MenopausePhase 1/2NCT03032185
Evaluation of the Effect of Transcutaneous Electrical Nerve Stimulation (TENS) in Postmenopausal Women
A Phase 1/2 study testing Transcutaneous Elevtrical Nerve Stimulation in people with Menopause, run by Secretaria Municipal de Saúde de Rolante at 1 site in Brazil.
Trial summary
Introduction: Menopause is the last menstrual period, it is a natural phenomenon to all women. Postmenopausal, some women may experience unpleasant symptoms such as hot flushes, urogenital pain, headache and pains in the musculoskeletal system. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- Transcutaneous Elevtrical Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2017to Jul 2017
- Phase
- Phase 1/2
- 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 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be in the period of post-menopause;
- Do not have chronic diseases or comorbidities in drug treatment;
- Accept to participate in the study and sign the free and informed consent form.
Who cannot join
- Start continuous medication during the study period;
- Display cognitive problems that make it difficult to understand the questionnaires and proposals;
- History of alcohol or drug abuse in the last 6 months;
- History of neurological disorders;
- History of cardiac arrhythmias;
- History of moderate or severe head injury;
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- History of neurosurgery;
- Uncompensated systemic diseases, and chronic inflammatory diseases (diabetes, lupus, rheumatoid arthritis, Sjogren's syndrome, Reiter's syndrome);
- History of uncompensated hypothyroidism;
- History of personal cancer, past or treatment.
- Wish referred to leave the study at any time.
- No attendance to the stages that make up the research.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Andressa de Souza
Canoas, Rio Grande do Sul
Andressa de Souza, PhD, +55 51 81975718, andressa.souza@unilasalle.edu.br
About this study
Official title: Evaluation of Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Autonomic and Psychophysical Parameters in Postmenopausal Women
Introduction: Menopause is the last menstrual period, it is a natural phenomenon to all women. Postmenopausal, some women may experience unpleasant symptoms such as hot flushes, urogenital pain, headache and pains in the musculoskeletal system. That happens due to the decreased ovarian hormone secretion and changes in the autonomic system. Pain is also caused by a complex autonomic activity. For pain management, a therapeutic electrical stimulation of the peripheral nervous system promotes modulation of nociceptive incentives and release of endogenous opioids. According to reviewed studies, the use of transcutaneous electrical nerve stimulation (TENS), by directly stimulating the central nervous system, has presented results of manipulation of the autonomic system, being observed change in heart rate and cognitive improvement in dementia. Given this possibility, the present study aims to investigate whether the use of Transcutaneous Electrical Nerve Stimulation in low frequency can generate autonomic and psychophysical changes in healthy postmenopausal women.
Objective: To evaluate the effectiveness of Transcutaneous Electrical Nerve Stimulation on autonomic and psychophysical parameters in postmenopausal women.
Methods: randomized, crossover, double-blind. A sample of thirty patients will be selected according to inclusion and exclusion criteria previously established. The autonomic and psychophysical functions will be evaluated by Quantitative Sensory Testing and Conditioned Pain Modulation (pain thresholds to heat and modulation of conditioned pain, respectively), as well as scales to evaluate catastrophism and sleep quality (by scale of Pittsburgh Sleep Quality Index). After application of the scales, the participants will be subject to active Ttranscutaneous Electrical Nerve Stimulation session or sham with a fortnight washout as randomization. All the research subjects will be invited to participate in the study and sign an Informed Consent and Informed (ICI). This study will be registered in the Clinical Trials.
- Conditions
- Menopause
- Being tested
- Transcutaneous Elevtrical Nerve Stimulation
- Keywords
- menopause, post-menopause, transcutaneous electrical nerve stimulation, electrical stimulation therapy, women's health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Elevtrical Nerve StimulationDevice
Also called Transcutaneous Electrical Nerve Stimulation
| Study group | Role | What they receive |
|---|---|---|
| Active TENS | Active comparator | Active TENS, 10 Hz/200 μs Receives: Device: Transcutaneous Elevtrical Nerve Stimulation |
| Not Active TENS | Sham comparator | Sham TENS Receives: Device: Transcutaneous Elevtrical Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autonomic changes in postmenopausal women's health
Heart rate's modification tested by R-R interval on electrocardiogram.
Measured: 30 days
Psychophysical changes in postmenopausal women´s health
pain evaluated by Quality Sensitive Test
Measured: 30 days
Secondary outcomes (1)
Descendent Inibitory System Pain changes in postmenopausal women´s health
evaluated by conditioned pain modulated test
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Secretaria Municipal de Saúde de Rolante
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Universitario La Salle
- Responsible party
- Principal investigator, Lucélia Caroline dos santos Cardoso, Secretaria Municipal de Saúde de Rolante
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03032185
- Sponsor's protocol ID
- 48302915.1.0000.5307
- Status last verified
- Jan 2017
- First submitted
- 22 Jan 2016
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Autonomic and Psychophysical Parameters in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT03032185
- Acronym / sponsor ID
- 48302915.1.0000.5307
- Conditions
- Menopause
- Keywords
- menopause, post-menopause, transcutaneous electrical nerve stimulation, electrical stimulation therapy, women's health
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Secretaria Municipal de Saúde de RolanteUniversity, hospital or other
- Collaborators
- Centro Universitario La Salle
- Study start
- Jan 2017
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 26 Jan 2017 (estimated)
- 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.
Introduction: Menopause is the last menstrual period, it is a natural phenomenon to all women. Postmenopausal, some women may experience unpleasant symptoms such as hot flushes, urogenital pain, headache and pains in the musculoskeletal system. That happens due to the decreased ovarian hormone secretion and changes in the autonomic system. Pain is also caused by a complex autonomic activity. For pain management, a therapeutic electrical stimulation of the peripheral nervous system promotes modulation of nociceptive incentives and release of endogenous opioids. According to reviewed studies, the use of transcutaneous electrical nerve stimulation (TENS), by directly stimulating the central nervous system, has presented results of manipulation of the autonomic system, being observed change in heart rate and cognitive improvement in dementia. Given this possibility, the present study aims to investigate whether the use of Transcutaneous Electrical Nerve Stimulation in low frequency can generate autonomic and psychophysical changes in healthy postmenopausal women.
Objective: To evaluate the effectiveness of Transcutaneous Electrical Nerve Stimulation on autonomic and psychophysical parameters in postmenopausal women.
Methods: randomized, crossover, double-blind. A sample of thirty patients will be selected according to inclusion and exclusion criteria previously established. The autonomic and psychophysical functions will be evaluated by Quantitative Sensory Testing and Conditioned Pain Modulation (pain thresholds to heat and modulation of conditioned pain, respectively), as well as scales to evaluate catastrophism and sleep quality (by scale of Pittsburgh Sleep Quality Index). After application of the scales, the participants will be subject to active Ttranscutaneous Electrical Nerve Stimulation session or sham with a fortnight washout as randomization. All the research subjects will be invited to participate in the study and sign an Informed Consent and Informed (ICI). This study will be registered in the Clinical Trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active TENS | Active comparator | Device: Transcutaneous Elevtrical Nerve StimulationActive TENS, 10 Hz/200 μs |
| Not Active TENS | Sham comparator | Device: Transcutaneous Elevtrical Nerve StimulationSham TENS |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- To be in the period of post-menopause;
- Do not have chronic diseases or comorbidities in drug treatment;
- Accept to participate in the study and sign the free and informed consent form.
Key exclusion criteria (12 listed)
- Start continuous medication during the study period;
- Display cognitive problems that make it difficult to understand the questionnaires and proposals;
- History of alcohol or drug abuse in the last 6 months;
- History of neurological disorders;
- History of cardiac arrhythmias;
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 |
|---|---|---|
| Transcutaneous Elevtrical Nerve StimulationAlso: Transcutaneous Electrical Nerve Stimulation | Device | Active TENS, Not Active TENS |
Primary outcome
Autonomic changes in postmenopausal women's health
Time frame: 30 days
Heart rate's modification tested by R-R interval on electrocardiogram.
Psychophysical changes in postmenopausal women´s health
Time frame: 30 days
pain evaluated by Quality Sensitive Test
1 secondary outcome
Descendent Inibitory System Pain changes in postmenopausal women´s health
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Transcutaneous Elevtrical Nerve Stimulation in people with Menopause, run by Secretaria Municipal de Saúde de Rolante at 1 site in Brazil.
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 3 inclusion and 12 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 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Lucélia Cardoso (55 51 93646778, enflucarol@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autonomic changes in postmenopausal women's health (time frame: 30 days). The study lists 2 primary outcomes in all. 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 26 Jan 2017.