NCT05607355

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
Last Updated

July 11, 2023

Status Verified

July 1, 2023

Enrollment Period

7 months

First QC Date

October 31, 2022

Last Update Submit

July 10, 2023

Conditions

Pediatric ALL

Keywords

Manual therapyChiropracticVertebral mobilisationPediatricBiomechanicsSafety

Outcome Measures

Primary Outcomes (2)

  • Spinal mobilization force

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

    During the intervention.

  • Spinal mobilization rate of force application

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

    During the intervention.

Secondary Outcomes (1)

  • Adverse events

    5-min following the intervention

Eligibility Criteria

AgeUp to 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

A total of 60 children 5 years old and less will be recruited.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université du Québec à Trois-Rivières

Trois-Rivières, Quebec, G8Z 4M3, Canada

Location

Related Publications (3)

  • Triano JJ, Lester S, Starmer D, Hewitt EG. Manipulation Peak Forces Across Spinal Regions for Children Using Mannequin Simulators. J Manipulative Physiol Ther. 2017 Mar-Apr;40(3):139-146. doi: 10.1016/j.jmpt.2017.01.001. Epub 2017 Mar 6.

    PMID: 28274487BACKGROUND

  • Marchand AM. A Proposed Model With Possible Implications for Safety and Technique Adaptations for Chiropractic Spinal Manipulative Therapy for Infants and Children. J Manipulative Physiol Ther. 2015 Nov-Dec;38(9):713-726. doi: 10.1016/j.jmpt.2013.05.015. Epub 2013 Jul 8.

    PMID: 23845198BACKGROUND

  • Pohlman KA, Carroll L, Tsuyuki RT, Hartling L, Vohra S. Comparison of active versus passive surveillance adverse event reporting in a paediatric ambulatory chiropractic care setting: a cluster randomised controlled trial. BMJ Open Qual. 2020 Nov;9(4):e000972. doi: 10.1136/bmjoq-2020-000972.

    PMID: 33203708BACKGROUND

Related Links

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Isabelle Pagé, PhD

    Département de Chiropratique

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 31, 2022

First Posted

November 7, 2022

Study Start

November 1, 2022

Primary Completion

May 15, 2023

Study Completion

May 15, 2023

Last Updated

July 11, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)