Influences of the Autonomic Nervous System on Experimental Pain Sensitization
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- Magnitude of the Nociceptive Withdrawl Reflex
研究概览
简要总结
In this study, we want to investigate how pain processing and sensation are related to a certain part of the nervous system, the so-called autonomic nervous system.
For this purpose, we apply heat and pressure stimuli to the skin and test pain processing by means of ratings scales and sensory tests. Breathing, heart rate and sweat response are also measured. To assess the spinal cord level, we measure muscle response (measured by electromyography, EMG) to electrical stimulation. Additionally, sensory nerves will be stimulated at the ear and participants will also be given various questionnaires to complete.
详细描述
This study investigates the effects of autonomic regulation on pain perception and experimentally induced pain sensitivity. Participants come for one or two study visits, that will last approximately 3 hours. The study is divided into two phases: the pilot phase and the main experimental phase.
During the pilot phase, the perception of pressure and heat stimuli, as well as spinal excitability, will be assessed before and during different types of electrical stimulation of sensory nerves at the outer ear.
During the main experimental phase, skin sensitivity and spinal excitability will be assessed before and after repetitive heat stimulation and stimulation of sensory nerves at the outer ear.
In both study phases, the activity of the autonomic nervous system will be assessed throughout the experiment, and questionnaires will be completed.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Over 18 and below 40 years of age
- •Good general health
- •Able to give informed consent
排除标准
- •Any major medical or psychiatric condition (e.g. heart disease, diabetes, autoimmune disorders, infectious diseases, major depressive disorder), any chronic pain condition, any respiratory problems, any acute pain at time of study
- •Inability to follow study instructions, e.g. due to language problems
- •Pregnancy (female participants will be asked if pregnancy could be possible)
- •Increased alcohol (>2 (for women)/4 (for men) standard glasses per day or >5 (for women)/4 (for men) glasses at least once a month within a few hours) or caffeine consumption (≥ 400mg per day)
- •Consumption of alcohol, drugs, analgesics within the last 24 h
- •Consumption of more than 100 mg of caffeine within the last 8 h
- •Scar tissue or generally reduced sensitivity in the designated testing site areas
- •Shoe size < 38 (if experiment is conducted at the feet)
- •History of cardiovascular disease or carotid artery disease
- •Medication or Substances inferring with the autonomic nervous system or with pain sensitivity (e.g. Benzodiazepines, Nicotine)
结局指标
主要结局
Magnitude of the Nociceptive Withdrawl Reflex
时间窗: Before, during, and/or immediately after the intervention
Muscle responses of the biceps fermoris to an electrical stimulation of the sural nerve will be measured using an electromyogramm
次要结局
未报告次要终点
研究者
Schweinhardt Petra
Prof. Dr. med.
Balgrist University Hospital