Remote Ischemic Preconditioning Effects on Central and Peripheral Sensitization in Healthy Volunteers-A Pilot Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Areas of hyperalgesia and allodynia to mechanical stimuli.
研究概览
简要总结
This research is being done because pain is a significant problem for patients with a variety of medical problems and following surgery or traumatic injury. Currently available pain medications may not relieve all types of pain or may relieve pain only at doses that produce side effects and potential complications.
Although Remote Ischemic Preconditioning (RIPC) appears promising, there remain several unanswered questions about how it works. This research trial will help determine how RIPC may activate the bodies natural pain control system. The goals of this study are to see if RIPC has any effect 1) on a small area of skin that will be expose to a small amount of UV- B radiation (a mild sunburn), 2) on acute thermal heat temperatures that will be applied to skin, and 3) on the sunburn-like sensation to light touch after putting capsaicin cream (the active ingredient in hot chili peppers) on skin.
Remote ischemic preconditioning is done by inflating a balloon (very similar to a blood pressure cuff) on the leg until it blocks blood flow for a few minutes. The cuff is then deflated and blood flow resumes. The process is repeated up to three times. This procedure causes the body to increase its natural pain relief system that may help to decrease the amount of postsurgical pain.
详细描述
The purpose of this pilot study is to determine whether RIPC effects peripheral sensitization, central sensitization or both and determine effect size since there is no data regarding the presumed effect. These issues cannot be easily sorted out in patients experiencing postoperative pain and hypersensitivity, since surgery affects both components. In order to address this purpose the investigators will examine, in healthy volunteers, the effect of RIPC on a manipulation which generates hypersensitivity by an exclusive peripheral mechanism (ultraviolet B (UV-B) burn) and a manipulation which generates hypersensitivity by an exclusive central mechanism (topical capsaicin). Understanding the sites at which RIPC reduces the amplification of pain after injury will be useful in determining where it would be most logically applied clinically and in guiding preclinical mechanistic studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy volunteers of both sexes ASA 1 or II classification
- •between the ages of 18-55
- •weighing less than 250 pounds
- •without chronic pain
- •not taking analgesics
- •off caffeine for 2 days.
排除标准
- •pregnancy
- •allergy to capsaicin
- •lower extremity vascular insufficiency
- •active treatment for DVT
- •severe thigh pain
- •taking psychotropic medications, including anti-depressants.
研究组 & 干预措施
Capsaicin, UV-B, RIPC
干预措施: Remote Ischemic Preconditioning, Capsaicin, UV-B (Device)
Capsaicin, UV-B
干预措施: Remote Ischemic Preconditioning, Capsaicin, UV-B (Device)
结局指标
主要结局
Areas of hyperalgesia and allodynia to mechanical stimuli.
时间窗: 24 hours
Hyperalgesia will be measured with vonFrey fibers and allodynia will be measured with a cotton wisp. The area will be measured in cm2.
次要结局
- Pain intensity and unpleasantness to mechanical stimuli(24 hours)
- Presence of parathesias where RIPC was used(24 hours)