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ED Physical Therapy for Lower Back Pain

N/A

Waitlist Available

Led By Howard S Kim, MD MS

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Low back pain (originating between 12th rib and buttocks)

Age ≥ 18 years

Must not have

Obvious non-musculoskeletal etiology for low back pain (e.g., shingles, kidney stone)

Unable to ambulate at baseline

Timeline

Screening 3 weeks

Treatment Varies

Follow Up three months after the index ed visit.

Awards & highlights

No Placebo-Only Group

Summary

This 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 is the study for?

This trial is for adults over 18 with chronic low back pain who can be treated and discharged from the emergency department. They must be available during specific hours, speak English, and able to follow up electronically or by phone. It's not for those in another main trial, with severe symptoms like loss of bladder control, non-muscle related back pain causes, pregnant women, detainees, or those unable to consent.

What is being tested?

The study tests a new approach where a physical therapist works inside the emergency department to treat chronic low back pain. The goal is to see if this helps improve patient function and reduces their need for opioids compared to usual care.

What are the potential side effects?

Since the intervention involves physical therapy rather than medication, side effects may include muscle soreness or discomfort following treatment sessions. However, serious side effects are unlikely given the non-invasive nature of physical therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have low back pain between my rib and buttocks.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My low back pain is not caused by conditions like shingles or kidney stones.

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I cannot walk on my own without assistance.

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I do not have severe symptoms like loss of bladder control, numbness in the groin area, or significant weakness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ three months after the index ed visit.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~three months after the index ed visit.

This trial's timeline: 3 weeks for screening, Varies for treatment, and three months after the index ed visit. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PROMIS Pain Interference (PROMIS-PI)

Secondary study objectives

Modified Oswestry Disability Index (ODI)

Patient-Reported Opioid Use in Last 24 Hours

Other study objectives

Advanced Healthcare Resource Utilization

ED Diagnostic Imaging Utilization

Global Rating of Change (GROC)

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Embedded ED Physical TherapyExperimental Treatment1 Intervention

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 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 embedded PT intervention will supplement any usual care performed by the treating physician.

Group II: Usual CareActive Control1 Intervention

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.

0 / 5Eligibility criteria met