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

360 Participants Needed

Trial Summary

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 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 clinical outcomes for conditions like low back pain. Additionally, physical therapy interventions have been shown to improve patient functioning in outpatient settings, which may indicate potential benefits when applied in the ED setting. ^{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 improvements in clinical outcomes without any reported safety concerns. ^{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 it emphasizes early intervention and education to improve outcomes for patients with acute low back pain. ^{1 2 4 7 9}

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

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 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

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

Treatment Details

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.

Participant Groups

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+

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]