Adverse Events Associated With Manual Therapies in Children

Adverse Event Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05409859
• Other study ID #: UQTR_peds_2021-2022
• Status: Completed
• Start date: June 1, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: June 2022
• Source: Université du Québec à Trois-Rivières
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Adverse Event

Intervention

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.

Locations

Country	Name	City	State
Canada	Université du Québec à Trois-Rivières	Trois-Rivières	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université du Québec à Trois-Rivières

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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