NCT05523466

Effect of Acupuncture on Heart Rate Variability in Multiple Sclerosis

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
OTHER	Acupuncture Active	Immediately after the placement of the Polar V800, an instrument for analyzing heart rate variability, the placing of needles at the points carefully selected for this research begins. The needling will proceed for the Active acupuncture using specific Traditional Chinese Acupuncture points: E36, BP6, F3, IG4, for 20 minutes.
OTHER	Acupuncture Sham	Immediately after the placement of the Polar V800, an instrument for analyzing heart rate variability, the placing of needles at the points carefully selected for this research begins. The needling will proceed for the Sham acupuncture using sham points (points not recognized as Acupuncture points), with the duration of 20 minutes

Timeline

• Start date: 2022-12-01
• Primary completion: 2023-07-01
• Completion: 2023-12-01
• First posted: 2022-08-31
• Last updated: 2022-08-31