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ED Physical Therapy for Lower Back Pain

N/A

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up three months after the index ed visit.

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ three months after the index ed visit.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

PROMIS Pain Interference (PROMIS-PI)

Secondary outcome measures

Modified Oswestry Disability Index (ODI)

Patient-Reported Opioid Use in Last 24 Hours

Other outcome measures

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.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

Agency for Healthcare Research and Quality (AHRQ)FED

399 Previous Clinical Trials

6,821,988 Total Patients Enrolled

Northwestern UniversityLead Sponsor

1,586 Previous Clinical Trials

916,659 Total Patients Enrolled

Howard S Kim, MD MSPrincipal InvestigatorNorthwestern University Feinberg School of Medicine

1 Previous Clinical Trials

200 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available slots left for participants in this medical investigation?

"As per the clinicaltrials.gov website, this ongoing medical trial is actively seeking participants. The initial post was published on July 12th 2021 with a recent edit occurring on April 8th 2022."

Answered by AI

To what extent is participation in this medical study being sought?

"Affirmative. According to clinicaltrials.gov, this research trial is actively recruiting participants who initially responded on July 12th 2021 and was updated April 8th 2022. The recruitment process requires 360 patients from 1 medical centre."

Answered by AI