Acute Low Back Pain. Topical Diclofenac and Oral Ibuprofen.

Study Overview
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Brief Summary
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This is a randomized, double-blind study comparing two different treatments for acute low back pain, oral ibuprofen and topical diclofenac. Participants will be randomized to one of three study arms: 1) Oral ibuprofen + topical diclofenac; 2) Oral ibuprofen + topical placebo; 3) Oral placebo + topical diclofenac. We will determine outcomes 2 days later.

Official Title
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A Randomized Study of Topical Diclofenac Versus Oral Ibuprofen for Acute Non-radicular Low Back Pain

Conditions
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Low Back Pain

Intervention / Treatment
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* Drug: Ibuprofen 400 mg
* Drug: Topical diclofenac


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Present to ED primary for management of LBP, defined as pain originating between the lower border of the scapulae and the upper gluteal folds. Flank pain, that is pain originating from tissues lateral to the paraspinal muscles, will not be included. Musculoskeletal etiology of low back. Patients with non-musculoskeletal etiologies such as urinary tract infection, ovarian cysts, or influenza like illness will be excluded. The primary clinical diagnosis, at the conclusion of the ED visit, must be a diagnosis consistent with non-traumatic, non-radicular, musculoskeletal LBP. Patient is to be discharged home. Age 18-69 Enrollment will be limited to adults younger than 70 years because of the increased risk of adverse medication effects in the elderly. Non-radicular pain. Patients will be excluded if the pain radiates below the gluteal folds in a radicular pattern. Pain duration <2 weeks (336 hours). Prior to the acute attack of LBP, back pain must occur less frequently than once per month. Non-traumatic LBP: no substantial and direct trauma to the back within the previous month Functionally impairing back pain: A baseline score of > 5 on the Roland-Morris Disability Questionnaire Exclusion Criteria: Not available for follow-up Pregnant Any analgesic medication use on a daily or near-daily basis Allergic to or intolerant of investigational medications Open wounds or skin breakdown of the lower back 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: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Oral ibuprofen + topical diclofenac<br>Oral ibuprofen 400mg Topical diclofenac 2gm | Drug: Ibuprofen 400 mg<br>* Ibuprofen 400mg<br>Drug: Topical diclofenac<br>* Diclofenac 1% gel 4gm<br>|
| Active Comparator: Oral ibuprofen + topical placebo<br>Oral ibuprofen 400mg Topical placebo | Drug: Ibuprofen 400 mg<br>* Ibuprofen 400mg<br>|
| Active Comparator: Oral placebo + topical diclofenac<br>Oral placebo Topical diclofenac 2gm | Drug: Topical diclofenac<br>* Diclofenac 1% gel 4gm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Roland Morris Disability Questionnaire | The Roland-Morris is a 24-item self-report questionnaire about how low-back pain affects functional activities. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability) | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Moderate or severe low back pain | Participants will be asked to describe their worst pain over the previous 24 hours using the terms severe, moderate, mild, or none | 48 hours | 
| Use of medication for low back pain | Participants will be asked if they used any medication for low back pain in the previous 24 hours | 48 hours |