Adverse Events Associated With Manual Therapies in Children

NCT ID: NCT05409859

Last Updated: 2022-06-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 74 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2022-02-28

Brief Summary

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.

Detailed Description

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.

Conditions

Adverse Event

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Participants

Children patients of 5 years and younger who received manual therapies by a chiropractor in private practice.

Manual therapies

Intervention Type: OTHER

Manual therapies were determined based on the clinician evaluation and could include spinal mobilization delivered by hands or mechanically assisted and soft tissue therapies.

Interventions

Manual therapies

Manual therapies were determined based on the clinician evaluation and could include spinal mobilization delivered by hands or mechanically assisted and soft tissue therapies.

Intervention Type: OTHER

Other Intervention Names

Manual therapy; Spinal mobilization delivered by hands; Soft tissue therapy; Mechanically assisted spinal mobilization

Eligibility Criteria

Inclusion Criteria

• Children of 5 years or younger
• First or second treatment at one of the chiropractic clinic
• Spinal mobilization has to be clinically indicated

Exclusion Criteria

• Children of 6 years or older
• Spinal mobilization not indicated

• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Université du Québec à Trois-Rivières

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Isabelle Pagé, PhD

Role: PRINCIPAL_INVESTIGATOR

Université du Québec à Trois-Rivières

Locations

Université du Québec à Trois-Rivières

Trois-Rivières, Quebec, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 38481318 (View on PubMed)

Other Identifiers

UQTR_peds_2021-2022

Identifier Type: -

Identifier Source: org_study_id