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ED Physical Therapy for Lower Back Pain

N/A
Waitlist Available
Led By Howard S Kim, MD MS
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Symptom duration ≤ 30 days (current episode)
Age ≥ 18 years
Must not have
Unable to ambulate at baseline
Serious red-flag signs/symptoms (bladder/bowel incontinence, saddle anesthesia, debilitating motor weakness)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up three months after the index ed visit.
Awards & highlights

Summary

This trial will evaluate a new model of an emergency department "embedded" physical therapist to treat patients with acute low back pain. The goal is to improve patient functioning and reduce opioid use.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While not explicitly listed here, potential side effects from ED-initiated physical therapy may include temporary increased discomfort or muscle soreness post-treatment. Usual care side effects depend on the treatment given but could involve medication-related issues such as drowsiness or gastrointestinal upset.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My current symptoms have lasted for 30 days or less.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot walk by myself.
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I do not have severe symptoms like loss of bladder control, numbness in the groin area, or significant weakness.
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I have chronic low back pain or had surgery on my lower back.
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My low back pain is not caused by shingles or kidney stones.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~three months after the index ed visit.
This trial's timeline: 3 weeks for screening, Varies for treatment, and three months after the index ed visit. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
PROMIS Pain Interference (PROMIS-PI)
Secondary study objectives
Modified Oswestry Disability Index (ODI)
Patient-Reported Opioid Use in Last 24 Hours
Other study objectives
Advanced Healthcare Resource Utilization
Diagnostic Imaging
Global Rating of Change (GROC)
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Usual CareExperimental Treatment1 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 Treatment1 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.

Find a Location

Who is running the clinical trial?

Agency for Healthcare Research and Quality (AHRQ)FED
405 Previous Clinical Trials
6,756,305 Total Patients Enrolled
Northwestern UniversityLead Sponsor
1,625 Previous Clinical Trials
936,929 Total Patients Enrolled
Howard S Kim, MD MSPrincipal InvestigatorNorthwestern University Feinberg School of Medicine
1 Previous Clinical Trials
128 Total Patients Enrolled

Media Library

ED Physical Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04921449 — N/A
Lower Back Pain Research Study Groups: Usual Care, Embedded ED Physical Therapy (NEED-PT)
Lower Back Pain Clinical Trial 2023: ED Physical Therapy Highlights & Side Effects. Trial Name: NCT04921449 — N/A
ED Physical Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04921449 — N/A
Lower Back Pain Patient Testimony for trial: Trial Name: NCT04921449 — N/A
~0 spots leftby Oct 2024
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