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Nonsteroidal Anti-inflammatory Drug (NSAID)
Ibuprofen + Dexamethasone for Lower Back Pain
Phase 4
Recruiting
Led By Eddie Irizarry, MD
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pain duration <2 week
Age 18-70 Enrollment will be limited to adults <70 years because of the increased risk of adverse medication effects in older adults.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 days (48 hours)
Awards & highlights
Study Summary
This trial studies how well a 2-day dose of dexamethasone and ibuprofen help patients with acute low back pain. Patients will get a low back pain education session too.
Who is the study for?
This trial is for adults aged 18-70 with acute radicular low back pain, which hasn't lasted more than two weeks and radiates from the lower back to the leg. Participants should have a significant level of disability due to their pain but can't have had frequent back pain in the past three months or direct trauma recently. They must not be pregnant, suffer from chronic pain syndromes, or have conditions that make ibuprofen or dexamethasone risky.Check my eligibility
What is being tested?
The study tests if adding dexamethasone to standard care (ibuprofen and education on low back pain) helps improve outcomes for acute radicular low back pain when given during an emergency department visit. Patients are randomly assigned to receive either dexamethasone or a placebo alongside ibuprofen, without knowing which one they're getting.See study design
What are the potential side effects?
Possible side effects include stomach issues like ulcers and bleeding for ibuprofen; while dexamethasone may cause mood changes, increased blood sugar levels, insomnia, and weakened immunity among others.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My pain has lasted less than 2 weeks.
Select...
I am between 18 and 70 years old.
Select...
My back pain severely affects my daily activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 days (48 hours)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 days (48 hours)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Roland Morris Disability Questionnaire (RMDQ) score
Secondary outcome measures
Absolute Roland Morris Disability Questionnaire (RMDQ) score
Analgesic or LBP medication within the previous 24 hours
Frequency of Radicular LBP
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ibuprofen + dexamethasone + educational interventionExperimental Treatment3 Interventions
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.
Group II: Ibuprofen + placebo + educational interventionPlacebo Group2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Educational Intervention
2013
N/A
~7120
Dexamethasone Oral
2020
N/A
~14110
Ibuprofen 400 mg
2021
Completed Phase 4
~1930
Find a Location
Who is running the clinical trial?
Montefiore Medical CenterLead Sponsor
446 Previous Clinical Trials
582,642 Total Patients Enrolled
Eddie Irizarry, MDPrincipal InvestigatorMontefiore Medical Center
1 Previous Clinical Trials
198 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My pain has lasted less than 2 weeks.My back pain is not due to a recent injury.You will be excluded from the study if you have:
1) Stomach ulcers, ongoing stomach discomfort, or history of stomach bleeding
2) Severe heart failure
3) Chronic kidney disease
4) Taking anti-coagulants
5) Liver disease or hepatitis with specific liver enzyme levels.I take pain medication almost every day for chronic pain.I have severe lower back pain that spreads to my buttock or leg.I am between 18 and 70 years old.I regularly use steroids for a long-term condition.My back pain severely affects my daily activities.I haven't had back pain on more than half the days in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Ibuprofen + dexamethasone + educational intervention
- Group 2: Ibuprofen + placebo + educational intervention
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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