Musculoskeletal PainPedEDmskNCT06069011
Direct Access Physiotherapy in the Pediatric Emergency Department
A study testing Interdisciplinary management in people with Musculoskeletal Pain and Musculoskeletal Diseases or Conditions, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Musculoskeletal Pain, Musculoskeletal Diseases or Conditions
- What is being tested?
- Interdisciplinary management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteCanada
- Study dates
- 18 Sep 2023to 31 Dec 2023
- Phase
- Interventional
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- Interdisciplinary management, usual care
- Medical subject headings
- Musculoskeletal Pain, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interdisciplinary managementOther
assessment and treatment in an interdisciplinary model
usual careOther
assessment and treatment in usual care model
| Study group | Role | What they receive |
|---|---|---|
| Interdisciplinary | Experimental | Interdisciplinary model for management of low acuity msk complaint Receives: Other: Interdisciplinary management |
| Usual care | Active comparator | usual care Receives: Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of consent
rate of consented patients related to patients approached rate of randomization, feasibility of administration of outcomes
Measured: through study completion an average of 4 weeks post-enrolment
Completed outcome measures
proportion of participants who complete all outcome measures
Measured: through study completion an average of 4 weeks post-enrolment
Secondary outcomes (2)
Pain intensity on faces rating scale
Pain intensity on faces rating scale, scale from 0 to 10, with 10 being a worse score
Measured: through study completion an average of 4 weeks post-enrolment
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
Measured: through study completion an average of 4 weeks post-enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start18 Sep 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
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 Musculoskeletal PainStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabelle Gagnon, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06069011
- Sponsor's protocol ID
- 2024-9673
- Acronym
- PedEDmsk
- Status last verified
- Apr 2024
- First submitted
- 11 Sep 2023
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Langevin P, Plotnick LH, Turner M, Friedman D, Agnihotram R, Greenstone I, Hebert LJ, Beaulieu C, Brody D, Osseiran L, Verboom Hahn M, Sutera E, Gagnon I. Direct-Access Physiotherapy to Improve Access to Quality Care for Children and Adolescents Presenting to the Pediatric Emergency Department With Musculoskeletal Problems: The PEDPT-MSK Pilot Randomized Control Trial. J Orthop Sports Phys Ther. 2025 Jun;55(6):1-11. doi: 10.2519/jospt.2025.13321.
PubMed 40418362
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06069011
- Acronym / sponsor ID
- PedEDmsk / 2024-9673
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 5 Oct 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interdisciplinary | Experimental | Other: Interdisciplinary managementInterdisciplinary model for management of low acuity msk complaint |
| Usual care | Active comparator | Other: usual careusual care |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Interdisciplinary managementassessment and treatment in an interdisciplinary model | Other | Interdisciplinary |
| usual careassessment and treatment in usual care model | Other | Usual care |
Primary outcome
Rate of consent
Time frame: through study completion an average of 4 weeks post-enrolment
rate of consented patients related to patients approached rate of randomization, feasibility of administration of outcomes
Completed outcome measures
Time frame: through study completion an average of 4 weeks post-enrolment
proportion of participants who complete all outcome measures
2 secondary outcomes
Pain intensity on faces rating scale
Time frame: through study completion an average of 4 weeks post-enrolment
Pain interference with function PROMIS scale
Time frame: through study completion an average of 4 weeks post-enrolment
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 2 Apr 2024.
- Derived from this study: PubMed 40418362Langevin P, Plotnick LH, Turner M, Friedman D, Agnihotram R, Greenstone I, Hebert LJ, Beaulieu C, Brody D, Osseiran L, Verboom Hahn M, Sutera E, Gagnon I. Direct-Access Physiotherapy to Improve Access to Quality Care for Children and Adolescents Presenting to the Pediatric Emergency Department With Musculoskeletal Problems: The PEDPT-MSK Pilot Randomized Control Trial. J Orthop Sports Phys Ther. 2025 Jun;55(6):1-11. doi: 10.2519/jospt.2025.13321.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interdisciplinary management in people with Musculoskeletal Pain and Musculoskeletal Diseases or Conditions, run by McGill University Health Centre/Research Institute of the McGill University Health Centre 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 4 inclusion and 3 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 2 Apr 2024. 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?
Rate of consent (time frame: through study completion an average of 4 weeks post-enrolment). 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 NCT06069011, 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 2 Apr 2024.