NCT06069011

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

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

September 11, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

September 18, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 5, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

April 2, 2024

Status Verified

April 1, 2024

Enrollment Period

3 months

First QC Date

September 11, 2023

Last Update Submit

April 1, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • Completed outcome measures

    proportion of participants who complete all outcome measures

    through study completion an average of 4 weeks post-enrolment

Secondary Outcomes (2)

  • Pain intensity on faces rating scale

    through study completion an average of 4 weeks post-enrolment

  • Pain interference with function PROMIS scale

    through study completion an average of 4 weeks post-enrolment

Study Arms (2)

Interdisciplinary

EXPERIMENTAL

Interdisciplinary model for management of low acuity msk complaint

Other: Interdisciplinary management

Usual care

ACTIVE COMPARATOR

usual care

Other: usual care

Interventions

assessment and treatment in an interdisciplinary model

Interdisciplinary

assessment and treatment in usual care model

Usual care

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University Health Center

Montreal, Quebec, H4A 3S5, Canada

Location

MeSH Terms

Conditions

Musculoskeletal PainMusculoskeletal Diseases

Condition Hierarchy (Ancestors)

Muscular DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Investigator

Study Record Dates

First Submitted

September 11, 2023

First Posted

October 5, 2023

Study Start

September 18, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

April 2, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations