<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/NCT03255525</url>
  </required_header>
  <id_info>
    <org_study_id>DFM_1</org_study_id>
    <nct_id>NCT03255525</nct_id>
  </id_info>
  <brief_title>Deep Friction Massage Effects: Asymptomatic</brief_title>
  <acronym>DFM_Asymp</acronym>
  <official_title>Deep Friction Massage Effects on Analgesia of the Asymptomatic Patellar Tendon</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 and, consequently how it&#xD;
      affects the time needed promote an analgesic response.&#xD;
&#xD;
      Having this, our general objective is to establish a dose-response relationship between the&#xD;
      pressure applied during DFM and time of onset of analgesia, in the asymptomatic patellar&#xD;
      tendon.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 26, 2017</start_date>
  <completion_date type="Actual">August 16, 2017</completion_date>
  <primary_completion_date type="Actual">August 16, 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>Self reported sensation of analgesia, controlled by a chronometer</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Deep Friction Massage</condition>
  <arm_group>
    <arm_group_label>Deep friction massage P50</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this group it was applied a pressure previously found to be the mean pressure applied by physiotherapists during deep friction massage.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Deep friction massage P25</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this group it was applied the percentile 25, of the pressure previously found to be the mean pressure applied by physiotherapists during deep friction massage.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Deep friction massage P75</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this group it was applied the percentile 75, of the pressure previously found to be the mean pressure applied by physiotherapists during deep friction massage.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Deep friction massage P50</intervention_name>
    <description>Deep friction massage as described by Dr. James Cyriax, applied with the mean pressure (P50)</description>
    <arm_group_label>Deep friction massage P50</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Deep friction massage P25</intervention_name>
    <description>Deep friction massage as described by Dr. James Cyriax, applied with the percentile 25 of the mean pressure (P25)</description>
    <arm_group_label>Deep friction massage P25</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Deep friction massage P75</intervention_name>
    <description>Deep friction massage as described by Dr. James Cyriax, applied with the percentile 75 of the mean pressure (P75)</description>
    <arm_group_label>Deep friction massage P75</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  the participants should have an asymptomatic patellar tendon&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of previous injury 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 tendinous tissue&#xD;
             as well as with the awareness and sensibility to pain.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</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>August 2017</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>August 18, 2017</last_update_submitted>
  <last_update_submitted_qc>August 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2017</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>
  <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/NCT03255525
org study id: DFM_1
nct id: NCT03255525
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 and, consequently how it
      affects the time needed promote an analgesic response.

      Having this, our general objective is to establish a dose-response relationship between the
      pressure applied during DFM and time of onset of analgesia, in the asymptomatic patellar
      tendon.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Time until analgesia
time frame: 10 minutes
description: Self reported sensation of analgesia, controlled by a chronometer
arm group label: Deep friction massage P50
arm group type: Active Comparator
description: In this group it was applied a pressure previously found to be the mean pressure applied by physiotherapists during deep friction massage.
arm group label: Deep friction massage P25
arm group type: Experimental
description: In this group it was applied the percentile 25, of the pressure previously found to be the mean pressure applied by physiotherapists during deep friction massage.
arm group label: Deep friction massage P75
arm group type: Experimental
description: In this group it was applied the percentile 75, of the pressure previously found to be the mean pressure applied by physiotherapists during deep friction massage.
intervention type: Other
intervention name: Deep friction massage P50
description: Deep friction massage as described by Dr. James Cyriax, applied with the mean pressure (P50)
arm group label: Deep friction massage P50
intervention type: Other
intervention name: Deep friction massage P25
description: Deep friction massage as described by Dr. James Cyriax, applied with the percentile 25 of the mean pressure (P25)
arm group label: Deep friction massage P25
intervention type: Other
intervention name: Deep friction massage P75
description: Deep friction massage as described by Dr. James Cyriax, applied with the percentile 75 of the mean pressure (P75)
arm group label: Deep friction massage P75
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
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
sharing ipd: No