Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05721027

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Albert Einstein College of Medicine/Montefiore Medical Center - Weiler ED, The Bronx, New York, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ibuprofen 400 mg

Drug

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

Dexamethasone Oral

Drug

Dexamethasone 16 mg PO during ED visit and next day

Educational intervention

Behavioral

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 outcomes

  1. Change in Roland Morris Disability Questionnaire (RMDQ) score

    Time frame: 2 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)

Secondary outcomes

  1. Worst Radicular LBP

    Time frame: 2 days and 7 days after ED discharge

    Worst Radicular LBP pain incurred over the previous 24 hours will be assessed at 2 days and 7 days after ED discharge using a four point ordinal scale: Severe, Moderate, Mild, or None

  2. Frequency of Radicular LBP

    Time frame: 2 days and 7 days after ED discharge

    Frequency of Radicular LBP is evaluated at 2 days and 7 days after ED discharge based on a five point Likert scale: Not at all, Rarely, Sometimes, Usually, and Always

  3. Analgesic or LBP medication within the previous 24 hours

    Time frame: 2 days and 7 days after ED discharge

    Administration of any analgesic or LBP medication (Yes or No) within the previous 24 hours will be assessed at 2 days and 7 days after ED discharge

  4. Absolute Roland Morris Disability Questionnaire (RMDQ) score

    Time frame: 2 days and 7 days after ED discharge

    The Absolute RMDQ score will be tabulated at 2 days and 7 days after ED discharge. 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

  5. Return to all usual activities

    Time frame: 2 days and 7 days after ED discharge

    The patient will be evaluated for the ability to return to all usual activities at 2 days and 7 days after ED discharge based on a binary (Yes/No) response

  6. Number of visits to any healthcare provider

    Time frame: 2 days and 7 days after ED discharge

    The number of aggregate visits to any healthcare provider will be tabulated at 2 days and 7 days after ED discharge

  7. Satisfaction with Treatment

    Time frame: 2 days and 7 days after ED discharge

    Satisfaction with treatment will be evaluated based on a binary (Yes/No) response at 2 days and 7 days after ED discharge

Study contacts

Contact information is provided by the study sponsor or research team.

Eddie Irizarry, MD

CONTACT

[email protected]

718-920-6626

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 9, 2023
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.