Adverse Event
Conditions
Keywords
Manual therapy, Spinal mobilization, Complementary and alternative therapy, Pediatric, Chiropractic
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.
Interventions
OTHERManual 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.
Sponsors
Université du Québec à Trois-Rivières
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 5 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immediate adverse event | 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 |
| Delayed adverse event | 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 |
Countries
Canada
Outcome results
None listed