Effect of Acupuncture on Heart Rate Variability in Multiple Sclerosis

Not Applicable

• Conditions: Multiple Sclerosis
• Interventions: Other: Acupuncture Active; Other: Acupuncture Sham

• Registration Number: NCT05523466
• Lead Sponsor: University of Sao Paulo

Brief 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.

Study Timeline

• Study First Submitted: 2022-07-25
• Status Verified: 2022-08
• Study First Submitted QC: 2022-08-29
• Last Update Submitted: 2022-08-29
• Study First Posted: 2022-08-31
• Last Update Posted: 2022-08-31
• Study Start: 2022-12
• Primary Completion: 2023-07
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham-Active group	Acupuncture Active	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.
Active-Sham group	Acupuncture Active	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.
Sham-Active group	Acupuncture Sham	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.
Active-Sham group	Acupuncture Sham	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.

Primary Outcome Measures

Name	Time	Method
Changes in the Heart Rate Variability after intervention	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