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

NCT03032185 | Unknown Phase 1 DMC

• 1 other identifier: 48302915.1.0000.5307
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause

Keywords

menopause; post-menopause; transcutaneous electrical nerve stimulation; electrical stimulation therapy; women's health

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Descendent Inibitory System Pain changes in postmenopausal women´s health

  30 days

Study Arms (2)

Active TENS

ACTIVE COMPARATOR

Active TENS, 10 Hz/200 μs

Device: Transcutaneous Elevtrical Nerve Stimulation

Not Active TENS

SHAM COMPARATOR

Sham TENS

Device: Transcutaneous Elevtrical Nerve Stimulation

Interventions

Transcutaneous Elevtrical Nerve Stimulation DEVICE

Also known as: Transcutaneous Electrical Nerve Stimulation

Active TENS; Not Active TENS

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Secretaria Municipal de Saúde de Rolante: lead
• Centro Universitario La Salle: collaborator

Study Sites (1)

Andressa de Souza

Canoas, Rio Grande do Sul, Brazil

RECRUITING

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Central Study Contacts

Lucélia Cardoso

CONTACT

55 51 93646778; enflucarol@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master of Science

Study Record Dates

• First Submitted: January 22, 2016
• First Posted: January 26, 2017
• Study Start: January 1, 2017
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: January 26, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)