Pediatric ALLNCT05607355
Measurement of Spinal Mobilization in Pediatric Population
An observational study of Pediatric ALL, run by Université du Québec à Trois-Rivières at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric ALL
- How many people
- 47 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2022to 15 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: A total of 60 children 5 years old and less will be recruited.
Who may be able to join
- 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.
Who cannot join
- Not requiring a spinal mobilization on the day of data collection.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Université du Québec à Trois-Rivières
Trois-Rivières, Quebec, G8Z 4M3
About this study
Official title: Measurement of Spinal Mobilization Biomechanical Parameters in the Preschool 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.
Read the detailed description
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
- Conditions
- Pediatric ALL
- Keywords
- Manual therapy, Chiropractic, Vertebral mobilisation, Pediatric, Biomechanics, Safety
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Spinal mobilization force
For each spinal mobilization delivered by the chiropractor on the participant, the peak force will be measured.
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.
Measured: During the intervention.
Secondary outcomes (1)
Adverse events
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).
Measured: 5-min following the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start1 Nov 2022
- Primary completion15 May 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pediatric ALLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université du Québec à Trois-Rivières
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Chiropratique du Québec, Canadian Chiropractic Research Foundation
- Responsible party
- Principal investigator, Isabelle Pagé, Université du Québec à Trois-Rivières
- Investigators
- Isabelle Pagé, PhD, Principal investigator, Département de Chiropratique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05607355
- Sponsor's protocol ID
- UQTR_PEDS_MOB_2022-2023
- Status last verified
- Jul 2023
- First submitted
- 31 Oct 2022
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28274487Marchand 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.
PubMed 23845198Pohlman 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.
PubMed 33203708
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Spinal Mobilization Biomechanical Parameters in the Preschool Pediatric Population
- ClinicalTrials.gov ID
- NCT05607355
- Acronym / sponsor ID
- UQTR_PEDS_MOB_2022-2023
- Conditions
- Pediatric ALL
- Keywords
- Manual therapy, Chiropractic, Vertebral mobilisation, Pediatric, Biomechanics, Safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Université du Québec à Trois-RivièresUniversity, hospital or other
- Collaborators
- Fondation Chiropratique du Québec, Canadian Chiropractic Research Foundation
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 7 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- A total of 60 children 5 years old and less will be recruited.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Not requiring a spinal mobilization on the day of data collection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
1 secondary outcome
Adverse events
Time frame: 5-min following the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Background: PubMed 28274487Triano 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.
- Background: PubMed 23845198Marchand 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.
- Background: PubMed 33203708Pohlman 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.
- Journal interview about the studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle Pagé, PhD principal investigator
Département de Chiropratique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric ALL, run by Université du Québec à Trois-Rivières at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spinal mobilization force (time frame: During the intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05607355, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2023.