ClinicalTrials.gg
CompletedNCT07443098DirectPhysioUpdated Mar 10, 2026

Front Line Agreement in Diagnosis and Treatment for Musculoskeletal Dysfunctions

An interventional study of Intervention: ED - physiotherapist group and Control: resident physician group in Musculoskeletal Diseases, Low Back Pain and Emergency Service, Hospital, sponsored by Bern University of Applied Sciences. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-03-10.

Sponsored by Bern University of Applied Sciences · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 2 years 4 months after the study started (first participant enrolled Oct 2023, registered Feb 2026).

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Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
18 Years to 79 Years
Sex
All
01

Study 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). 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.

02

Conditions studied

  • Musculoskeletal Diseases
  • Low Back Pain
  • Emergency Service, Hospital
  • Physical Therapy Modalities
  • Diagnostic Techniques and Procedures
  • Clinical Competence
  • Patient Discharge

Keywords

  • Diagnostic & management
  • emergency department
  • musculoskeletal disorders
  • advanced practice physiotherapy
  • RCT
03

In context

Musculoskeletal Diseases

752 studies on the registry are indexed under Musculoskeletal Diseases; 164 are open to participants now.

This study's enrollment of 102 is above the median of 76 across 518 interventional studies indexed under Musculoskeletal Diseases.

Browse Musculoskeletal Diseases studies →

Lead sponsor

Bern University of Applied Sciences is the lead sponsor of 21 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

  • 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)
  • allergic reaction with or without skin rashes
  • acute mental illness (psychological condition)
  • Patients who are unwilling or unable to provide or lacking decision-making capacity.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
102 participants (actual)

Study arms

  • Experimental
    Intervention Arm (Advanced Practice Physiotherapist-Led Care)

    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 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.

    Diagnostic Test: Intervention: ED - physiotherapist group

  • Active comparator
    Experimental: Control Arm (Resident physician-Led Care)

    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).

    Diagnostic Test: Control: resident physician group

Interventions

  • Diagnostic testIntervention: ED - physiotherapist group

    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.

  • Diagnostic testControl: resident physician group

    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).

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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

    Time frame: From enrollment to the end of treatment at 13 weeks

07

Study locations

1 site
  • Bethesda Spital AG - Basel
    Basel, 4052, Switzerland
08

References and documents

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 ↗

Individual participant data

Plan to share: 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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2023 to primary completion in Dec 2023, 2 months.

Of 251 non-industry interventional studies with no phase under Musculoskeletal Diseases, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 38. This study's 2 months is below that.

Counting every sponsor, half of 266 studies reached it within 16 months; a quarter within 6 and three quarters within 36.

Musculoskeletal Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 25, 2026
First posted
Mar 2, 2026
StartActual
Oct 3, 2023
Primary completionActual
Dec 23, 2023
CompletionActual
Jan 31, 2024
Last update
Mar 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07443098
Lead sponsor
Bern University of Applied Sciences
Responsible party
Amir Tal (Prof. Dr. Amit Tal, Bern University of Applied Sciences) — Principal investigator
First posted
Mar 2, 2026
Start date
Oct 3, 2023
Primary completion
Dec 23, 2023
Completion
Jan 31, 2024
Last update
Mar 10, 2026

Study contacts

Amir Tal, PhD
principal investigator · Bern University of Applied Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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