What this study is
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.
What's being tested
- Embedded Emergency Department Physical Therapy
Intervention · OTHER
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 Care
Intervention · OTHER
Standard-of-care treatment for low back pain presenting in the emergency department
Study details
- Sponsor
- Northwestern University
- Conditions
- Low Back Pain
- Enrolling
- 140 people
- Starts
- 2026-01-05
- Est. completion
- 2028-01-04
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- "Red flag" symptoms indicating a life or limb-threatening process
- Currently in police custody
- Unable to consent
- Known pregnancy
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openNorthwestern Memorial Hospital
Chicago, Illinois, United States
- Howard Kim, MD, MS · Contact312-926-0591howard.kim@northwestern.edu
RecruitingUniversity of Utah
Salt Lake City, Utah, United States
- Scott T Youngquist, MD, MS · Contact801-581-2417scott.youngquist@utah.edu
Recruiting
Study team
Sponsor
Northwestern University
Study ID FEED-PT
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.