Multiple SclerosisNCT05523466
Effect of Acupuncture on Heart Rate Variability in Multiple Sclerosis
A study testing Acupuncture Active in people with Multiple Sclerosis, run by University of Sao Paulo.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Acupuncture Active
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Dec 2022to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Do not understand the evaluations
- Cardiac diseases that impede the assessment of HRV
- Have a cardiac pacemaker.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Acupuncture on Heart Rate Variability in Individuals With Multiple Sclerosis
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Acupuncture Active, Acupuncture Sham
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture ActiveOther
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 ShamOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Acupuncture Active; Other: Acupuncture Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study startDec 2022 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Talita Dias da Silva, University of Sao Paulo
- Investigators
- Celso Ferreira, Dr, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523466
- Sponsor's protocol ID
- 1239/2018
- Status last verified
- Aug 2022
- First submitted
- 25 Jul 2022
- Last updated
- 31 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acupuncture on Heart Rate Variability in Individuals With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05523466
- Acronym / sponsor ID
- 1239/2018
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 31 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active-Sham group | Experimental | Other: Acupuncture Active, Other: Acupuncture Shamwill 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. |
| Sham-Active group | Experimental | Other: Acupuncture Active, Other: Acupuncture Shamwill 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Do not understand the evaluations
- Cardiac diseases that impede the assessment of HRV
- Have a cardiac pacemaker.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture ActiveImmediately 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 | Active-Sham group, Sham-Active group |
| Acupuncture ShamImmediately 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 | Other | Active-Sham group, Sham-Active group |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Celso Ferreira, Dr principal investigator
Federal University of São Paulo
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture Active in people with Multiple Sclerosis, run by University of Sao Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Talita D Silva, Dr (+5511998590188, ft.talitadias@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the Heart Rate Variability after intervention (time frame: 84 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2022.