Clinical trial NCT05409859: Adverse Events Associated With Manual Therapies in Children
Official title: Assessing Adverse Events Associated With Manual Therapies in Preschool Pediatric Population: a Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adverse Event
Keywords: Manual therapy
Spinal mobilization
Complementary and alternative therapy
Pediatric
Chiropractic
Lead sponsor: Université du Québec à Trois-Rivières
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 74
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Immediate adverse event
timeFrame: 5 minutes following the intervention
measure: Delayed adverse event
timeFrame: 48 hours following the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Trois-Rivières
country: Canada
facility: Université du Québec à Trois-Rivières
state: Quebec
Study officials:
affiliation: Université du Québec à Trois-Rivières
name: Isabelle Pagé, PhD
role: PRINCIPAL_INVESTIGATOR
References: