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

Part of paid clinical trials in The Bronx, New York.

Sponsor
Montefiore Medical Center
Study ID
NCT05721027
Phase
PHASE4
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Ibuprofen 400 mg — DRUG
    Ibuprofen 400 mg PO every 8 hours as needed for 7 days
  • Dexamethasone Oral — DRUG
    Dexamethasone 16 mg PO during ED visit and next day
  • Educational Intervention — BEHAVIORAL
    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

Study Details

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.

Key Dates

Start date
Jul 5, 2023
Status verified
Apr 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
132 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Change in Roland Morris Disability Questionnaire (RMDQ) score [ Time Frame: 2 days (48 hours) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Albert Einstein College of Medicine/Montefiore Medical Center - Weiler EDThe BronxNew York10461-
Montefiore Medical Center - Moses EDThe BronxNew York10467
Eddie Irizarry, MD

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By research site
Albert Einstein College of Medicine/Montefiore Medical Center - Weiler ED· The Bronx, NYMontefiore Medical Center - Moses ED· The Bronx, NY

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