Physiological Responses to Osteopathic Manipulative Techniques in Healthy Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 主要终点
- Change in blood pressure 10 minutes after manipulation
研究概览
简要总结
This study was designed to investigate the effect of selected osteopathic manipulative techniques (OMT) on cardiovascular functions in healthy young men and women.
This work addressed questions regarding physiological responses to OMT in maintaining the cardiovascular homeostasis by (1) measuring changes in the cardiac autonomic nerves activity, (2) measuring changes in cardiovascular parameters such as blood pressure, cardiac contractility, and heart rate, and (3) investigating if changes in the cardiac autonomic nerves activity were related to changes in blood pressure, cardiac contractility, or heart rate.
This controlled not-randomized pilot study with repeated measures was conducted at the Touro University Nevada College of Osteopathic Medicine. Healthy 21-35 years old students and employees volunteered in the study. The experimental group received the three cranial osteopathic manipulative techniques, occipital-atlantal decompression, occipital-mastoid decompression, and compression of the fourth ventricle, consecutively applied. This study included two control groups; one group received sham manipulations, and the second group did not receive any manipulations and was the non-touch group.
The computerized MP150 BIOPAC System was used for data collection and analysis. The skin electrodes were used for the one-lead ECG and impedance cardiography. Digital data were recorded during the entire experimental protocol. The blood pressure was measured manually before and after the experimental procedure using blood pressure cuff and stethoscope. Cardiovascular responses to OMT were evaluated by using the heart rate variability test (HRV), calculating changes in cardiac contractility, and comparing changes in pre- and post- blood pressure readings.
An analysis of variance (ANOVA) with a Bonferroni post-hoc test was used to evaluate treatment effects. The type I error rate (alpha) was set at 0.05.
详细描述
Healthy, 21-35 year old, male and female volunteers were recruited from Touro University students, faculty and staff using a brochure, poster, e-mail or personal conversation. Each participant signed an informed consent form. Participants were allowed to participate in multiple experiments (in the experimental and control groups) at least 7 days after the last experiment.
Each subject's weight and height were measured before the procedure. Anthropometric measures were used in cardiac impedance analysis, and as descriptive statistics of the studied population. All cardiovascular parameters were recorded by using a non-invasive method. The disposable skin electrodes were used for impedance cardiography and a one-lead ECG.
The subjects were lying in the supine position and were asked to relax. All surface electrodes were connected to the computerized MP150 BIOPAC System for data recording. The duration of experimental protocol was about 30 minutes, and included three intervals: 10 minutes, pre-OMT rest phase (Rest); 8 to12 minutes (about 10 minutes) of the OMT/Sham (Manipulations); and 10 minutes post-OMT recovery phase (Recovery).
OMT and sham manipulations were administered by an osteopathic physician. The participants were told to lie supine with physician seated at the side of the table facing the participant. Cranial OMT included three techniques and was administered in the following sequence: occipital-atlantal decompression, occipital-mastoid joint, and compression of the fourth ventricle. Control subjects received the sham manipulative procedure or relaxed in supine position (non-touch control). The total duration of OMT controlled by an osteopathic physician and was about 10 minutes.
OMT and sham manipulations Occipital-atlantal decompression: Patient is in the supine position. The operator places the tip of a finger against the posterior tubercle of the atlas and holds that bone anteriorly, preventing it from moving posteriorly with the condyles as the patient nods or tips the head forward. This will release tension between the occipital condyles and the first cervical vertebrae.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Young adults
排除标准
- •Clinical diagnosis of chronic cardiovascular diseases
- •Clinical diagnosis of pulmonary diseases
- •Clinical diagnosis of renal diseases
- •Clinical diagnosis of diabetes mellitus
- •Clinical diagnosis of endocrine disorders affecting the cardiovascular system
- •Clinical diagnosis of pregnancy
- •Clinical diagnosis of musculoskeletal conditions that can affect the use of the cranial OMTs
- •Any acute illness that necessitates consulting a healthcare provider
结局指标
主要结局
Change in blood pressure 10 minutes after manipulation
时间窗: Baseline and 10 minutes after manipulation
Blood pressure was measured by sphygmomanometer. Changes in blood pressure would indicate the effect of manipulation on vascular sympathetic tone.
Change in heart rate variability immediately after manipulation
时间窗: Baseline and 2 minutes after manipulation
The heart rate variability test was used to study the effect of OMT on heart rate and, by inference, on autonomic nervous system activity. A decrease in heart rate accompanied by an increase in vagal and decrease in sympathetic activity would indicate parasympathetic activation by OMT.
Change in heart rate variability 10 min after manipulation
时间窗: Baseline and 10 minutes after manipulation
The heart rate variability test was used to study the effect of OMT on heart rate and, by inference, on autonomic nervous system activity. A decrease in heart rate accompanied by an increase in vagal and decrease in sympathetic activity would indicate parasympathetic activation by OMT.
Change in cardiac impedance immediately after manipulation
时间窗: Baseline and 2 minutes after manipulation
Changes in impedance cardiography were used to evaluate the effect of OMT on myocardial contractility.
Change in cardiac impedance 10 minutes after manipulation
时间窗: Baseline and 10 minutes after manipulation
Changes in impedance cardiography were used to evaluate the effect of OMT on myocardial contractility.
次要结局
未报告次要终点
研究者
Marina Ioudina
Assistant Professor
Touro University Nevada