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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral, Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
View:

• 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

Locations
United States
New York
Albert Einstein College of Medicine/Montefiore Medical Center - Weiler ED
RECRUITING
The Bronx
Montefiore Medical Center - Moses ED
RECRUITING
The Bronx
Contact Information
Primary
Eddie Irizarry, MD
eddiriza@montefiore.org
718-920-6626
Time Frame
Start Date: 2023-07-05
Estimated Completion Date: 2026-10
Participants
Target number of participants: 132
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Montefiore Medical Center

This content was sourced from clinicaltrials.gov