ED Physical Therapy for Acute Low Back Pain

NCT04921449 | Completed DMC

• 1 other identifier: R01HS027426
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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

Conditions

Low Back Pain

Keywords

low back pain; physical therapy; emergency department; functioning; disability; opioid

Outcome Measures

Primary Outcomes (1)

• PROMIS Pain Interference (PROMIS-PI)

  PROMIS-PI measures the self-reported consequences of pain on relevant aspects of a person's life, including social, cognitive, emotional, physical, and recreational activities. We will use the computer-adaptive format to minimize respondent burden. Scores are standardized to the general U.S. population, with a score of 50 representing the population mean. The time frame of interest for the PROMIS-PI is "in the past 7 days," meaning that participants provide responses based on their symptoms over the last week.

  Three months after the index ED visit.

Secondary Outcomes (2)

• Modified Oswestry Disability Index (ODI)

  Three months after the index ED visit.

• Patient-Reported Opioid Use in Last 24 Hours

  Three months after the index ED visit.

Other Outcomes (9)

• Opioid Prescription Filling

  Three months after the index ED visit.

• Patient-Reported Prescription Analgesic Use in Last 24 Hours

  Three months after the index ED visit.

• Prescription Analgesic Filling

  Three months after the index ED visit.

Study Arms (2)

Embedded ED Physical Therapy (NEED-PT)

EXPERIMENTAL

An ED physical therapist will be embedded with the primary treatment team to evaluate patients presenting with low back pain at the beginning of the overall treatment course. The physical therapist will utilize a clinical protocol (NEED-PT) that matches the patient's history and exam findings to an appropriate treatment classification consisting of directional preference exercises, manual traction, stabilization exercises, non-thrust manipulation/mobilization, and/or psychologically informed rehabilitation. The NEED-PT intervention will supplement any usual care performed by the treating physician.

Other: ED Physical Therapy

Usual Care

OTHER

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 reassurance, and administration and/or prescribing of analgesic medications.

Other: Usual Care

Interventions

ED Physical Therapy OTHER

All ED Physical Therapy treatment classifications involve a combination of exercise, range of motion, education, prognostic guidance, and reassurance. Patients are provided with an individualized home exercise plan based on their matched treatment classification and/or active rest.

Embedded ED Physical Therapy (NEED-PT)

Usual Care OTHER

Includes any diagnostic imaging, patient education and reassurance, and administration or prescribing of analgesic medications, as per the treating physician's usual and customary practice.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• English-speaking

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Kim HS, Muschong KM, Fishman IL, Schauer JM, Seitz AL, Strickland KJ, Lambert BL, McCarthy DM, Vu MH, Ciolino JD. Embedded emergency department physical therapy versus usual care for acute low back pain: a protocol for the NEED-PT randomised trial. BMJ Open. 2022 May 24;12(5):e061283. doi: 10.1136/bmjopen-2022-061283.

  PMID: 35613820 DERIVED

MeSH Terms

Conditions

Low Back Pain; Emergencies

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Howard S Kim, MD MS

  Northwestern University Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: June 10, 2021
• Study Start: July 12, 2021
• Primary Completion: October 3, 2024
• Study Completion: July 25, 2025
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data requests can be submitted starting 12 months after article publication. Data will be made accessible for up to 12 months.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research. Access will be provided following review and approval of the research proposal and execution of data use authorization agreement.

Locations

US (1)