What is the Best Osteopathic Manipulative Medicine (OMM) Approach to Affect Autonomic Nervous System (ANS) Control of Heart Rate Variability (HRV)?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Change in Heart Rate Variability
研究概览
简要总结
The purpose this study is to determine which manual medicine technique or combination of techniques has the greatest effect on the natural changes in heart rate.
详细描述
This study intends to examine how three different OMM techniques, sub-occipital release, rib-raising, and stellate ganglion release, impact autonomic nervous system tone. Subjects will be randomly assigned to one of four cohort groups, receiving either sub-occipital release, rib-raising, stellate ganglion release or all three treatment techniques. A shift towards sympathetic tone will be induced in all subjects using a tilted-to-seated-position test (Tilt-Seated Position test) and cognitive challenge test, consisting of computerized questions that become progressively more difficult, and which subjects are asked to answer as quickly and accurately as possible. These stress tests will be induced twice, once without any OMM treatment and a second time with the designated OMM treatment(s). The sympathetic-dependent response to orthostatic change and cognitive challenges will be determined by Fourier analysis of heart rate variability, recorded using an EKG attached to each subject.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Individual capable of giving consent between the ages of 20-50
- •Normal blood pressure as defined by the Seventh Report of US National Committee on Prevention, Detection, Education and Treatment of High Blood Pressure
- •Normal EKG
- •Normal Heart Rate
排除标准
- •Chronic Cardiovascular Disease (including but not limited to: congestive heart failure, previous myocardial infarction, any cardiomyopathy, any arrhythmia, or previous cardiac surgery)
- •Hypertension as defined by the Seventh Report of US National Committee on Prevention, Detection, Education and Treatment of High Blood Pressure or hypertensive medications
- •Pregnancy
- •Current or recent illness (within the past 7 days)
- •Any manipulative therapies within the previous 7 days (including but not limited to: osteopathic manipulative treatment, massage or acupuncture)
- •Well conditioned athletes (such as long distance runners)
- •Anyone who fails to have an increased heart rate with the passive tilt test (50 degrees head-up)
研究组 & 干预措施
Stellate Ganglion Release
Osteopathic Manual Medicine
干预措施: Osteopathic Manual Medicine (Other)
All techniques
Osteopathic Manual Medicine
干预措施: Osteopathic Manual Medicine (Other)
All Techniques-S
Sham Osteopathic Manual Medicine
干预措施: Sham (Other)
Sub-Occipital Release-S
Sham Osteopathic Manual Medicine
干预措施: Sham (Other)
Rib-Raising-S
Sham Osteopathic Manual Medicine
干预措施: Sham (Other)
Stellate Ganglion Release -S
Sham Osteopathic Manual Medicine
干预措施: Sham (Other)
Sub-Occipital Release
Osteopathic Manual Medicine
干预措施: Osteopathic Manual Medicine (Other)
Rib-Raising
Osteopathic Manual Medicine
干预措施: Osteopathic Manual Medicine (Other)
结局指标
主要结局
Change in Heart Rate Variability
时间窗: one hour
The participant will lay on a table with electrocardiogram leads recording heart rate while an investigator manually engages the soft tissue on different areas of the participant's head, neck, or back.
次要结局
- Effect of Diet and sleep on Heart Rate Variability(Three days)