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

Montefiore Medicine Academic Health System

Status and phase: Enrolling; Phase 4

Conditions: Radiculopathy, Lumbosacral Region; Back Pain With Radiation; Low Back Pain

Treatments: Drug: Ibuprofen 400 mg; Behavioral: Educational Intervention; Drug: Dexamethasone Oral

Study type: Interventional

Funder types: Other

Identifiers

NCT05721027

2023-14723

Details and patient eligibility

About

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.

Enrollment: 132 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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132 participants in 2 patient groups, including a placebo group

Ibuprofen + dexamethasone + educational intervention

Experimental group

Description:

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.

Treatment:

Drug: Dexamethasone Oral

Behavioral: Educational Intervention

Drug: Ibuprofen 400 mg

Ibuprofen + placebo + educational intervention

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Educational Intervention

Drug: Ibuprofen 400 mg