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

NCT ID: NCT05721027

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-05
• Study Completion Date: 2026-10-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Ibuprofen 400 mg

Intervention Type: DRUG

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

Dexamethasone Oral

Intervention Type: DRUG

Dexamethasone 16 mg PO during ED visit and next day

Educational Intervention

Intervention Type: 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

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.

Group Type: PLACEBO_COMPARATOR

Ibuprofen 400 mg

Intervention Type: DRUG

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

Educational Intervention

Intervention Type: 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

Interventions

Ibuprofen 400 mg

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

Intervention Type: DRUG

Dexamethasone Oral

Dexamethasone 16 mg PO during ED visit and next day

Intervention Type: DRUG

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eddie Irizarry, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

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

The Bronx, New York, United States

Site Status: RECRUITING

Montefiore Medical Center - Moses ED

The Bronx, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Eddie Irizarry, MD

Role: CONTACT

eddiriza@montefiore.org

718-920-6626

Facility Contacts

Eddie Irizarry, MD

Role: primary

Related Links

https://www.niams.nih.gov/health-topics/back-pain

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

Other Identifiers

2023-14723

Identifier Type: -

Identifier Source: org_study_id