Adjunctive 5% Lidocaine Patches in the Treatment of Acute Non-radicular Low Back Pain in Patients Discharged From the Emergency Department
Overview
- Phase
- Phase 4
- Intervention
- lidocaine 5% patch
- Conditions
- Low Back Pain
- Sponsor
- Cook County Health
- Locations
- 1
- Primary Endpoint
- Numerical Pain Rating Scale (NRS)
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
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.
Investigators
Neeraj Chhabra
Attending Physician, Department of Emergency Medicine, Principal Investigator
Cook County Health
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
Arms & Interventions
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.
Intervention: lidocaine 5% patch
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.
Intervention: standard therapy
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.
Intervention: standard therapy
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.
Intervention: Non-medicated patch
Outcomes
Primary Outcomes
Numerical Pain Rating Scale (NRS)
Time Frame: 1 week
Patient description of pain on a scale of 0-10
Secondary Outcomes
- Roland-Morris-24 back pain disability scale(1 week and 1 month)
- Numerical Pain Rating Scale (NRS)(1 month)