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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06069011
Other study ID # 2024-9673
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 18, 2023
Est. completion date December 31, 2023

Study information

Verified date April 2024
Source McGill University Health Centre/Research Institute of the McGill University Health Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare two methods of managing low acuity musculoskeletal complaints in children and adolescents ages 6 to 17.99 years in the pediatric emergency department. The main question it aims to answer is whether delivering care in two methods is feasible. Participants will receive care while in the emergency department and will be followed for a period of 1-month post-presentation.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 6 Years to 17 Years
Eligibility Inclusion Criteria: - aged 6.00-17.99 years of age - present to the Montreal Children's Hospital Emergency Department with a suspected MSK complaint, traumatic or not - are given a triage score of 3 (urgent), 4 (less urgent), or 5 (nonurgent) according to the Canadian Triage and Acuity Scale (CTAS) - are able to communicate in French or English Exclusion Criteria: - present with a major MSK condition requiring urgent care (e.g., open fracture, open wound) - a red flag (e.g. progressive neurological disorder, infectious symptoms) - a co-morbid unstable condition.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Interdisciplinary management
assessment and treatment in an interdisciplinary model
usual care
assessment and treatment in usual care model

Locations

Country Name City State
Canada McGill University Health Center Montréal Quebec

Sponsors (1)

Lead Sponsor Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of consent rate of consented patients related to patients approached rate of randomization, feasibility of administration of outcomes through study completion an average of 4 weeks post-enrolment
Primary Completed outcome measures proportion of participants who complete all outcome measures through study completion an average of 4 weeks post-enrolment
Secondary Pain intensity on faces rating scale Pain intensity on faces rating scale, scale from 0 to 10, with 10 being a worse score through study completion an average of 4 weeks post-enrolment
Secondary Pain interference with function PROMIS scale PROMIS Pediatric Pain Interference - Short Form 8a, 8 items scores from 1-5 with 5 being a worse outcome through study completion an average of 4 weeks post-enrolment
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