An Exploratory Study of the Epigenetic Influences on Post-Surgical Acute and Chronic Pain
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- pain score
研究概览
简要总结
Pain is the way our brain interprets certain bodily sensations. It is very difficult to describe or to put into words as perception and tolerance of pain varies widely between individuals. It is known that age, gender and past experience and memory of past experience all contribute to patients' feelings of discomfort and tolerance of pain, but the reason why some patients actually do not experience any pain at all post surgery is still unknown.
Because pain affects every person at some point in their lives, it is of utmost importance that we can find more effective analgesic methods, and provide analgesia tailored to an individual's need as well as discovering new methods which may be able to identify those individuals who are more prone to suffering serious, or chronic pain. It has been proposed that epigenetic modifications may play a role in sensitivity to analgesia and response to trauma, such as post surgery. The effects of epigenetic changes on key genes and the role this plays in analgesia sensitivity and pain perception is deserving of further research.
Epigenetics is a growing field of study in which there are genetic modifications that do not involve changes to base sequences in a gene, but that result nonetheless in changes to gene expression. It has long been known that changes in gene expression play an important role in the establishment of pain states. But it is not known whether a priming injury can induce lasting epigenetic marks which would result in an increase in both postoperative acute pain and the risk for chronic pain. Only by fully understanding these epigenetic mechanisms will we be able to offer better drugs for the treatment of pain, and to identify those at high risk of postoperative pain and postsurgical chronic pain.
The purpose of this study is to determine whether severity of pain following surgical procedures, such as third molar surgery is related to baseline methylation status of the promoter region of IL-6 and TNF-α and changes in methylation status post surgery.
详细描述
(i) Subjects: Sixty subjects who will be undergoing third molar surgery (hereafter known as 'cases') will be recruited from The Queen Mary Hospital and The Prince Philip Dental Hospital and sixty, aged and sex matched controls who will not be undergoing surgery in the next 3 months, nor have undergone surgery in the past year (hereafter known as 'controls') will also be recruited from the Outpatients department of the same hospital.
(ii) Methods: The study aims and details will be explained to each subject and informed consent will be sought from each of them. A pain diaryquestionnaire developed by our group will be adapted for the use of assessing pain experienced by each subject pre and post surgery. Research personnel will accompany each case subject, and fill out the pain diaryquestionnaire with them during the visit when the patients' blood is taken.
The following health questionaires will be completed by the subjects recruites:
SF-36: 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures HADS: Assessment of the psychological status of the subjects (anxiety & depression)
Pain assessment:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient requires third molar surgery for case group and patient does not require surgery for control group
- •Age 18 or above
- •Ability to read and understand the study information and consent form
- •Written consent obtained
排除标准
- •Patient does not requires third molar surgery for case group and patient requires third molar surgery for control group
- •Age below 18
- •Major cognitive or psychiatric disorders that affect the ability to complete study
- •Refuse to participate
结局指标
主要结局
pain score
时间窗: From postoperative 1 hour to postoperative 3 months
次要结局
- IL-6 and TNF-α expression(From postoperative 1 hr to postoperative 3 month)
研究者
Cheung Chi Wai
Associate Professor
The University of Hong Kong
