ED Physical Therapy for Acute Low Back Pain

NCT ID: NCT04921449

Last Updated: 2025-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-12
• Study Completion Date: 2025-07-25

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.

Detailed Description

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.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Embedded ED Physical Therapy (NEED-PT)

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.

Group Type: EXPERIMENTAL

ED Physical Therapy

Intervention Type: 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.

Usual Care

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.

Group Type: OTHER

Usual Care

Intervention Type: 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.

Interventions

ED Physical Therapy

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.

Intervention Type: OTHER

Usual Care

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.

Intervention Type: OTHER

Eligibility Criteria

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
• English-speaking

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Howard Kim

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Howard S Kim, MD MS

Role: PRINCIPAL_INVESTIGATOR

Northwestern University Feinberg School of Medicine

Locations

Northwestern Memorial Hospital

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35613820 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

R01HS027426

Identifier Type: AHRQ

Identifier Source: org_study_id

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