RECRUITING

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

Conditions

Radiculopathy, Lumbosacral Region Back Pain With Radiation Low Back Pain ibuprofen dexamethasone radiculopathy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-07-05

Study Completion:2025-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05721027

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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)

Inclusion Criteria

Exclusion 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

* 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)

Contacts and Locations

Study Contact

Eddie Irizarry, MD

CONTACT

718-920-6626

eddiriza@montefiore.org

Principal Investigator

Eddie Irizarry, MD

PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Study Locations (Sites)

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

Bronx, New York, 10461

United States

Montefiore Medical Center - Moses ED

Bronx, New York, 10467

United States

Collaborators and Investigators

Sponsor: Montefiore Medical Center

Eddie Irizarry, MD, PRINCIPAL_INVESTIGATOR, Montefiore Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-05

Study Completion Date2025-08

Study Record Updates

Study Start Date2023-07-05

Study Completion Date2025-08

Terms related to this study

Keywords Provided by Researchers

ibuprofen
dexamethasone
radiculopathy
low back pain
back pain with radiation

Additional Relevant MeSH Terms

Radiculopathy, Lumbosacral Region
Back Pain With Radiation
Low Back Pain