Effect of Acupuncture on Heart Rate Variability in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05523466
• Other study ID #: 1239/2018
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2022
• Est. completion date: December 2023

Study information

• Verified date: August 2022
• Source: University of Sao Paulo
• Contact: Talita D Silva, Dr
• Phone: +5511998590188
• Email: ft.talitadias[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the Heart Rate Variability after intervention	the capture strap will be placed on the volunteers' chests, and the heart rate receiver (V800, Polar) will be placed on their wrists	84 days