Ibuprofen With or Without Dexamethasone for Acute Radicular Low Back Pain

This study is looking at how well ibuprofen works for acute radicular low back pain (pain that starts in your lower back and travels down your leg), and if adding a medication called dexamethasone helps even more. You might be able to join if you are 18 to 70 years old and come to the emergency department (ED) with this type of back pain, and are able to go home afterward. All participants will receive ibuprofen and an educational session about back pain. Some will also receive dexamethasone, while others will receive a placebo (an inactive substance). Researchers will check your pain and disability levels after two days to see how well the treatments are working. The study plans to include 132 people, but its current status is unclear.

Study design: This is a randomized, double-blind study, meaning participants are randomly assigned to a treatment group and neither you nor your doctors will know which treatment you are receiving. It aims to enroll 132 participants.
What's involved: You would be enrolled during an emergency department visit and followed by telephone two and seven days later. You would receive ibuprofen for 7 days and an oral dose of dexamethasone or placebo for 2 days, plus a 15-minute educational session.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed by telephone two and seven days after their emergency department visit.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting

PHASE4Ages 18–70InterventionalTreatment

Montefiore Medical Center

~132 participants

Updated 2026-04-13 on ClinicalTrials.gov

What's tested:Ibuprofen 400 mgDexamethasone OralEducational Intervention

At a glance

Recruiting sites

2 of 2 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Change in Roland Morris Disability Questionnaire (RMDQ) score

Measured over 2 days (48 hours)

Conditions

Radiculopathy, Lumbosacral Region

Back Pain With Radiation

Low Back Pain

Where it's being run

2 sites across 1 states

New York2

Study leadership

Eddie Irizarry, MD · PRINCIPAL_INVESTIGATOR · Montefiore Medical Center

Who to contact

Eddie Irizarry, MD

[email protected]

718-920-6626

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

Change in Roland Morris Disability Questionnaire (RMDQ) score2 days (48 hours)
The change in RMDQ will be evaluated using the 24-item Roland Morris Low Back Pain Disability Questionnaire. The RMDQ is a 24-item patient-reported outcome measure that inquires about pain-related disability resulting from LBP. Items are scored 0 if left blank or 1 if endorsed, for a total RMDQ score ranging from 0 to 24. Higher scores represent higher levels of pain-related disability. The change will be calculated as a difference between the baseline ED visit and the two day follow-up visit (Roland-Morris baseline - Roland-Morris day 2)

Trialytics