Effect of Acupuncture on Heart Rate Variability in Multiple Sclerosis

NCT05523466 | Unknown

• 1 other identifier: 1239/2018
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Active-Sham group

EXPERIMENTAL

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.

Other: Acupuncture Active; Other: Acupuncture Sham

Sham-Active group

EXPERIMENTAL

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.

Other: Acupuncture Active; Other: Acupuncture Sham

Interventions

Acupuncture Active OTHER

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.

Active-Sham group; Sham-Active group

Acupuncture Sham OTHER

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

Active-Sham group; Sham-Active group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo: lead

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Celso Ferreira, Dr

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Talita D Silva, Dr

CONTACT

+5511998590188; ft.talitadias@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: August 31, 2022
• Study Start: December 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 31, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share