A Multi-Site Feasibility Trial of Embedded Emergency Department Physical Therapy (FEED-PT)

January 5, 2026 updated by: Howard Kim, Northwestern University
This is a multi-site feasibility trial of an embedded emergency department (ED) physical therapy care model for low back pain at two EDs in the Northwestern Medicine and University of Utah Health systems. The study intervention (embedded ED physical therapy) is a reconceptualization of the traditional outpatient physical therapy care model in which we place a physical therapist directly in the ED to initiate timely care for patients with low back pain; we previously evaluated this intervention in a single center randomized trial. This multi-site feasibility trial will be comprised of 9 months of active intervention and 12 months of longitudinal data collection. The two sites will be parallel randomized 1:1 to receive either the embedded ED physical therapy condition (intervention, n=1) or usual care (control, n=1) via simple randomization. This trial focuses on feasibility outcomes - such as our ability to enroll participants, deliver the intervention with fidelity, and collect longitudinal patient-reported outcome data and electronic health record data - but a future multi-site full-scale trial will focus on the outcomes of pain-interference and opioid use.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

After a 12-month milestone-driven planning and preparation phase, we will conduct a 21-month randomized feasibility clinical trial of the embedded ED physical therapy intervention at the Northwestern Medicine and University of Utah health systems, comprised of 9 months of active intervention and 12 months of longitudinal data collection. Two hospital EDs (Northwestern Memorial Hospital, University of Utah Hospital) will be randomized to receive either the embedded ED physical therapist intervention (treatment, n=1) or usual care (control, n=1). Following completion of the feasibility trial, the control site will receive the intervention as per standard waitlist procedures for randomized trials. A third hospital ED (Northwestern Lake Forest Hospital) will not participate in randomization or participant enrollment but will contribute baseline electronic health record data to assist in feasibility assessments for a future full-scale trial.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • University of Utah
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Emergency Department (ED) visit with primary diagnosis related to low back pain
  • ED visit occurring at an ED site participating in randomization (Northwestern Memorial Hospital, University of Utah Hospital)
  • ED visit check-in time during the hours of 8am-8pm
  • Current episode of low back pain less than or equal to 30 days, defined as pain between the 12th rib and buttocks
  • Age greater than or equal to 18 years; there is no age maximum
  • English or Spanish-speaking

Exclusion Criteria:

  • "Red flag" symptoms indicating a life or limb-threatening process
  • Currently in police custody
  • Unable to consent
  • Known pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Embedded Emergency Department Physical Therapy
We place a physical therapist directly in the emergency department to initiate timely care for patients with low back pain rather than waiting on an outpatient referral to physical therapy, which can often take weeks to accomplish, if ever at all. The actual techniques and approaches used by the embedded ED physical therapist in this study (e.g., exercises, maneuvers, coaching) are standard-of-care and do not involve investigational interventions, devices, or drugs.
Other: Embedded Emergency Department Physical Therapy
We place a physical therapist directly in the emergency department to initiate timely care for patients with low back pain rather than waiting on an outpatient referral to physical therapy, which can often take weeks to accomplish, if ever at all. The actual techniques and approaches used by the embedded ED physical therapist in this study (e.g., exercises, maneuvers, coaching) are standard-of-care and do not involve investigational interventions, devices, or drugs.
Other: Usual Care
Usual care treatment for low back pain presenting in the emergency department (ED). Usual care consists of any ED testing or treatment not involving an ED physical therapist in accordance with the treating physician's usual and customary practice. This could include diagnostic imaging, patient education and resources, and administration and/or prescribing of analgesic medications.
Other: Usual Care
Standard-of-care treatment for low back pain presenting in the emergency department

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Longitudinal participant surveys (effectiveness): screening-to-enrollment ratio
Time Frame: Baseline
Number of participants who enter screening compared to the number of participants who enroll in the study. Variable type: binary / proportion.
Baseline
Clinician surveys before and after implementation of the intervention (implementation): Normalisation Measure Development Questionnaire (NoMAD) questionnaire scores
Time Frame: 1-6 months prior to opening study to accrual and 1-6 months after the last participant enrolls at the site.
1-6 months prior to opening study to accrual and 1-6 months after the last participant enrolls at the site. Variable type: continuous.
1-6 months prior to opening study to accrual and 1-6 months after the last participant enrolls at the site.
Longitudinal participant surveys (effectiveness): missing data rate for the Patient-Reported Outcome Measurement Information System (PROMIS)-Pain Interference (PI) assessment.
Time Frame: 12 months
Rate of missing data for assessments administered between baseline and 12 months. Variable type: binary / proportion.
12 months
Longitudinal participant surveys (effectiveness): participant retention rate defined as completion of at least one follow-up survey.
Time Frame: 12 months.
Ratio of participants enrolled to the number who complete at least one follow-up survey.
12 months.
Electronic Health Record (EHR) extraction (implementation): adoption of Emergency Department (ED) physical therapy
Time Frame: Baseline
Adoption is defined as the number of potentially eligible low back pain ED visits have a documented order for a physical therapy evaluation. Cross-sectional at the level of site/Emergency Department during the trial. Variable type: Proportion.
Baseline
Electronic Health Record (EHR) extraction (implementation): fidelity of Emergency Department (ED) physical therapy
Time Frame: Baseline
Fidelity is defined as the number of low back pain ED visits that have a structured research note documenting use of the protocol. Cross-sectional at the level of site/Emergency Department (ED) during the trial. Variable type: proportion.
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Electronic Health Record (EHR) extraction (effectiveness): rate of subsequent health care encounters.
Time Frame: 12 months
Variable type: count, may be considered binary / proportion
12 months
Electronic Health Record (EHR) extraction (effectiveness): rate of advanced diagnostic imaging
Time Frame: 12 months
Variable type: count, may be considered binary / proportion
12 months
Clinician surveys before and after implementation of the intervention (implementation): Acceptability of Intervention Measure (AIM)
Time Frame: 1-6 months prior to opening study to accrual and 1-6 months after the last participant enrolls at the site.
1-6 months prior to opening study to accrual and 1-6 months after the last participant enrolls at the site. Variable type: continuous. Minimum value is 4, Maximum value is 20. Higher scores = higher agreement with outcome.
1-6 months prior to opening study to accrual and 1-6 months after the last participant enrolls at the site.
Clinician surveys before and after implementation of the intervention (implementation): Intervention Appropriateness Measure (IAM)
Time Frame: 1-6 months prior to opening study to accrual and 1-6 months after the last participant enrolls at the site.
1-6 months prior to opening study to accrual and 1-6 months after the last participant enrolls at the site. Variable type: continuous. Minimum value is 4, Maximum value is 20. Higher scores = higher agreement with outcome.
1-6 months prior to opening study to accrual and 1-6 months after the last participant enrolls at the site.
Clinician surveys before and after implementation of the intervention (implementation): Feasibility of Intervention measure (FIM).
Time Frame: 1-6 months prior to opening study to accrual and 1-6 months after the last participant enrolls at the site.
1-6 months prior to opening study to accrual and 1-6 months after the last participant enrolls at the site. Variable type: continuous. Minimum value is 4, Maximum value is 20. Higher scores = higher agreement with outcome.
1-6 months prior to opening study to accrual and 1-6 months after the last participant enrolls at the site.
Longitudinal participant surveys (effectiveness): a sum of the missing data rate for the remaining Participant Reported Outcomes (PROs) combined.
Time Frame: 12 months
Missing data rate for each PRO will not be analyzed separately, but will be combined into one measurement as one outcome. PROs: modified Oswestry Disability Index (ODI), four-item Pain Catastrophizing Score, four item Pain Self-Efficacy Questionnaire, Global Rating of Change, Numeric Pain Rating Scale, additional healthcare utilization (e.g., physical therapy, ED, doctor's office), and a medication use survey.
12 months
Electronic Health Record (EHR) extraction (effectiveness): rate of opioid prescribing
Time Frame: 12 months
Variable type: count, may be considered binary / proportion
12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Participant and clinician focus groups (implementation)
Time Frame: 1-6 months before the first participant enrolls and 1-6 months after the study closes to follow-up.
These data will be collected and analyzed qualitatively.
1-6 months before the first participant enrolls and 1-6 months after the study closes to follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northwestern University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Center for Complementary and Integrative Health (NCCIH)
University of Utah
Northwestern Memorial Hospital
Northwestern Lake Forest Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 5, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 4, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 4, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 5, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FEED-PT
  • R01AT012367 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Scientific data and metadata will be archived into Northwestern University Libraries' institutional repository, Arch (https://arch.library.northwestern.edu/). Northwestern University faculty, students, and staff with a current NetID are allowed unlimited storage, file uploads, and hosting for their scientific work.

Scientific data will be made available at the end of the award period or at the time of the corresponding publication, in the case of any publications that pre-date the award end date. Datasets resulting from this work will remain available in the repository in perpetuity or until deaccessioned at the discretion of the repository. Should the funding or organizational imperatives of the Northwestern University Libraries change, the Libraries will strive to provide at least one year notice, and devote resources to support the transition to another host institution and/or returning the data to the data producers.

IPD Sharing Time Frame

Scientific data will be made available at the end of the award period or at the time of the corresponding publication, in the case of any publications that pre-date the award end date. Datasets resulting from this work will remain available in the repository in perpetuity or until deaccessioned at the discretion of the repository.

IPD Sharing Access Criteria

Access to scientific data and metadata will not be controlled after archiving. Arch is an open access repository that is focused on digital data archiving and unmediated public access to research results.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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