NCT07224945 · Northwestern University
A Multi-Site Feasibility Trial of Embedded Emergency Department Physical Therapy
(FEED-PT)
What this study is about
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.
View original scientific description
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.
Interventions
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
Standard-of-care treatment for low back pain presenting in the emergency department
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Chicago, Illinois
- Salt Lake City, Utah
Collaborators
National Center for Complementary and Integrative Health (NCCIH), University of Utah, Northwestern Lake Forest Hospital, Northwestern Memorial Hospital
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 6, 2026 · Source of record for eligibility and locations