Adverse Events Associated With Manual Therapies in Children

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

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.

Study Overview

• Status: Completed
• Conditions: Adverse Event
• Intervention / Treatment: Other: Manual therapies

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 Type: Observational
• Enrollment (Actual): 74

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Trois-Rivières, Quebec, Canada, G8Z4M3
      • Université du Québec à Trois-Rivières

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children of 5 years or less consulting at one of the participating chiropractors' private practice localized in Québec province (Canada).

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants; Children patients of 5 years and younger who received manual therapies by a chiropractor in private practice.	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.; Other Names: Manual therapy; Spinal mobilization delivered by hands; Soft tissue therapy; Mechanically assisted spinal mobilization

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Université du Québec à Trois-Rivières
• Investigators: Principal Investigator: Isabelle Pagé, PhD, Université du Québec à Trois-Rivières

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: June 3, 2022
• First Submitted That Met QC Criteria: June 3, 2022
• First Posted (Actual): June 8, 2022

Study Record Updates

• Last Update Posted (Actual): June 14, 2022
• Last Update Submitted That Met QC Criteria: June 9, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Pediatric; Manual therapy; Chiropractic; Spinal mobilization; Complementary and alternative therapy
• Other Study ID Numbers: UQTR_peds_2021-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No