Adverse Events Associated With Manual Therapies in Children

Completed

• Conditions: Adverse Event
• Interventions: Other: Manual therapies

• Registration Number: NCT05409859
• Lead Sponsor: Université du Québec à Trois-Rivières

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.

Study Timeline

• Study Start: 2021-06-01
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28
• Status Verified: 2022-06
• Study First Submitted: 2022-06-03
• Study First Submitted QC: 2022-06-03
• Study First Posted: 2022-06-08
• Last Update Submitted: 2022-06-09
• Last Update Posted: 2022-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants	Manual therapies	Children patients of 5 years and younger who received manual therapies by a chiropractor in private practice.

Primary Outcome Measures

Name	Time	Method
Delayed adverse event	48 hours following the intervention	New symptom or aggravation of a preexisting symptom noted by the legal tutor of the children 48h following the manual therapies
Immediate adverse event	5 minutes following the intervention	New symptom or aggravation of a preexisting symptom noted by the legal tutor of the children immediately following the manual therapies

Trial Locations

Locations (1)

Université du Québec à Trois-Rivières; 🇨🇦 Trois-Rivières, Quebec, Canada