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OpenTrials
Completed

NCT Number: NCT07443098

Front Line Agreement in Diagnosis and Treatment for Musculoskeletal Dysfunctions

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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 informed consent or lacking decision-making capacity.

Treatment and study plan

Intervention: ED - physiotherapist group

Diagnostic 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 group

Diagnostic 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).

Primary outcomes

  1. Agreement

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

    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.

  2. Diagnostic Competence APP

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

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

Sponsors and collaborators

Lead sponsor

Bern University of Applied Sciences

Other

Registry information

Official study title

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

Acronym: DirectPhysio

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Mar 2, 2026
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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