Ibuprofen With or Without Dexamethasone for Acute Radicular Low Back Pain.
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMontefiore Medical Center
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Ibuprofen 400 mg
- Dexamethasone Oral
- Educational Intervention
Treatment groups
132 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov