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

Study Overview
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Brief Summary
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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
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Ibuprofen With or Without Dexamethasone for Acute Radicular Low Back Pain.

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

Intervention / Treatment
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* Drug: Ibuprofen 400 mg
* Drug: Dexamethasone Oral
* Behavioral: Educational Intervention


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ibuprofen + dexamethasone + educational intervention<br>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. | Drug: Ibuprofen 400 mg<br>* Ibuprofen 400 mg PO every 8 hours as needed for 7 days<br>Drug: Dexamethasone Oral<br>* Dexamethasone 16 mg PO during ED visit and next day<br>Behavioral: Educational Intervention<br>* 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<br>|
| Placebo Comparator: Ibuprofen + placebo + educational intervention<br>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. | Drug: Ibuprofen 400 mg<br>* Ibuprofen 400 mg PO every 8 hours as needed for 7 days<br>Behavioral: Educational Intervention<br>* 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<br>|

What is the study measuring?
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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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ibuprofen, dexamethasone, radiculopathy, low back pain, back pain with radiation