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

Phase 1

• Conditions: Menopause
• Interventions: Device: Transcutaneous Elevtrical Nerve Stimulation

• Registration Number: NCT03032185
• Lead Sponsor: Secretaria Municipal de Saúde de Rolante

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-22
• Status Verified: 2017-01
• Study Start: 2017-01
• Study First Submitted QC: 2017-01-23
• Last Update Submitted: 2017-01-23
• Study First Posted: 2017-01-26
• Last Update Posted: 2017-01-26
• Primary Completion: 2017-07
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active TENS	Transcutaneous Elevtrical Nerve Stimulation	Active TENS, 10 Hz/200 μs
Not Active TENS	Transcutaneous Elevtrical Nerve Stimulation	Sham TENS

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Descendent Inibitory System Pain changes in postmenopausal women´s health	30 days	evaluated by conditioned pain modulated test

Trial Locations

Locations (1)

Andressa de Souza; 🇧🇷 Canoas, Rio Grande do Sul, Brazil