<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/NCT02196948</url>
  </required_header>
  <id_info>
    <org_study_id>URJC 22/2014</org_study_id>
    <nct_id>NCT02196948</nct_id>
  </id_info>
  <brief_title>Electrolysis Percutaneous Therapeutic (EPTE) for Supraspinatus Tendinopathy</brief_title>
  <official_title>Electrolysis Percutaneous Therapeutic (EPTE) for the Management of Supraspinatus Tendinopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Rey Juan Carlos</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Rey Juan Carlos</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Therapeutic management of supraspinatus tendinopathy is conflicting. There is evidence that&#xD;
      eccentric exercise protocols can be effective for this condition. The inclusion of other&#xD;
      therapeutic modalities could help to the management of these patients. A new therapeutic&#xD;
      approach, called Electrolysis Percutaneous Therapeutic (EPTE) has been clinically developed.&#xD;
      The objective of this randomized clinical trial is to determine the effectiveness of the&#xD;
      inclusion of EPTE into a eccentric exercise protocol for the management of patients with&#xD;
      unilateral supraspinatus tendinopathy&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Changes in pain intensity before and after the intervention</measure>
    <time_frame>Baseline, after 2 weeks of treatment and one week after the last session</time_frame>
    <description>A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of shoulder pain, and the worst and lowest level of pain experienced in the preceding week in the shoulder area.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in disability before and after the intervention</measure>
    <time_frame>Baseline, after 2 weeks of treatment and one week after the last session</time_frame>
    <description>The Disabilities of the Arm, Shoulder and Hand (DASH) will be used to determine the disability induced by shoulder pain</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Supraspinatus Tendinopathy</condition>
  <arm_group>
    <arm_group_label>Electrolysis Percutaneous Therapeutic (EPTE)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Electrolysis Percutaneous Therapeutic (EPTE) consists of the application of a galvanic electrical current with an acupuncture needle in the soft tissue, in this case the supraspinatus tendon, to initiate a local inflammatory process allowing phagocytosis and repair of the affected tissue. The technique is pain-free since the electrical intensity is adapted to each patient. In addition, patients will be asked to perform an eccentric loading exercise program for the shoulder musculature, particularly the supraspinatus and infraspinatus muscles, to be performed on an individual basis twice every day. The therapeutic protocol will be applied for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Eccentric exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be asked to perform an eccentric loading exercise program for the shoulder musculature, particularly the supraspinatus and infraspinatus muscles, to be performed on an individual basis twice every day. The therapeutic protocol will be applied for 4 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Electrolysis Percutaneous Therapeutic (EPTE)</intervention_name>
    <arm_group_label>Electrolysis Percutaneous Therapeutic (EPTE)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Eccentric exercise</intervention_name>
    <arm_group_label>Eccentric exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Unilateral supraspinatus tendinopathy&#xD;
&#xD;
          -  Shoulder pain from at least 3 months&#xD;
&#xD;
          -  Shoulder pain of more than 4 points on a NPRS&#xD;
&#xD;
          -  Positive findings of supraspinatus tendinopathy on MRI&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  bilateral shoulder symptoms&#xD;
&#xD;
          -  younger than 18 or older than 65 years&#xD;
&#xD;
          -  history of shoulder fractures or dislocation&#xD;
&#xD;
          -  cervical radiculopathy&#xD;
&#xD;
          -  previous interventions with steroid injections&#xD;
&#xD;
          -  fibromyalgia syndrome&#xD;
&#xD;
          -  previous history of shoulder or neck surgery&#xD;
&#xD;
          -  any type of intervention for the neck-shoulder area during the previous year&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jose Luis Arias Buría, PT, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitario Gregorio Marañón-Universidad Rey Juan Carlos</affiliation>
  </overall_official>
  <overall_official>
    <last_name>César Fernández de las Peñas, PT, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad Rey Juan Carlos</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universidad Rey Juan Carlos</name>
      <address>
        <city>Alcorcon</city>
        <state>Madrid</state>
        <zip>28922</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>July 19, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>December 2, 2014</last_update_submitted>
  <last_update_submitted_qc>December 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 3, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Rey Juan Carlos</investigator_affiliation>
    <investigator_full_name>César Fernández-de-las-Peñas</investigator_full_name>
    <investigator_title>Proffesor</investigator_title>
  </responsible_party>
  <keyword>Supraspinatus, tendinopathy, pain, disability, EPTE</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tendinopathy</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/NCT02196948
org study id: URJC 22/2014
nct id: NCT02196948
lead sponsor: 
has dmc: Yes
Therapeutic management of supraspinatus tendinopathy is conflicting. There is evidence that
      eccentric exercise protocols can be effective for this condition. The inclusion of other
      therapeutic modalities could help to the management of these patients. A new therapeutic
      approach, called Electrolysis Percutaneous Therapeutic (EPTE) has been clinically developed.
      The objective of this randomized clinical trial is to determine the effectiveness of the
      inclusion of EPTE into a eccentric exercise protocol for the management of patients with
      unilateral supraspinatus tendinopathy
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Changes in pain intensity before and after the intervention
time frame: Baseline, after 2 weeks of treatment and one week after the last session
description: A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of shoulder pain, and the worst and lowest level of pain experienced in the preceding week in the shoulder area.
measure: Changes in disability before and after the intervention
time frame: Baseline, after 2 weeks of treatment and one week after the last session
description: The Disabilities of the Arm, Shoulder and Hand (DASH) will be used to determine the disability induced by shoulder pain
arm group label: Electrolysis Percutaneous Therapeutic (EPTE)
arm group type: Experimental
description: Electrolysis Percutaneous Therapeutic (EPTE) consists of the application of a galvanic electrical current with an acupuncture needle in the soft tissue, in this case the supraspinatus tendon, to initiate a local inflammatory process allowing phagocytosis and repair of the affected tissue. The technique is pain-free since the electrical intensity is adapted to each patient. In addition, patients will be asked to perform an eccentric loading exercise program for the shoulder musculature, particularly the supraspinatus and infraspinatus muscles, to be performed on an individual basis twice every day. The therapeutic protocol will be applied for 4 weeks.
arm group label: Eccentric exercise
arm group type: Experimental
description: Patients will be asked to perform an eccentric loading exercise program for the shoulder musculature, particularly the supraspinatus and infraspinatus muscles, to be performed on an individual basis twice every day. The therapeutic protocol will be applied for 4 weeks.
intervention type: Other
intervention name: Electrolysis Percutaneous Therapeutic (EPTE)
arm group label: Electrolysis Percutaneous Therapeutic (EPTE)
intervention type: Other
intervention name: Eccentric exercise
arm group label: Eccentric exercise
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Jose Luis Arias Buría, PT, MSc
role: Principal Investigator
affiliation: Hospital Universitario Gregorio Marañón-Universidad Rey Juan Carlos
last name: César Fernández de las Peñas, PT, PhD
role: Principal Investigator
affiliation: Universidad Rey Juan Carlos
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad Rey Juan Carlos
investigator full name: César Fernández-de-las-Peñas
investigator title: Proffesor
mesh term: Tendinopathy