Recruiting

Embedded ED Physical Therapy

Sponsor:

Northwestern University

Code:

NCT07224945

Conditions

Low Back Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Embedded Emergency Department Physical Therapy

Usual Care

Study Details

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.

Conditions

Low Back Pain

Study ID

NCT07224945

Start date

Jan 5, 2026

Status verified date

Jan, 2026

Completion date

Jan 4, 2028

Anticipated

Primary completion date

Jan 4, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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

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.

Interventions

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.

Usual Care

Standard-of-care treatment for low back pain presenting in the emergency department

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 ]
  • Longitudinal participant surveys (effectiveness): screening-to-enrollment ratio [ Time Frame: Baseline ]
  • Longitudinal participant surveys (effectiveness): participant retention rate defined as completion of at least one follow-up survey. [ Time Frame: 12 months. ]
  • Electronic Health Record (EHR) extraction (implementation): adoption of Emergency Department (ED) physical therapy [ Time Frame: Baseline ]
  • Electronic Health Record (EHR) extraction (implementation): fidelity of Emergency Department (ED) physical therapy [ Time Frame: Baseline ]
  • 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. ]

Central Contacts and Locations

Central contacts

Howard Kim, MD, MS

312-926-0591howard.kim@northwestern.edu

Locations

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Howard Kim, MD, MS

312-926-0591howard.kim@northwestern.edu

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Scott T Youngquist, MD, MS

801-581-2417scott.youngquist@utah.edu

More Information

Sponsor

Northwestern University

Last update posted

Jan 6, 2026

Last verified

Jan, 2026

Keywords

  • Low back pain
  • Physical therapy
  • FEED-PT
  • Feasibility
  • Emergency department

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-01-06.