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

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

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.

Study Overview

• Status: Unknown
• Conditions: Menopause
• Intervention / Treatment: Device: Transcutaneous Elevtrical Nerve Stimulation

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Lucélia Cardoso; Phone Number: 55 51 93646778; Email: enflucarol@gmail.com

Study Locations

• Brazil
  • Rio Grande do Sul
    • Canoas, Rio Grande do Sul, Brazil
      • Recruiting
      • Andressa de Souza
      • Contact: Andressa de Souza, PhD; Phone Number: +55 51 81975718; Email: andressa.souza@unilasalle.edu.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active TENS; Active TENS, 10 Hz/200 μs	Device: Transcutaneous Elevtrical Nerve Stimulation; Other Names: Transcutaneous Electrical Nerve Stimulation
Sham Comparator: Not Active TENS; Sham TENS	Device: Transcutaneous Elevtrical Nerve Stimulation; Other Names: Transcutaneous Electrical Nerve Stimulation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Secretaria Municipal de Saúde de Rolante
• Collaborators: Centro Universitario La Salle

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): July 1, 2017
• Study Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: January 22, 2016
• First Submitted That Met QC Criteria: January 23, 2017
• First Posted (Estimate): January 26, 2017

Study Record Updates

• Last Update Posted (Estimate): January 26, 2017
• Last Update Submitted That Met QC Criteria: January 23, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: menopause; women's health; transcutaneous electrical nerve stimulation; post-menopause; electrical stimulation therapy
• Other Study ID Numbers: 48302915.1.0000.5307

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES