Musculoskeletal DisordersNCT07137754
Effect and Cost of a Physiotherapy-led Care Model in Emergency Departments for Patients With Minor Musculoskeletal Injuries
A study testing Advanced practice physiotherapy in people with Musculoskeletal Disorders and Emergency Care, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
Both in Denmark and internationally, emergency departments have been overwhelmed for several years by a growing number of patients, combined with a shortage of doctors and nurses. This problem is expected to continue because the number of elderly people with multiple health problems is increasing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Disorders, Emergency Care, Physiotherapy
- What is being tested?
- Advanced practice physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Aug 2025to 1 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Musculoskeletal pain and injury to the upper or lower extremities
- Triaged non-urgent (blue) in the emergency department
- Speaks and understands Danish
Who cannot join
- High velocity trauma
- Cognitively unable to participate
- Non-malignant conditions (cancer, inflammation, infection)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Louise Mortensen, PhD student contact
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus N, 8200
Nanna Rolving, Associate professor, +45 40321618, Nanna.Rolving@rm.dk
About this study
Official title: Effect and Cost-effectiveness of a Physiotherapy-led Care Model for Patients Referred to an Emergency Department Due to Musculoskeletal Injuries: A Multicentre Quasi-randomized Clinical Trial
Both in Denmark and internationally, emergency departments have been overwhelmed for several years by a growing number of patients, combined with a shortage of doctors and nurses. This problem is expected to continue because the number of elderly people with multiple health problems is increasing. To keep providing good quality care in emergency departments, we need to consider new ways of organizing treatment.
In Canada, Australia, and the UK, some hospitals have tried a model where specially trained physiotherapists examine and treat patients who come in with muscle and joint injuries and pain. Since these patients make up about 25% of all those referred to emergency departments, this model could help take some pressure off doctors and nurses. That way, doctors and nurses can spend more time caring for seriously ill patients who need urgent help.
Read more
Several studies on these physiotherapist-led models show benefits for both patients and the healthcare system. Patients report being more satisfied and better informed about their injury and treatment. They wait less, have fewer unnecessary tests, and need fewer repeat visits to the emergency department.
However, similar studies have never been done in Scandinavia, even though some Danish emergency departments have tested similar models. Healthcare systems and the education of physiotherapists differ between Scandinavian countries and the countries mentioned above. So, we don't know if we would see the same benefits here. Also, there has been no research on whether this model is cost-effective, which is important for decision-makers when planning future healthcare budgets.
With this research project, we want to test a model in Danish hospitals where specially trained physiotherapists take care of examining, treating, and discharging patients with muscle and joint pain and injuries. We will look at how this model affects patient experiences (like pain and satisfaction) and clinical outcomes (like repeat emergency visits and use of imaging tests), compared to the usual practice where doctors handle these patients. We will also study whether the model is cost-effective, meaning whether the benefits of using this approach are worth the costs, or even greater than the costs.
The study will be conducted at 4-5 hospitals, where a total of 800 patients with minor musculoskeletal injuries will be included in connection with their visit at the emergency department. Patients will receive questionnaires at 1, 4, 12 and 26 weeks after injury regarding patient reported outcomes. Register data will be retrieved at 26 weeks regarding the patients' health care use during follow-up.
- Conditions
- Musculoskeletal Disorders, Emergency Care, Physiotherapy
- Being tested
- Advanced practice physiotherapy, Usual Care
- 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 physiotherapyOther
Physiotherapists undergoing post-graduate education as advanced practice physiotherapists will independently diagnose, manage and discharge patients.
Usual CareOther
Nurses and physicians in the emergency department will diagnose, manage and discharge patients as usual
| Study group | Role | What they receive |
|---|---|---|
| Advanced practice physiotherapy | Experimental | Advanced practice physiotherapists will independently diagnose, manage and discharge patients Receives: Other: Advanced practice physiotherapy |
| Usual care | Active comparator | Nurses and physicians in the emergency department will diagnose, manage and discharge patients as per usual care Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief pain inventory short form
BPI short form is a self-reported questionnaire, using the 7 items pain interference on functional ability, mood, sleep and work. The patient completes the assessment at baseline, 1, 4, 12 and 26 weeks after injury
Measured: From baseline (time of injury) to 12 weeks follow-up
Euroqol 5 Dimensions 5 Levels
The EQ5D assesses health-related quality of life using 5 items. It is used as the primary outcome for qualculation of QUALYs in the health economic analysis.
Measured: From baseline to 26 weeks
Secondary outcomes (6)
Visit-specific satisfaction questionnaire
VSQ-9 is a selfreported questionnaire with 9 items on different aspects of patient satisfaction with their visit to the emergency department
Measured: Is collected at week 1 after baseline
PROMIS short form physical function
The questionnaire contains 8 questions on limitations in functional ability due to injuries in the lowe extremeties. It is collected via self-reported questionnaires at baseline, weeks 1, 4, 12 and 26 after baseline
Measured: From baseline to 12 weeks after.
PROMIS short form upper extremety
Contains questions about functional limitations due to injuries in the upper extremeties. Measured at baseline, weeks 1, 4, 12 and 26 after discharge
Measured: From baseline to 12 weeks
Work Productivity and Activity Impairment
The WPAI measures number of hours missed from work, volunteer work (unpaid work) and studies due to health related issues. Further it measures hours with reduced productivity at work due to health related issues. Assessed at baseline, weeks 1, 4, 12 and 26 using self-reported questionnaires
Measured: From baseline to 12 weeks
Return-visits to emergency department
Return-visits and phone calls to the emergency department due to the same injury during follow-up, assessed using self-report and register-based data.
Measured: From baseline to 12 week follow-up
Health care use in primary care
Includes visits with general practice and physiotherapy practice during follow-up. This will be collected via the National Health Service Register
Measured: From baseline to 26 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start15 Aug 2025
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
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.
- More trials run by Aarhus University HospitalThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Slagelse Hospital, Gødstrup Hospital, Université de Montréal, Independent Research Fund Denmark, University of Aarhus, Danske Fysioterapeuter
- Responsible party
- Principal investigator, Nanna Rolving, Aarhus University Hospital
- Investigators
- Nanna Rolving, Associate professor, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07137754
- Sponsor's protocol ID
- Journal no. 1-10-72-137-24
- Other IDs
- 4285-00270B
- Status last verified
- Aug 2025
- First submitted
- 15 Aug 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Decision on IPD sharing plan awaits steering group meeting, with the expectation that a plan for IPD sharing will be registered later on.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect and Cost-effectiveness of a Physiotherapy-led Care Model for Patients Referred to an Emergency Department Due to Musculoskeletal Injuries: A Multicentre Quasi-randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07137754
- Acronym / sponsor ID
- Journal no. 1-10-72-137-24
- Conditions
- Musculoskeletal Disorders, Emergency Care, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Slagelse Hospital, Gødstrup Hospital, Université de Montréal, Independent Research Fund Denmark, University of Aarhus, Danske Fysioterapeuter
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 22 Aug 2025 (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.
Both in Denmark and internationally, emergency departments have been overwhelmed for several years by a growing number of patients, combined with a shortage of doctors and nurses. This problem is expected to continue because the number of elderly people with multiple health problems is increasing. To keep providing good quality care in emergency departments, we need to consider new ways of organizing treatment.
In Canada, Australia, and the UK, some hospitals have tried a model where specially trained physiotherapists examine and treat patients who come in with muscle and joint injuries and pain. Since these patients make up about 25% of all those referred to emergency departments, this model could help take some pressure off doctors and nurses. That way, doctors and nurses can spend more time caring for seriously ill patients who need urgent help.
Several studies on these physiotherapist-led models show benefits for both patients and the healthcare system. Patients report being more satisfied and better informed about their injury and treatment. They wait less, have fewer unnecessary tests, and need fewer repeat visits to the emergency department.
However, similar studies have never been done in Scandinavia, even though some Danish emergency departments have tested similar models. Healthcare systems and the education of physiotherapists differ between Scandinavian countries and the countries mentioned above. So, we don't know if we would see the same benefits here. Also, there has been no research on whether this model is cost-effective, which is important for decision-makers when planning future healthcare budgets.
With this research project, we want to test a model in Danish hospitals where specially trained physiotherapists take care of examining, treating, and discharging patients with muscle and joint pain and injuries. We will look at how this model affects patient experiences (like pain and satisfaction) and clinical outcomes (like repeat emergency visits and use of imaging tests), compared to the usual practice where doctors handle these patients. We will also study whether the model is cost-effective, meaning whether the benefits of using this approach are worth the costs, or even greater than the costs.
The study will be conducted at 4-5 hospitals, where a total of 800 patients with minor musculoskeletal injuries will be included in connection with their visit at the emergency department. Patients will receive questionnaires at 1, 4, 12 and 26 weeks after injury regarding patient reported outcomes. Register data will be retrieved at 26 weeks regarding the patients' health care use during follow-up.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advanced practice physiotherapy | Experimental | Other: Advanced practice physiotherapyAdvanced practice physiotherapists will independently diagnose, manage and discharge patients |
| Usual care | Active comparator | Other: Usual CareNurses and physicians in the emergency department will diagnose, manage and discharge patients as per usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Musculoskeletal pain and injury to the upper or lower extremities
- Triaged non-urgent (blue) in the emergency department
- Speaks and understands Danish
Key exclusion criteria (3 listed)
- High velocity trauma
- Cognitively unable to participate
- Non-malignant conditions (cancer, inflammation, infection)
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 physiotherapyPhysiotherapists undergoing post-graduate education as advanced practice physiotherapists will independently diagnose, manage and discharge patients. | Other | Advanced practice physiotherapy |
| Usual CareNurses and physicians in the emergency department will diagnose, manage and discharge patients as usual | Other | Usual care |
Primary outcome
Brief pain inventory short form
Time frame: From baseline (time of injury) to 12 weeks follow-up
BPI short form is a self-reported questionnaire, using the 7 items pain interference on functional ability, mood, sleep and work. The patient completes the assessment at baseline, 1, 4, 12 and 26 weeks after injury
Euroqol 5 Dimensions 5 Levels
Time frame: From baseline to 26 weeks
The EQ5D assesses health-related quality of life using 5 items. It is used as the primary outcome for qualculation of QUALYs in the health economic analysis.
6 secondary outcomes
Visit-specific satisfaction questionnaire
Time frame: Is collected at week 1 after baseline
PROMIS short form physical function
Time frame: From baseline to 12 weeks after.
PROMIS short form upper extremety
Time frame: From baseline to 12 weeks
Work Productivity and Activity Impairment
Time frame: From baseline to 12 weeks
Return-visits to emergency department
Time frame: From baseline to 12 week follow-up
Health care use in primary care
Time frame: From baseline to 26 week follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: Undecided. Decision on IPD sharing plan awaits steering group meeting, with the expectation that a plan for IPD sharing will be registered later on.
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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.
Louise Mortensen, PhD student contact
Nanna Rolving, Associate professor principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advanced practice physiotherapy in people with Musculoskeletal Disorders and Emergency Care, run by Aarhus University Hospital at 1 site in Denmark.
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 3 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: looking for participants now, as of the sponsor's last update on 28 Aug 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nanna Rolving, Associate professor (+45 40321618, Nanna.Rolving@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief pain inventory short form (time frame: From baseline (time of injury) to 12 weeks follow-up). 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?
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 Aug 2025.