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Musculoskeletal DiseasesDirectPhysioNCT07443098

Front Line Agreement in Diagnosis and Treatment for Musculoskeletal Dysfunctions

A study testing Intervention: ED - physiotherapist group in people with Musculoskeletal Diseases and Low Back Pain, run by Bern University of Applied Sciences at 1 site in Switzerland.

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

Background: This randomized study, conducted from October to December 2023 in the emergency department of Bethesda Hospital Basel, Switzerland, investigated a new model of care for patients presenting with non-urgent musculoskeletal disorders (MSKDs). Read more about this study

Who is it for?
Ages 18 to 79 years
What is being tested?
Intervention: ED - physiotherapist group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
1 siteSwitzerland
Study dates
3 Oct 2023to 31 Jan 2024
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 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged 18 to 79 years presenting with non-serious musculoskeletal conditions
  • report a pain intensity between 3 and 7 on a 0-10 Numeric Rating Scale (NRS).

Who cannot join

  • major trauma, fracture
  • systemic signs (e.g., fever or unexplained profuse sweating)
  • progressive neurological deficits (i.e., severe sensory loss or weakness)
  • cauda equina syndrome with bladder or bowel dysfunction
  • progressive deterioration of the general condition
  • severe acute medical distress (e.g., suspected myocardial infarction)
Show all 9Show fewer
  • allergic reaction with or without skin rashes
  • acute mental illness (psychological condition)
  • Patients who are unwilling or unable to provide informed consent or lacking decision-making capacity.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • Bethesda Spital AG - Basel

    Basel, 4052

Other trials in Switzerland

About this study

Official title: The Direct Physio Project Front Line Agreement in Diagnosis and Treatment for Musculoskeletal Dysfunctions. A Prospective, Randomized, Controlled Study

Background: This randomized study, conducted from October to December 2023 in the emergency department of Bethesda Hospital Basel, Switzerland, investigated a new model of care for patients presenting with non-urgent musculoskeletal disorders (MSKDs). It was initiated in response to two major challenges in the Swiss healthcare system: a shortage of general practitioners and a rising number of ED visits for conditions such as back, neck, and shoulder pain, sprains, and other joint or muscle complaints without serious underlying pathology. Internationally, Advanced Physiotherapy Practice (APP) roles, in which specially trained physiotherapists independently assess, diagnose, treat, and discharge patients with appropriate MSKDs, have been successfully implemented in emergency settings, but this model is still novel in Switzerland, and local evidence on safety and comparability to medical care is lacking.

Methods: A total of 102 patients with musculoskeletal complaints and no signs of serious structural or systemic disease were included after informed consent. Patients were randomly assigned either to an intervention group, managed by physiotherapists working in an advanced practice role, or to a control group receiving standard care from resident physicians. Senior physicians, acting as reference standard, reviewed clinical findings, diagnoses, treatment recommendations, and discharge decisions from both groups. Agreement between each provider group and senior physicians was quantified using established measures of inter-rater reliability, specifically Cohen's Kappa (κ) and Gwet's AC1, to determine concordance beyond chance.

Conclusions: This study aims to determine whether advanced practice physiotherapists can provide clinical decision-making comparable to resident physicians for non-urgent MSKDs in the ED. Demonstrating high levels of agreement in diagnosis, management, and discharge planning would support the safe integration of APP roles into Swiss emergency workflows, with potential benefits including reduced waiting times, more efficient use of physician resources, improved patient flow, and maintenance of high standards of care and patient safety, thereby informing workforce planning and task-sharing strategies in acute care.

Read the detailed description

The study will be conducted between October and December 2023 in the emergency department (ED) of Bethesda Hospital Basel (BSAG), Switzerland, to evaluate a new model of care for patients presenting with non-urgent musculoskeletal conditions (MSKDs). This study was motivated by two major challenges in the Swiss healthcare system: a shortage of general practitioners and an increasing number of ED visits for conditions such as back pain, neck pain, shoulder pain, sprains, and other joint or muscle complaints that do not involve serious structural injury or underlying disease.

Internationally, Advanced Physiotherapy Practice (APP) roles have been successfully implemented in emergency departments. In this model, specially trained physiotherapists assess, diagnose, treat, and discharge patients with appropriate musculoskeletal complaints, working alongside medical staff.

While this approach has been successfully implemented internationally, it remains relatively new in Switzerland, and evidence was needed to determine whether it is safe and comparable to standard medical care in the ED setting.

The aim of this study was to evaluate the level of agreement in diagnosis, treatment decisions, and discharge planning between physiotherapists and resident physicians, using senior physicians as the reference standard. A total of 102 patients presenting with musculoskeletal complaints without signs of serious underlying or structural pathology were included. After providing consent, patients were randomly assigned to one of two groups: the intervention group, in which they were assessed and managed by physiotherapists working in an advanced practice role, or the control group, in which they received standard care from resident physicians.

To ensure patient safety and provide a benchmark for comparison, senior physicians reviewed the clinical findings, diagnoses, treatment recommendations, and discharge decisions from both groups. The degree of agreement between each group and the senior physicians was analyzed using established statistical measures of inter-rater reliability, specifically Cohen's Kappa (κ) and Gwet's AC1. These methods quantify how closely clinical decisions align beyond what would be expected by chance.

This study is highly relevant for patients and families, as it explores whether qualified physiotherapists can safely and effectively manage non-urgent musculoskeletal cases in the emergency department. If agreement levels are high, this would support the safe integration of advanced practice physiotherapists into ED workflows. Potential benefits include reduced waiting times, more efficient use of physician resources, and improved patient flow, while maintaining high standards of care and patient safety.

For healthcare providers and policymakers, the findings contribute important evidence regarding task-sharing and interprofessional collaboration in acute care settings. Demonstrating comparable clinical decision-making between physiotherapists and resident physicians could support workforce innovation, help address physician shortages, and inform future healthcare planning in Switzerland. Overall, the study provides structured and objective data on the feasibility and safety of implementing Advanced Physiotherapy Practice within a Swiss emergency department context.

Being tested
Intervention: ED - physiotherapist group, Control: resident physician group
Keywords
Diagnostic & management, emergency department, musculoskeletal disorders, advanced practice physiotherapy, RCT
Medical subject headings
Musculoskeletal Diseases, Low Back Pain, Emergencies, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intervention: ED - physiotherapist groupDiagnostic test

    All patients in the ED-PT groups (3 subgroups) will undergo a medical history assessment and standardized red flag screening (Boissonnault, 2011; Lüdtke, 2021) to exclude non-musculoskeletal causes. The questionnaire will be signed by both the patient and the ED-PT. Patients with identified red flags will be excluded before randomization. Additionally, all cases will be reviewed by a senior physician to ensure safety. After exclusion of red flags, the ED-PT will perform the clinical assessment, establish a provisional diagnosis, and develop a management and discharge plan. All data will be recorded in a case report form (CRF). Before discharge, a senior physician will review and confirm the plan (yes/no) and retain final medical responsibility. A written report to the GP will conclude the ED consultation.

  • Control: resident physician groupDiagnostic test

    Resident physicians (RPs) will perform the initial clinical assessment and propose a diagnosis and management plan, which will be reviewed and approved by a senior physician prior to discharge, in accordance with standard emergency department procedures at Bethesda Hospital AG (BSAG). The same predefined clinical workflow will be applied in both groups (RP and ED-PT).

Study groups in NCT07443098
Study groupRoleWhat they receive
Intervention Arm (Advanced Practice Physiotherapist-Led Care)ExperimentalAll patients in the ED-PT groups (3 subgroups) will undergo a medical history assessment and standardized red flag screening (Boissonnault, 2011; Lüdtke, 2021) to exclude non-musculoskeletal causes. The questionnaire will be signed by both the patient and the ED-PT. Patients with identified red flags will be excluded before randomization. Additionally, all cases will be reviewed by a senior physician to ensure safety. After exclusion of red flags, the ED-PT will perform the clinical assessment, establish a provisional diagnosis, and develop a management and discharge plan. All data will be recorded in a CRF. Before discharge, a senior physician will review and confirm the plan (yes/no) and retain final medical responsibility. A written report to the GP will conclude the ED consultation.
Receives: Diagnostic Test: Intervention: ED - physiotherapist group
Experimental: Control Arm (Resident physician-Led Care)Active comparatorResident physicians (RPs) will perform the initial clinical assessment and propose a diagnosis and management plan, which will be reviewed and approved by a senior physician prior to discharge, in accordance with standard emergency department procedures at Bethesda Hospital AG (BSAG). The same predefined clinical workflow will be applied in both groups (RP and ED-PT).
Receives: Diagnostic Test: Control: resident physician group

What is being measured

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

  1. Agreement

    Description:The primary outcome will be the level of agreement, measured using Cohen's Kappa (κ) and Gwet's AC1 (AC1), regarding diagnosis and follow-up recommendations between ED-PTs resp. residents (control group), and the senior physician.

    Measured: From enrollment to the end of treatment at 13 weeks.

  2. Diagnostic Competence APP

    Cohen's Kappa (κ) and Gwet's AC1 (AC1) with 95% confidence interval (CI) for the review of the diagnosis and follow-up recommendations

    Measured: From enrollment to the end of treatment at 13 weeks

Timeline

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

  1. First posted2 Mar 2026
  2. Study start3 Oct 2023
  3. Primary completion23 Dec 2023
  4. Study completion31 Jan 2024

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
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study will use a prospective, randomized, controlled, single-center interventional design conducted in the emergency department of Bethesda Hospital Basel. Eligible adult patients presenting with non-urgent musculoskeletal conditions will be randomly assigned to either assessment and management by an Advanced Practice Physiotherapist (intervention group) or standard care by a resident physician (control group). Randomization will be performed using concealed allocation with sealed envelopes. In both groups, diagnoses, treatment recommendations, and discharge decisions will be reviewed by a senior physician, who will serve as the reference standard. The study will compare agreement in clinical decision-making between groups to evaluate the safety and competence of advanced physiotherapy practice in the emergency department setting.
Masking
None (open label)
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07443098
Sponsor's protocol ID
Bern UniversityApplied Science
Other IDs
2023-01399, 2023
Acronym
DirectPhysio
Status last verified
Mar 2026
First submitted
25 Feb 2026
Last updated
10 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The informed consent obtained from participants did not include explicit provisions for public sharing of individual-level data beyond the research team. In accordance with Swiss data protection regulations and institutional policies, data access is therefore restricted to authorized study personnel.

Publications

  • Winteler, B., Geese, F., Lehmann, B., & Schmitt, K.-U. (2022). Musculoskeletal Physiotherapy in the Emergency Department - Evaluation of a New Physiotherapy Service in a Swiss University Hospital. Physioscience, 18(02), 69-76. https://doi.org/10.1055/a-1500-1077

  • Goodwin RW, Hendrick PA. Physiotherapy as a first point of contact in general practice: a solution to a growing problem? Prim Health Care Res Dev. 2016 Sep;17(5):489-502. doi: 10.1017/S1463423616000189. Epub 2016 Jun 6.

    PubMed 27263326
  • Ferreira GE, Traeger AC, Maher CG. Review article: A scoping review of physiotherapists in the adult emergency department. Emerg Med Australas. 2019 Feb;31(1):43-57. doi: 10.1111/1742-6723.12987. Epub 2018 Apr 17.

    PubMed 29664184
  • Downie F, McRitchie C, Monteith W, Turner H. Physiotherapist as an alternative to a GP for musculoskeletal conditions: a 2-year service evaluation of UK primary care data. Br J Gen Pract. 2019 May;69(682):e314-e320. doi: 10.3399/bjgp19X702245. Epub 2019 Apr 8.

    PubMed 30962224
  • de Gruchy A, Granger C, Gorelik A. Physical Therapists as Primary Practitioners in the Emergency Department: Six-Month Prospective Practice Analysis. Phys Ther. 2015 Sep;95(9):1207-16. doi: 10.2522/ptj.20130552. Epub 2015 Apr 30.

    PubMed 25929528
  • Bird S, Thompson C, Williams KE. Primary contact physiotherapy services reduce waiting and treatment times for patients presenting with musculoskeletal conditions in Australian emergency departments: an observational study. J Physiother. 2016 Oct;62(4):209-14. doi: 10.1016/j.jphys.2016.08.005. Epub 2016 Aug 24.

    PubMed 27637771

Questions about this trial

What is this clinical trial studying?

A study testing Intervention: ED - physiotherapist group in people with Musculoskeletal Diseases and Low Back Pain, run by Bern University of Applied Sciences at 1 site in Switzerland.

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 2 inclusion and 9 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 10 Mar 2026. 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 Switzerland. 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?

Agreement (time frame: From enrollment to the end of treatment at 13 weeks.). 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 NCT07443098, which also lists 6 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 10 Mar 2026.

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