ED Physical Therapy for Chronic Low Back Pain

October 10, 2025 updated by: Howard Kim, Northwestern University

An Ancillary Cluster-Randomized Trial of Embedded Physical Therapy for Chronic Low Back Pain

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This trial is ancillary to an ongoing single-center physician-randomized trial of an embedded physical therapy intervention versus usual care in ED patients with acute low back pain (NEED-PT, NCT04921449), comparing a primary outcome of pain-related functioning and a secondary outcome of opioid use at three months. The main trial aims to enroll up to 360 participants with acute low back pain, defined as ≤ 30 days in duration and no history of lumber surgery or chronic low back pain. Using the same procedures and physician-randomization assignments as the main trial, this ancillary trial will enroll an additional 200 participants with chronic low back pain (i.e. non-acute low back pain) in order to obtain initial point estimates for the outcomes of interest and assess participant enrollment and retention rates in this population. The ancillary trial's sample size of 200 participants is an estimate of patient accrual over the anticipated remaining duration of the main trial (i.e., there is not a separate power calculation for this ancillary trial given its exploratory nature), and the actual number accrued may differ depending on the main trial's actual end date.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
128

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Low back pain (originating between 12th rib and buttocks)
  • Evaluated by a physician randomized to either study arm
  • Evaluated when ED physical therapy is available (e.g., Mon-Fri, 8am-4pm)
  • Likely to be discharged home (based on physician assessment)
  • Ability to complete follow-up data collection electronically or by telephone
  • English-speaking

Exclusion Criteria:

  • Enrollment in the main trial (NEED-PT, NCT04921449)
  • Serious red-flag signs/symptoms (bladder/bowel incontinence, saddle anesthesia, debilitating motor weakness)
  • Obvious non-musculoskeletal etiology for low back pain (e.g., shingles, kidney stone)
  • Other concomitant injuries or pain (e.g., closed head injury, shoulder pain)
  • Unable to ambulate at baseline
  • Known pregnancy, under police custody, unable to consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Embedded ED Physical Therapy
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.
Other: ED Physical Therapy
All ED Physical Therapy treatment classifications involve a combination of exercise, range of motion, education, prognostic guidance, and reassurance. Patients are provided with an individualized home exercise plan based on their matched treatment classification and/or active rest.
No Intervention: Usual Care
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PROMIS Pain Interference (PROMIS-PI)
Time Frame: Three months after the index ED visit.
PROMIS-PI measures the self-reported consequences of pain on relevant aspects of a person's life, including social, cognitive, emotional, physical, and recreational activities. The investigators will use the computer-adaptive format to minimize respondent burden. Scores are standardized to the general U.S. population, with a score of 50 representing the population mean. The time frame of interest for the PROMIS-PI is "in the past 7 days," meaning that participants provide responses based on their symptoms over the last week.
Three months after the index ED visit.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Modified Oswestry Disability Index (ODI)
Time Frame: Three months after the index ED visit.
The ODI contains 10 questions relating to low back pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and employment/homemaking. The ODI score ranges from zero (no disability) to 100 (maximum disability). The time frame of interest for the ODI is "today," meaning that participants provide responses based on their current symptoms on the day of survey response. The modified ODI replaces an item from the original ODI pertaining to sex life with a new item pertaining to employment/homemaking.
Three months after the index ED visit.
Patient-Reported Opioid Use in Last 24 Hours
Time Frame: Three months after the index ED visit.
Patient-reported opioid use will be collected using a customized instrument assessing whether participants have taken any opioid medication in the last 24 hours (binary yes/no). The 24-hour timeframe was selected to maximize accuracy in patient recall and has been used previously. In brief, opioid medications are listed by brand and generic names; a "yes" response to any medication triggers an additional query asking the participant to specify the medication dose (e.g., oxycodone 10mg) and quantity (e.g., four pills), allowing for standardization by morphine milligram equivalents.
Three months after the index ED visit.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Opioid Prescription Filling
Time Frame: Three months after the index ED visit.
Opioid prescription filling data will be queried in the state prescription monitoring database.
Three months after the index ED visit.
Patient-Reported Prescription Analgesic Use in Last 24 Hours
Time Frame: Three months after the index ED visit.
Patient-reported prescription analgesic use will be collected using the same customized instrument described above for opioid use. Prescription analgesics include the following: opioids, benzodiazepines, skeletal muscle relaxants, and gabapentinoids.
Three months after the index ED visit.
Prescription Analgesic Filling
Time Frame: Three months after the index ED visit.
Prescription analgesic filling data will be queried in the state prescription drug monitoring database. Prescription analgesics include opioids, benzodiazepines, skeletal muscle relaxants, and gabapentinoids.
Three months after the index ED visit.
Numeric Pain Rating Scale (NPRS)
Time Frame: Three months after the index ED visit.
The NPRS measures pain intensity from 0 to 10 (higher score indicates higher intensity) and is easily understood by laypersons, clinicians, and researchers. The investigators will assess a single item relating to average pain intensity over the last 24 hours.
Three months after the index ED visit.
Global Rating of Change (GROC)
Time Frame: Three months after the index ED visit.
The GROC is a single-item survey used to evaluate overall recovery from low back pain from "the time that you began having pain until now." Responses are provided on a 15-point Likert scale ranging from "a very great deal worse" to "a very great deal better" (higher scores indicate better outcome).
Three months after the index ED visit.
Pain Catastrophizing Scale (PCS-4)
Time Frame: Three months after the index ED visit.
The original PCS is a 13-item survey measuring the degree to which an individual catastrophizes in response to pain. PCS scores correlate closely with pain intensity and disability over time; higher PCS scores are associated with progression from acute to chronic pain. The investigators will utilize the brief 4-item PCS measure containing original items 3, 6, 8, and 11 (total score range 0-16, higher score indicates higher catastrophizing).
Three months after the index ED visit.
Pain Self-Efficacy Questionnaire (PSEQ-4)
Time Frame: Three months after the index ED visit.
The original PSEQ is a 10-item survey measuring the confidence with which individuals can do things despite pain. The investigators will utilize the brief 4-item PSEQ measure containing original items 4, 6, 8, and 9 (total score range 0-24, higher score indicates higher confidence).
Three months after the index ED visit.
Advanced Healthcare Resource Utilization
Time Frame: Three months after the index ED visit.
The investigators will assess the proportion of participants who utilized any advanced healthcare resources for low back pain after their index ED visit, defined as advanced imaging (e.g., magnetic resonance imaging) or procedures/surgery (e.g., epidural steroid injection, lumbar discectomy).
Three months after the index ED visit.
ED Diagnostic Imaging Utilization
Time Frame: Index ED 1 day visit.
The investigators will assess the proportion of ED visits in which any diagnostic imaging of the lower back was performed, including plain radiography, computed tomography, or magnetic resonance imaging.
Index ED 1 day visit.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northwestern University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Agency for Healthcare Research and Quality (AHRQ)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Howard S Kim, MD MS, Northwestern University Feinberg School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 11, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 3, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 25, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 25, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STU00213134

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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