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

NCT03032185 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-01-26

No results posted yet for this study

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. 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

Interventions

DEVICE

Transcutaneous Elevtrical Nerve Stimulation

Sponsors & Collaborators

  • Centro Universitario La Salle

    collaborator OTHER

  • Secretaria Municipal de Saúde de Rolante

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2017-07-31
Completion
2017-07-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03032185 on ClinicalTrials.gov