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: Pregnancy, Police custody, 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 to treating low back pain directly in the emergency department (ED). The goal is to determine if collaboration between a physical therapist and doctors in the ED can improve patient function and reduce the need for pain medications like opioids. Participants will receive either the usual care or treatment involving an ED physical therapist. This trial suits those with low back pain who are likely to go home after their ED visit and can complete follow-ups. As an unphased trial, it offers a unique opportunity to contribute to innovative care strategies that could enhance patient outcomes in emergency settings.

Do I need to stop my current medications for this trial?

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 any requirements about other medications.

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

Research has shown that using physical therapy in emergency departments is generally safe and well-tolerated. Studies have found that physical therapists can safely manage minor muscle and bone issues, such as back pain, in emergency settings. Evidence suggests that starting physical therapy in the emergency department can improve patient function without major safety concerns.

One study demonstrated promising results when involving physical therapists in the care of patients with low back pain in emergency departments, with no significant adverse effects. Including a physical therapist in treating back pain in emergency rooms appears to be a safe and beneficial addition to usual care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for embedded emergency department (ED) physical therapy for lower back pain because it offers a fresh approach to patient care. Unlike standard treatments that rely heavily on imaging, medications, and general advice, this method integrates a physical therapist directly into the ED care team. This allows for immediate, tailored interventions like specific exercises and manual techniques based on the patient's unique needs. By addressing the root cause of pain early on, this approach has the potential to improve outcomes and reduce dependency on medications.

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

Research has shown that physical therapy in the emergency department (ED) can help treat low back pain. In this trial, some participants will receive embedded ED physical therapy, which includes exercises and treatments tailored to each patient's needs, improving movement and reducing reliance on pain medication. One study found that patients who received physical therapy in the ED experienced less pain upon discharge compared to those who received standard care. These patients also improved their mobility more quickly and required fewer painkillers. Overall, physical therapy in the ED appears promising for effectively managing low back pain. ^{6 7 8 9 10}

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 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.

Inclusion Criteria

Likely to be discharged home (based on physician assessment)

Ability to complete follow-up data collection electronically or by telephone

I have low back pain between my rib and buttocks.

Exclusion Criteria

I have other injuries or pain, such as a head injury or shoulder pain.

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive embedded physical therapy intervention or usual care in the ED for chronic low back pain

3 months

Regular visits as per ED protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of pain-related functioning and opioid use

3 months

What Are the Treatments Tested in This Trial?

Interventions

• ED Physical Therapy

Trial Overview 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.

How Is the Trial Designed?

Group I: Embedded ED Physical Therapy 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 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 Care Active Control 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.

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

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35613820/

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

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04921449

ED Physical Therapy for Acute 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 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2688115224012475

A prospective cohort study from an Alternatives to Opioids ... In the short term, patients receiving PT in the ED reported a greater reduction in pain at ED discharge than standard ED care. Beyond short‐term outcomes, ...

4. trial.medpath.com trial.medpath.com/clinical-trial/dd41f3c3894b4587/cluster-randomized-trial-emergency-physical-therapy-low-back-pain

ED Physical Therapy for Acute Low Back Pain | MedPath Preliminary data indicate that patients receiving ED-PT, compared to usual care, report more rapid functional improvement and use fewer opioids. However, these ...

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0231476

Dedicated emergency department physical therapy is ... Over the 18-month study period, we identified 524 patients presenting to the ED with musculoskeletal pain. 381 (72.7%) received ED-initiated PT.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04921449

ED Physical Therapy for Acute 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9131058/

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

8. apta.org apta.org/your-practice/practice-models-and-settings/hospitals/emergency-department/physical-therapy-in-emergency-care-value-of-physical-therapy

Physical Therapy in Emergency Care: Research on the ... Research is increasingly demonstrating that PTs are capable of independent, safe, and effective management of low-urgent musculoskeletal conditions in the ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7970627/

A Prospective Observational Study of Emergency Department ... In this single-center observational study, ED-initiated physical therapy for acute low back pain was associated with improvements in functioning ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S0031940624004632

Systematic review Effect of involving physiotherapists in the ... The present review indicates that there may be beneficial effects of involving PTs in the management of patients with LBP in EDs.