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

Launched by MONTEFIORE MEDICAL CENTER · Feb 8, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of ibuprofen, a common pain reliever, used alone or combined with dexamethasone, a steroid that can help reduce inflammation, for patients experiencing acute radicular low back pain. This type of pain often starts in the lower back and radiates down to the legs. The trial is taking place in the emergency department, where patients will be randomly assigned to receive either dexamethasone or a placebo (a pill with no active medication) for two days. Every participant will also receive a week’s supply of ibuprofen and information about managing low back pain.

To participate, patients need to be between 18 and 70 years old, have been experiencing radicular low back pain for less than two weeks, and must be able to go home after their emergency department visit. They should not have a history of frequent back pain in the past three months or any serious health conditions that would make taking these medications unsafe. Throughout the study, participants will be followed up with phone calls two and seven days after their visit to track their pain and recovery. This trial aims to find out the best treatment approach for improving symptoms and helping patients feel better.

Gender

ALL

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)