Effects of an Osteopathic Treatment Protocol on Sleep Quality
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Sleep Quality
研究概览
简要总结
SIngle-centre interventional single-blinded randomized controlled trial, with random assignment of the subjects in two groups (intervention and control, 1: 1 ratio) and to be carried out with volunteers that present alterations in the quality of sleep. Eligible and accepting subjects participating in the study will be assigned to receive an osteopathic treatment protocol or a placebo technique
详细描述
Intervention protocol in the intervention group:
The intervention protocol consists of 4 techniques that will be performed according to the following order:
- Inhibition of the suboccipital muscles.
- Parietal Lift.
- Sutherland Technique of Sphenobasilar Synchondrosis.
- Compression technique of the fourth ventricle (CV4).
Intervention protocol in the control group:
Placebo technique that consists of placing the hands on top of the skull without any therapeutic intention for five minutes.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Eligible and recruited patients will be Randomized using OxMaR software (Oxford Minimization and Randomization).
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults ranging from 18 to 80 years old and with a score greater than 5 on the Pittsburgh Sleep Quality Index
排除标准
- •Recent head injuries or fractures.
- •Having suffered a stroke or intracranial hemorrhage.
- •Bradycardia.
- •Hypotension.
- •Heart disease
- •Neurological problems
- •Psychiatric problems
结局指标
主要结局
Sleep Quality
时间窗: 1 month
Sleep quality is measured using the Pittsburgh Sleep Quality Index before the intervention and one month after, having received three treatment sessions.
次要结局
- Heart Rate Variability(1 month)
- Perceived Stress(1 month)
研究者
Ramón Mateos Alpuente
Principal Investigator
Ramon Mateos Fisioterapia y Osteopatía