NCT01908920已完成不适用
Osteopathic Manipulative Treatment Effects on High Frequency Parameters in Healthy Subjects
European Institute for Evidence Based Osteopathic Medicine1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from baseline high frequency (HF) value at 1 week
研究概览
简要总结
The aim of the present study is to determine the extend to which osteopathic manipulative treatment (OMT) is effective on a sample of healthy subjects in changing high frequency (HF) parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 45;
- •No chronic symptomatology;
- •No acute symptomatology during the last 72 hours before intervention;
- •No pathologies
排除标准
- •Age below 18 or over 45;
- •Pregnancy;
- •Menopause;
- •Abuse of alcool during the last 48 hours;
- •Chronic pain;
- •Acute pain during the last 72 hours;
- •Conclamate pathologies;
- •Use of drugs during the last 72 hours ;
- •Use of ortothic devices during the last 3 months;
- •Any type of surgery;
- •Osteopathic treatment during the last 3 months.
结局指标
主要结局
Change from baseline high frequency (HF) value at 1 week
时间窗: baseline and 1 week
次要结局
- Change from baseline in low frequency (LF) value at 1 week(baseline and 1 week)
- Change from baseline LF/HF ratio value at 1 week(baseline and 1 week)
- Change from baseline very low frequency (VLF) value at 1 week(baseline and 1 week)
- Change from baseline standard deviation beat-to-beat (SDNN) value at 1 week(baseline and 1 week)
- Changes from baseline square root of the mean squared difference of successive beat-to-beat (RMSSD) at 1 week(baseline and 1 week)
- Change from baseline proportion of beat-to-beat50 divided by total number of beat-to-beats in (pNN50) at 1 week(baseline and 1 week)
- Change from baseline detrended fluctuation scaling exponent (DFAa1) value at 1 week(baseline and 1 week)
- Change in LF value(during treatment session)
- Change in LF/HF ratio value(during treatment session)
- Change in VLF value(during treatment session)
- Change in SDNN value(during treatment session)
- Change in RMSSD value(during treatment session)
- Change in pNN50 value(during treatment session)
- Change in DFAa1 value(during treatment session)
- Change from baseline intrasubject HF value at 1 week(baseline and 1 week)
- Change from baseline heart rate variability parameters between smokers and no-smokers at 1 week(baseline and 1 week)
- Change from baseline 15D questionnaire at 1 week(baseline and 1 week)
- Differences in skin conductance value between groups(1 week)
研究者
Francesco Cerritelli
MS, DO
European Institute for Evidence Based Osteopathic Medicine
研究点 (1)
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