Mechanisms of Acupuncture Analgesia on Experimental Dental Pain - A Randomized, Single Blinded, Sham-controlled Psychophysical Study (Phase1)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 4
- 主要终点
- Comparison of the - mean post-pre acupuncture intervention pain intensity rating differences - and mean post-pre sham-acupuncture rating differences
研究概览
简要总结
The investigators will assess the effects of manual acupuncture on experimental dental pain in 36 healthy subjects by means of subjective pain intensity ratings and pain-specific autonomic nervous system (ANS) reactions.
详细描述
This psychophysical and -physiological study is the first part of a two-phase project which pursues to explore how acupuncture-induced pain modulation interacts with pain-specific brain processing patterns by means of functional magnetic resonance imaging (fMRI) and by using an experimental dental pain model.
In this preceding study, the characterization of manual acupuncture effects on the experimental dental pain model will be tested under laboratory conditions and without restrictions of an fMRI-measurement in order to provide a sound foundation for the following fMRI-experiment. Pain modulating effects of the manual acupuncture intervention (4 points: needle manipulation of bilateral large-intestine 4 (LI4), stomach 6 and 7 (ST6, ST7) ipsilateral to the stimulated tooth) will be compared to sham-acupuncture (insertion and manipulation of 4 non-acupuncture points) and a control intervention (no acupuncture) which will each be performed at 3 different days in a randomized order. Intervention effects on experimental dental pain will be assessed by testing of 36 healthy volunteers by means of subjective pain intensity ratings and pain-specific ANS reactions such as electrodermal activity and heart rate/respiratory changes. Besides laying the groundwork for the following fMRI experiment, this study could provide valuable basic insights into the dynamics of the tested manual acupuncture effects and further provide important knowledge for the planning of future clinical studies encompassing dental conditions and development of acupuncture treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •right-handed
- •Written informed consent
- •Fluent in German language
- •Sufficient dental sensitivity for the tooth stimulation
- •No acupuncture treatment in the previous 12 months
- •No medical knowledge about acupuncure
排除标准
- •Alcohol, drug, and analgesics consumption within the last 24 hours
- •Complaints of diseases of the oral cavity
- •Pre-existing neurological and(or psychiatric conditions
- •History of severe dental pain
- •Regular intake of pain medication
- •History of brain injuries
- •Alcohol and drug abuse
- •Chronic diseases that require a permanent intake of drugs
结局指标
主要结局
Comparison of the - mean post-pre acupuncture intervention pain intensity rating differences - and mean post-pre sham-acupuncture rating differences
时间窗: 15 minutes
In case of a significant effect in outcome 1, outcome 2 will be tested using a hierarchical procedure in order to avoid multiple testing.
Comparison of the - mean post-pre acupuncture intervention pain intensity rating differences - and mean post-pre control intervention (no acupuncture) rating differences
时间窗: 15 minutes
次要结局
- Changes in heart rate variability (HRV) during the three intervention types (acupuncture, sham-Acupuncture, no acupuncture).(10 minutes)
- Changes in respiratory frequency during the three intervention types (acupuncture, sham-Acupuncture, no acupuncture).(10 minutes)
- Longer lasting effects of acupuncture on subjective intensity ratings(50 minutes)
- Changes in skin conductance during the three intervention types (acupuncture, sham-Acupuncture, no acupuncture).(10 minutes)
- Frequency of SAEs(1 month)
- Longer lasting effects of acupuncture on pain-specific changes in heart rate.(50 minutes)
- Longer lasting effects of acupuncture on pain-specific changes in skin conductance.(50 minutes)
- Longer lasting effects of acupuncture on pain-specific changes in respiratory frequency.(50 minutes)
研究者
Claudia Witt
Prof. Dr. med. Claudia M. Witt, MBA
University of Zurich