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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03301766
• Other study ID #: 17-510
• Status: Withdrawn
• Phase: Phase 4
• Start date: March 10, 2017
• Est. completion date: May 22, 2023

Study information

• Verified date: June 2023
• Source: Cook County Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 22, 2023
• Est. primary completion date: May 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Emergencies
• Low Back Pain

Intervention

Drug:
• lidocaine 5% patch
transdermal patch
• standard therapy
Drugs prescribed at the discretion of the treating physician (acetaminophen, NSAIDs, muscle relaxants, etc)
• Non-medicated patch
non-medicated patch

Locations

Country	Name	City	State
United States	John H Stroger Jr Hospital of Cook County	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Cook County Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Repeat visits	Repeat visits to an emergency department	1 week and 1 month
Primary	Numerical Pain Rating Scale (NRS)	Patient description of pain on a scale of 0-10	1 week
Secondary	Roland-Morris-24 back pain disability scale	24 point back pain disability scale	1 week and 1 month
Secondary	Numerical Pain Rating Scale (NRS)	Patient description of pain on a scale of 0-10	1 month