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Effect of Acupuncture on Heart Rate Variability in Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT05523466
Recruitment Status : Not yet recruiting
First Posted : August 31, 2022
Last Update Posted : August 31, 2022
Sponsor:
Information provided by (Responsible Party):
Talita Dias da Silva, 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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: Acupuncture Active Other: Acupuncture Sham Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Acupuncture on Heart Rate Variability in Individuals With Multiple Sclerosis
Estimated Study Start Date : December 2022
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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

Experimental: Sham-Active group
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
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




Primary Outcome Measures :
  1. Changes in the Heart Rate Variability after intervention [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05523466


Contacts
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Contact: Talita D Silva, Dr +5511998590188 ft.talitadias@gmail.com

Sponsors and Collaborators
University of Sao Paulo
Investigators
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Principal Investigator: Celso Ferreira, Dr Federal University of São Paulo
  Study Documents (Full-Text)

Documents provided by Talita Dias da Silva, University of Sao Paulo:
Study Protocol  [PDF] January 18, 2019
Informed Consent Form  [PDF] January 18, 2019

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Responsible Party: Talita Dias da Silva, Clinical professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT05523466    
Other Study ID Numbers: 1239/2018
First Posted: August 31, 2022    Key Record Dates
Last Update Posted: August 31, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases