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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05523466
Other study ID # 1239/2018
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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