Adverse Events Associated With Manual Therapies in Children

Université du Québec à Trois-Rivières74 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Adverse Event

Interventions

Manual therapiesOTHER

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

Eligibility

Sex: ALLMax age: 5 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Université du Québec à Trois-Rivières

Trois-Rivières, Quebec, Canada

Outcomes

Primary Outcomes

Immediate adverse event

New symptom or aggravation of a preexisting symptom noted by the legal tutor of the children immediately following the manual therapies

Time frame: 5 minutes following the intervention

Delayed adverse event

New symptom or aggravation of a preexisting symptom noted by the legal tutor of the children 48h following the manual therapies

Time frame: 48 hours following the intervention

Data from ClinicalTrials.gov

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