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

Last updated: April 7, 2025
Sponsor: Montefiore Medical Center
Overall Status: Active - Recruiting

Phase

4

Condition

Chronic Pain

Radiculopathy

Treatment

Ibuprofen 400 mg

Dexamethasone Oral

Educational Intervention

Clinical Study ID

NCT05721027
2023-14723
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Present to ED primarily for management of acute radicular LBP, defined as pain orparesthesia originating from the lower back and radiating to the buttock and or legin a radicular pattern. Some patients may not have prominent LBP but a radicularsymptom--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 increasedrisk of adverse medication effects in older adults.

  • Pain duration <2 week

  • Prior to the acute attack of radicular LBP, back pain cannot occur more frequentlythan half of the days in the last 3 months. Patients with more frequent backpain/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 theprevious month

  • Functionally impairing radicular LBP: A baseline score of > 5 on the Roland-MorrisDisability Questionnaire

Exclusion

Exclusion Criteria:

  • Not available for follow-up

  • Pregnant

  • Chronic pain syndrome defined as use of any analgesic medication on a daily ornear-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 ofanti-coagulants 5) cirrhosis (Child Pugh A or worse) or hepatitis (transaminases 2xthe upper limit of normal)

Study Design

Total Participants: 132
Treatment Group(s): 3
Primary Treatment: Ibuprofen 400 mg
Phase: 4
Study Start date:
July 05, 2023
Estimated Completion Date:
October 31, 2026

Connect with a study center

  • Albert Einstein College of Medicine/Montefiore Medical Center - Weiler ED

    Bronx, New York 10461
    United States

    Active - Recruiting

  • Montefiore Medical Center - Moses ED

    Bronx, New York 10467
    United States

    Active - Recruiting

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