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

Cook County Health

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Low Back Pain

Interventions

lidocaine 5% patchDRUG

transdermal patch

standard therapyDRUG

Drugs prescribed at the discretion of the treating physician (acetaminophen, NSAIDs, muscle relaxants, etc)

Non-medicated patchDRUG

non-medicated patch

Eligibility

Sex: ALLMin age: 24 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Locations (1)

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Numerical Pain Rating Scale (NRS)

Patient description of pain on a scale of 0-10

Time frame: 1 week

Secondary Outcomes

Roland-Morris-24 back pain disability scale

24 point back pain disability scale

Time frame: 1 week and 1 month

Numerical Pain Rating Scale (NRS)

Patient description of pain on a scale of 0-10

Time frame: 1 month

Data from ClinicalTrials.gov

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