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

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-07-31

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.

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Detailed Description

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Conditions

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Menopause

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active TENS

Active TENS, 10 Hz/200 μs

Group Type ACTIVE_COMPARATOR

Transcutaneous Elevtrical Nerve Stimulation

Intervention Type DEVICE

Not Active TENS

Sham TENS

Group Type SHAM_COMPARATOR

Transcutaneous Elevtrical Nerve Stimulation

Intervention Type DEVICE

Interventions

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Transcutaneous Elevtrical Nerve Stimulation

Intervention Type DEVICE

Other Intervention Names

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Transcutaneous Electrical Nerve Stimulation

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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes