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

NCT ID: NCT03301766

Last Updated: 2023-06-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-10
• Study Completion Date: 2023-05-22

Brief Summary

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

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.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

lidocaine 5% patch

Intervention Type: DRUG

transdermal patch

standard therapy

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

standard therapy

Intervention Type: DRUG

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

Non-medicated patch

Intervention Type: DRUG

non-medicated patch

Interventions

lidocaine 5% patch

transdermal patch

Intervention Type: DRUG

standard therapy

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

Intervention Type: DRUG

Non-medicated patch

non-medicated patch

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 24 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cook County Health

OTHER_GOV

Sponsor Role: lead

Responsible Party

Neeraj Chhabra

Attending Physician, Department of Emergency Medicine, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, United States

Countries

United States

Other Identifiers

17-510

Identifier Type: -

Identifier Source: org_study_id