Adjunctive 5% Lidocaine Patches in the Treatment of Acute Non-radicular Low Back Pain in Patients Discharged From the Emergency Department
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Numerical Pain Rating Scale (NRS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 24 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pain originating between the lower border of the scapulae and the upper gluteal folds
- •treating ED physician plan for discharge of the patient
排除标准
- •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
研究组 & 干预措施
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.
干预措施: lidocaine 5% patch (Drug)
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.
干预措施: standard therapy (Drug)
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.
干预措施: standard therapy (Drug)
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.
干预措施: Non-medicated patch (Drug)
结局指标
主要结局
Numerical Pain Rating Scale (NRS)
时间窗: 1 week
Patient description of pain on a scale of 0-10
次要结局
- Roland-Morris-24 back pain disability scale(1 week and 1 month)
- Numerical Pain Rating Scale (NRS)(1 month)
研究者
Neeraj Chhabra
Attending Physician, Department of Emergency Medicine, Principal Investigator
Cook County Health