Low Back PainFEED-PTNCT07224945
A Multi-Site Feasibility Trial of Embedded Emergency Department Physical Therapy
A study testing Embedded Emergency Department Physical Therapy in people with Low Back Pain, run by Northwestern University at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Embedded Emergency Department Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Jan 2026to 4 Jan 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
- 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
Who cannot join
- "Red flag" symptoms indicating a life or limb-threatening process
- Currently in police custody
- Unable to consent
- Known pregnancy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Howard Kim, MD, MS, 312-926-0591, howard.kim@northwestern.edu
- Recruiting
University of Utah
Salt Lake City, Utah, 84112
Scott T Youngquist, MD, MS, 801-581-2417, scott.youngquist@utah.edu
About this study
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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Embedded Emergency Department Physical Therapy, Usual Care
- Keywords
- Low back pain, Physical therapy, FEED-PT, Feasibility, Emergency department
- Medical subject headings
- Low Back Pain, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embedded Emergency Department Physical TherapyOther
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.
Usual CareOther
Standard-of-care treatment for low back pain presenting in the emergency department
| Study group | Role | What they receive |
|---|---|---|
| Embedded Emergency Department Physical Therapy | Experimental | 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. Receives: Other: Embedded Emergency Department Physical Therapy |
| Usual Care | Other | 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal participant surveys (effectiveness): missing data rate for the Patient-Reported Outcome Measurement Information System (PROMIS)-Pain Interference (PI) assessment.
Rate of missing data for assessments administered between baseline and 12 months. Variable type: binary / proportion.
Measured: 12 months
Longitudinal participant surveys (effectiveness): screening-to-enrollment ratio
Number of participants who enter screening compared to the number of participants who enroll in the study. Variable type: binary / proportion.
Measured: Baseline
Longitudinal participant surveys (effectiveness): participant retention rate defined as completion of at least one follow-up survey.
Ratio of participants enrolled to the number who complete at least one follow-up survey.
Measured: 12 months.
Electronic Health Record (EHR) extraction (implementation): adoption of Emergency Department (ED) physical therapy
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.
Measured: Baseline
Electronic Health Record (EHR) extraction (implementation): fidelity of Emergency Department (ED) physical therapy
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.
Measured: Baseline
Clinician surveys before and after implementation of the intervention (implementation): Normalisation Measure Development Questionnaire (NoMAD) questionnaire scores
1-6 months prior to opening study to accrual and 1-6 months after the last participant enrolls at the site. Variable type: continuous.
Measured: 1-6 months prior to opening study to accrual and 1-6 months after the last participant enrolls at the site.
Secondary outcomes (7)
Longitudinal participant surveys (effectiveness): a sum of the missing data rate for the remaining Participant Reported Outcomes (PROs) combined.
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.
Measured: 12 months
Electronic Health Record (EHR) extraction (effectiveness): rate of subsequent health care encounters.
Variable type: count, may be considered binary / proportion
Measured: 12 months
Electronic Health Record (EHR) extraction (effectiveness): rate of opioid prescribing
Variable type: count, may be considered binary / proportion
Measured: 12 months
Electronic Health Record (EHR) extraction (effectiveness): rate of advanced diagnostic imaging
Variable type: count, may be considered binary / proportion
Measured: 12 months
Clinician surveys before and after implementation of the intervention (implementation): Acceptability of Intervention Measure (AIM)
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.
Measured: 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)
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.
Measured: 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).
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.
Measured: 1-6 months prior to opening study to accrual and 1-6 months after the last participant enrolls at the site.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2025
- Study start5 Jan 2026
- Primary completion4 Jan 2027 (estimated)
- Study completion4 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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 electronic health record data to assist in feasibility assessments for a future full-scale trial.
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), University of Utah, Northwestern Lake Forest Hospital, Northwestern Memorial Hospital
- Responsible party
- Principal investigator, Howard Kim, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07224945
- Sponsor's protocol ID
- FEED-PT
- Other IDs
- R01AT012367
- Acronym
- FEED-PT
- Status last verified
- Jan 2026
- First submitted
- 10 Oct 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Site Feasibility Trial of Embedded Emergency Department Physical Therapy
- ClinicalTrials.gov ID
- NCT07224945
- Acronym / sponsor ID
- FEED-PT / FEED-PT
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Physical therapy, FEED-PT, Feasibility, Emergency department
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), University of Utah, Northwestern Lake Forest Hospital, Northwestern Memorial Hospital
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 4 Jan 2027 (estimated)
- Study completion
- 4 Jan 2028 (estimated)
- First posted
- 5 Nov 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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 electronic health record data to assist in feasibility assessments for a future full-scale trial.
| Arm | Type | Receives |
|---|---|---|
| Embedded Emergency Department Physical Therapy | Experimental | Other: Embedded Emergency Department Physical TherapyWe 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. |
| Usual Care | Other | Other: Usual CareUsual 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- "Red flag" symptoms indicating a life or limb-threatening process
- Currently in police custody
- Unable to consent
- Known pregnancy
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 |
|---|---|---|
| Embedded Emergency Department Physical TherapyWe 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 |
| Usual CareStandard-of-care treatment for low back pain presenting in the emergency department | Other | Usual Care |
Primary outcome
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.
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.
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.
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.
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.
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.
7 secondary outcomes
Longitudinal participant surveys (effectiveness): a sum of the missing data rate for the remaining Participant Reported Outcomes (PROs) combined.
Time frame: 12 months
Electronic Health Record (EHR) extraction (effectiveness): rate of subsequent health care encounters.
Time frame: 12 months
Electronic Health Record (EHR) extraction (effectiveness): rate of opioid prescribing
Time frame: 12 months
Electronic Health Record (EHR) extraction (effectiveness): rate of advanced diagnostic imaging
Time frame: 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.
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.
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.
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 6 Jan 2026.
- Individual participant dataSharing planned: Yes. 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.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embedded Emergency Department Physical Therapy in people with Low Back Pain, run by Northwestern University at 2 sites in United States.
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 6 inclusion and 4 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 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 Howard Kim, MD, MS (312-926-0591, howard.kim@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Longitudinal participant surveys (effectiveness): missing data rate for the Patient-Reported Outcome Measurement Information System (PROMIS)-Pain Interference (PI) assessment. (time frame: 12 months). The study lists 6 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 6 Jan 2026.