Emergency Department Physical Therapy for Lower Back Pain

(FEED-PT Trial)

Not yet recruiting at 1 trial location

Overseen By Howard Kim, MD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Red flag symptoms, Police custody, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist people with low back pain directly in the emergency room. Instead of waiting weeks to see a physical therapist, patients receive immediate care while still in the ER. The trial assesses the feasibility of this approach and collects data over time to prepare for a larger study. Individuals who have recently visited the ER for low back pain and speak English or Spanish may qualify, provided they do not have serious underlying issues. As an unphased trial, this study offers a unique opportunity to receive immediate care and contribute to innovative research that could enhance ER treatment for low back pain.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this embedded ED physical therapy model is safe for patients with low back pain?

Research has shown that providing physical therapy in the emergency department (ED) is a safe method for treating low back pain. Studies have found that patients respond well to this type of treatment. Physical therapists employ exercises and techniques identical to those used in regular physical therapy sessions. Studies have reported no negative effects from this approach. Since these methods are standard practice, no experimental treatments, devices, or drugs are involved. This suggests the treatment is likely as safe as regular physical therapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about embedded emergency department physical therapy for lower back pain because it offers immediate, hands-on care right in the emergency room. Unlike the usual practice, where patients might wait weeks for a physical therapy referral, this approach allows for instant intervention, potentially alleviating pain sooner. By integrating physical therapists into the emergency department, this method aims to reduce reliance on pain medications and improve the overall patient experience by providing timely and targeted care.

What evidence suggests that embedded emergency department physical therapy is effective for low back pain?

This trial will compare the effectiveness of embedding a physical therapist in the emergency department (ED) with usual care for patients with low back pain. Studies have shown that having a physical therapist in the ED can expedite treatment for low back pain. In a previous trial, this approach resulted in better pain relief and fewer follow-up visits compared to usual care, which often involves medications and delayed physical therapy referrals. Research indicates this method can quickly ease pain and improve movement, reducing the need for pain medication. Early evidence also suggests that having a physical therapist available in the ED helps patients start exercises and receive guidance immediately, which can speed up recovery. Overall, this new model shows promise in managing low back pain more effectively than traditional methods. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals experiencing low back pain who visit the emergency departments at Northwestern Medicine and University of Utah Health systems. Specific eligibility criteria are not provided, but typically participants would need to meet certain health conditions to be included.

Inclusion Criteria

My current low back pain started less than 30 days ago.

I am 18 years old or older.

I speak English or Spanish.

Exclusion Criteria

I am experiencing severe symptoms that could threaten my life or limbs.

Currently in police custody

I am unable to give consent by myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Planning and Preparation

Milestone-driven planning and preparation phase before the trial begins

12 months

Active Intervention

Embedded ED physical therapy intervention is conducted at two sites

9 months

Longitudinal Data Collection

Collection of longitudinal patient-reported outcome data and electronic health record data

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Embedded Emergency Department Physical Therapy

Trial Overview The study tests a new care model where a physical therapist provides immediate treatment in the ED for low back pain, compared with usual care. Participants will be randomly assigned to either receive this embedded physical therapy or continue with standard practices.

How Is the Trial Designed?

Group I: Usual Care Experimental Treatment 1 Intervention

Usual care treatment for low back pain presenting in the emergency department (ED). 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 resources, and administration and/or prescribing of analgesic medications.

Group II: Embedded Emergency Department Physical Therapy Experimental Treatment 1 Intervention

We place a physical therapist directly in the emergency department to initiate timely care for patients with low back pain rather than waiting on an outpatient referral to physical therapy, which can often take weeks to accomplish, if ever at all. The actual techniques and approaches used by the embedded ED physical therapist in this study (e.g., exercises, maneuvers, coaching) are standard-of-care and do not involve investigational interventions, devices, or drugs.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

Northwestern Memorial Hospital

Collaborator

Trials

42

Recruited

15,800+

Northwestern Lake Forest Hospital

Collaborator

Trials

1

Recruited

290+

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. bmjopen.bmj.com bmjopen.bmj.com/content/12/5/e061283

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.

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 Despite this aggressive medication-based approach, patient outcomes after an ED visit for back pain remain poor: after three months, nearly half of all patients ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07224945

Study Details | NCT07224945 | A Multi-Site Feasibility Trial ... This is a multi-site feasibility trial of an embedded emergency department (ED) physical therapy care model for low back pain at two EDs in ...

6. 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.

7. 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 ...

8. bmjopen.bmj.com bmjopen.bmj.com/content/bmjopen/12/5/e061283.full.pdf

Embedded emergency department physical therapy versus ... In a prior observational study we demonstrated that ED. PT for low back pain is associated with greater improve- ments in pain- related ...

9. researchgate.net researchgate.net/publication/360841576_Embedded_emergency_department_physical_therapy_versus_usual_care_for_acute_low_back_pain_a_protocol_for_the_NEED-PT_randomised_trial

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