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Assessing adverse events associated with chiropractic care in preschool pediatric population: a feasibility study
Anne Dolbec1,2, Chantale Doucet3, Katherine A Pohlman4
1Département d'anatomie, Université du Québec à Trois-Rivières, 3351 Boul. des Forges, G8Z 4M3, Trois-Rivières, Québec, Canada.
Insights
This study found it feasible to prospectively track adverse events (AEs) from manual therapies in young children. About 30% of children experienced AEs, mostly mild and immediate, like irritability or fatigue.
Area of Science:
- Pediatric healthcare research
- Clinical trial methodology
- Manual therapy safety
Background:
- Manual therapies are common in pediatric care, but prospective data on adverse events (AEs) are limited.
- This study addresses the need for evidence on the safety of manual therapies in children.
- Focuses on children aged 5 years or younger receiving manual therapy.
Purpose of the Study:
- To assess the feasibility of a pragmatic prospective study on AEs of manual therapies in young children.
- To collect preliminary data on the frequency and nature of immediate and delayed AEs.
- To inform future, larger-scale safety studies.
Main Methods:
- Recruited chiropractors in Quebec via purposive sampling and a Facebook group.
- Enrolled legal guardians of children aged 5 or younger.
- Collected AEs using the SafetyNET system via immediate and 48-hour post-treatment questionnaires.
Main Results:
- 80 guardians consented, with data from 73 children analyzed.
- 30% (22/73) of children experienced at least one AE, primarily immediate.
- Most common AEs were irritability/crying and fatigue/tiredness.
Conclusions:
- A prospective pragmatic study on AEs of manual therapies in pediatric private practices is feasible.
- Effective clinician communication and targeted recruitment are crucial for feasibility.
- Further research with a larger sample size is needed to confirm AE frequency.
Background:
Manual therapies are commonly used by healthcare professionals when caring for children. However, few prospective studies have evaluated their adverse events (AEs). This study aims to assess the feasibility of a pragmatic prospective study aiming to report the immediate and delayed (48-hours post-treatment) AEs associated with manual therapies in children aged 5 or younger. Preliminary data on AEs frequency are also reported.
Methods:
Between July 2021 and March 2022, chiropractors were recruited through purposive sampling and via a dedicated Facebook group for Quebec chiropractors interested in pediatrics. Legal guardians of patients aged 5 or younger were invited to fill out an online information and consent form. AEs were collected using the SafetyNET reporting system, which had been previously translated by the research team. Immediate AEs were collected through a questionnaire filled out by the legal guardian immediately after the treatment, while delayed AEs were collected through a questionnaire sent by email to the legal guardian 48 h after the treatment. Feasibility was assessed qualitatively through feedback from chiropractors and quantitatively through recruitment data.
Results:
Overall, a total of 28 chiropractors expressed interest following the Facebook publication, and 5 participated. An additional two chiropractors were enrolled through purposive sampling. In total, 80 legal guardians consented to their child's participation, and data from 73 children were included for the analysis of AEs. At least one AE was reported in 30% of children (22/73), and AEs were mainly observed immediately following the treatment (16/22). The most common AEs were irritability/crying (11 children) or fatigue/tiredness (11 children). Feasibility analysis demonstrated that regular communication between the research team and clinicians, as well as targeting clinicians who showed great interest in pediatrics, were key factors for successful research.
Conclusion:
Results suggest that it is feasible to conduct a prospective pragmatic study evaluating AEs associated with manual therapies in private practices. Direct communication with the clinicians, a strategic clinicians' recruitment plan, and the resulting administrative burden should be considered in future studies. A larger study is required to confirm the frequency of AEs reported in the current study.
Trial Registration:
ClinicalTrials.gov., NCT05409859, Registered on June 3 2022. https://clinicaltrials.gov/study/NCT05409859 .
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