Recruiting

Ibuprofen with Dexamethasone

Sponsor:

Montefiore Medical Center

Code:

NCT05721027

Conditions

Radiculopathy, Lumbosacral Region

Back Pain With Radiation

Low Back Pain

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

Ibuprofen 400 mg

Dexamethasone Oral

Educational Intervention

Study Details

Brief summary:

This will be a placebo controlled, randomized, double-blind, comparative effectiveness study, in which we patients are enrolled during an emergency department (ED) visit for acute radicular low back pain (LBP) and followed by telephone two and seven days later. Patients will be randomized to receive an oral dose of dexamethasone for 2 consecutive days or placebo during an ED visit for acute radicular LBP. Every patient will receive a 7 day supply of ibuprofen and a low back pain education session.

Conditions

Radiculopathy, Lumbosacral Region

Back Pain With Radiation

Low Back Pain

Study ID

NCT05721027

Start date

Jul 5, 2023

Status verified date

Apr, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

132 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ibuprofen + dexamethasone + educational intervention

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.

placebo comparator: Ibuprofen + placebo + educational intervention

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.

Interventions

Ibuprofen 400 mg

Ibuprofen 400 mg PO every 8 hours as needed for 7 days

Dexamethasone Oral

Dexamethasone 16 mg PO during ED visit and next day

Educational Intervention

Research personnel will provide each patient with a 15-minute educational intervention. This will be based on National Institute of Arthritis and Musculoskeletal and Skin Diseases Handout on Health: Back Pain information

Primary outcome measure

  • Change in Roland Morris Disability Questionnaire (RMDQ) score [ Time Frame: 2 days (48 hours) ]

Central Contacts and Locations

Central contacts

Eddie Irizarry, MD

718-920-6626eddiriza@montefiore.org

Locations

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

Recruiting

The Bronx, New York, United States, 10461

Montefiore Medical Center - Moses ED

Recruiting

The Bronx, New York, United States, 10467

More Information

Sponsor

Montefiore Medical Center

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

  • ibuprofen
  • dexamethasone
  • radiculopathy
  • low back pain
  • back pain with radiation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2026-04-13.