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临床试验/NCT06169917
NCT06169917招募中不适用

Potential Influences of Respiration Patterns on Experimental Pain Sensitization

Balgrist University Hospital2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年5月14日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
2
主要终点
Area of Hypersensitivity surrounding the primary stimulation site

研究概览

简要总结

The goal of this clinical trial is to investigate the effect of breathing on the processing of experimental pain in healthy participants. The main questions are:

  1. Does breathing rate influence the spatial extent of thermally induced secondary hyperalgesia, a proxy of central sensitization?
  2. Does resonance frequency breathing influence the autonomic nervous system, compared to baseline and compared to paced breathing at a natural frequency?
  3. Is spinal excitability, measured using the magnitude of the nociception withdrawal reflex (NWR), affected by resonance frequency breathing, compared to paced breathing at a natural frequency?

Participants:

  • will receive heat stimuli
  • 's skin's sensitivity will be tested using quantitative sensory testing tools.
  • will receive various instructions on the speed of their breathing
  • 's heart rate, respiratory rate and sweat response will be measured
  • will fill in questionnaires

Researchers will compare the spatial extent of sensitivity resulting from application of heat stimuli during paced resonance frequency breathing compared to paced breathing at a natural frequency to see if the breathing rhythm influences central sensitization processes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

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 current acute pain at time of study
  • inability to follow study instructions, e.g. due to language problems
  • Consumption of alcohol, drugs, analgesics within the last 24 h
  • Consumption of no more than 100 mg of caffeine within the last 8 h
  • Scar tissue or generally reduced sensitivity in the designated testing site areas
  • Additional exclusion criteria for experiments 3 and 4
  • Shoe size < 38
  • Restless-Legs-Syndrome

结局指标

主要结局

Area of Hypersensitivity surrounding the primary stimulation site

时间窗: 40 minutes

Before and after thermal stimulations, the sensitivity of the skin is tested using a von Frey Filament, a Pin Prick and a brush. Thermal stimulations cause hypersensitivity of the skin, resulting in an area of hypersensitivity surrounding the stimulation site. The primary outcome measure is the amount of change in the area of hypersensitivity from before to after the thermal stimulations. The measuring unit of this outcome is square centimetres.

次要结局

  • Root Mean Square of Successive Differences of the Heart Rate Variability(25 minutes)
  • Galvanic Skin Potential(25 minutes)
  • Threshold and Magnitude of the Nociceptive Withdrawal Reflex(25 minutes)
  • Power in the Low-frequency Range of the Heart Rate Variability(25 minutes)

研究者

发起方
Balgrist University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Schweinhardt Petra

Prof. Dr. med

Balgrist University Hospital

研究点 (2)

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