Placebo Modulation of Orthodontic Pain: a Single-blind Functional MRI Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 主要终点
- fMRI data change during MRI scan
研究概览
简要总结
How placebo modulates orthodontic pain remains largely unknown. The present study aimed to investigate the placebo modulation of brain activity associated with orthodontic pain using fMRI.
详细描述
How placebo modulates orthodontic pain remains largely unknown. The present study aimed to investigate the placebo modulation of brain activity associated with orthodontic pain using fMRI. 23 voluneers were recruited in a longitudinal fMRI experiment. At both the baseline and the one-month follow-up, orthodontic separators were placed between right lower molars 24 hours before MRI scans. At baseline, the subjects were scanned without placebo while all subjects took placebos half an hour before the scan at follow-up. Scans include a bite/non-bite task fMRI and a followed resting state fMRI. A generalized linear model was used to identify pain-regulating network from task fMRI, and functional connectivity analysis of pain related brain regions was performed to study the possible modulation of placebo on connectivity of pain-regulating networks using resting-state fMRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 25 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female, 20-25 years old;
- •Right handed;
- •Understand the Visual Analog Scale;
- •No history of serious illness, surgery, psychiatric disorders or neurological;
- •No history of drug or alcohol abuse;
- •No Maxillofacial diseases, agomphiasis, caries, metal filling material or crown;
- •Individual normal occlusion with no orthodontic treatment history.
排除标准
- •claustrophobic or experienced obvious adverse reactions including fear, nausea, vomiting
- •discomfort during the scan process or during menstruation.
研究组 & 干预措施
placebo arm
Orthodontic pain was introduced by placement of orthodontic elastic separators to the mesial and distal sides of the right mandibular first molar. Participants took placebos (pills made by starch) that were told to be an effective analgesic
干预措施: placebo (Other)
placebo arm
Orthodontic pain was introduced by placement of orthodontic elastic separators to the mesial and distal sides of the right mandibular first molar. Participants took placebos (pills made by starch) that were told to be an effective analgesic
干预措施: orthodontic elastic separators (Device)
sham arm
Orthodontic pain was introduced by placement of orthodontic elastic separators to the mesial and distal sides of the right mandibular first molar. But participants do not take placebos
干预措施: orthodontic elastic separators (Device)
结局指标
主要结局
fMRI data change during MRI scan
时间窗: Day 1
The fMRI data were collected with a Siemens 3.0T MRI system at West China Hospital. Scans include a bite/non-bite task fMRI and a followed resting state fMRI. Through MRI data we can investigate the modulation of brain activity associated with orthodontic pain using fMRI.
次要结局
- The chronological changes of anxiety level(Day 1)
研究者
Meiya Gao
Principal Investigator
West China Hospital