<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/NCT03834077</url>
  </required_header>
  <id_info>
    <org_study_id>Ujaenflossing</org_study_id>
    <nct_id>NCT03834077</nct_id>
  </id_info>
  <brief_title>Tissue Flossing in Tennis Elbow Patients</brief_title>
  <acronym>FLOSS</acronym>
  <official_title>The Effect of Tissue Flossing in Patients With Tennis Elbow</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Jaén</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Jaén</source>
  <oversight_info>
    <has_dmc>Yes</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 the present intervention is to determine the effectiveness of the application of&#xD;
      tissue flossing in patients with tennis elbow&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The application of tissue flossing has been deemed to provide beneficial results in patients&#xD;
      with ankle range of motion limitation. Although, tissue flossing is widely extended among&#xD;
      athletes due to its effectiveness in pain, function and range of motion, the evidence is&#xD;
      limited.&#xD;
&#xD;
      The aim of the present protocol is to determine the effectiveness of tissue flossing in&#xD;
      patients with tennis elbow.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 20, 2019</start_date>
  <completion_date type="Anticipated">April 10, 2019</completion_date>
  <primary_completion_date type="Anticipated">March 28, 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>
    <intervention_model_description>Randomized controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Patients will be allocated to intervention (flossing) or control group (conventional physiotherapy) using a randomized list of allocated numbers generated by a computer program. Opaque envelope will contain the patients allocation while outcome assessors, care provider and principal investigator will be blinded to the allocation process.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Patient-related Tennis Elbow Questionnaire change</measure>
    <time_frame>At baseline, after 1 week and after 4 week.</time_frame>
    <description>Self reported questionnaire ranged from 0 to 150 with greater scores associated with severe disability.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Numeric rating scale change</measure>
    <time_frame>At baseline, after 1 week and after 4 week.</time_frame>
    <description>10 point rating scale of pain where 0 is associated with no pain and 10 with greatest pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pressure Pain Threshold change</measure>
    <time_frame>At baseline, after 1 week and after 4 week.</time_frame>
    <description>Determine the pain free pression with a validated instrument</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Tennis Elbow</condition>
  <arm_group>
    <arm_group_label>Tissue flossing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Conventional physiotherapy consisted in electrotherapy and stretching in addition to tissue flossing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo comparator</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Conventional physiotherapy consisted in electrotherapy and stretching in addition with tissue flossing without tension.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Tissue flossing</intervention_name>
    <description>Electrotherapy (transcutaneous electrical nerve stimulation) and Ultrasound in addition to tissue flossing.</description>
    <arm_group_label>Tissue flossing</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo comparator</intervention_name>
    <description>Conventional physiotherapy in addition to flossing without tension</description>
    <arm_group_label>Placebo comparator</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elbow pain for at least 6 weeks and satisfy the widely accepted diagnostic criteria of&#xD;
             lateral epicondylalgia.&#xD;
&#xD;
          -  Diagnostic criteria are pain over the lateral humeral epicondyle that is provoked by&#xD;
             gripping activities.&#xD;
&#xD;
          -  Reduced grip strength and increased sensitivity to manual palpation over the lateral&#xD;
             epicondyle.&#xD;
&#xD;
          -  Pain with stretching or contraction of the wrist extensor muscles.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Upper limb fractures, surgery or concomitant disease.&#xD;
&#xD;
          -  Red flags presence.&#xD;
&#xD;
          -  Mental disorders.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Cruz-Diaz, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Jaen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>David Cruz-Diaz, PhD</last_name>
    <phone>953213408</phone>
    <email>dcruz@ujaen.es</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Jaen</name>
      <address>
        <city>Jaen</city>
        <zip>23071</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>February 6, 2019</last_update_submitted>
  <last_update_submitted_qc>February 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Jaén</investigator_affiliation>
    <investigator_full_name>DAVID CRUZ DÍAZ</investigator_full_name>
    <investigator_title>Vice Dean</investigator_title>
  </responsible_party>
  <keyword>physiotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tennis Elbow</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>This intervention could be beneficial to support or refuse the use of tissue flossing.</ipd_description>
  </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/NCT03834077
org study id: Ujaenflossing
nct id: NCT03834077
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of the present intervention is to determine the effectiveness of the application of
      tissue flossing in patients with tennis elbow
The application of tissue flossing has been deemed to provide beneficial results in patients
      with ankle range of motion limitation. Although, tissue flossing is widely extended among
      athletes due to its effectiveness in pain, function and range of motion, the evidence is
      limited.

      The aim of the present protocol is to determine the effectiveness of tissue flossing in
      patients with tennis elbow.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled trial
primary purpose: Treatment
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
masking description: Patients will be allocated to intervention (flossing) or control group (conventional physiotherapy) using a randomized list of allocated numbers generated by a computer program. Opaque envelope will contain the patients allocation while outcome assessors, care provider and principal investigator will be blinded to the allocation process.
measure: Patient-related Tennis Elbow Questionnaire change
time frame: At baseline, after 1 week and after 4 week.
description: Self reported questionnaire ranged from 0 to 150 with greater scores associated with severe disability.
measure: Numeric rating scale change
time frame: At baseline, after 1 week and after 4 week.
description: 10 point rating scale of pain where 0 is associated with no pain and 10 with greatest pain.
measure: Pressure Pain Threshold change
time frame: At baseline, after 1 week and after 4 week.
description: Determine the pain free pression with a validated instrument
arm group label: Tissue flossing
arm group type: Experimental
description: Conventional physiotherapy consisted in electrotherapy and stretching in addition to tissue flossing.
arm group label: Placebo comparator
arm group type: Placebo Comparator
description: Conventional physiotherapy consisted in electrotherapy and stretching in addition with tissue flossing without tension.
intervention type: Other
intervention name: Tissue flossing
description: Electrotherapy (transcutaneous electrical nerve stimulation) and Ultrasound in addition to tissue flossing.
arm group label: Tissue flossing
intervention type: Other
intervention name: Placebo comparator
description: Conventional physiotherapy in addition to flossing without tension
arm group label: Placebo comparator
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: David Cruz-Diaz, PhD
role: Principal Investigator
affiliation: University of Jaen
last name: David Cruz-Diaz, PhD
phone: 953213408
email: dcruz@ujaen.es
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: University of Jaén
investigator full name: DAVID CRUZ DÍAZ
investigator title: Vice Dean
mesh term: Tennis Elbow
sharing ipd: Undecided
ipd description: This intervention could be beneficial to support or refuse the use of tissue flossing.