search
Back to results

Direct Access Physiotherapy in the Pediatric Emergency Department (PedEDmsk)

Primary Purpose

Musculoskeletal Pain, Musculoskeletal Diseases or Conditions

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Interdisciplinary management
usual care
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Musculoskeletal Pain

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • McGill University Health CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interdisciplinary

Usual care

Arm Description

Interdisciplinary model for management of low acuity msk complaint

usual care

Outcomes

Primary Outcome Measures

Rate of consent
rate of consented patients related to patients approached rate of randomization, feasibility of administration of outcomes
Completed outcome measures
proportion of participants who complete all outcome measures

Secondary Outcome Measures

Pain intensity on faces rating scale
Pain intensity on faces rating scale, scale from 0 to 10, with 10 being a worse score
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

Full Information

First Posted
September 11, 2023
Last Updated
October 3, 2023
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
search

1. Study Identification

Unique Protocol Identification Number
NCT06069011
Brief Title
Direct Access Physiotherapy in the Pediatric Emergency Department
Acronym
PedEDmsk
Official Title
Improving Access to Quality Care for Children and Adolescents Presenting to the Pediatric Emergency Department With Musculoskeletal Problems: a Pilot Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 18, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Pain, Musculoskeletal Diseases or Conditions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interdisciplinary
Arm Type
Experimental
Arm Description
Interdisciplinary model for management of low acuity msk complaint
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
usual care
Intervention Type
Other
Intervention Name(s)
Interdisciplinary management
Intervention Description
assessment and treatment in an interdisciplinary model
Intervention Type
Other
Intervention Name(s)
usual care
Intervention Description
assessment and treatment in usual care model
Primary Outcome Measure Information:
Title
Rate of consent
Description
rate of consented patients related to patients approached rate of randomization, feasibility of administration of outcomes
Time Frame
through study completion an average of 4 weeks post-enrolment
Title
Completed outcome measures
Description
proportion of participants who complete all outcome measures
Time Frame
through study completion an average of 4 weeks post-enrolment
Secondary Outcome Measure Information:
Title
Pain intensity on faces rating scale
Description
Pain intensity on faces rating scale, scale from 0 to 10, with 10 being a worse score
Time Frame
through study completion an average of 4 weeks post-enrolment
Title
Pain interference with function PROMIS scale
Description
PROMIS Pediatric Pain Interference - Short Form 8a, 8 items scores from 1-5 with 5 being a worse outcome
Time Frame
through study completion an average of 4 weeks post-enrolment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eva Sutera, BSc
Phone
514-412-4400
Email
eva.sutera@muhc.mcgill.ca
Facility Information:
Facility Name
McGill University Health Center
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A 3S5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle Gagnon
Phone
5144124400
Email
isabelle.gagnon8@mcgill.ca

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Direct Access Physiotherapy in the Pediatric Emergency Department

We'll reach out to this number within 24 hrs