ACTRN12613000004763已完成未知
The effect of thermal stimuli on the outcomes spontaneous pain, flare, allodynia and hyperalgesia in response to intradermal capsaicin in healthy male participants
Professor Paul Rolan0 个研究点目标入组 12 人开始时间: 2013年1月3日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- Male
入选标准
- •A participant will be eligible for inclusion in this study only if all of the following criteria apply:
- •2.Right handed
- •3.Aged between 18-65 years inclusive
- •4.In good general health without clinically significant renal, hepatic, cardiac or other disease, as determined by the Principal Investigator
- •5.Agree to and be capable of signing the Informed Consent Form
排除标准
- •A participant will be excluded from the study if any of the following criteria apply:
- •1.Significant scarring on the planned site of investigation
- •2.Tattoos on the planned site of investigation
- •3.Suffering from an active inflammatory process (e.g. acute pain, influenza, active infection, rheumatoid arthritis etc.)
- •4.Have had a clinically significant infection in the 4 weeks prior to study day 1
- •5.Suffering form an impaired immune response, e.g. HIV/AIDS sufferers, Hep B or C sufferers, organ transplant recipients or known current history of malignancy. Significance is to be determined by the investigator
- •6.Taking immunosuppressant drugs e.g. azathioprine, methotrexate, cyclosporine
- •7.Dark skin colouration that precludes flare assessment
- •8.Positive urine drug screen for presence of non-prescribed drugs of abuse
- •9.Positive breath alcohol concentration prior to study day 1 and 2
- •10.Recent use of opioids (e.g. morphine use within 1 week, or codeine use (<30 mg) within last 5 days)
- •11.Use of anxiolytics, anti-depressants and anti-epileptic medications within the previous 4 weeks
- •12.Clinically significant abnormalities in blood tests conducted during screening, as determined by the Principal Investigator
- •13.Sensory deficits at the planned quantitative sensory testing (QST) site resulting from medical conditions, such as diabetes; alcohol neuropathy; severe thyroid, liver or kidney diseases
- •14.Suffering from a clinically diagnosed major psychiatric disorder, such as major depression; bipolar disorder; schizophrenia; anxiety disorder and psychosis
- •15.History of excessive use of alcohol, defined as more than 28 units of alcohol per week
- •16.Known disorder of thermal pain sensitivity (e.g. Raynaud’s Phenomenon)
- •17.Inability to tolerate study procedures at screening familiarisation session
- •18.Current or history of a chronic pain condition
- •19.Frequent migraines, as determined by the Principal Investigator
研究者
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