<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/NCT03255538</url>
  </required_header>
  <id_info>
    <org_study_id>DFM_2</org_study_id>
    <nct_id>NCT03255538</nct_id>
  </id_info>
  <brief_title>Deep Friction Massage: Symptomatic</brief_title>
  <official_title>Deep Friction Massage Effects on Pain and Function in Patellar Tendinopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cooperativa de Ensino Superior, Politécnico e Universitário</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cooperativa de Ensino Superior, Politécnico e Universitário</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Despite DFM being a widely-used technique and the empirical grounding regarding the&#xD;
      importance of the pressure applied, there is no study characterizing the pressure applied&#xD;
      during DFM, remaining it a discretion of the physiotherapist. Additionally, it is not known&#xD;
      how the amount of pressure applied may influence pain mechanisms or function in the&#xD;
      symptomatic patellar tendon. Having this, our objective is to characterize the pressure&#xD;
      applied during deep friction massage and evaluate the immediate effects of different&#xD;
      pressures applied during deep friction massage in the time until analgesia as well as in&#xD;
      function, in patellar tendinopathy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 21, 2017</start_date>
  <completion_date type="Actual">November 20, 2017</completion_date>
  <primary_completion_date type="Actual">November 20, 2017</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time until analgesia</measure>
    <time_frame>10 minutes</time_frame>
    <description>Time until self reported sensation of analgesia, controlled by a chronometer, since the application of deep friction massage.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Numeric Pain Rating Scale</measure>
    <time_frame>20 minutes</time_frame>
    <description>Self-reported pain intensity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximal isometric strength of quadriceps</measure>
    <time_frame>20 minutes</time_frame>
    <description>Measure of maximal isometric strength, through a dynamometer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee flexion range of movement</measure>
    <time_frame>20 minutes</time_frame>
    <description>Measure of knee flexion range of movement, through a goniometer</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Tendinopathy</condition>
  <arm_group>
    <arm_group_label>DFM: Mean pressure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this group, deep friction massage will be applied with the mean pressure, previously obtained in a baseline assessment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DFM: Mean pressure - 25%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this group, deep friction massage will be applied will less 25% of the pressure previously obtained in a baseline assessment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DFM: Mean pressure +25%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this group, deep friction massage will be applied will an increment of 25% of the pressure previously obtained in a baseline assessment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control session</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In this group, the participants will rest for 15 minutes</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>DFM: Mean pressure</intervention_name>
    <description>Deep friction massage as described by Dr. James Cyriax, performed with the mean pressure previously obtained in a baseline assessment.</description>
    <arm_group_label>DFM: Mean pressure</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>DFM: Mean pressure - 25%</intervention_name>
    <description>Deep friction massage as described by Dr. James Cyriax, performed with the mean pressure previously obtained in a baseline assessment decremented by 25%.</description>
    <arm_group_label>DFM: Mean pressure - 25%</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>DFM: Mean pressure + 25%</intervention_name>
    <description>Deep friction massage as described by Dr. James Cyriax, performed with the mean pressure previously obtained in a baseline assessment incremented by 25%.</description>
    <arm_group_label>DFM: Mean pressure +25%</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The participants should have a symptomatic patellar tendon&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of other previous injuries of the lower limbs;&#xD;
&#xD;
          -  Intake of medication that could interfere with pain mechanisms;&#xD;
&#xD;
          -  Presence of any factors or conditions that could interfere with the awareness and&#xD;
             sensibility to pain.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria A Paço, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cooperativa Ensino Superior Politécnico e Universitário</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cooperativa Ensino Superior Politécnico e Universitário</name>
      <address>
        <city>Gandra</city>
        <state>Paredes</state>
        <zip>4585-116</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>March 5, 2018</last_update_submitted>
  <last_update_submitted_qc>March 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cooperativa de Ensino Superior, Politécnico e Universitário</investigator_affiliation>
    <investigator_full_name>Maria Paço</investigator_full_name>
    <investigator_title>PhD, Clinical research</investigator_title>
  </responsible_party>
  <keyword>patellar tendon</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tendinopathy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03255538
org study id: DFM_2
nct id: NCT03255538
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Despite DFM being a widely-used technique and the empirical grounding regarding the
      importance of the pressure applied, there is no study characterizing the pressure applied
      during DFM, remaining it a discretion of the physiotherapist. Additionally, it is not known
      how the amount of pressure applied may influence pain mechanisms or function in the
      symptomatic patellar tendon. Having this, our objective is to characterize the pressure
      applied during deep friction massage and evaluate the immediate effects of different
      pressures applied during deep friction massage in the time until analgesia as well as in
      function, in patellar tendinopathy.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Time until analgesia
time frame: 10 minutes
description: Time until self reported sensation of analgesia, controlled by a chronometer, since the application of deep friction massage.
measure: Numeric Pain Rating Scale
time frame: 20 minutes
description: Self-reported pain intensity.
measure: Maximal isometric strength of quadriceps
time frame: 20 minutes
description: Measure of maximal isometric strength, through a dynamometer.
measure: Knee flexion range of movement
time frame: 20 minutes
description: Measure of knee flexion range of movement, through a goniometer
arm group label: DFM: Mean pressure
arm group type: Experimental
description: In this group, deep friction massage will be applied with the mean pressure, previously obtained in a baseline assessment.
arm group label: DFM: Mean pressure - 25%
arm group type: Experimental
description: In this group, deep friction massage will be applied will less 25% of the pressure previously obtained in a baseline assessment.
arm group label: DFM: Mean pressure +25%
arm group type: Experimental
description: In this group, deep friction massage will be applied will an increment of 25% of the pressure previously obtained in a baseline assessment.
arm group label: Control session
arm group type: No Intervention
description: In this group, the participants will rest for 15 minutes
intervention type: Other
intervention name: DFM: Mean pressure
description: Deep friction massage as described by Dr. James Cyriax, performed with the mean pressure previously obtained in a baseline assessment.
arm group label: DFM: Mean pressure
intervention type: Other
intervention name: DFM: Mean pressure - 25%
description: Deep friction massage as described by Dr. James Cyriax, performed with the mean pressure previously obtained in a baseline assessment decremented by 25%.
arm group label: DFM: Mean pressure - 25%
intervention type: Other
intervention name: DFM: Mean pressure + 25%
description: Deep friction massage as described by Dr. James Cyriax, performed with the mean pressure previously obtained in a baseline assessment incremented by 25%.
arm group label: DFM: Mean pressure +25%
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Maria A Paço, PhD
role: Principal Investigator
affiliation: Cooperativa Ensino Superior Politécnico e Universitário
facility: 
country: Portugal
responsible party type: Principal Investigator
investigator affiliation: Cooperativa de Ensino Superior, Politécnico e Universitário
investigator full name: Maria Paço
investigator title: PhD, Clinical research
mesh term: Tendinopathy
sharing ipd: No