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Completed

NCT Number: NCT05607355

Measurement of Spinal Mobilization in Pediatric Population

The goal of this cross-sectional study is to measure the biomechanical parameters during a vertebral mobilization delivered by chiropractors on patients of five years old of age and younger. The main questions it aims to answer are:

* What is the force and rate of force application of spinal mobilizations in children consulting in chiropractic? * What are the adverse events observed by legal tutors immediately following the intervention received by the child?

Participants will receive the clinically indicated spinal mobilization by their treating chiropractor. The chiropractor will have a small sensor on the finger during the delivery of the spinal mobilization. The legal tutor will complete a questionnaire immediately after the intervention to report adverse events.

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Key information

Age range

Up to 5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Université du Québec à Trois-Rivières

Trois-Rivières, Quebec, G8Z 4M3, Canada

About this study

Scope: Number of parents consulting complementary and alternative medicine practitioners for their children's health is increasing. Spinal mobilization is commonly provided by these practitioners, including chiropractors, to address health disorders in children. Spinal mobilization involves the application of a controlled force to a vertebra using a slow speed and is considered an appropriate technique in young children. Despite the popularity of spinal mobilization in the pediatric population, only a paucity of data exists on its biomechanics. One study has evaluated the force used by chiropractors on manikins and one study calculated theoretical values of the maximum force that should be applied in function of the patient age. To date, no studies have characterized spinal mobilization biomechanics using a pragmatic approach: measurement directly at the clinician's hands during spinal mobilization delivered on real pediatric patients.

Purpose: The aims are to (1) measure the biomechanical parameters during spinal mobilization delivered by chiropractors on patients of 5 years of age or younger and (2) to report immediate adverse events.

Methodology:

Design: This research proposal is a pragmatic cross-sectional study. Participants: Patients seeking care at our collaborating chiropractic clinics and aged between 0 (newborn) and 5 years old will be recruited. Spinal mobilization will have to be clinically indicated. A total of 60 participants will be recruited.

Experiment: To measure spinal mobilization parameters, the chiropractor will wear a small sensor on their finger tip used to deliver the spinal mobilization (MedicalSensor 9811E, Tekscan, Boston, US). The sensor record force by time data using a 100 Hz acquisition frequency. Legal guardians will complete a short online questionnaire (pediatric version of the SafetyNet system) immediately following the intervention to report any adverse events. Participant characteristics (age, weight, height, sex, reason to seek care) will also be collected.

Primary outcomes: Spinal mobilization peak force and rate of force applications (i.e., speed).

Secondary outcomes: Immediate adverse events observed by the legal guardian. Analyses: The sample of participants will be descriptively analyzed. The mean, range and standard deviation of the peak force and rate of force applications measured during the spinal mobilizations will be reported. Adverse events frequency and nature will be reported. Exploratory analyzes will be conducted to explore the associations between participants' characteristics, treated region of the spine and spinal mobilization's peak force and rate of force applications

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Being aged between 0 (newborn) and 5 years old
  • Consulting a chiropractor involved in the study
  • Having at spinal mobilization included in the care plan.

Exclusion criteria

  • Not requiring a spinal mobilization on the day of data collection.

Treatment and study plan

Primary outcomes

  1. Spinal mobilization force

    Time frame: During the intervention.

    For each spinal mobilization delivered by the chiropractor on the participant, the peak force will be measured.

  2. Spinal mobilization rate of force application

    Time frame: During the intervention.

    For each spinal mobilization delivered by the chiropractor on the participant, the rate of force will be measured.

Secondary outcomes

  1. Adverse events

    Time frame: 5-min following the intervention

    Adverse events of the intervention observed by the legal guardian of the participant will be reported using a validated questionnaire (pediatric verson of the SafetyNet reporting system).

Sponsors and collaborators

Lead sponsor

Université du Québec à Trois-Rivières

Other

Collaborators

  • Canadian Chiropractic Research Foundation
  • Fondation Chiropratique du Québec

Registry information

Official study title

Measurement of Spinal Mobilization Biomechanical Parameters in the Preschool Pediatric Population

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 7, 2022
Registry last updated
Jul 11, 2023

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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