The Effect of Transauricular Electrical Vagal Nerve Stimulation on Temporal Summation of Heat Pain in Patients With Chronic Low-back Pain
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Unpleasantness of pain
研究概览
简要总结
The effect of transauricular electrical vagal nerve stimulation (taVNS) will be studied on temporal summation of heat pain (TSP) in 30 patients with chronic low-back pain and in 30 heathy volunteers. Participants will receive either taVNS or sham stimulation before and during TSP induction in a randomized crossover manner. The participants will be unaware regarding the type of intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and outcome assessor will be unaware regarding the type (real or sham) taVNS intervention
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with chronic low-back pain
- •age 30-60 yrs old
- •without heart disease
- •low-back pain intensity at least 4 out of 10 points measured using NRS-10
- •without cognitive deficits (Mini Mental State Shake < 23)
排除标准
- •opioid medication
- •more than 1 low-back surgery
- •sensory of motor neurological deficits at the level of back pain
- •spinal stenosis
- •diabetic polyneuropathy
- •skin pathology at the site (cymba conchae) of stimulation
研究组 & 干预措施
Real taVNS intervention
taVNS will be administered to cymba conchae of both ears using ECO2-TENS device
干预措施: Transauricular electrical vagal nerve stimulation (Device)
Real taVNS intervention
taVNS will be administered to cymba conchae of both ears using ECO2-TENS device
干预措施: taVNS sham (Device)
Sham
aVNS will be administered to lobes of both ears using ECO2-TENS device
干预措施: Transauricular electrical vagal nerve stimulation (Device)
Sham
aVNS will be administered to lobes of both ears using ECO2-TENS device
干预措施: taVNS sham (Device)
结局指标
主要结局
Unpleasantness of pain
时间窗: Continuously 5 minutes during the experimental heat pain stimulation
Perceived unpleasantness of pain, which participants will rate continuously during the repetitive heat stimulation using a computerized visual analogue scale (CoVAS, Medoc Advanced Medical Systems, Ramat Yishai, Israel) ranging from 0 (= not unpleasant at all) to 100 (= intolerable pain)
次要结局
- Heart rate(10 minutes (before, during and after stimulation of heat pain))
- blood pressure(10 minutes (before, during and after stimulation of heat pain))