Effect of a Sequence of Specific Manual Therapy Techniques Targeting the Autonomic Nervous System in Healthy Adults: a Single-application Double-blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Heart rate
研究概览
简要总结
The activity of the autonomic nervous system has been shown to influence the appearance of symptoms in some diseases such as rheumatoid arthritis, fibromyalgia, or migraine, among others. In the bibliography we find different authors who, through intervention using manual therapy, have demonstrated its effects on the autonomic nervous system, especially on the increase in parasympathetic activity and reduction in sympathetic activity. A clinical trial is proposed to verify these effects.
详细描述
The aim of the study is to analyse the effects of applying a specific sequence of manual therapy techniques focused on the regulation of the autonomic nervous system. This intervention sequence will be applied in a single intervention. As a result, an immediate increase in parasympathetic activity could occur, measured by different parameters of heart rate variability, heart rate and respiratory rate. If the results confirm the expected effects, this treatment sequence could be used as a therapeutic resource in patients with pathologies whose symptoms may be related to the deregulation of the autonomic nervous system, such as rheumatoid arthritis, migraine or fibromyalgia, among others.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The participants don't know what intervention are they receiving The outcomes assessor don't know the intervention that the participant is receiving
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of informed consent
- •Aged between 18-65
排除标准
- •Regular consumtion of alcohol or illegal drugs
- •Consumption of medications whose effect acts on the autonomic nervous system (cholinergic agonists and antagonists, or adrenergic agonists and antagonists)
- •Diagnostic of disease that may affect the activity of the autonomic nervous system or the perception of pain (such as generalized anxiety disorder, fibromyalgia, or chronic fatigue).
- •Pregnancy
研究组 & 干预措施
Sequence of manual therapy techniques
Participants receive a manual therapy secuence of techniques
干预措施: Sequence of manual therapy techniques (Procedure)
Simulated manual therapy techniques
Participants receive a sequence of simulated manual therapy techniques
干预措施: Simulated manual therapy techniques (Procedure)
结局指标
主要结局
Heart rate
时间窗: Day 1
The investigators will examine the difference between Time 1 and Time 2 and between groups in beats per minute.
Root mean square of the successive differences between adjacent RR intervals (RMSSD) in heart rate variability index
时间窗: Day 1
The investigators will examine the difference between Time 1 and Time 2 and between groups in HRV measured by Root mean square of the successive differences between adjacent RR intervals (RMSSD) in heart rate variability index
次要结局
- Respiratory rate(Day 1)
- High frequency (HF) band in heart rate variability index(Day 1)
- Incidence of Treatment-Emergent Adverse Events(Day 1)
研究者
Pere Ramón Rodríguez Rubio
PhD
Universitat Internacional de Catalunya