Adjunctive 5% Lidocaine Patches for Acute Non-radicular Low Back Pain in Emergency Department Patients
- Conditions
- Low Back Pain
- Interventions
- Registration Number
- NCT03301766
- Lead Sponsor
- Cook County Health
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- pain originating between the lower border of the scapulae and the upper gluteal folds
- treating ED physician plan for discharge of the patient
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 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. Lidocaine 5% patch standard therapy 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. Non-medicated patch standard therapy 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. Non-medicated patch 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.
- Primary Outcome Measures
Name Time Method Numerical Pain Rating Scale (NRS) 1 week Patient description of pain on a scale of 0-10
- Secondary Outcome Measures
Name Time Method Roland-Morris-24 back pain disability scale 1 week and 1 month 24 point back pain disability scale
Numerical Pain Rating Scale (NRS) 1 month Patient description of pain on a scale of 0-10
Trial Locations
- Locations (1)
John H Stroger Jr Hospital of Cook County
🇺🇸Chicago, Illinois, United States