<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/NCT03781349</url>
  </required_header>
  <id_info>
    <org_study_id>EBD624/6-2-15</org_study_id>
    <nct_id>NCT03781349</nct_id>
  </id_info>
  <brief_title>TENS of MENS for Rotator Cuff Tear</brief_title>
  <official_title>Comparative Efficacy on Pain of Two Non-pharmacological Treatments (TENS or MENS) in Patients With Partial Rotator Cuff Tears. A Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Attikon Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Attikon Hospital</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>
      The aim of this study was to clarify the effectiveness of physiotherapeutic intervention&#xD;
      through the TENS or MENS in conjunction with kinesiotherapy in patients with partial&#xD;
      thickness rotator cuff tear.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary characteristic of a rotator cuff tear is pain, while muscle weakness appears as a&#xD;
      secondary feature, leading to further disability.&#xD;
&#xD;
      The aim of this study was to clarify the effectiveness of physiotherapeutic intervention&#xD;
      through the TENS or MENS in conjunction with kinesiotherapy in patients with partial&#xD;
      thickness rotator cuff tear.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2015</start_date>
  <completion_date type="Actual">December 2019</completion_date>
  <primary_completion_date type="Actual">December 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>Pain intensity: NRS</measure>
    <time_frame>up to 3 months after intervention</time_frame>
    <description>Numeric Rating Scale, ranging from 0-10 (with 0 = no pain, and 10=worst pain). It measures pain intensity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disability</measure>
    <time_frame>up to 3 months after intervention</time_frame>
    <description>SPADI questionnaire (shoulder pain and disability questionnaire). It measures pain and disability caused by shoulder diseases, each question ranging between 0 and 10 (with 0 indicating no disability and 10 indicating worst disability). It includes 5 questions about pain and 8 questions about disability.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>quality of patients' life: EQ 5D</measure>
    <time_frame>up to 3 months after intervention</time_frame>
    <description>EQ 5D, EuroQol measuring of perceived Health today, Scale 0-100 (with 0 indicating worst health, and 100 indicating best imaginable health as perceived by the patient)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Rotator Cuff Tear</condition>
  <arm_group>
    <arm_group_label>MENS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>MENS are applied through placement of six electrodes (size of 4x4cm), of which four were placed exactly like the TENS electrodes and the other two, one in the palm and the other at the height of the asteroid ganglion. Duration of the intervention was 24 min for a total of 15 sessions. The frequency was 50 Hz and the intensity was 100 μA.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TENS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>TENS are applied through the placement of four electrodes on either side of the deltoid muscle, on the front and back surfaces of the shoulder joint for 20 min and each patient received 15 sessions (five per week). A constant current of high frequency was used (100 HZ) and its intensity was initiated at 10mA and was then gradually increased to 15mA</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MENS</intervention_name>
    <arm_group_label>MENS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TENS</intervention_name>
    <arm_group_label>TENS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients suffering shoulder pain because of partial thickness rotator cuff tear,&#xD;
             confirmed with MRI and ultrasound scanning.&#xD;
&#xD;
          -  Patients not receiving any recent pharmacotherapy with NSAIDs during the last month,&#xD;
             or surgery at the shoulder area at any time point,&#xD;
&#xD;
          -  The referral orthopedic had suggested physiotherapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with open wounds or skin diseases in the shoulder area&#xD;
&#xD;
          -  pregnant women&#xD;
&#xD;
          -  patients with any type of neoplastic disease&#xD;
&#xD;
          -  patients with pacemakers or serious cardiovascular diseases including arrhythmia, -&#xD;
             patients with collagen diseases&#xD;
&#xD;
          -  history of shoulder surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.</name>
      <address>
        <city>Athens</city>
        <zip>12462</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>April 10, 2020</last_update_submitted>
  <last_update_submitted_qc>April 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Attikon Hospital</investigator_affiliation>
    <investigator_full_name>Chrysanthi Batistaki</investigator_full_name>
    <investigator_title>Assistant Professor of Anesthesiology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rotator Cuff Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03781349
org study id: EBD624/6-2-15
nct id: NCT03781349
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to clarify the effectiveness of physiotherapeutic intervention
      through the TENS or MENS in conjunction with kinesiotherapy in patients with partial
      thickness rotator cuff tear.
The primary characteristic of a rotator cuff tear is pain, while muscle weakness appears as a
      secondary feature, leading to further disability.

      The aim of this study was to clarify the effectiveness of physiotherapeutic intervention
      through the TENS or MENS in conjunction with kinesiotherapy in patients with partial
      thickness rotator cuff tear.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Pain intensity: NRS
time frame: up to 3 months after intervention
description: Numeric Rating Scale, ranging from 0-10 (with 0 = no pain, and 10=worst pain). It measures pain intensity
measure: Disability
time frame: up to 3 months after intervention
description: SPADI questionnaire (shoulder pain and disability questionnaire). It measures pain and disability caused by shoulder diseases, each question ranging between 0 and 10 (with 0 indicating no disability and 10 indicating worst disability). It includes 5 questions about pain and 8 questions about disability.
measure: quality of patients' life: EQ 5D
time frame: up to 3 months after intervention
description: EQ 5D, EuroQol measuring of perceived Health today, Scale 0-100 (with 0 indicating worst health, and 100 indicating best imaginable health as perceived by the patient)
arm group label: MENS
arm group type: Active Comparator
description: MENS are applied through placement of six electrodes (size of 4x4cm), of which four were placed exactly like the TENS electrodes and the other two, one in the palm and the other at the height of the asteroid ganglion. Duration of the intervention was 24 min for a total of 15 sessions. The frequency was 50 Hz and the intensity was 100 μA.
arm group label: TENS
arm group type: Active Comparator
description: TENS are applied through the placement of four electrodes on either side of the deltoid muscle, on the front and back surfaces of the shoulder joint for 20 min and each patient received 15 sessions (five per week). A constant current of high frequency was used (100 HZ) and its intensity was initiated at 10mA and was then gradually increased to 15mA
intervention type: Device
intervention name: MENS
arm group label: MENS
intervention type: Device
intervention name: TENS
arm group label: TENS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Greece
responsible party type: Principal Investigator
investigator affiliation: Attikon Hospital
investigator full name: Chrysanthi Batistaki
investigator title: Assistant Professor of Anesthesiology
mesh term: Rotator Cuff Injuries
sharing ipd: Undecided