ED Physical Therapy for Lower Back Pain

Overseen By Howard S Kim, MD MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Chronic low back pain, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach for treating lower back pain directly in the emergency department. The focus is on using an on-site physical therapist to enhance patient mobility and reduce the need for opioid painkillers. Participants will be divided into two groups: one receiving usual care and the other receiving additional treatment from the physical therapist. The trial seeks individuals who have experienced sudden lower back pain for 30 days or less and are likely to go home after their ER visit. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for immediate pain relief.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on physical therapy for low back pain and aims to reduce opioid use, but it doesn't mention other medications.

What prior data suggests that ED Physical Therapy is safe for treating lower back pain?

Research has shown that having physical therapists in emergency rooms to treat low back pain is safe and helpful. Studies have found that starting physical therapy in the emergency room is usually easy for patients to handle. No major negative effects have been reported from these treatments. This indicates that having a physical therapist assist patients in the emergency room is a safe way to manage sudden low back pain.

For those considering joining a trial, it's reassuring to know that this method has been used before with positive results for patient safety and comfort. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Embedded ED Physical Therapy (NEED-PT) approach for lower back pain because it offers a hands-on, personalized treatment right in the emergency department. Unlike the usual care, which often relies on imaging, medication, and general advice, NEED-PT integrates a physical therapist directly with the care team to tailor exercises and manual techniques to each individual’s needs. This approach not only addresses the immediate physical symptoms but also incorporates psychologically informed rehabilitation, potentially offering a more holistic and immediate relief for patients.

What evidence suggests that ED Physical Therapy is effective for lower back pain?

Research has shown that having a physical therapist in the emergency department (ED) can help patients with sudden low back pain recover more quickly. In this trial, some participants will receive the Embedded ED Physical Therapy (NEED-PT) intervention, where a physical therapist evaluates and treats patients with tailored exercises and techniques. Studies have found that patients who received physical therapy in the ED reported less pain upon discharge compared to those who received standard care without a physical therapist. Early data also suggest that these patients improve their movement faster and require fewer pain medications, such as opioids. Overall, using physical therapy directly in the ED shows promising results for treating sudden low back pain. ^{2 6 7 8 9}

Who Is on the Research Team?

Howard S Kim, MD MS

Principal Investigator

Northwestern University Feinberg School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 18 with new low back pain between the bottom rib and buttocks, lasting no more than 30 days. Participants must be evaluated during specific hours when ED physical therapy is available and able to follow up electronically or by phone. Exclusions include chronic back pain, prior surgery, severe symptoms like incontinence or weakness, non-musculoskeletal causes of pain, other injuries or pains, inability to walk, pregnancy, police custody or unable to consent.

Inclusion Criteria

My current symptoms have lasted for 30 days or less.

I have low back pain between my bottom rib and buttocks.

Evaluated by a physician randomized to either study arm

Exclusion Criteria

I cannot walk by myself.

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

Known pregnancy, under police custody, unable to consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either usual care or the NEED-PT intervention, which includes evaluation and treatment by an embedded ED physical therapist.

3 months

Multiple visits as needed during ED stay

Follow-up

Participants are monitored for pain-related functioning and opioid use after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• ED Physical Therapy

Trial Overview

The study tests if having a physical therapist in the emergency department can help improve function and reduce opioid use for patients with acute low back pain. Patients are randomly assigned to receive either this new 'embedded' physical therapy approach or usual care provided in the emergency setting.

How Is the Trial Designed?

Group I: Usual Care Experimental Treatment 1 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.

Group II: Embedded ED Physical Therapy (NEED-PT) Experimental Treatment 1 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 (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.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Published Research Related to This Trial

Early physical therapy (PT) for acute low back pain significantly reduces short-term pain and disability compared to non-PT care, with a moderate effect size based on a meta-analysis of 7 studies involving various participants.

However, early PT does not show significant advantages over delayed PT in terms of pain or disability outcomes, indicating that while early intervention is beneficial compared to no therapy, the timing of PT may not greatly impact long-term recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of physical therapy timing on patient-reported outcomes for individuals with acute low back pain: A systematic review with meta analysis of randomized controlled trials. McDevitt, AW., Cooper, CG., Friedrich, JM., et al.[2023]

In a study of 6,523 patients with low back pain, 42.7% achieved a 30% improvement in disability by the third physical therapy visit, and this increased to 49% by the sixth visit, indicating that many patients benefit from early intervention.

The initial and third visit disability scores were strong predictors of improvement, with excellent diagnostic accuracy (area under the curve values of 0.84 and 0.85) for forecasting significant clinical progress by the sixth visit, highlighting the importance of routine outcome assessments in physical therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Significant Clinical Improvement Was Predicted in a Cohort of Patients With Low Back Pain Early in the Care Process. Brennan, GP., Snow, G., Minick, KI., et al.[2023]

Citations

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sciencedirect.com/science/article/pii/S2688115224012475

A prospective cohort study from an Alternatives to Opioids ...

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This is a single-centre cluster-randomised trial of an embedded ED physical therapy intervention for acute low back pain.

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sciencedirect.com

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