Vurdering af Perifere GABAA-receptorer Med Henblik på Lokal Smertelindring
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Pain Intensity Rating
研究概览
简要总结
The effect of peripheral GABAA receptor activation on pain and sensitivity in healthy human subjects has never been investigated. However, as earlier studies suggest that activation of peripheral GABAA receptors is anti-nociceptive in rats, it is important to determine if these findings can be translated into human subjects to determine if peripheral GABAA receptors are a viable target for future analgesic drug development.
详细描述
Subproject I This study will test if oral administration of GABA containing solutions will reduce the pain and sensitivity induced by application of capsaicin to the tongue of healthy human subjects. Thirty, pain-free men (n=15) and women (n=15) for the oral cavity study.
Subproject II This study will test the hypothesis that intramuscular injection of GABA alone will not be painful, but will reduce muscle pain sensitivity in healthy human subjects. Thirty, pain-free men (n=15) and women (n=15) will be recruited for the intramuscular GABA injection studies
Subproject III This study will test the hypothesis that intramuscular injection of GABA with glutamate will decrease the intensity of glutamate-evoked muscle pain in healthy human subjects. Thirty, pain-free men (n=15) and women (n=15) will be recruited for the intramuscular glutamate and GABA injection studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 20-40 years
- •Free from ongoing or chronic pain
- •Adequate conversational English
排除标准
- •Pregnancy or intent to become pregnant, breast feeding
- •Signs or symptoms of any serious systemic diseases
- •Current malignancies
- •High blood pressure
- •Requirement for chronic administration of psychiatric, analgesic or other medications that might influence their response to pain
- •Frequent recreational drug or alcohol use
- •Previous neurologic, musculoskeletal or mental illnesses
- •Lack of ability to cooperate
研究组 & 干预措施
GABA oral solution
This study will test if oral administration of GABA containing solutions will reduce the pain and sensitivity induced by application of capsaicin to the tongue of healthy human subjects.
干预措施: GABA oral solution (Drug)
Intramuscular GABA
This study will test the hypothesis that intramuscular injection of GABA alone will not be painful, but will reduce muscle pain sensitivity in healthy human subjects.
干预措施: Intramuscular GABA (Drug)
Pain modulation
This study will test the hypothesis that intramuscular injection of GABA with glutamate will decrease the intensity of glutamate-evoked muscle pain in healthy human subjects.
干预措施: Pain modulation (Drug)
结局指标
主要结局
Pain Intensity Rating
时间窗: continuously for 95 minutes
visual analogue scale
次要结局
- Jaw Function Tests(every 5 min for 50 minutes)
- Quantitative Sensory testing(every 10 min for 90 min)
研究者
Brian E Cairns
Professor
Aalborg University