Adverse Events Associated With Manual Therapies in Children

NCT05409859 | Completed

• 1 other identifier: UQTR_peds_2021-2022
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Adverse Event

Keywords

Manual therapy; Spinal mobilization; Complementary and alternative therapy; Pediatric; Chiropractic

Outcome Measures

Primary Outcomes (2)

• Immediate adverse event

  New symptom or aggravation of a preexisting symptom noted by the legal tutor of the children immediately following the manual therapies

  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

  48 hours following the intervention

Study Arms (1)

Participants

Children patients of 5 years and younger who received manual therapies by a chiropractor in private practice.

Other: Manual therapies

Interventions

Manual therapies OTHER

Manual therapies were determined based on the clinician evaluation and could include spinal mobilization delivered by hands or mechanically assisted and soft tissue therapies.

Also known as: Manual therapy, Spinal mobilization delivered by hands, Soft tissue therapy, Mechanically assisted spinal mobilization

Participants

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children of 5 years or less consulting at one of the participating chiropractors' private practice localized in Québec province (Canada).

You may qualify if:

• Children of 5 years or younger
• First or second treatment at one of the chiropractic clinic
• Spinal mobilization has to be clinically indicated

You may not qualify if:

• Children of 6 years or older
• Spinal mobilization not indicated

Sponsors & Collaborators

• Université du Québec à Trois-Rivières: lead

Study Sites (1)

Université du Québec à Trois-Rivières

Trois-Rivières, Quebec, G8Z4M3, Canada

Location

Related Publications (1)

• 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.

  PMID: 38481318 DERIVED

MeSH Terms

Interventions

Musculoskeletal Manipulations; Therapy, Soft Tissue

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Isabelle Pagé, PhD

  Université du Québec à Trois-Rivières

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2022
• First Posted: June 8, 2022
• Study Start: June 1, 2021
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: June 14, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)