Adjunctive 5% Lidocaine Patches for Acute Non-radicular Low Back Pain in Emergency Department Patients

Study Overview
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Brief Summary
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This study will evaluate the addition of lidocaine % transdermal patches to standard therapy in the treatment of acute non-radicular low back pain in patients discharged from the Emergency Department. In addition to standard therapy, half of the participants will receive medicated patches while the other half will receive non-medicated patches.

Detailed Description
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Low back pain is a common emergency department (ED) chief complaint. Multiple therapies have been evaluated in the treatment of ED patients with low back pain including acetaminophen, NSAIDS, opioids, steroids, and muscle relaxants. Lidocaine is a local anesthetic that can be administered by various routes. It is used in a transdermal patch for the treatment of pain. It is commonly used for focal causes of pain, including low back pain. The addition of lidocaine 5% patches to standard low back pain therapy has not been rigorously evaluated, although it is frequently used.

Official Title
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Adjunctive 5% Lidocaine Patches in the Treatment of Acute Non-radicular Low Back Pain in Patients Discharged From the Emergency Department

Conditions
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Low Back Pain

Intervention / Treatment
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* Drug: lidocaine 5% patch
* Drug: standard therapy
* Drug: Non-medicated patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pain originating between the lower border of the scapulae and the upper gluteal folds treating ED physician plan for discharge of the patient Exclusion Criteria: radicular pain defined as pain radiating below the gluteal folds direct trauma to the back within previous month pain of greater than 2 weeks duration or greater than 1 LBP episode per month in the past 3 months patient being pregnant or lactating; no access to phone or ability to participate in follow-up phone calls known allergy to lidocaine or skin breakdown over site of pain treating physician plan for opioid prescription (tramadol, codeine, hydrocodone) personal history of malignancy, fever (temperature greater than 37.9ºC), or previous spinal surgery patients who are detainees previous enrollment in the study

Ages Eligible for Study
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Minimum Age: 24 Years
Maximum Age: 64 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine 5% patch<br>Patients will receive a 7 day supply (21 patches) of lidocaine 5% patches upon discharge from the emergency department in addition to standard therapy at the discretion of the treating emergency department physician. | Drug: lidocaine 5% patch<br>* transdermal patch<br>Drug: standard therapy<br>* Drugs prescribed at the discretion of the treating physician (acetaminophen, NSAIDs, muscle relaxants, etc)<br>|
| Active Comparator: Non-medicated patch<br>Patients will receive a 7 day supply (21 patches) of non-medicated patches upon discharge from the emergency department in addition to standard therapy at the discretion of the treating emergency department physician. | Drug: standard therapy<br>* Drugs prescribed at the discretion of the treating physician (acetaminophen, NSAIDs, muscle relaxants, etc)<br>Drug: Non-medicated patch<br>* non-medicated patch<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Pain Rating Scale (NRS) | Patient description of pain on a scale of 0-10 | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Roland-Morris-24 back pain disability scale | 24 point back pain disability scale | 1 week and 1 month | 
| Numerical Pain Rating Scale (NRS) | Patient description of pain on a scale of 0-10 | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lidocaine