<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03032185</url>
  </required_header>
  <id_info>
    <org_study_id>48302915.1.0000.5307</org_study_id>
    <nct_id>NCT03032185</nct_id>
  </id_info>
  <brief_title>Evaluation of the Effect of Transcutaneous Electrical Nerve Stimulation (TENS) in Postmenopausal Women</brief_title>
  <official_title>Evaluation of Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Autonomic and Psychophysical Parameters in Postmenopausal Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Secretaria Municipal de Saúde de Rolante</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centro Universitario La Salle</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Secretaria Municipal de Saúde de Rolante</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Introduction: Menopause is the last menstrual period, it is a natural phenomenon to all&#xD;
      women. Postmenopausal, some women may experience unpleasant symptoms such as hot flushes,&#xD;
      urogenital pain, headache and pains in the musculoskeletal system. That happens due to the&#xD;
      decreased ovarian hormone secretion and changes in the autonomic system. Pain is also caused&#xD;
      by a complex autonomic activity. For pain management, a therapeutic electrical stimulation of&#xD;
      the peripheral nervous system promotes modulation of nociceptive incentives and release of&#xD;
      endogenous opioids. According to reviewed studies, the use of transcutaneous electrical nerve&#xD;
      stimulation (TENS), by directly stimulating the central nervous system, has presented results&#xD;
      of manipulation of the autonomic system, being observed change in heart rate and cognitive&#xD;
      improvement in dementia. Given this possibility, the present study aims to investigate&#xD;
      whether the use of Transcutaneous Electrical Nerve Stimulation in low frequency can generate&#xD;
      autonomic and psychophysical changes in healthy postmenopausal women.&#xD;
&#xD;
      Objective: To evaluate the effectiveness of Transcutaneous Electrical Nerve Stimulation on&#xD;
      autonomic and psychophysical parameters in postmenopausal women.&#xD;
&#xD;
      Methods: randomized, crossover, double-blind. A sample of thirty patients will be selected&#xD;
      according to inclusion and exclusion criteria previously established. The autonomic and&#xD;
      psychophysical functions will be evaluated by Quantitative Sensory Testing and Conditioned&#xD;
      Pain Modulation (pain thresholds to heat and modulation of conditioned pain, respectively),&#xD;
      as well as scales to evaluate catastrophism and sleep quality (by scale of Pittsburgh Sleep&#xD;
      Quality Index). After application of the scales, the participants will be subject to active&#xD;
      Ttranscutaneous Electrical Nerve Stimulation session or sham with a fortnight washout as&#xD;
      randomization. All the research subjects will be invited to participate in the study and sign&#xD;
      an Informed Consent and Informed (ICI). This study will be registered in the Clinical Trials.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">July 2017</completion_date>
  <primary_completion_date type="Anticipated">July 2017</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Autonomic changes in postmenopausal women's health</measure>
    <time_frame>30 days</time_frame>
    <description>Heart rate's modification tested by R-R interval on electrocardiogram.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Psychophysical changes in postmenopausal women´s health</measure>
    <time_frame>30 days</time_frame>
    <description>pain evaluated by Quality Sensitive Test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Descendent Inibitory System Pain changes in postmenopausal women´s health</measure>
    <time_frame>30 days</time_frame>
    <description>evaluated by conditioned pain modulated test</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Menopause</condition>
  <arm_group>
    <arm_group_label>Active TENS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Active TENS, 10 Hz/200 μs</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Not Active TENS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham TENS</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcutaneous Elevtrical Nerve Stimulation</intervention_name>
    <arm_group_label>Active TENS</arm_group_label>
    <arm_group_label>Not Active TENS</arm_group_label>
    <other_name>Transcutaneous Electrical Nerve Stimulation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  To be in the period of post-menopause;&#xD;
&#xD;
          -  Do not have chronic diseases or comorbidities in drug treatment;&#xD;
&#xD;
          -  Accept to participate in the study and sign the free and informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Start continuous medication during the study period;&#xD;
&#xD;
          -  Display cognitive problems that make it difficult to understand the questionnaires and&#xD;
             proposals;&#xD;
&#xD;
          -  History of alcohol or drug abuse in the last 6 months;&#xD;
&#xD;
          -  History of neurological disorders;&#xD;
&#xD;
          -  History of cardiac arrhythmias;&#xD;
&#xD;
          -  History of moderate or severe head injury;&#xD;
&#xD;
          -  History of neurosurgery;&#xD;
&#xD;
          -  Uncompensated systemic diseases, and chronic inflammatory diseases (diabetes, lupus,&#xD;
             rheumatoid arthritis, Sjogren's syndrome, Reiter's syndrome);&#xD;
&#xD;
          -  History of uncompensated hypothyroidism;&#xD;
&#xD;
          -  History of personal cancer, past or treatment.&#xD;
&#xD;
          -  Wish referred to leave the study at any time.&#xD;
&#xD;
          -  No attendance to the stages that make up the research.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Lucélia Cardoso</last_name>
    <phone>55 51 93646778</phone>
    <email>enflucarol@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Andressa de Souza</name>
      <address>
        <city>Canoas</city>
        <state>Rio Grande do Sul</state>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andressa de Souza, PhD</last_name>
      <phone>+55 51 81975718</phone>
      <email>andressa.souza@unilasalle.edu.br</email>
    </contact>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 22, 2016</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>January 23, 2017</last_update_submitted>
  <last_update_submitted_qc>January 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Secretaria Municipal de Saúde de Rolante</investigator_affiliation>
    <investigator_full_name>Lucélia Caroline dos santos Cardoso</investigator_full_name>
    <investigator_title>Master of Science</investigator_title>
  </responsible_party>
  <keyword>menopause</keyword>
  <keyword>post-menopause</keyword>
  <keyword>transcutaneous electrical nerve stimulation</keyword>
  <keyword>electrical stimulation therapy</keyword>
  <keyword>women's health</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03032185
org study id: 48302915.1.0000.5307
nct id: NCT03032185
lead sponsor: 
collaborator: 
has dmc: Yes
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Autonomic changes in postmenopausal women's health
time frame: 30 days
description: Heart rate's modification tested by R-R interval on electrocardiogram.
measure: Psychophysical changes in postmenopausal women´s health
time frame: 30 days
description: pain evaluated by Quality Sensitive Test
measure: Descendent Inibitory System Pain changes in postmenopausal women´s health
time frame: 30 days
description: evaluated by conditioned pain modulated test
arm group label: Active TENS
arm group type: Active Comparator
description: Active TENS, 10 Hz/200 μs
arm group label: Not Active TENS
arm group type: Sham Comparator
description: Sham TENS
intervention type: Device
intervention name: Transcutaneous Elevtrical Nerve Stimulation
arm group label: Active TENS
arm group label: Not Active TENS
other name: Transcutaneous Electrical Nerve Stimulation
criteria: 
gender: Female
minimum age: 45 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lucélia Cardoso
phone: 55 51 93646778
email: enflucarol@gmail.com
facility: 
status: Recruiting
contact: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Secretaria Municipal de Saúde de Rolante
investigator full name: Lucélia Caroline dos santos Cardoso
investigator title: Master of Science
sharing ipd: Yes