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Effect of Acupuncture on Heart Rate Variability in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acupuncture Active
Acupuncture Sham
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Active-Sham group

    Sham-Active group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    July 25, 2022
    Last Updated
    August 29, 2022
    Sponsor
    University of Sao Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05523466
    Brief Title
    Effect of Acupuncture on Heart Rate Variability in Multiple Sclerosis
    Official Title
    Effect of Acupuncture on Heart Rate Variability in Individuals With Multiple Sclerosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2022 (Anticipated)
    Primary Completion Date
    July 2023 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Sao Paulo

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Sclerosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Active-Sham group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Sham-Active group
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Acupuncture Active
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Acupuncture Sham
    Intervention Description
    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 Measure Information:
    Title
    Changes in the Heart Rate Variability after intervention
    Description
    the capture strap will be placed on the volunteers' chests, and the heart rate receiver (V800, Polar) will be placed on their wrists
    Time Frame
    84 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Talita D Silva, Dr
    Phone
    +5511998590188
    Email
    ft.talitadias@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Celso Ferreira, Dr
    Organizational Affiliation
    Federal University of São Paulo
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effect of Acupuncture on Heart Rate Variability in Multiple Sclerosis

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