Anne Dolbec, Chantale Doucet, Katherine A Pohlman, Stéphane Sobczak, Isabelle Pagé
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引用次数: 0
Abstract
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 .
期刊介绍：
Chiropractic & Manual Therapies publishes manuscripts on all aspects of evidence-based information that is clinically relevant to chiropractors, manual therapists and related health care professionals.
Chiropractic & Manual Therapies is an open access journal that aims to provide chiropractors, manual therapists and related health professionals with clinically relevant, evidence-based information. Chiropractic and other manual therapies share a relatively broad diagnostic practice and treatment scope, emphasizing the structure and function of the body''s musculoskeletal framework (especially the spine). The practices of chiropractic and manual therapies are closely associated with treatments including manipulation, which is a key intervention. The range of services provided can also include massage, mobilisation, physical therapies, dry needling, lifestyle and dietary counselling, plus a variety of other associated therapeutic and rehabilitation approaches.
Chiropractic & Manual Therapies continues to serve as a critical resource in this field, and as an open access publication, is more readily available to practitioners, researchers and clinicians worldwide.
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