Comparing ibuprofen and dexamethasone for treating acute low back pain
Ibuprofen With or Without Dexamethasone for Acute Radicular Low Back Pain.
This study is testing if adding dexamethasone to ibuprofen can help people with acute low back pain feel better compared to just taking ibuprofen alone.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 132 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Montefiore Medical Center Academic / other |
| Locations | 2 sites (The Bronx, New York and 1 other locations) |
| Trial ID | NCT05721027 on ClinicalTrials.gov |
What this trial studies
This study is a randomized, double-blind, placebo-controlled trial that aims to evaluate the effectiveness of dexamethasone in addition to ibuprofen for patients experiencing acute radicular low back pain. Patients will be enrolled during an emergency department visit and will receive either dexamethasone or a placebo for two days, along with a seven-day supply of ibuprofen and educational support on managing low back pain. Follow-up assessments will occur via telephone at two and seven days post-treatment to monitor outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 who present to the emergency department with acute radicular low back pain lasting less than two weeks.
Not a fit: Patients with chronic back pain or those who have experienced significant trauma to the back in the past month may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from acute radicular low back pain.
How similar studies have performed: Previous studies have shown promising results for the use of corticosteroids in managing acute pain, suggesting that this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
The Bronx, New York and 1 other locations
- 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)
Study contacts
- Principal investigator: Eddie Irizarry, MD — Montefiore Medical Center
- Study coordinator: Eddie Irizarry, MD
- Email: eddiriza@montefiore.org
- Phone: 718-920-6626
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.