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Musculoskeletal PainNCT04009369

Impacts of Physiotherapy Services in a Quebec Emergency Department

A study testing Direct access to a PT in people with Musculoskeletal Pain and Musculoskeletal Diseases, run by Rose Gagnon at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Emergency departments (ED) in several countries integrated physiotherapists in order to reduce wait times for patients with musculoskeletal disorders (MSKD). These initiatives have indeed reduced wait times, length of stay, time waited before seeing a professional and the prescription of unnecessary consultations and… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Direct access to a PT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteCanada
Study dates
10 Sep 2018to 27 Jun 2019
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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Triage category 3, 4 or 5
  • Discharged home with a minor MSKD after ED care
  • Able to consent
  • Able to understand French and to complete the questionnaire either verbally or in writing

Who cannot join

  • Major MSKD requiring urgent care
  • Presence of a red flag or an unstable clinical condition
  • Living in a long-term care facility

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Centre Hospitalier de l'Université Laval (CHUL)

    Québec, Quebec, G1V 4G2

Other trials in Canada

About this study

Official title: Impacts of Physiotherapy Services in a Quebec Emergency Department - Randomized Clinical Trial

Emergency departments (ED) in several countries integrated physiotherapists in order to reduce wait times for patients with musculoskeletal disorders (MSKD). These initiatives have indeed reduced wait times, length of stay, time waited before seeing a professional and the prescription of unnecessary consultations and diagnostic tests. In Canada, such initiatives are marginal and their effects have not been studied.

The objectives of the project are to evaluate the effects of physiotherapy management of patients with MSKD in ED compared to usual practice on clinical course of patients, use of services and resources, and waiting time and length of stay in ED. The hypothesis is that patients presenting with a MSKD to the ED with direct access to a physiotherapist will have better clinical outcomes and that use of services, waiting time, and length of stay are going to be inferior to those of the EP group.

Read the detailed description

Background and rationale: Emergency departments (ED) in several countries integrated physiotherapists, which led, for patients with musculoskeletal disorders (MSKD), to a reduction in wait times, length of stay, time waited before seeing a professional and the prescription of unnecessary consultations and diagnostic tests. Furthermore, early access to physiotherapy is associated with a decrease in pain and psychological symptoms and decreased risks of developing persistent pain. In Canada, such initiatives are still marginal and their effects have not been studied.

Objectives: Evaluate the effects of direct access physiotherapy management of patients with MSKD in the ED compared to the usual management by the emergency physician on clinical course of patients (pain, quality of life and disability) and use of services and resources at one and three months, and waiting time and length of stay in the ED.

Methods: A randomized controlled trial is currently in progress at the Centre hospitalier de l'Université Laval (CHUL). Two groups of 50 participants each are recruited over a six months period: one group with direct access to a physiotherapist (PT) in the ED and one control group with the usual access care to the emergency physician. Data is extracted from the patients' medical record, administrative data from the ED, self-administered forms given to the patients during their ED stay and either electronic or phone follow-ups (1 and 3 months). Data will be analysed using descriptive (demographic and clinical profiles) and inferential statistics (repeated ANOVA between groups across time points and Student T tests for independent samples).

Importance of potential findings for MSK health: ED overcrowding causes prolonged lengths of stay, increased rates of patient leaving without being seen, increased medical errors, increased mortality among ambulatory and non-ambulatory patients and decreased patient satisfaction. This project will measure the effects of integrating PTs into the ED in a Canadian hospital setting and help identify ways to improve the current services offered to patients with a MSKD presenting to the ED. Direct access to PT may improve musculoskeletal health outcomes and support positive patient experience.

Being tested
Direct access to a PT
Keywords
Health care access, Health services, Professional practices
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.

  • Direct access to a PTOther

    Direct access to a PT in the ED immediately after triage and prior to physician assessment.

Study groups in NCT04009369
Study groupRoleWhat they receive
Emergency Physician GroupNo interventionUsual care by the EP without the intervention of the ED PT.
Physical Therapist GroupExperimentalDirect access to a PT in the ED immediately after triage and prior to physician assessment.
Receives: Other: Direct access to a PT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Level of Pain: Numeric Pain Rating Scale

    Scale ranging from 0 to 10 where 0 means no pain at all and 10 means the worst pain ever.

    Measured: Baseline, 1 and 3 months

  2. Pain Interference on Function: Brief Pain Inventory

    List of 10 items (work, sleep, general activity, etc.) represented on a scale ranging from 0 to 10 where 0 means "Does Not Interfere" and 10 means "Completely Interferes". Subscales are averaged and the resulting score is out of 10. A higher score means a higher interference of pain on function.

    Measured: Baseline, 1 and 3 months

Secondary outcomes (7)

  1. Pain Catastrophizing: Pain Catastrophizing Scale

    List of 13 items (thoughts and feelings about pain) represented on a scale ranging from 0 to 4 where 0 means "Not at all" and 4 means "All the time". Subscales are summed and the resulting score is out of 52. A higher score means a higher tendency to catastrophise pain.

    Measured: Baseline

  2. Interventions received by the participants : Standardized Form

    Form were every intervention received by the patient was checked as a "Yes" or "No" answer. (Advice, medication, technical aids, referral to another health professional, etc.)

    Measured: Baseline, 1 and 3 months

  3. Diagnostic Tests : Standardized Form

    Form were every diagnostic test received by the patient was checked as a "Yes" or "No" answer. (X-ray, MRI, CT Scan, ultrasound, etc.)

    Measured: Baseline, 1 and 3 months

  4. Consultations with Another Health Professional : Standardized Form

    Form were every consultation being prescribed to the patient was checked as a "Yes" or "No" answer.

    Measured: Baseline, 1 and 3 months

  5. Satisfaction: Visit-Specific Satisfaction Instrument

    List of 7 items (Answers to your questions, Technical skills of the healthcare provider, etc.) represented on a scale ranging from 1 to 5 where 1 means "Excellent" and 5 means "Poor". Subscales are transformed in results out of 100 (1 = 100% and 5 = 0%), averaged and the resulting score is out of 100%. A higher score means higher satisfaction.

    Measured: Baseline

  6. Wait Time

    Difference between beginning of the intervention and time of arrival between groups during their ED visit

    Measured: Baseline

  7. Length of Stay

    Difference between departure time and time of arrival between groups during their ED visit

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2019
  2. Study start10 Sep 2018
  3. Primary completion27 Jun 2019
  4. Study completion27 Jun 2019

Resources

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
None (open label)
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04009369
Sponsor's protocol ID
MP-20-2019-4307
Status last verified
Oct 2020
First submitted
2 Jul 2019
Last updated
28 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gagnon R, Guertin JR, Perreault K, LaRue S, Berthelot S, Gatovo KE, Lafrance S, Hebert LJ. Could Primary Contact Physical Therapy Improve Emergency Department Care While Being Efficient? A 3-Month Cost-Utility Analysis. J Orthop Sports Phys Ther. 2026 Feb;56(2):109-118. doi: 10.2519/jospt.2025.13429.

    PubMed 41620834

  • Gagnon R, Perreault K, Matifat E, Desmeules F, Berthelot S, Hebert LJ. Diagnostic Concordance Between Physiotherapist and Emergency Physicians for Patients With a Musculoskeletal Disorder in the Emergency Department. Musculoskeletal Care. 2024 Dec;22(4):e70014. doi: 10.1002/msc.70014.

    PubMed 39578620

  • Gagnon R, Perreault K, Berthelot S, Matifat E, Desmeules F, Achou B, Laroche MC, Van Neste C, Tremblay S, Leblond J, Hebert LJ. Direct-access physiotherapy to help manage patients with musculoskeletal disorders in an emergency department: Results of a randomized controlled trial. Acad Emerg Med. 2021 Aug;28(8):848-858. doi: 10.1111/acem.14237. Epub 2021 Apr 16.

    PubMed 33617696

Questions about this trial

What is this clinical trial studying?

A study testing Direct access to a PT in people with Musculoskeletal Pain and Musculoskeletal Diseases, run by Rose Gagnon 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 28 Oct 2020. 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?

Level of Pain: Numeric Pain Rating Scale (time frame: Baseline, 1 and 3 months). 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 NCT04009369, which also lists 3 linked publications.

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 28 Oct 2020.

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