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
About this trial
This is an interventional treatment trial for Multiple Sclerosis
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.
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
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
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Effect of Acupuncture on Heart Rate Variability in Multiple Sclerosis
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