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

Last updated: June 27, 2023
Sponsor: Cook County Health
Overall Status: Trial Not Available

Phase

4

Condition

Chronic Pain

Treatment

standard therapy

Non-medicated patch

lidocaine 5% patch

Clinical Study ID

NCT03301766
17-510
  • Ages 24-64
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 thepast 3 months
  • patient being pregnant or lactating; no access to phone or ability to participate infollow-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 previousspinal surgery
  • patients who are detainees
  • previous enrollment in the study

Study Design

Treatment Group(s): 3
Primary Treatment: standard therapy
Phase: 4
Study Start date:
March 10, 2017
Estimated Completion Date:
May 22, 2023

Study 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.

Connect with a study center

  • John H Stroger Jr Hospital of Cook County

    Chicago, Illinois 60612
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.