Adverse Events Associated With Manual Therapies in Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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Assessing Adverse Events Associated With Manual Therapies in Preschool Pediatric Population: a Feasibility Study

Conditions
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Adverse Event

Intervention / Treatment
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* Other: Manual therapies


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants<br>Children patients of 5 years and younger who received manual therapies by a chiropractor in private practice. | Other: Manual therapies<br>* Manual therapies were determined based on the clinician evaluation and could include spinal mobilization delivered by hands or mechanically assisted and soft tissue therapies.<br>* Other names: Mechanically assisted spinal mobilization;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immediate adverse event | New symptom or aggravation of a preexisting symptom noted by the legal tutor of the children immediately following the manual therapies | 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 | 48 hours following the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chiropractic, Manual therapy, Spinal mobilization, Complementary and alternative therapy, Pediatric