A Multi-Site Feasibility Trial of Embedded Emergency Department Physical Therapy
Recruiting now · Not applicable
Conditions studied: Low Back Pain
In brief
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.
Key facts
- Study ID
- NCT07224945
- Run by
- Northwestern University
- People needed
- 140
- Starts
- 2026-01-05
- Expected to finish
- 2028-01-04
- Last updated by the study team
- 2026-01-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You 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 may not qualify if…
- "Red flag" symptoms indicating a life or limb-threatening process
- Currently in police custody
- Unable to consent
- Known pregnancy
Where it is running
- Northwestern Memorial Hospital — Chicago, Illinois, United States (enrolling)
- University of Utah — Salt Lake City, Utah, United States (enrolling)
Full record on ClinicalTrials.gov
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