Ibuprofen With or Without Dexamethasone for Acute Radicular Low Back Pain.
Radiculopathy, Lumbosacral Region, Back Pain With Radiation, Low Back Pain
About this trial
This is an interventional treatment trial for Radiculopathy, Lumbosacral Region focused on measuring ibuprofen, dexamethasone, radiculopathy, low back pain, back pain with radiation
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 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)
Sites / Locations
- Albert Einstein College of Medicine/Montefiore Medical Center - Weiler EDRecruiting
- Montefiore Medical Center - Moses EDRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Ibuprofen + dexamethasone + educational intervention
Ibuprofen + placebo + 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.
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.