We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified January 2017 by Lucélia Caroline dos santos Cardoso, Secretaria Municipal de Saúde de Rolante
Sponsor:
ClinicalTrials.gov Identifier:
NCT03032185
First Posted: January 26, 2017
Last Update Posted: January 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Centro Universitario La Salle
Information provided by (Responsible Party):
Lucélia Caroline dos santos Cardoso, Secretaria Municipal de Saúde de Rolante
  Purpose

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.


Condition Intervention Phase
Menopause Device: Transcutaneous Elevtrical Nerve Stimulation Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Autonomic and Psychophysical Parameters in Postmenopausal Women

Resource links provided by NLM:


Further study details as provided by Lucélia Caroline dos santos Cardoso, Secretaria Municipal de Saúde de Rolante:

Primary Outcome Measures:
  • Autonomic changes in postmenopausal women's health [ Time Frame: 30 days ]
    Heart rate's modification tested by R-R interval on electrocardiogram.

  • Psychophysical changes in postmenopausal women´s health [ Time Frame: 30 days ]
    pain evaluated by Quality Sensitive Test


Secondary Outcome Measures:
  • Descendent Inibitory System Pain changes in postmenopausal women´s health [ Time Frame: 30 days ]
    evaluated by conditioned pain modulated test


Estimated Enrollment: 30
Study Start Date: January 2017
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active TENS
Active TENS, 10 Hz/200 μs
Device: Transcutaneous Elevtrical Nerve Stimulation
Other Name: Transcutaneous Electrical Nerve Stimulation
Sham Comparator: Not Active TENS
Sham TENS
Device: Transcutaneous Elevtrical Nerve Stimulation
Other Name: Transcutaneous Electrical Nerve Stimulation

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   45 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032185


Contacts
Contact: Lucélia Cardoso 55 51 93646778 enflucarol@gmail.com

Locations
Brazil
Andressa de Souza Recruiting
Canoas, Rio Grande do Sul, Brazil
Contact: Andressa de Souza, PhD    +55 51 81975718    andressa.souza@unilasalle.edu.br   
Sponsors and Collaborators
Secretaria Municipal de Saúde de Rolante
Centro Universitario La Salle
  More Information

Responsible Party: Lucélia Caroline dos santos Cardoso, Master of Science, Secretaria Municipal de Saúde de Rolante
ClinicalTrials.gov Identifier: NCT03032185     History of Changes
Other Study ID Numbers: 48302915.1.0000.5307
First Submitted: January 22, 2016
First Posted: January 26, 2017
Last Update Posted: January 26, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Lucélia Caroline dos santos Cardoso, Secretaria Municipal de Saúde de Rolante:
menopause
post-menopause
transcutaneous electrical nerve stimulation
electrical stimulation therapy
women's health