<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/NCT02998957</url>
  </required_header>
  <id_info>
    <org_study_id>PIC-195-15</org_study_id>
    <nct_id>NCT02998957</nct_id>
  </id_info>
  <brief_title>Acupoint Transcutaneous Electrical Nerve Stimulation in Hospitalized COPD Patients With Severe Dyspnoea</brief_title>
  <official_title>Efficacy of Transcutaneous Electrical Stimulation at Dingchuan (EX-B1) in Hospitalized COPD Patients With Severe Dyspnoea: Patient and Assessor Blinded Randomized Placebo Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundació Sant Joan de Déu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundació Sant Joan de Déu</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Introduction:&#xD;
&#xD;
      Chronic obstructive pulmonary disease (COPD) presents with a gradual reduction and little&#xD;
      bitterness reversible airflow causing shortness of breath, chronic cough and sputum abnormal.&#xD;
      Patients with COPD often suffer exacerbations of their symptoms, particularly dyspnea,&#xD;
      causing hospital admissions. Recent studies have shown that acupuncture stimulation&#xD;
      transcutánea (AcuTENS) Dingchuan point (EX-B1) could help reduce dyspnea in patients with&#xD;
      COPD.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      The aim of this study was to evaluate the possible utility of adding to the usual treatment&#xD;
      stimulation AcuTENS in COPD patients admitted with severe dyspnea.&#xD;
&#xD;
      Methodology:&#xD;
&#xD;
      Patients who agree to participate will be randomly divided into two groups. The intervention&#xD;
      group will receive a daily treatment, during the period of hospitalization, 45 minutes&#xD;
      stimulation at acupuncture point AcuTENS Dingchuan (EX-B1), while the control group performed&#xD;
      the same procedure with a device TENS simulated. The extent of dyspnea in both groups as well&#xD;
      as the number of days of hospitalization and the number of drugs consumed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 1, 2018</start_date>
  <completion_date type="Anticipated">September 2019</completion_date>
  <primary_completion_date type="Anticipated">June 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dyspnoea</measure>
    <time_frame>At baseline, day 1, day 2, day 3 day 4 and day 5 of the study.</time_frame>
    <description>Change from baseline using the modified Borg scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospitalization days</measure>
    <time_frame>Up to 1 months after discharge</time_frame>
    <description>Number of days from the time of admission until discharge will be collected from the patient's clinical history</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantity of drug administered</measure>
    <time_frame>Up to 1 months after discharge</time_frame>
    <description>Amount of drugs administered during the hospitalization will be determined by data collected from the patient's clinical history</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak expiratory flow</measure>
    <time_frame>At baseline, day 1, day 2, day 3 day 4 and day 5 of the study.</time_frame>
    <description>Change from baseline using a peak flow meter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PaO2</measure>
    <time_frame>At baseline, day 1, day 2, day 3 day 4 and day 5 of the study. (only if there is a medical indication for it)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>Up to 3 months after discharge</time_frame>
    <description>Percentage of deaths 3 months after discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PaCO2</measure>
    <time_frame>At baseline, day 1, day 2, day 3 day 4 and day 5 of the study. (only if there is a medical indication for it)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arterial blood pH</measure>
    <time_frame>At baseline, day 1, day 2, day 3 day 4 and day 5 of the study. (only if there is a medical indication for it)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SaO2</measure>
    <time_frame>At baseline, day 1, day 2, day 3 day 4 and day 5 of the study. (only if there is a medical indication for it)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relapses</measure>
    <time_frame>Up to 3 months after discharge</time_frame>
    <description>Percentage of relapses 3 months after discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readmissions</measure>
    <time_frame>Up to 3 months after discharge</time_frame>
    <description>Percentage of readmissions 3 months after discharge</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Pulmonary Disease, Chronic Obstructive</condition>
  <arm_group>
    <arm_group_label>AcuTENS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stimulation using a portable TENS electrostimulation device at Dingchuan point using a biphasic rectangular wave with a frequency of 2Hz and a pulse width of 200 ms. The stimulation will be achieved using the highest intensity tolerated by the patient without pain during 40 minuts.&#xD;
Once a day during 5 consecutive days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham AcuTENS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Stimulation using a modified portable TENS electrostimulation device at Dingchuan point with no electrical output, even though the screen will light up and display the same data as in the unmodified device during 40 minuts. Patients in this group will be informed that, due to the frequency of stimulation, it is unlikely that they will feel the electric stimulation.&#xD;
Once a day during 5 consecutive days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>AcuTENS</intervention_name>
    <description>Stimulation of acupuncture point Dingchuan using transcutaneous electrical nerve stimulation (TENS) instead of needles</description>
    <arm_group_label>AcuTENS</arm_group_label>
    <other_name>TENS</other_name>
    <other_name>Acupoint transcutaneous electrical nerve stimulation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham AcuTENS</intervention_name>
    <description>Portable TENS electrostimulation device with no electrical output</description>
    <arm_group_label>Sham AcuTENS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients aged between 45 and 70 years, with a diagnose of COPD according to the GOLD&#xD;
             guidelines.&#xD;
&#xD;
          2. Patients with one episode of hospitalization for COPD exacerbation in the past year,&#xD;
             but not more than three episodes.&#xD;
&#xD;
          3. Smoking habit history of more than 10 packages-year.&#xD;
&#xD;
          4. Patients able to correctly understand and answer the modified Borg scale.&#xD;
&#xD;
          5. Patiens with an initial degree of dyspnoea with a score of at least 5 in the modified&#xD;
             Borg scale.&#xD;
&#xD;
          6. Patients recruited for the study during the first 48 hours of their hospitalization.&#xD;
&#xD;
          7. Patients who accept to participate in the study and sign the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with any contraindication for transcutaneous electrical stimulation (patiens&#xD;
             with pacemakers, skin injury in the application area ...).&#xD;
&#xD;
          2. Patiens with any cardiovascular, neurological or psychiatric disease that may affect&#xD;
             the perception of dyspnea.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Carlres Fernández, MSc</last_name>
    <phone>0034651503494</phone>
    <email>carlesfj@blanquerna.url.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital Sant Joan de Déu de Manresa</name>
      <address>
        <city>Manresa</city>
        <state>Barcelona</state>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Esther Casado, Dr</last_name>
      <email>ecasado@althaia.cat</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Parc Sanitari de Sant Joan de Déu</name>
      <address>
        <city>Sant Boi de Llobregat</city>
        <state>Barcelona</state>
        <zip>08830</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Raffaele MD Fiorillo, MD</last_name>
      <phone>+34 6770640899</phone>
      <email>r.fiorillo@pssjd.org</email>
    </contact>
    <investigator>
      <last_name>Carles Fernández, MSc</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Raffaele Fiorillo, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jordi Vilaró, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital del Mar</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Diego Austin Rodriguez, Dr</last_name>
      <email>darodriguez@parcdesalutmar.cat</email>
    </contact>
    <investigator>
      <last_name>Anna Rodó</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>September 30, 2018</last_update_submitted>
  <last_update_submitted_qc>September 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acupuncture</keyword>
  <keyword>TENS</keyword>
  <keyword>Physiotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyspnea</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <!-- 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/NCT02998957
org study id: PIC-195-15
nct id: NCT02998957
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Introduction:

      Chronic obstructive pulmonary disease (COPD) presents with a gradual reduction and little
      bitterness reversible airflow causing shortness of breath, chronic cough and sputum abnormal.
      Patients with COPD often suffer exacerbations of their symptoms, particularly dyspnea,
      causing hospital admissions. Recent studies have shown that acupuncture stimulation
      transcutánea (AcuTENS) Dingchuan point (EX-B1) could help reduce dyspnea in patients with
      COPD.

      Objective:

      The aim of this study was to evaluate the possible utility of adding to the usual treatment
      stimulation AcuTENS in COPD patients admitted with severe dyspnea.

      Methodology:

      Patients who agree to participate will be randomly divided into two groups. The intervention
      group will receive a daily treatment, during the period of hospitalization, 45 minutes
      stimulation at acupuncture point AcuTENS Dingchuan (EX-B1), while the control group performed
      the same procedure with a device TENS simulated. The extent of dyspnea in both groups as well
      as the number of days of hospitalization and the number of drugs consumed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Dyspnoea
time frame: At baseline, day 1, day 2, day 3 day 4 and day 5 of the study.
description: Change from baseline using the modified Borg scale
measure: Hospitalization days
time frame: Up to 1 months after discharge
description: Number of days from the time of admission until discharge will be collected from the patient's clinical history
measure: Quantity of drug administered
time frame: Up to 1 months after discharge
description: Amount of drugs administered during the hospitalization will be determined by data collected from the patient's clinical history
measure: Peak expiratory flow
time frame: At baseline, day 1, day 2, day 3 day 4 and day 5 of the study.
description: Change from baseline using a peak flow meter
measure: PaO2
time frame: At baseline, day 1, day 2, day 3 day 4 and day 5 of the study. (only if there is a medical indication for it)
measure: Mortality
time frame: Up to 3 months after discharge
description: Percentage of deaths 3 months after discharge
measure: PaCO2
time frame: At baseline, day 1, day 2, day 3 day 4 and day 5 of the study. (only if there is a medical indication for it)
measure: Arterial blood pH
time frame: At baseline, day 1, day 2, day 3 day 4 and day 5 of the study. (only if there is a medical indication for it)
measure: SaO2
time frame: At baseline, day 1, day 2, day 3 day 4 and day 5 of the study. (only if there is a medical indication for it)
measure: Relapses
time frame: Up to 3 months after discharge
description: Percentage of relapses 3 months after discharge
measure: Readmissions
time frame: Up to 3 months after discharge
description: Percentage of readmissions 3 months after discharge
arm group label: AcuTENS
arm group type: Experimental
description: Stimulation using a portable TENS electrostimulation device at Dingchuan point using a biphasic rectangular wave with a frequency of 2Hz and a pulse width of 200 ms. The stimulation will be achieved using the highest intensity tolerated by the patient without pain during 40 minuts.
Once a day during 5 consecutive days.
arm group label: Sham AcuTENS
arm group type: Sham Comparator
description: Stimulation using a modified portable TENS electrostimulation device at Dingchuan point with no electrical output, even though the screen will light up and display the same data as in the unmodified device during 40 minuts. Patients in this group will be informed that, due to the frequency of stimulation, it is unlikely that they will feel the electric stimulation.
Once a day during 5 consecutive days.
intervention type: Device
intervention name: AcuTENS
description: Stimulation of acupuncture point Dingchuan using transcutaneous electrical nerve stimulation (TENS) instead of needles
arm group label: AcuTENS
other name: TENS
other name: Acupoint transcutaneous electrical nerve stimulation
intervention type: Device
intervention name: Sham AcuTENS
description: Portable TENS electrostimulation device with no electrical output
arm group label: Sham AcuTENS
criteria: 
gender: All
minimum age: 45 Years
maximum age: 80 Years
healthy volunteers: No
last name: Carlres Fernández, MSc
phone: 0034651503494
email: carlesfj@blanquerna.url.edu
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Spain
responsible party type: Sponsor
mesh term: Dyspnea
mesh term: Pulmonary Disease, Chronic Obstructive