NCT07224945 A Multi-Site Feasibility Trial of Embedded Emergency Department Physical Therapy
| NCT ID | NCT07224945 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Northwestern University |
| Condition | Low Back Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2026-01-05 |
| Primary Completion | 2027-01-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2026-01-05 with a primary completion date of 2027-01-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07224945 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Low Back Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07224945 currently recruiting?
Yes, NCT07224945 is actively recruiting participants. Contact the research team at howard.kim@northwestern.edu for enrollment information.
Where is the NCT07224945 trial being conducted?
This trial is being conducted at Chicago, United States, Salt Lake City, United States.
Who is sponsoring the NCT07224945 clinical trial?
NCT07224945 is sponsored by Northwestern University. The trial plans to enroll 140 participants.