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Adverse Events Associated With Manual Therapies in Children

U

Université du Québec à Trois-Rivières

Status

Completed

Conditions

Adverse Event

Treatments

Other: Manual therapies

Study type

Observational

Funder types

Other

Identifiers

NCT05409859
UQTR_peds_2021-2022

Details and patient eligibility

About

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.

Full 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.

Enrollment

74 patients

Sex

All

Ages

Under 5 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

74 participants in 1 patient group

Participants
Description:
Children patients of 5 years and younger who received manual therapies by a chiropractor in private practice.
Treatment:
Other: Manual therapies

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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