To Determine the Degree of Association Between Heat Pain Detection Threshold and Area of Secondary Hyperalgesia Following Brief Thermal Sensitization in Healthy Male Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 2
- 主要终点
- Size of the Area of secondary hyperalgesia following Brief thermal sensitization, evaluated by cm2, and heat pain detection threshold registered by degrees celsius.
研究概览
简要总结
The purpose of this prospective study is to investigate how close Heat Pain Detection Threshold is associated with the area of secondary hyperalgesia, elicited by the clinical pain model Brief Thermal Sensitization.
Furthermore we wish to investigate how close the clinical pain model: Pain during 1 min. heating of the skin (45 degrees celsius), and the psychological tests, Pain Catastrophizing Scale and Hospital Anxiety and Depression Scale are associated with the area of secondary hyperalgesia, elicited by the clinical pain model Brief Thermal Sensitization.
详细描述
The study participants will be tested with 3 types of clinical pain models on two separate identical study days. A minimum of 7 days will separate the two study days, thus, the minimum length of the study is 7 days, but can be higher.
The 3 types of pain conditioning consist of 1) Brief thermal sensitisation (BTS), 2) Heat pain detection threshold (HPDT), and pain during 1 min. thermal stimulation (p-TS.
The order of the stimulations (HPDT and BTS) is randomised for each patient and each study day, by a random allocation sequence, computer-generated by Copenhagen Trial Unit and stored in sealed and opaque envelopes to secure adequate allocation concealment. p-TS is conducted subsequent to BTS and HPDT.
The participants will complete the psychological tests Pain Catastrophizing Scale (PCS) and Hospital Anxiety and Depression Scale (HADS) in their private home prior to study day 1. The completed tests will be placed in opaque sealed envelopes to secure blinding of the investigator and outcome assessor.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age >18 years and <35 years
- •Speak and understand Danish
- •Male gender
- •Study participants who have understood and signed the informed consent
- •No prescription medicine during the last 30 days.
排除标准
- •Study participants that cannot cooperate to the test.
- •Study participants who have a weekly intake of >21 units of alcohol, or a have consumed >3 units of alcohol within 24 hours before experimental day.
- •Study participants with a substance abuse, assessed by the investigator.
- •Study participants, who have consumed analgesics less than 3 days before experimental day.
- •Study participants, who have consumed antihistamines less than 48 hours before experimental day.
- •Study participants, who have consumed antidepressant medication during the last 30 days before experimental day.
- •Study participants with chronic pain.
- •Study participants with neurological illnesses.
- •Study participants with psychiatric diagnoses.
- •Study participants with tattoos on the extremities.
- •Study participants with eczema, wounds or sunburns on the sites of stimulation.
- •Study participants with a Body Mass Index of >30 kg/m2 or <18 kg/m2
结局指标
主要结局
Size of the Area of secondary hyperalgesia following Brief thermal sensitization, evaluated by cm2, and heat pain detection threshold registered by degrees celsius.
时间窗: 7 days
How close is the Heat Pain Detection Threshold associated with the size of the area of secondary hyperalgesia induced by Brief thermal sensitization? Area of secondary hyperalgesia will be investigated on two separate study days separated with a minimum of 7 days. The association will be expressed in R2 and prediction intervals for the area of BTS given fixed values of HPDT.
次要结局
- Pain during 1 min. thermal stimulation, evaluated by Area Under the Curve of the visual analog scale, 0-100 mm.(Study day 1 and 2. A minimum of 7 days)
- Pain during 1 min. thermal stimulation, evaluated by maximum on the visual analog scale, 0-100mm.(Study day 1 and 2. A minimum of 7 days.)
- Score of Pain Catastrophizing Scale(Study day 1 and 2. A minimum of 7 days.)
- Score of Hospital Anxiety and Depression Scale(Study day 1 and 2. A minimum of 7 days.)
- Score of Subscales of Pain Catastrophizing Scale and Hospital Anxiety and Depression Scale.(Study day 1 and 2. A minimum of 7 days.)
研究者
Morten Sejer Hansen
M.D.
Rigshospitalet, Denmark