NCT04009369

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

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

Study Start

First participant enrolled

September 10, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2019

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 2, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
Last Updated

October 28, 2020

Status Verified

October 1, 2020

Enrollment Period

10 months

First QC Date

July 2, 2019

Last Update Submit

October 26, 2020

Conditions

Keywords

Health care accessHealth servicesProfessional practices

Outcome Measures

Primary Outcomes (2)

  • 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.

    Baseline, 1 and 3 months

  • 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.

    Baseline, 1 and 3 months

Secondary Outcomes (7)

  • Pain Catastrophizing: Pain Catastrophizing Scale

    Baseline

  • Interventions received by the participants : Standardized Form

    Baseline, 1 and 3 months

  • Diagnostic Tests : Standardized Form

    Baseline, 1 and 3 months

  • Consultations with Another Health Professional : Standardized Form

    Baseline, 1 and 3 months

  • Satisfaction: Visit-Specific Satisfaction Instrument

    Baseline

  • +2 more secondary outcomes

Study Arms (2)

Emergency Physician Group

NO INTERVENTION

Usual care by the EP without the intervention of the ED PT.

Physical Therapist Group

EXPERIMENTAL

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

Other: Direct access to a PT

Interventions

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

Physical Therapist Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de l'Université Laval (CHUL)

Québec, Quebec, G1V 4G2, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Musculoskeletal PainMusculoskeletal Diseases

Condition Hierarchy (Ancestors)

Muscular DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Rose Gagnon, MPT, MSc(c)

    Laval University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Master's Student

Study Record Dates

First Submitted

July 2, 2019

First Posted

July 5, 2019

Study Start

September 10, 2018

Primary Completion

June 27, 2019

Study Completion

June 27, 2019

Last Updated

October 28, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations