Adverse EventNCT05409859
Adverse Events Associated With Manual Therapies in Children
An observational study of Adverse Event, run by Université du Québec à Trois-Rivières at 1 site in Canada.
Trial summary
This study aims to evaluate the feasibility to conduct a prospective cohort study evaluating the adverse events associated with manual therapies in children of 5 years 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
- Adverse Event
- What is being tested?
- Manual therapies
- How many people
- 74 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2021to 28 Feb 2022
- 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: Children of 5 years or less consulting at one of the participating chiropractors' private practice localized in Québec province (Canada).
Who may be able to join
- Children of 5 years or younger
- First or second treatment at one of the chiropractic clinic
- Spinal mobilization has to be clinically indicated
Who cannot join
- Children of 6 years or older
- Spinal mobilization not indicated
Trial locations and contacts
1 site in 1 country.
Canada1 site
Université du Québec à Trois-Rivières
Trois-Rivières, Quebec, G8Z4M3
About this study
Official title: Assessing Adverse Events Associated With Manual Therapies in Preschool Pediatric Population: a Feasibility Study
This study aims to evaluate the feasibility to conduct a prospective cohort study evaluating the adverse events associated with manual therapies in children of 5 years and younger. A validated reporting system will be used to evaluate the adverse events and include a total of four questionnaires that are filled online. Adverse events will be evaluated immediately following the intervention and at 48h post-intervention.
Read the detailed description
The aim of this study is to investigate (1) the feasibility to conduct a prospective cohort study evaluating the adverse events associated with manual therapies in children of 5 years and younger and (2) to report preliminary data on the frequency and nature of the adverse events. Participating chiropractors will advertise the study in their private clinic through flyers and posters. Legal tutors interested to participate will access an information sheet and consent form using a link available on the flyers/posters. Legal tutors of participants will complete three questionnaires, one before the intervention to describe the child (e.g. age, sex, reason(s) to seek care), one immediately following the intervention to report immediate adverse events and one 48h following the intervention to report delayed adverse events. Clinicians will complete one questionnaire immediately following the intervention to describe the manual therapies delivered to the children. All questionnaires will be available online on a secured platform. The intervention will be determined by the clinician according the their evaluation of the child and could include spinal mobilization as well as soft tissue therapies.
- Conditions
- Adverse Event
- Being tested
- Manual therapies
- Keywords
- Manual therapy, Spinal mobilization, Complementary and alternative therapy, Pediatric, Chiropractic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapiesOther
Also called Manual therapy, Spinal mobilization delivered by hands, Soft tissue therapy, Mechanically assisted spinal mobilization
Manual therapies were determined based on the clinician evaluation and could include spinal mobilization delivered by hands or mechanically assisted and soft tissue therapies.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Children patients of 5 years and younger who received manual therapies by a chiropractor in private practice. Receives: Other: Manual therapies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate adverse event
New symptom or aggravation of a preexisting symptom noted by the legal tutor of the children immediately following the manual therapies
Measured: 5 minutes following the intervention
Delayed adverse event
New symptom or aggravation of a preexisting symptom noted by the legal tutor of the children 48h following the manual therapies
Measured: 48 hours 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 posted8 Jun 2022
- Study start1 Jun 2021
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adverse EventStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université du Québec à Trois-Rivières
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle Pagé, PhD, Principal investigator, Université du Québec à Trois-Rivières
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05409859
- Sponsor's protocol ID
- UQTR_peds_2021-2022
- Status last verified
- Jun 2022
- First submitted
- 3 Jun 2022
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dolbec A, Doucet C, Pohlman KA, Sobczak S, Page I. Assessing adverse events associated with chiropractic care in preschool pediatric population: a feasibility study. Chiropr Man Therap. 2024 Mar 13;32(1):9. doi: 10.1186/s12998-024-00529-0.
PubMed 38481318
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Adverse Events Associated With Manual Therapies in Preschool Pediatric Population: a Feasibility Study
- ClinicalTrials.gov ID
- NCT05409859
- Acronym / sponsor ID
- UQTR_peds_2021-2022
- Conditions
- Adverse Event
- Keywords
- Manual therapy, Spinal mobilization, Complementary and alternative therapy, Pediatric, Chiropractic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Université du Québec à Trois-RivièresUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 8 Jun 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.
This study aims to evaluate the feasibility to conduct a prospective cohort study evaluating the adverse events associated with manual therapies in children of 5 years and younger. A validated reporting system will be used to evaluate the adverse events and include a total of four questionnaires that are filled online. Adverse events will be evaluated immediately following the intervention and at 48h post-intervention.
Detailed description
The aim of this study is to investigate (1) the feasibility to conduct a prospective cohort study evaluating the adverse events associated with manual therapies in children of 5 years and younger and (2) to report preliminary data on the frequency and nature of the adverse events. Participating chiropractors will advertise the study in their private clinic through flyers and posters. Legal tutors interested to participate will access an information sheet and consent form using a link available on the flyers/posters. Legal tutors of participants will complete three questionnaires, one before the intervention to describe the child (e.g. age, sex, reason(s) to seek care), one immediately following the intervention to report immediate adverse events and one 48h following the intervention to report delayed adverse events. Clinicians will complete one questionnaire immediately following the intervention to describe the manual therapies delivered to the children. All questionnaires will be available online on a secured platform. The intervention will be determined by the clinician according the their evaluation of the child and could include spinal mobilization as well as soft tissue therapies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Other: Manual therapiesChildren patients of 5 years and younger who received manual therapies by a chiropractor in private practice. |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children of 5 years or less consulting at one of the participating chiropractors' private practice localized in Québec province (Canada).
Key inclusion criteria (3 listed)
- Children of 5 years or younger
- First or second treatment at one of the chiropractic clinic
- Spinal mobilization has to be clinically indicated
Key exclusion criteria (2 listed)
- Children of 6 years or older
- Spinal mobilization not indicated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual therapiesAlso: Manual therapy, Spinal mobilization delivered by hands, Soft tissue therapy, Mechanically assisted spinal mobilizationManual therapies were determined based on the clinician evaluation and could include spinal mobilization delivered by hands or mechanically assisted and soft tissue therapies. | Other | Participants |
Primary outcome
Immediate adverse event
Time frame: 5 minutes following the intervention
New symptom or aggravation of a preexisting symptom noted by the legal tutor of the children immediately following the manual therapies
Delayed adverse event
Time frame: 48 hours following the intervention
New symptom or aggravation of a preexisting symptom noted by the legal tutor of the children 48h following the manual therapies
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 14 Jun 2022.
- Derived from this study: PubMed 38481318Dolbec A, Doucet C, Pohlman KA, Sobczak S, Page I. Assessing adverse events associated with chiropractic care in preschool pediatric population: a feasibility study. Chiropr Man Therap. 2024 Mar 13;32(1):9. doi: 10.1186/s12998-024-00529-0.
- 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
Université du Québec à Trois-Rivières
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 Adverse Event, 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 2 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 14 Jun 2022. 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?
Immediate adverse event (time frame: 5 minutes following 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 NCT05409859, which also lists 1 linked publication.
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 14 Jun 2022.