Effect of Acupuncture on Heart Rate Variability in Multiple Sclerosis
NCT ID: NCT05523466
Last Updated: 2022-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2022-12-31
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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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.
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
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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* Cardiac diseases that impede the assessment of HRV
* Have a cardiac pacemaker.
18 Years
50 Years
ALL
No
Sponsors
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University of Sao Paulo
OTHER
Responsible Party
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Talita Dias da Silva
Clinical professor
Principal Investigators
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Celso Ferreira, Dr
Role: PRINCIPAL_INVESTIGATOR
Federal University of São Paulo
Central Contacts
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Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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1239/2018
Identifier Type: -
Identifier Source: org_study_id