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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

Low back pain (originating between 12th rib and buttocks)

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 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.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since the intervention involves physical therapy rather than medication, side effects may include muscle soreness or discomfort following treatment sessions. However, serious side effects are unlikely given the non-invasive nature of physical therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have low back pain between my rib and buttocks.

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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

ED Diagnostic Imaging Utilization

Global Rating of Change (GROC)

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Embedded ED Physical TherapyExperimental 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 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 CareActive Control1 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.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,586 Previous Clinical Trials

917,051 Total Patients Enrolled

Agency for Healthcare Research and Quality (AHRQ)FED

399 Previous Clinical Trials

6,822,148 Total Patients Enrolled

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

1 Previous Clinical Trials

360 Total Patients Enrolled

Media Library

ED Physical Therapy Clinical Trial Eligibility Overview. Trial Name: NCT05206630 — N/A

Lower Back Pain Research Study Groups: Usual Care, Embedded ED Physical Therapy

Lower Back Pain Clinical Trial 2023: ED Physical Therapy Highlights & Side Effects. Trial Name: NCT05206630 — N/A

ED Physical Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05206630 — N/A

Frequently Asked Questions

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

Are enrolment slots still available for this clinical experiment?

"That is correct. According to information found on clinicaltrials.gov, this medical trial was initially published on 11th January 2022 and underwent its latest update 26th January of the same year; it presently requires 200 volunteers from a single location."

Answered by AI

In what quantity are participants engaging with this research?

"Affirmative. Information on clinicaltrials.gov verifies that this research project, which was posted initially in 11th January 2022 is presently recruiting subjects. It seeks to enroll 200 individuals from a single center."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ED Physical Therapy for Chronic Low Back Pain

Howard Kim 2022. "ED Physical Therapy for Chronic Low Back Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05206630.

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