Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2026-01-06 @ 7:58 AM
Study NCT ID:
NCT07071792
Status:
COMPLETED
Last Update Posted:
2025-07-17
First Post:
2025-07-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Helmet Associated Neck Pain Among TCS Riders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019547', 'term': 'Neck Pain'}], 'ancestors': [{'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-15', 'studyFirstSubmitDate': '2025-07-06', 'studyFirstSubmitQcDate': '2025-07-15', 'lastUpdatePostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neck Disability Index', 'timeFrame': '12 weeks', 'description': 'to measure helmet associated neck disability, ranging from 0 (no disability) to 50 (complete disability)'}, {'measure': 'Numeric Pain Rating Scale', 'timeFrame': '12 weeks', 'description': 'to measure helmet associated neck pain, high score indicates worse patient condition'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Helmet use', 'neck pain', 'motorcycles', 'head protective devices', 'disability'], 'conditions': ['Neck Pain']}, 'referencesModule': {'references': [{'pmid': '39591956', 'type': 'BACKGROUND', 'citation': 'Makkiyah FA, Natashia K, Kristanti M, Purwaningastuti DA. Associated Factors with Neck Pain among Productive Adult Motorcyclists in Metropolitan University Settings : A Cross-Sectional Study. J Korean Neurosurg Soc. 2025 Jul;68(4):425-435. doi: 10.3340/jkns.2024.0114. Epub 2024 Nov 26.'}, {'pmid': '26735233', 'type': 'BACKGROUND', 'citation': 'Harrison MF, Forde KA, Albert WJ, Croll JC, Neary JP. Posture and Helmet Load Influences on Neck Muscle Activation. Aerosp Med Hum Perform. 2016 Jan;87(1):48-53. doi: 10.3357/AMHP.4301.2016.'}]}, 'descriptionModule': {'briefSummary': 'The aim and objective of this study is to check the prevalence of helmet associated neck pain among TCS riders.', 'detailedDescription': 'Finding the overall prevalence of neck pain linked to helmet use is the goal of the study. On the other hand, the TCS delivery riders of Gujranwala, who wear helmets for extended periods of time throughout their daily employment, are a larger and more pertinent demographic in our study. Furthermore, our study is a significant and much-needed addition to this field as no prior research has explicitly examined the prevalence of helmet-associated neck pain among TCS riders.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'TCS riders who use helmets for at least 6 hours per day', 'genderDescription': 'Males were selected for this study because, in Pakistan, the occupation of TCS rider is predominantly held by men. Therefore, to ensure relevance and accuracy, the study population was limited to male participants', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-45-year age\n* male TCS riders\n* All TCS riders who are using helmet for past six months or above\n* Minimum duration of helmet use\n* who will be willing to participate\n\nExclusion Criteria:\n\n* Subjects had any known disorder that causes pain in neck or upper limb\n* Any traumatic injury to cervical spine (fractures)\n* cervical spine pathologies'}, 'identificationModule': {'nctId': 'NCT07071792', 'briefTitle': 'Prevalence of Helmet Associated Neck Pain Among TCS Riders', 'organization': {'class': 'OTHER', 'fullName': 'Elite College of Management Sciences, Gujranwala, Pakistan'}, 'officialTitle': 'Prevalence of Helmet Associated Neck Pain Among Tcs Riders', 'orgStudyIdInfo': {'id': '2020-GCUF-079260'}}, 'contactsLocationsModule': {'locations': [{'zip': '52250', 'city': 'Gujranwala', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'TCS centers', 'geoPoint': {'lat': 32.15567, 'lon': 74.18705}}], 'overallOfficials': [{'name': 'Syeda Mahnoor Hassan, MSPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Elite College of ManagementSciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elite College of Management Sciences, Gujranwala, Pakistan', 'class': 'OTHER'}, 'collaborators': [{'name': 'World Health Organization', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}