NCT05409859

Adverse Events Associated With Manual Therapies in Children

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 74 (actual)
• Sponsor: Université du Québec à Trois-Rivières · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2021-06-01
• Primary completion: 2022-02-28
• Completion: 2022-02-28
• First posted: 2022-06-08
• Last updated: 2022-06-14

Locations

1 site across 1 country: Canada