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

Description

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.

Conditions

Radiculopathy, Lumbosacral Region, Back Pain With Radiation, Low Back Pain

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Radiculopathy, Lumbosacral Region
Intervention / Treatment

-

Contacts and Locations

Bronx

Albert Einstein College of Medicine/Montefiore Medical Center - Weiler ED, Bronx, New York, United States, 10461

Bronx

Montefiore Medical Center - Moses ED, Bronx, New York, United States, 10467

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Montefiore Medical Center,

Eddie Irizarry, MD, PRINCIPAL_INVESTIGATOR, Montefiore Medical Center

Study Record Dates

2025-08