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

Phase 4RecruitingNCT05721027

Montefiore Medical Center132 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

132

Conditions

Radiculopathy, Lumbosacral Region Back Pain With Radiation Low Back Pain

Interventions

Educational InterventionBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (2)

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

The Bronx, New York, United States

RECRUITING

Montefiore Medical Center - Moses ED

The Bronx, New York, United States

RECRUITING

Outcomes

Primary Outcomes

Change in Roland Morris Disability Questionnaire (RMDQ) score

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)

Time frame: 2 days (48 hours)

Secondary Outcomes

Worst Radicular LBP

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