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.

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain; Back Pain With Radiation; Radiculopathy, Lumbosacral Region
• Intervention / Treatment: Behavioral: Educational Intervention; Drug: Ibuprofen 400 mg; Drug: Dexamethasone Oral

• Study Type: Interventional
• Enrollment (Estimated): 132
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Eddie Irizarry, MD; Phone Number: 718-920-6626; Email: eddiriza@montefiore.org

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10461
      • Recruiting
      • Albert Einstein College of Medicine/Montefiore Medical Center - Weiler ED
    • Bronx, New York, United States, 10467
      • Recruiting
      • Montefiore Medical Center - Moses ED
      • Contact: Eddie Irizarry, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: 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; Drug: Ibuprofen 400 mg; Ibuprofen 400 mg PO every 8 hours as needed for 7 days; Drug: Dexamethasone Oral; Dexamethasone 16 mg PO during ED visit and next day
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.	Behavioral: 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; Drug: Ibuprofen 400 mg; Ibuprofen 400 mg PO every 8 hours as needed for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Roland Morris Disability Questionnaire (RMDQ) score	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)	2 days (48 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Worst Radicular LBP	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 days and 7 days after ED discharge
Frequency of Radicular LBP	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	2 days and 7 days after ED discharge
Analgesic or LBP medication within the previous 24 hours	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	2 days and 7 days after ED discharge
Return to all usual activities	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	2 days and 7 days after ED discharge
Number of visits to any healthcare provider	The number of aggregate visits to any healthcare provider will be tabulated at 2 days and 7 days after ED discharge	2 days and 7 days after ED discharge
Satisfaction with Treatment	Satisfaction with treatment will be evaluated based on a binary (Yes/No) response at 2 days and 7 days after ED discharge	2 days and 7 days after ED discharge
Absolute Roland Morris Disability Questionnaire (RMDQ) score	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	2 days and 7 days after ED discharge

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Investigators: Principal Investigator: Eddie Irizarry, MD, Montefiore Medical Center

Publications and helpful links

Helpful Links

• National Institute of Arthritis and Musculoskeletal and Skin Diseases Handout on Health: Back Pain information

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2023
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: January 31, 2023
• First Submitted That Met QC Criteria: February 8, 2023
• First Posted (Actual): February 9, 2023

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 18, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: low back pain; ibuprofen; dexamethasone; radiculopathy; back pain with radiation
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Back Pain; Low Back Pain; Radiculopathy; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone; Ibuprofen
• Other Study ID Numbers: 2023-14723

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes