ED Physical Therapy for Acute Low Back Pain

  • End date
    Jun 6, 2024
  • participants needed
  • sponsor
    Northwestern University
Updated on 6 May 2022
back pain
physical therapy treatment
low back pain


Emergency department (ED)-initiated physical therapy is a rapidly growing resource and represents a promising treatment approach to low back pain. This clinical trial will evaluate an innovative model of an emergency department "embedded" physical therapist to treat patients with acute low back pain, with a focus on improving patient functioning and reducing opioid use.


Low back pain represents a significant health care burden in the United States and accounts for nearly four million emergency department (ED) visits per year. In nearly two thirds of these visits, an opioid medication is administered or prescribed, making low back pain the most common reason for which opioids are prescribed. Despite this aggressive medication-based approach, patient outcomes after an ED visit for back pain remain poor: after three months, nearly half of all patients report persistent functional impairment, and one in five patients report continued opioid use.

ED-initiated physical therapy (ED-PT) is a promising new resource to improve patient care for low back pain. A growing number of EDs now have dedicated physical therapists that evaluate and treat patients through a combination of education, prognostic guidance, and early mobilization and exercise. Preliminary data indicate that patients receiving ED-PT, compared to usual care, report more rapid functional improvement and use fewer opioids. However, these observational data are limited by biases in treatment selection due to physician discretion in which patients receive ED-PT, as well as other measured and unmeasured confounders.

To more rigorously evaluate the efficacy of ED-PT for acute low back pain, the investigators will conduct a single-center physician-randomized trial of an embedded physical therapy intervention (NEED-PT) versus usual care in ED patients with acute low back pain, comparing a primary outcome of pain-related functioning and a secondary outcome of opioid use at the primary endpoint of three months.

Condition Low Back Pain
Treatment Usual Care, ED Physical Therapy
Clinical Study IdentifierNCT04921449
SponsorNorthwestern University
Last Modified on6 May 2022


Yes No Not Sure

Inclusion Criteria

Age ≥ 18 years
Low back pain (originating between 12th rib and buttocks)
Symptom duration ≤ 30 days (current episode)
Evaluated by a physician randomized to either study arm
Evaluated when ED physical therapy is available (e.g., Mon-Fri, 8am-4pm)
Likely to be discharged home (based on physician assessment)
Ability to complete follow-up data collection electronically or by telephone

Exclusion Criteria

Chronic low back pain or prior lumbar surgery
Serious red-flag signs/symptoms (bladder/bowel incontinence, saddle anesthesia, debilitating motor weakness)
Obvious non-musculoskeletal etiology for low back pain (e.g., shingles, kidney stone)
Other concomitant injuries or pain (e.g., closed head injury, shoulder pain)
Unable to ambulate at baseline
Known pregnancy, under police custody, unable to consent
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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