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Could a common steroid plus ibuprofen ease shooting back pain faster?

NCT ID NCT05721027

Symptom relief Sponsor: Montefiore Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether adding a short course of dexamethasone (a steroid) to standard ibuprofen treatment can improve pain and disability in people with acute radicular low back pain (pain that shoots from the back down the leg). About 132 adults visiting the emergency department will be randomly assigned to get either dexamethasone or a placebo for two days, plus ibuprofen for a week and a brief education session. Researchers will check how well participants are doing two and seven days later using a disability questionnaire and pain scales.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ibuprofen and dexamethasone
What this could lead to
If adding dexamethasone works, it could offer a better short-term pain relief option for people with nerve-related back pain seen in the emergency room.
What could go wrong
This is a small, early-phase trial (132 people) testing a very short treatment (2 days of dexamethasone). The benefit may be small or no better than ibuprofen alone, and results may not apply to everyone with back pain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 132 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2023

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

Back Pain Low Back Pain radiculopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Back pain with radiation Low back pain Radiculopathy, lumbosacral region

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Albert Einstein College of Medicine/Montefiore Medical Center - Weiler ED

    RECRUITING

    The Bronx, New York, 10461, United States

  • Montefiore Medical Center - Moses ED

    RECRUITING

    The Bronx, New York, 10467, United States

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