'studyFirstSubmitDate': '2016-04-25', 'studyFirstSubmitQcDate': '2016-04-27', 'lastUpdatePostDateStruct': {'date': '2016-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cervical Spine Mobility', 'timeFrame': 'Day one of the study', 'description': 'Patients will fill out the questionnaire once, at the beginning of the study.'}], 'secondaryOutcomes': [{'measure': 'Pain Visual Analogue Pain Rating Scale', 'timeFrame': 'Day one of the study', 'description': 'Patients will fill out the questionnaire once, at the beginning of the study.'}, {'measure': 'Disability on Neck Disability Index', 'timeFrame': 'Day one of the study', 'description': 'Patients will fill out the questionnaire once, at the beginning of the study.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['chronic'], 'conditions': ['Neck Pain']}, 'referencesModule': {'references': [{'pmid': '29656846', 'type': 'DERIVED', 'citation': 'Langenfeld A, Bastiaenen C, Sieben J, Swanenburg J. Development and validation of a self-administered neck mobility assessment tool (S-ROM-Neck) in chronic neck pain patients. Musculoskelet Sci Pract. 2018 Oct;37:75-79. doi: 10.1016/j.msksp.2018.04.004. Epub 2018 Apr 10.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates, if the movement of the cervical spine, assessed via a specific questionnaire by the patient, is a valid and reliable tool and could be used in daily clinical routine.', 'detailedDescription': 'Cervical range of motion is a frequently used assessment methods in patients with neck pain.\n\nAlthough it seems to be used frequently, clinicians still prefer hands-on assessment. Furthermore it is interesting, if cervical range of motion,self-assessed by the patient is a valid and reliable tool.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Investigators will include 50 participants with chronic neck pain', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Neck pain \\> 90 days\n* Able to speak, read and write German\n\nExclusion Criteria:\n\n* Red Flags e.g. Fracture of the cervical spine'}, 'identificationModule': {'nctId': 'NCT02754934', 'briefTitle': 'Development of a Self-administered Neck Mobility Assessment Tool in Chronic Neck Pain Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Balgrist University Hospital'}, 'officialTitle': 'Development of a Self-administered Neck Mobility Assessment Tool in Chronic Neck Pain Patients.', 'orgStudyIdInfo': {'id': '2016-00164'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cervical range of motion', 'type': 'OTHER', 'description': 'Patients will fill out the Neck Disability Index, Visual Analogue Pain Rating Scale and the Self-administered Neck range of motion questionnaire.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8008', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'Balgrist University Hospital', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Jaap Swanenburg, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Balgrist University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Balgrist University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Maastricht University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Researcher', 'investigatorFullName': 'Swanenburg', 'investigatorAffiliation': 'Balgrist University Hospital'}}}}