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

• Sponsor: John H. Stroger Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03301766
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 29.3
• Patients Per Site Per Month: 3.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain	Drug: lidocaine 5% patch; Drug: standard therapy; Drug: Non-medicated patch	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Adjunctive 5% Lidocaine Patches in the Treatment of Acute Non-radicular Low Back Pain in Patients Discharged From the Emergency Department
• Actual Study Start Date: Jan 20, 2018
• Anticipated Primary Completion Date: Jun 1, 2020
• Anticipated Study Completion Date: Jul 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Numerical Pain Rating Scale (NRS) [1 week]

   Patient description of pain on a scale of 0-10

Secondary Outcome Measures

1. Roland-Morris-24 back pain disability scale [1 week and 1 month]

   24 point back pain disability scale

2. Numerical Pain Rating Scale (NRS) [1 month]

   Patient description of pain on a scale of 0-10

Other Outcome Measures

1. Repeat visits [1 week and 1 month]

   Repeat visits to an emergency department

Eligibility Criteria

Criteria

• Ages Eligible for Study: 24 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	John H Stroger Jr Hospital of Cook County	Chicago	Illinois	United States	60612

Sponsors and Collaborators

• John H. Stroger Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Neeraj Chhabra, Attending Physician, Department of Emergency Medicine, Principal Investigator, John H. Stroger Hospital
• ClinicalTrials.gov Identifier: NCT03301766
• Other Study ID Numbers: 17-510
• First Posted: Oct 4, 2017
• Last Update Posted: Mar 1, 2019
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Neeraj Chhabra, Attending Physician, Department of Emergency Medicine, Principal Investigator, John H. Stroger Hospital: lidocaine
• Additional relevant MeSH terms: Back Pain; Emergencies; Low Back Pain; Lidocaine

Study Results

No Results Posted as of Mar 1, 2019