跳至主要内容
临床试验/NCT05523466
NCT05523466Unknown不适用

Effect of Acupuncture on Heart Rate Variability in Individuals With Multiple Sclerosis

University of Sao Paulo0 个研究点目标入组 40 人开始时间: 2022年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
主要终点
Changes in the Heart Rate Variability after intervention

研究概览

简要总结

The Objective of this study is to evaluate the heart rate variability in individuals with multiple sclerosis during the applicability of Acupuncture, to analyze the behavior of the autonomic nervous system before, during, and after therapy and the changes of the condition.

详细描述

A double-blinded randomized sham-controlled crossover trial with a 1:1 allocation ratio will be conducted, 40 individuals without previous illness will be evaluated, who will constitute the control group and 40 individuals with MS will constitute the experimental group, paired by age and gender. All participants will undertake active or sham acupuncture sessions. Active-Sham group will start with 5 sessions (1 per week) of active acupuncture combined with HRV evaluation for 20 min. After a 2-week washout, this group will be reallocated to another 5 sessions (1 per week) of sham acupuncture for 20 min combined with HRV evaluation. Meanwhile, Sham-Active group will carry out the opposite protocol, participants will start an allocated 5 sessions (1 per week) of sham acupuncture combined with HRV evaluation, and after a 1-week washout period will be reallocated to 5 sessions (1 per week) of active acupuncture combined with HRV evaluation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals diagnosed with Multiple Sclerosis
  • Aged over 18 years
  • Motor and intellectual capacity to understand the evaluations
  • Light and moderate functional classification levels (EDSS scale)
  • Who accept to participate in the study through agreement with informed consent form

排除标准

  • Do not understand the evaluations
  • Cardiac diseases that impede the assessment of HRV
  • Have a cardiac pacemaker.

结局指标

主要结局

Changes in the Heart Rate Variability after intervention

时间窗: 84 days

the capture strap will be placed on the volunteers' chests, and the heart rate receiver (V800, Polar) will be placed on their wrists

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Talita Dias da Silva

Clinical professor

University of Sao Paulo

相似试验