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

128 Participants Needed

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the treatment ED Physical Therapy for lower back pain?

Early data suggests that emergency department-initiated physical therapy (ED PT) is viewed favorably by both physicians and patients, and is associated with improvements in important clinical outcomes for conditions like low back pain. ^{1 2 3 4 5}

Is ED Physical Therapy safe for humans?

Early data suggest that ED Physical Therapy is viewed favorably by both physicians and patients, and it is associated with positive outcomes like reduced imaging and opioid use, indicating it is generally safe for humans. ^{1 4 6 7 8}

How does ED Physical Therapy for lower back pain differ from other treatments?

ED Physical Therapy is unique because it is initiated directly in the emergency department, providing immediate, individualized care from physical therapists who collaborate with physicians. This approach contrasts with traditional treatments that often rely on medications like opioids and may not offer the same level of personalized attention and early intervention. ^{1 2 4 7 9}

Research Team

Howard S Kim, MD MS

Principal Investigator

Northwestern University Feinberg School of Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Prospective Observational Study of Emergency Department-Initiated Physical Therapy for Acute Low Back Pain. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Embedded emergency department physical therapy versus usual care for acute low back pain: a protocol for the NEED-PT randomised trial. [2022]

3. France pubmed.ncbi.nlm.nih.gov

Rehabilitation of low back pain patients. A review. [2005]

4. United States pubmed.ncbi.nlm.nih.gov

Physical therapy in the emergency department: A new opportunity for collaborative care. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Significant Clinical Improvement Was Predicted in a Cohort of Patients With Low Back Pain Early in the Care Process. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Dedicated emergency department physical therapy is associated with reduced imaging, opioid administration, and length of stay: A prospective observational study. [2020]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Therapeutic Exercise Parameters, Considerations and Recommendations for the Treatment of Non-Specific Low Back Pain: International DELPHI Study. [2023]

8. United States 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. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Complex Rehabilitation Program on Reducing Pain and Disability in Patients with Lumbar Disc Protrusion-Is Early Intervention the Best Recommendation? [2022]