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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Low Back Pain
• Intervention / Treatment: Drug: lidocaine 5% patch; Drug: standard therapy; Drug: Non-medicated patch

Detailed Description

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
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Neeraj Chhabra, MD; Phone Number: 312-864-0065; Email: NChhabra@cookcountyhhs.org

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • John H Stroger Jr Hospital of Cook County

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 62 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lidocaine 5% patch; 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; transdermal patch; Drug: standard therapy; Drugs prescribed at the discretion of the treating physician (acetaminophen, NSAIDs, muscle relaxants, etc)
Active Comparator: Non-medicated patch; 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; Drugs prescribed at the discretion of the treating physician (acetaminophen, NSAIDs, muscle relaxants, etc); Drug: Non-medicated patch; non-medicated patch

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Repeat visits	Repeat visits to an emergency department	1 week and 1 month

Collaborators and Investigators

• Sponsor: Cook County Health

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2017
• Primary Completion (Actual): May 22, 2023
• Study Completion (Actual): May 22, 2023

Study Registration Dates

• First Submitted: September 29, 2017
• First Submitted That Met QC Criteria: September 29, 2017
• First Posted (Actual): October 4, 2017

Study Record Updates

• Last Update Posted (Actual): June 29, 2023
• Last Update Submitted That Met QC Criteria: June 27, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: lidocaine
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Emergencies; Back Pain; Low Back Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 17-510

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No