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

Secretaria Municipal de Saúde de Rolante

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Menopause

Treatments: Device: Transcutaneous Elevtrical Nerve Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03032185

48302915.1.0000.5307

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Active TENS

Active Comparator group

Description:

Active TENS, 10 Hz/200 μs

Treatment:

Device: Transcutaneous Elevtrical Nerve Stimulation

Not Active TENS

Sham Comparator group

Description:

Sham TENS

Treatment:

Device: Transcutaneous Elevtrical Nerve Stimulation