A Randomized Controlled Study Comparing Trigger Point Injections With 1% Lidocaine Versus 5% Lidocaine Patch for Myofascial Pain in the Emergency Department
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- absolute change in Numerical Rating Scale (NRS) of pain
研究概览
简要总结
The aim of this trial is to investigate the efficacy of trigger point injections with 1% lidocaine in reducing myofascial back and neck pain in the Emergency Department compared to lidocaine patches 5%.
详细描述
After being informed about the study and the potential risks and benefits, all patients will be randomized into either the trigger point injection group with 1% lidocaine, or the 5% lidocaine patch group. Pain scores will be recorded while in the emergency department, and we will have a 5 day follow-up phone call to assess efficacy. Patients who present to UCI Department of Emergency medicine will be screened and recruited prospectively, and information regarding this study will be available on clinicaltrials.gov as a method of recruitment.
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
- Single (Outcomes Assessor)
盲法说明
Given the trigger point injection is physician performed, and very different from placing a lidocaine patch, we cannot blind investigators nor the patient to the intervention. We will, however, blind our outcome assessors in regards to which intervention the patient had received.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years or older
- •Diagnosed with myofascial pain of the posterior neck or back. *The diagnosis of myofascial pain was based on established criteria of having a palpable taut band (trigger point) that when depressed reproduced the patient's pain.
排除标准
- •midline spinal tenderness
- •evidence of radiculopathy
- •have an allergy to lidocaine
- •altered or deemed incapable of making informed consent
- •had signs of infection or skin breakdown over the trigger point.
研究组 & 干预措施
Trigger point with 1% Lidocaine
The physician will withdraw 1cc of 1% lidocaine in a 25g needle, sterilely prep the field with a Chloraprep applicator, use index, and middle finger to squeeze the borders of the trigger point and raise the central aspect of the trigger point, insert the needle at 90-degree angle up to 5/8' deep, inject 1cc of the 1% lidocaine after ensuring needle is not in a blood vessel, removing the needle, and then covering the insertion site with a sterile bandage.
干预措施: Trigger point injection with 1% lidocaine (Procedure)
5% Lidocaine Patch
5% lidocaine patch will be placed at the point of maximal tenderness upon palpation. Location of placement will be described and instructed by physician and placed by nursing staff.
干预措施: Lidocaine patch 5% (Drug)
结局指标
主要结局
absolute change in Numerical Rating Scale (NRS) of pain
时间窗: 0 minutes and 20-minutes post- treatment, and every 30-60 minutes thereafter until discharge or admission and we will give the patient a hand out so that they can record their pain scores for up to 5 days after their emergency department visit.
Pain on a scale of 1-10. Minimum value is 1, maximum value is 10. Higher score means higher level of pain while lower score means lower level of pain.
次要结局
- disposition times(From initiation of the study up to the point the patient is discharged from the emergency department)
- use of other medications for treatment of pain including medications administered(From initiation of the study up to 5 days post discharge)
- satisfaction/experience surveys regarding their treatment(Immediately after the intervention is performed/administered)
研究者
Jonathan B Lee
Resident Physician
University of California, Irvine