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OpenTrials
Completed

NCT Number: NCT05409859

Adverse Events Associated With Manual Therapies in Children

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.

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Key information

Conditions

Age range

Up to 5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Université du Québec à Trois-Rivières

Trois-Rivières, Quebec, G8Z4M3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Manual therapies

Other

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

Primary outcomes

  1. Immediate adverse event

    Time frame: 5 minutes following the intervention

    New symptom or aggravation of a preexisting symptom noted by the legal tutor of the children immediately following the manual therapies

  2. Delayed adverse event

    Time frame: 48 hours following the intervention

    New symptom or aggravation of a preexisting symptom noted by the legal tutor of the children 48h following the manual therapies

Sponsors and collaborators

Lead sponsor

Université du Québec à Trois-Rivières

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 8, 2022
Registry last updated
Jun 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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