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

Menopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03032185
• Other study ID #: 48302915.1.0000.5307
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: January 22, 2016
• Last updated: January 23, 2017
• Start date: January 2017
• Est. completion date: July 2017

Study information

• Verified date: January 2017
• Source: Secretaria Municipal de Saúde de Rolante
• Contact: Lucélia Cardoso
• Phone: 55 51 93646778
• Email: enflucarol[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Menopause

Intervention

Device:
• Transcutaneous Elevtrical Nerve Stimulation

Locations

Country	Name	City	State
Brazil	Andressa de Souza	Canoas	Rio Grande do Sul

Sponsors (2)

Lead Sponsor	Collaborator
Secretaria Municipal de Saúde de Rolante	Centro Universitario La Salle

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Autonomic changes in postmenopausal women's health	Heart rate's modification tested by R-R interval on electrocardiogram.	30 days
Primary	Psychophysical changes in postmenopausal women´s health	pain evaluated by Quality Sensitive Test	30 days
Secondary	Descendent Inibitory System Pain changes in postmenopausal women´s health	evaluated by conditioned pain modulated test	30 days