Could Apnea Induce Hypoalgesia? An Explorative Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Pressure Pain Threshold
研究概览
简要总结
A randomized controlled trial (RCT) in healthy subjects will be conducted with the following aims: (1) Explore the effect of low pulmonary volume dynamic apnoea bouts on Pressure Pain Threshold (PPT) and conditioned pain modulation (CPM); (2) analyse whether CPM response correlates with apnoea induced hypoalgesia; (3) examine the association between apnoea bouts, Rate of Perceived Exertion, hypoxemia and Heart Rate changes in PPT.
详细描述
A randomized controlled trial (RCT) in healthy subjects will be conducted with the following aims: (1) Explore the effect of low pulmonary volume dynamic apnoea bouts on Pressure Pain Threshold (PPT) and conditioned pain modulation (CPM); (2) analyse whether CPM response correlates with apnoea induced hypoalgesia; (3) examine the association between apnoea bouts Rate of Perceived Exertion, hypoxemia and Heart Rate changes in PPT
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy participants
- •18-30 years
- •Currently pain-free
- •Basal SpO2 ≥95%
排除标准
- •Diabetes diagnosis
- •Hypertension or hypotension diagnosis
- •Pharmacological treatment
- •Frequent pain during last month
- •Drug consumption
- •Self-harming behaviours
- •Pregnant or potentially pregnant
- •Cardiac or respiratory pathology
- •Splenectomy or spleen disease
- •Having performed moderate or high intensity physical activity 24 hours prior to the study
- •Not having slept the previous night
- •Alcohol intake 24 hours prior to study.
结局指标
主要结局
Pressure Pain Threshold
时间窗: Before and immediately after the interventions
PPT refers to the minimal amount of pressure needed to cause the first sensation of pain. The mechanical pressure algometer (PAIN TEST™ FPX 25, Wagner Instruments, Greenwich, CT, USA) counted with a round rubber disc of 1 cm2, displaying values in Kg, hence, data was expressed in Kg/cm2. Two locations, in upper and lower limbs, were examined to examine systemic hypoalgesia effects. The dorsal distal-phalange base of the thumb and tibialis anterior muscle belly, both in the dominant limb, were tested. These regions were marked with a pen before assessments, to repeat the trials in the same place. Three trials were tested in each location, with 30 seconds rest between trials. Pressure speed was paced with a metronome applying a constant force of 0.5 Kg/cm2/s ± 0.1 Kg/cm2/s.
次要结局
- Conditioned pain modulation(Before and immediately after the interventions)
- Heart Rate and Oxygen Saturation(During the intervention and for 2 minutes additionally after the end of the intervention)
- Rated Perceived Exertion(This outcome was assessed immediately after having finished the intervention protocols)
研究者
José Fierro Marrero
Predoctoral researcher
Centro Universitario La Salle