Evaluation of the Effect of Transcutaneous Electrical Nerve Stimulation (TENS) in Postmenopausal Women

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Autonomic and Psychophysical Parameters in Postmenopausal Women

Conditions
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Menopause

Intervention / Treatment
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* Device: Transcutaneous Elevtrical Nerve Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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; 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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active TENS<br>Active TENS, 10 Hz/200 μs | Device: Transcutaneous Elevtrical Nerve Stimulation<br> <br> * Other names: Transcutaneous Electrical Nerve Stimulation;|
| Sham Comparator: Not Active TENS<br>Sham TENS | Device: Transcutaneous Elevtrical Nerve Stimulation<br> <br> * Other names: Transcutaneous Electrical Nerve Stimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Autonomic changes in postmenopausal women's health | Heart rate's modification tested by R-R interval on electrocardiogram. | 30 days | 
| Psychophysical changes in postmenopausal women´s health | pain evaluated by Quality Sensitive Test | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Descendent Inibitory System Pain changes in postmenopausal women´s health | evaluated by conditioned pain modulated test | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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menopause, post-menopause, transcutaneous electrical nerve stimulation, electrical stimulation therapy, women's health