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Recruiting Phase 4 NCT05721027

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

Trial Parameters

Condition Radiculopathy, Lumbosacral Region
Sponsor Montefiore Medical Center
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 132
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2023-07-05
Completion 2026-10
Interventions
Ibuprofen 400 mgDexamethasone OralEducational Intervention

Brief 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 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 availab

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