RecruitingPhase 4NCT05721027

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

Sponsor

Montefiore Medical Center

Enrollment

132 participants

Start Date

Jul 5, 2023

Study Type

INTERVENTIONAL

Conditions

Low Back Pain Radiculopathy, Lumbosacral Region Back Pain With Radiation

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria7

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 Criteria6

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)

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Interventions

DRUGIbuprofen 400 mg

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

DRUGDexamethasone Oral

Dexamethasone 16 mg PO during ED visit and next day

BEHAVIORALEducational 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