CompletedNot Applicable

ED Physical Therapy for Chronic Low Back Pain

United States128 participantsStarted 2022-01-11

Plain-language summary

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 chronic low back pain, with a focus on improving patient functioning and reducing opioid use.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥ 18 years * Low back pain (originating between 12th rib and buttocks) * 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 * English-speaking Exclusion Criteria: * Enrollment in the main trial (NEED-PT, NCT04921449) * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

PROMIS Pain Interference (PROMIS-PI)

Timeframe: Three months after the index ED visit.

Trial details

NCT IDNCT05206630

SponsorNorthwestern University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-03

View on ClinicalTrials.gov More Low Back Pain trials