Ibuprofen With or Without Dexamethasone for Acute Radicular Low Back Pain.

April 7, 2026 updated by: Montefiore Medical Center
This will be a placebo controlled, randomized, double-blind, comparative effectiveness study, in which we patients are enrolled during an emergency department (ED) visit for acute radicular low back pain (LBP) and followed by telephone two and seven days later. Patients will be randomized to receive an oral dose of dexamethasone for 2 consecutive days or placebo during an ED visit for acute radicular LBP. Every patient will receive a 7 day supply of ibuprofen and a low back pain education session.

Study Overview

Status

Status

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

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.

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 (Estimated)

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.
132

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.
  • Phase 4

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
    • New York
      • The Bronx, New York, United States, 10461
        • Recruiting
        • Albert Einstein College of Medicine/Montefiore Medical Center - Weiler ED
      • The Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center - Moses ED
        • Contact:
          • Eddie Irizarry, MD

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 to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Present to ED primarily for management of acute radicular LBP, defined as pain or paresthesia originating from the lower back and radiating to the buttock and or leg in a radicular pattern. Some patients may not have prominent LBP but a radicular symptom--we will include these patients as well.
  • Patient is to be discharged home.
  • Age 18-70 Enrollment will be limited to adults <70 years because of the increased risk of adverse medication effects in older adults.
  • Pain duration <2 week
  • Prior to the acute attack of radicular LBP, back pain cannot occur more frequently than half of the days in the last 3 months. Patients with more frequent back pain/sciatica are at increased risk of poor pain and functional outcomes.10
  • Non-traumatic cause of pain: no substantial and direct trauma to the back within the previous month
  • Functionally impairing radicular LBP: A baseline score of > 5 on the Roland-Morris Disability Questionnaire

Exclusion Criteria:

  • Not available for follow-up
  • Pregnant
  • Chronic pain syndrome defined as use of any analgesic medication on a daily or near-daily basis
  • Allergic to or intolerant of investigational medications
  • Chronic steroid use
  • Contra-indications to investigational medications: 1) known peptic ulcer disease, chronic dyspepsia, or history of gastrointestinal bleed 2) Severe heart failure (NYHA 2 or worse) 3) Chronic kidney disease (GFR <60ml/min) 4) Current use of anti-coagulants 5) cirrhosis (Child Pugh A or worse) or hepatitis (transaminases 2x the upper limit of normal)

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: Quadruple

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: Ibuprofen + dexamethasone + educational intervention
Ibuprofen 400 mg PO every 8 hours as needed for 7 days + dexamethasone 16 mg PO for day 1 and day 2. Research personnel will provide each participant with a 15-minute educational intervention.
Behavioral: Educational Intervention
Research personnel will provide each patient with a 15-minute educational intervention. This will be based on National Institute of Arthritis and Musculoskeletal and Skin Diseases Handout on Health: Back Pain information
Drug: Ibuprofen 400 mg
Ibuprofen 400 mg PO every 8 hours as needed for 7 days
Drug: Dexamethasone Oral
Dexamethasone 16 mg PO during ED visit and next day
Placebo Comparator: Ibuprofen + placebo + educational intervention
Ibuprofen 400 mg PO every 8 hours as needed for 7 days + placebo PO for day 1 and day 2. Research personnel will provide each participant with a 15-minute educational intervention.
Behavioral: Educational Intervention
Research personnel will provide each patient with a 15-minute educational intervention. This will be based on National Institute of Arthritis and Musculoskeletal and Skin Diseases Handout on Health: Back Pain information
Drug: Ibuprofen 400 mg
Ibuprofen 400 mg PO every 8 hours as needed for 7 days

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
Change in Roland Morris Disability Questionnaire (RMDQ) score
Time Frame: 2 days (48 hours)
The change in RMDQ will be evaluated using the 24-item Roland Morris Low Back Pain Disability Questionnaire. The RMDQ is a 24-item patient-reported outcome measure that inquires about pain-related disability resulting from LBP. Items are scored 0 if left blank or 1 if endorsed, for a total RMDQ score ranging from 0 to 24. Higher scores represent higher levels of pain-related disability. The change will be calculated as a difference between the baseline ED visit and the two day follow-up visit (Roland-Morris baseline - Roland-Morris day 2)
2 days (48 hours)

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
Worst Radicular LBP
Time Frame: 2 days and 7 days after ED discharge
Worst Radicular LBP pain incurred over the previous 24 hours will be assessed at 2 days and 7 days after ED discharge using a four point ordinal scale: Severe, Moderate, Mild, or None
2 days and 7 days after ED discharge
Frequency of Radicular LBP
Time Frame: 2 days and 7 days after ED discharge
Frequency of Radicular LBP is evaluated at 2 days and 7 days after ED discharge based on a five point Likert scale: Not at all, Rarely, Sometimes, Usually, and Always
2 days and 7 days after ED discharge
Analgesic or LBP medication within the previous 24 hours
Time Frame: 2 days and 7 days after ED discharge
Administration of any analgesic or LBP medication (Yes or No) within the previous 24 hours will be assessed at 2 days and 7 days after ED discharge
2 days and 7 days after ED discharge
Return to all usual activities
Time Frame: 2 days and 7 days after ED discharge
The patient will be evaluated for the ability to return to all usual activities at 2 days and 7 days after ED discharge based on a binary (Yes/No) response
2 days and 7 days after ED discharge
Number of visits to any healthcare provider
Time Frame: 2 days and 7 days after ED discharge
The number of aggregate visits to any healthcare provider will be tabulated at 2 days and 7 days after ED discharge
2 days and 7 days after ED discharge
Satisfaction with Treatment
Time Frame: 2 days and 7 days after ED discharge
Satisfaction with treatment will be evaluated based on a binary (Yes/No) response at 2 days and 7 days after ED discharge
2 days and 7 days after ED discharge
Absolute Roland Morris Disability Questionnaire (RMDQ) score
Time Frame: 2 days and 7 days after ED discharge
The Absolute RMDQ score will be tabulated at 2 days and 7 days after ED discharge. The RMDQ is a 24-item patient-reported outcome measure that inquires about pain-related disability resulting from LBP. Items are scored 0 if left blank or 1 if endorsed, for a total RMDQ score ranging from 0 to 24. Higher scores represent higher levels of pain-related disability
2 days and 7 days after ED discharge

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.
Montefiore Medical Center

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: Eddie Irizarry, MD, Montefiore Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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.
July 5, 2023

Primary Completion (Estimated)

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 1, 2027

Study Completion (Estimated)

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.
October 1, 2027

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 31, 2023

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.
February 8, 2023

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.
February 9, 2023

Study Record Updates

Last Update Posted (Actual)

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.
April 13, 2026

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.
April 7, 2026

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.
April 1, 2026

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.
  • 2023-14723

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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