Ignite Creation Date:
2025-12-24 @ 2:25 PM
Ignite Modification Date:
2026-02-23 @ 8:09 PM
Study NCT ID:
NCT05409859
Status:
COMPLETED
Last Update Posted:
2022-06-14
First Post:
2022-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adverse Events Associated With Manual Therapies in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D064746', 'term': 'Therapy, Soft Tissue'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-09', 'studyFirstSubmitDate': '2022-06-03', 'studyFirstSubmitQcDate': '2022-06-03', 'lastUpdatePostDateStruct': {'date': '2022-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immediate adverse event', 'timeFrame': '5 minutes following the intervention', 'description': 'New symptom or aggravation of a preexisting symptom noted by the legal tutor of the children immediately following the manual therapies'}, {'measure': 'Delayed adverse event', 'timeFrame': '48 hours following the intervention', 'description': 'New symptom or aggravation of a preexisting symptom noted by the legal tutor of the children 48h following the manual therapies'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Manual therapy', 'Spinal mobilization', 'Complementary and alternative therapy', 'Pediatric', 'Chiropractic'], 'conditions': ['Adverse Event']}, 'referencesModule': {'references': [{'pmid': '38481318', 'type': 'DERIVED', 'citation': 'Dolbec A, Doucet C, Pohlman KA, Sobczak S, Page I. Assessing adverse events associated with chiropractic care in preschool pediatric population: a feasibility study. Chiropr Man Therap. 2024 Mar 13;32(1):9. doi: 10.1186/s12998-024-00529-0.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the feasibility to conduct a prospective cohort study evaluating the adverse events associated with manual therapies in children of 5 years and younger. A validated reporting system will be used to evaluate the adverse events and include a total of four questionnaires that are filled online. Adverse events will be evaluated immediately following the intervention and at 48h post-intervention.', 'detailedDescription': 'The aim of this study is to investigate (1) the feasibility to conduct a prospective cohort study evaluating the adverse events associated with manual therapies in children of 5 years and younger and (2) to report preliminary data on the frequency and nature of the adverse events. Participating chiropractors will advertise the study in their private clinic through flyers and posters. Legal tutors interested to participate will access an information sheet and consent form using a link available on the flyers/posters. Legal tutors of participants will complete three questionnaires, one before the intervention to describe the child (e.g. age, sex, reason(s) to seek care), one immediately following the intervention to report immediate adverse events and one 48h following the intervention to report delayed adverse events. Clinicians will complete one questionnaire immediately following the intervention to describe the manual therapies delivered to the children. All questionnaires will be available online on a secured platform. The intervention will be determined by the clinician according the their evaluation of the child and could include spinal mobilization as well as soft tissue therapies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Children of 5 years or less consulting at one of the participating chiropractors' private practice localized in Québec province (Canada).", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children of 5 years or younger\n* First or second treatment at one of the chiropractic clinic\n* Spinal mobilization has to be clinically indicated\n\nExclusion Criteria:\n\n* Children of 6 years or older\n* Spinal mobilization not indicated'}, 'identificationModule': {'nctId': 'NCT05409859', 'briefTitle': 'Adverse Events Associated With Manual Therapies in Children', 'organization': {'class': 'OTHER', 'fullName': 'Université du Québec à Trois-Rivières'}, 'officialTitle': 'Assessing Adverse Events Associated With Manual Therapies in Preschool Pediatric Population: a Feasibility Study', 'orgStudyIdInfo': {'id': 'UQTR_peds_2021-2022'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants', 'description': 'Children patients of 5 years and younger who received manual therapies by a chiropractor in private practice.', 'interventionNames': ['Other: Manual therapies']}], 'interventions': [{'name': 'Manual therapies', 'type': 'OTHER', 'otherNames': ['Manual therapy', 'Spinal mobilization delivered by hands', 'Soft tissue therapy', 'Mechanically assisted spinal mobilization'], 'description': 'Manual therapies were determined based on the clinician evaluation and could include spinal mobilization delivered by hands or mechanically assisted and soft tissue therapies.', 'armGroupLabels': ['Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G8Z4M3', 'city': 'Trois-Rivières', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Université du Québec à Trois-Rivières', 'geoPoint': {'lat': 46.34515, 'lon': -72.5477}}], 'overallOfficials': [{'name': 'Isabelle Pagé, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université du Québec à Trois-Rivières'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université du Québec à Trois-Rivières', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}