Musculoskeletal DisordersNCT05714332
Impacts of an Advanced Practice Physiotherapy Model of Care for Adults With a Peripheral Musculoskeletal Disorders Referred to an Orthropaedic Outpatient Clinic
An observational study of Musculoskeletal Disorders, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
Trial summary
The goal of this prospective observational study is to evaluate advanced practice physiotherapy and orthopedic surgeon care and clinical outcomes for new patients with a peripheral musculoskeletal disorders consulting at the orthopedic outpatient clinic of the Hôpital Jean-Talon. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Disorders
- What is being tested?
- Advanced practice physiotherapy and orthopedic surgeon management and Orthopedic surgeon management
- How many people
- 104 participants
- Where
- 1 siteCanada
- Study dates
- 15 Nov 2022to 2 Jan 2024
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Adults with a peripheral musculoskeletal disorders
Who may be able to join
- Adults with peripheral musculoskeletal disorders
- New consultation at the Hôpital Jean-Talon orthopedic outpatient clinic
- Legally able to consent
- Understand and speak French or English
- Beneficiaries of the provincial universal health insurance coverage (RAMQ)
Who cannot join
- Patients directly referred from the emergency department (not considered as patients referred to the outpatient clinic).
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre de recherche de l'Hôpital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4
About this study
Official title: Impacts of an Advanced Practice Physiotherapy Model of Care for Adults With a Peripheral Musculoskeletal Disorders Referred to an Orthropaedic Outpatient Clinic: a Prospective Observational Study
The goal of this prospective observational study is to evaluate advanced practice physiotherapy and orthopedic surgeon care and clinical outcomes for new patients with a peripheral musculoskeletal disorders consulting at the orthopedic outpatient clinic of the Hôpital Jean-Talon.
The main questions it aims to answer are: 1. To describe the models of care at the Hôpital Jean-Talon orthopedic outpatient clinic; 2. To assess change in pain, disability, quality of life and pain catastrophizing at 6, 12 and 26 weeks after the initial evaluation; 3. To assess interprofessional collaboration between the advanced practice physiotherapists and orthopedic surgeons; 4. To assess patient satisfaction with care; 5. To assess waiting time before an initial consultation.
Researchers will compare patients cared in the advanced practice physiotherapy and orthopedic surgeon group and the orthopedic surgeon only group.
- Conditions
- Musculoskeletal Disorders
- Being tested
- Advanced practice physiotherapy and orthopedic surgeon management, Orthopedic surgeon management
- Keywords
- Advanced practice, Physiotherapy, Musculoskeletal disorders, Orthopedic, Observation
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced practice physiotherapy and orthopedic surgeon managementOther
Management of their musculoskeletal condition by an advanced practice physiotherapist and an orthopedic surgeon.
Orthopedic surgeon managementOther
Management of their musculoskeletal condition by an orthopedic surgeon.
| Study group | Role | What they receive |
|---|---|---|
| Advanced practice physiotherapy and orthopedic surgeon group | Patients cared by both an advanced practice physiotherapist and an orthopedic surgeon. Receives: Other: Advanced practice physiotherapy and orthopedic surgeon management | |
| Orthopedic surgeon only group | Patients cared only by an orthopedic surgeon. Receives: Other: Orthopedic surgeon management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief pain inventory severity
Pain questionnaire (0-10; higher score=worse)
Measured: 6 weeks (change from baseline)
Brief pain inventory severity
Pain questionnaire (0-10; higher score=worse)
Measured: 12 weeks (change from baseline)
Brief pain inventory severity
Pain questionnaire (0-10; higher score=worse)
Measured: 26 weeks (change from baseline)
Brief pain inventory inventory
Pain interference (disability) questionnaire (0-10; higher score=worse)
Measured: 6 weeks (change from baseline)
Brief pain inventory inventory
Pain interference (disability) questionnaire (0-10; higher score=worse)
Measured: 12 weeks (change from baseline)
Brief pain inventory inventory
Pain interference (disability) questionnaire (0-10; higher score=worse)
Measured: 26 weeks (change from baseline)
Secondary outcomes (32)
Shortened Disability of the Arm, Shoulder and Hand (QuickDASH)
Disability questionnaire for upper extremity disorders (0-100; higher=worse)
Measured: 6 weeks (change from baseline)
Shortened Disability of the Arm, Shoulder and Hand (QuickDASH)
Disability questionnaire for upper extremity disorders (0-100; higher=worse)
Measured: 12 weeks (change from baseline)
Shortened Disability of the Arm, Shoulder and Hand (QuickDASH)
Disability questionnaire for upper extremity disorders (0-100; higher=worse)
Measured: 26 weeks (change from baseline)
Hip disability and Osteoarthritis Outcomes Score (HOOS)
Disability questionnaire for hip disorders (0-100; higher=better)
Measured: 6 weeks (change from baseline)
Hip disability and Osteoarthritis Outcomes Score (HOOS)
Disability questionnaire for hip disorders (0-100; higher=better)
Measured: 12 weeks (change from baseline)
Hip disability and Osteoarthritis Outcomes Score (HOOS)
Disability questionnaire for hip disorders (0-100; higher=better)
Measured: 26 weeks (change from baseline)
Knee injury and Osteoarthritis Outcomes Score (KOOS)
Disability questionnaire for knee disorders (0-100; higher=better)
Measured: 6 weeks (change from baseline)
Knee injury and Osteoarthritis Outcomes Score (KOOS)
Disability questionnaire for knee disorders (0-100; higher=better)
Measured: 12 weeks (change from baseline)
Knee injury and Osteoarthritis Outcomes Score (KOOS)
Disability questionnaire for knee disorders (0-100; higher=better)
Measured: 26 weeks (change from baseline)
Foot and Ankle Ability Measure (FAAM)
Disability questionnaire for ankle/foot disorders (0-100; higher=better)
Measured: 6 weeks (change from baseline)
Foot and Ankle Ability Measure (FAAM)
Disability questionnaire for ankle/foot disorders (0-100; higher=better)
Measured: 12 weeks (change from baseline)
Foot and Ankle Ability Measure (FAAM)
Disability questionnaire for ankle/foot disorders (0-100; higher=better)
Measured: 26 weeks (change from baseline)
EQ-5D-5L
Health-related quality of life questionnaire (to be converted in QALYs 0-1; higher=better)
Measured: 6 weeks (change from baseline)
EQ-5D-5L
Health-related quality of life questionnaire (to be converted in QALYs 0-1; higher=better)
Measured: 12 weeks (change from baseline)
EQ-5D-5L
Health-related quality of life questionnaire (to be converted in QALYs 0-1; higher=better)
Measured: 26 weeks (change from baseline)
EQ-5D-VAS
Health-related quality of life questionnaire (0-100; higher=better)
Measured: 6 weeks (change from baseline)
EQ-5D-VAS
Health-related quality of life questionnaire (0-100; higher=better)
Measured: 12 weeks (change from baseline)
EQ-5D-VAS
Health-related quality of life questionnaire (0-100; higher=better)
Measured: 26 weeks (change from baseline)
Pain Catastrophizing Scale (PCS)
Health-related quality of life questionnaire (0-50; higher=worse)
Measured: 6 weeks (change from baseline)
Pain Catastrophizing Scale (PCS)
Health-related quality of life questionnaire (0-50; higher=worse)
Measured: 12 weeks (change from baseline)
Pain Catastrophizing Scale (PCS)
Health-related quality of life questionnaire (0-50; higher=worse)
Measured: 26 weeks (change from baseline)
Patient perceptions of team effectiveness (Patient-PTE)
Perceptions of team effectiveness questionnaire (24-144; higher=better)
Measured: 0 week (post initial consultation)
modified validated version of the 9-item visit-specific satisfaction questionnaire (VSQ-9)
Patient satisfaction questionnaire (0-100; higher=better)
Measured: 0 week (post initial consultation)
Modified MedRisk
Patient satisfaction questionnaire (0-100; higher=better)
Measured: 12 weeks
Modified MedRisk
Patient satisfaction questionnaire (0-100; higher=better)
Measured: 26 weeks
Provider perceptions of team effectiveness (Prodiver-PTE)
Perceptions of team effectiveness questionnaire (26-156; higher=better)
Measured: Through study completion (once)
Waiting time
Waiting time (time in days and minutes)
Measured: Pre-intervention
Adverse events
Rate of adverse events
Measured: 12 weeks
Adverse events
Rate of adverse events
Measured: 26 weeks
Treatment and compliance
Treatment received and % of treatment compliance
Measured: 6 weeks
Treatment and compliance
Treatment received and % of treatment compliance
Measured: 12 weeks
Treatment and compliance
Treatment received and % of treatment compliance
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start15 Nov 2022
- Primary completion2 Jan 2024
- Study completion2 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal DisordersStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ciusss de L'Est de l'Île de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05714332
- Sponsor's protocol ID
- v3
- Status last verified
- Aug 2024
- First submitted
- 7 Nov 2022
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon resonable request
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impacts of an Advanced Practice Physiotherapy Model of Care for Adults With a Peripheral Musculoskeletal Disorders Referred to an Orthropaedic Outpatient Clinic: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05714332
- Acronym / sponsor ID
- v3
- Conditions
- Musculoskeletal Disorders
- Keywords
- Advanced practice, Physiotherapy, Musculoskeletal disorders, Orthopedic, Observation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Ciusss de L'Est de l'Île de MontréalUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 2 Jan 2024 (actual)
- Study completion
- 2 Jan 2024 (actual)
- First posted
- 6 Feb 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 prospective observational study is to evaluate advanced practice physiotherapy and orthopedic surgeon care and clinical outcomes for new patients with a peripheral musculoskeletal disorders consulting at the orthopedic outpatient clinic of the Hôpital Jean-Talon.
The main questions it aims to answer are: 1. To describe the models of care at the Hôpital Jean-Talon orthopedic outpatient clinic; 2. To assess change in pain, disability, quality of life and pain catastrophizing at 6, 12 and 26 weeks after the initial evaluation; 3. To assess interprofessional collaboration between the advanced practice physiotherapists and orthopedic surgeons; 4. To assess patient satisfaction with care; 5. To assess waiting time before an initial consultation.
Researchers will compare patients cared in the advanced practice physiotherapy and orthopedic surgeon group and the orthopedic surgeon only group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advanced practice physiotherapy and orthopedic surgeon group | – | Other: Advanced practice physiotherapy and orthopedic surgeon managementPatients cared by both an advanced practice physiotherapist and an orthopedic surgeon. |
| Orthopedic surgeon only group | – | Other: Orthopedic surgeon managementPatients cared only by an orthopedic surgeon. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults with a peripheral musculoskeletal disorders
Key inclusion criteria (5 listed)
- Adults with peripheral musculoskeletal disorders
- New consultation at the Hôpital Jean-Talon orthopedic outpatient clinic
- Legally able to consent
- Understand and speak French or English
- Beneficiaries of the provincial universal health insurance coverage (RAMQ)
Key exclusion criteria (1 listed)
- Patients directly referred from the emergency department (not considered as patients referred to the outpatient clinic).
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 |
|---|---|---|
| Advanced practice physiotherapy and orthopedic surgeon managementManagement of their musculoskeletal condition by an advanced practice physiotherapist and an orthopedic surgeon. | Other | Advanced practice physiotherapy and orthopedic surgeon group |
| Orthopedic surgeon managementManagement of their musculoskeletal condition by an orthopedic surgeon. | Other | Orthopedic surgeon only group |
Primary outcome
Brief pain inventory severity
Time frame: 6 weeks (change from baseline)
Pain questionnaire (0-10; higher score=worse)
Brief pain inventory severity
Time frame: 12 weeks (change from baseline)
Pain questionnaire (0-10; higher score=worse)
Brief pain inventory severity
Time frame: 26 weeks (change from baseline)
Pain questionnaire (0-10; higher score=worse)
Brief pain inventory inventory
Time frame: 6 weeks (change from baseline)
Pain interference (disability) questionnaire (0-10; higher score=worse)
Brief pain inventory inventory
Time frame: 12 weeks (change from baseline)
Pain interference (disability) questionnaire (0-10; higher score=worse)
Brief pain inventory inventory
Time frame: 26 weeks (change from baseline)
Pain interference (disability) questionnaire (0-10; higher score=worse)
32 secondary outcomes
Shortened Disability of the Arm, Shoulder and Hand (QuickDASH)
Time frame: 6 weeks (change from baseline)
Shortened Disability of the Arm, Shoulder and Hand (QuickDASH)
Time frame: 12 weeks (change from baseline)
Shortened Disability of the Arm, Shoulder and Hand (QuickDASH)
Time frame: 26 weeks (change from baseline)
Hip disability and Osteoarthritis Outcomes Score (HOOS)
Time frame: 6 weeks (change from baseline)
Hip disability and Osteoarthritis Outcomes Score (HOOS)
Time frame: 12 weeks (change from baseline)
Hip disability and Osteoarthritis Outcomes Score (HOOS)
Time frame: 26 weeks (change from baseline)
Knee injury and Osteoarthritis Outcomes Score (KOOS)
Time frame: 6 weeks (change from baseline)
Knee injury and Osteoarthritis Outcomes Score (KOOS)
Time frame: 12 weeks (change from baseline)
Knee injury and Osteoarthritis Outcomes Score (KOOS)
Time frame: 26 weeks (change from baseline)
Foot and Ankle Ability Measure (FAAM)
Time frame: 6 weeks (change from baseline)
Foot and Ankle Ability Measure (FAAM)
Time frame: 12 weeks (change from baseline)
Foot and Ankle Ability Measure (FAAM)
Time frame: 26 weeks (change from baseline)
EQ-5D-5L
Time frame: 6 weeks (change from baseline)
EQ-5D-5L
Time frame: 12 weeks (change from baseline)
EQ-5D-5L
Time frame: 26 weeks (change from baseline)
EQ-5D-VAS
Time frame: 6 weeks (change from baseline)
EQ-5D-VAS
Time frame: 12 weeks (change from baseline)
EQ-5D-VAS
Time frame: 26 weeks (change from baseline)
Pain Catastrophizing Scale (PCS)
Time frame: 6 weeks (change from baseline)
Pain Catastrophizing Scale (PCS)
Time frame: 12 weeks (change from baseline)
Pain Catastrophizing Scale (PCS)
Time frame: 26 weeks (change from baseline)
Patient perceptions of team effectiveness (Patient-PTE)
Time frame: 0 week (post initial consultation)
modified validated version of the 9-item visit-specific satisfaction questionnaire (VSQ-9)
Time frame: 0 week (post initial consultation)
Modified MedRisk
Time frame: 12 weeks
Modified MedRisk
Time frame: 26 weeks
Provider perceptions of team effectiveness (Prodiver-PTE)
Time frame: Through study completion (once)
Waiting time
Time frame: Pre-intervention
Adverse events
Time frame: 12 weeks
Adverse events
Time frame: 26 weeks
Treatment and compliance
Time frame: 6 weeks
Treatment and compliance
Time frame: 12 weeks
Treatment and compliance
Time frame: 26 weeks
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 11 Jul 2025.
- Individual participant dataSharing planned: No. Data will be available upon resonable request
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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?
An observational study of Musculoskeletal Disorders, run by Ciusss de L'Est de l'Île de Montréal 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 5 inclusion and 1 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 11 Jul 2025. 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?
Brief pain inventory severity (time frame: 6 weeks (change from baseline)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jul 2025.