<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/NCT03006822</url>
  </required_header>
  <id_info>
    <org_study_id>Universidad de Alcalá</org_study_id>
    <nct_id>NCT03006822</nct_id>
  </id_info>
  <brief_title>Time Effect of the Pressure Release Technique Application in the Latent Myofascial Trigger Points</brief_title>
  <official_title>Time Effect of the Pressure Release Technique Application in the Latent Myofascial Trigger Points of the Levator Scapulae</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alcala</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alcala</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>
      Background: Latent myofascial trigger points (MTrPs) of the levator scapulae are high&#xD;
      prevalent and may influence the neck and shoulder conditions. The pressure release is one of&#xD;
      the most recommended manual therapy techniques.&#xD;
&#xD;
      Objective: To determine the time effect of the pressure release technique application in the&#xD;
      latent MTrPs of the levator scapulae muscle.&#xD;
&#xD;
      Design: A three-arm (1:1:1 ratio), double-blinded, parallel, randomized clinical trial.&#xD;
&#xD;
      The manual technique than us apply, be sustained digital pressure with thumbs or with the&#xD;
      2nd-3rd fingers on the PGM below the pain threshold and gradually increases up to a ceiling&#xD;
      of tissue resistance (barrier), as decreases, adds more pressure. different times of&#xD;
      sustained pressure and the number of repetitions depending on time 30 (group 1, acts as a&#xD;
      control), 60 (group 2) and 90 seconds (group 3) shall apply.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 15, 2017</start_date>
  <completion_date type="Actual">July 10, 2017</completion_date>
  <primary_completion_date type="Actual">March 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain pressure threshold (PPT)</measure>
    <time_frame>Change from Baseline PPT at one week</time_frame>
    <description>PPT is defined as the minimal amount of pressure that produce pain. The investigators will measure the muscle levator scapular tenderness.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Strength muscle</measure>
    <time_frame>Change from Baseline strength muscle at one week</time_frame>
    <description>The investigators will measure strength muscle with a handheld dynamometer. the subject will have to perform a movement of cervical extension resistance against.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Range of cervical mobility</measure>
    <time_frame>Change from Baseline range of cervical mobility at one week</time_frame>
    <description>The range of cervical mobility will has measure with cervical goniometer</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Myofascial Pain Syndrome</condition>
  <arm_group>
    <arm_group_label>Application 90 minutes pressure release</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive a pressure release technique for 90 seconds in the levator scapula muscle</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Application 60 minutes pressure release</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive a pressure release technique for 60 seconds in the levator scapula muscle</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Application 30 minutes pressure release</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive a pressure release technique for 30 seconds in the levator scapula muscle</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pressure release 90</intervention_name>
    <description>This is a massage technique that aims is eliminate myofascial trigger points for to treat muscle pain.</description>
    <arm_group_label>Application 90 minutes pressure release</arm_group_label>
    <other_name>soft tissue massage</other_name>
    <other_name>Compression ischemic massage technique</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pressure release 60</intervention_name>
    <description>This is a massage technique that aims is eliminate myofascial trigger points for to treat muscle pain.</description>
    <arm_group_label>Application 60 minutes pressure release</arm_group_label>
    <other_name>Compression ischemic massage technique</other_name>
    <other_name>soft tissue massage</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pressure release 30</intervention_name>
    <description>This is a massage technique that aims is eliminate myofascial trigger points for to treat muscle pain.</description>
    <arm_group_label>Application 30 minutes pressure release</arm_group_label>
    <other_name>Compression ischemic massage technique</other_name>
    <other_name>soft tissue massage</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects with aged between 18 and 60 years.&#xD;
&#xD;
          -  Subjects with presence of latent PGM levator scapulae muscle.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant.&#xD;
&#xD;
          -  Subjects with spontaneous pain.&#xD;
&#xD;
          -  Subjects with neck or shoulder pain.&#xD;
&#xD;
          -  Subjects with musculoskeletal injuries.&#xD;
&#xD;
          -  Subjects with neurological problems.&#xD;
&#xD;
          -  Fibromyalgia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Pecos-Martin, Doctor</last_name>
    <role>Study Director</role>
    <affiliation>Alcalá University (Physical Therapy and pain group)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Grupo Fisioterapia y Dolor</name>
      <address>
        <city>Alcala de Henares</city>
        <state>Madrid</state>
        <zip>28871</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 27, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>October 3, 2017</last_update_submitted>
  <last_update_submitted_qc>October 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alcala</investigator_affiliation>
    <investigator_full_name>Prof. Dr. Daniel Pecos Martín</investigator_full_name>
    <investigator_title>Dr. Pecos-Martin, Daniel (Principal Investigator)</investigator_title>
  </responsible_party>
  <keyword>Myofascial Trigger Points</keyword>
  <keyword>Liberation for Pression</keyword>
  <keyword>Therapy Soft Tissue</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myofascial Pain Syndromes</mesh_term>
    <mesh_term>Fibromyalgia</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/NCT03006822
org study id: Universidad de Alcalá
nct id: NCT03006822
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: Latent myofascial trigger points (MTrPs) of the levator scapulae are high
      prevalent and may influence the neck and shoulder conditions. The pressure release is one of
      the most recommended manual therapy techniques.

      Objective: To determine the time effect of the pressure release technique application in the
      latent MTrPs of the levator scapulae muscle.

      Design: A three-arm (1:1:1 ratio), double-blinded, parallel, randomized clinical trial.

      The manual technique than us apply, be sustained digital pressure with thumbs or with the
      2nd-3rd fingers on the PGM below the pain threshold and gradually increases up to a ceiling
      of tissue resistance (barrier), as decreases, adds more pressure. different times of
      sustained pressure and the number of repetitions depending on time 30 (group 1, acts as a
      control), 60 (group 2) and 90 seconds (group 3) shall apply.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Pain pressure threshold (PPT)
time frame: Change from Baseline PPT at one week
description: PPT is defined as the minimal amount of pressure that produce pain. The investigators will measure the muscle levator scapular tenderness.
measure: Strength muscle
time frame: Change from Baseline strength muscle at one week
description: The investigators will measure strength muscle with a handheld dynamometer. the subject will have to perform a movement of cervical extension resistance against.
measure: Range of cervical mobility
time frame: Change from Baseline range of cervical mobility at one week
description: The range of cervical mobility will has measure with cervical goniometer
arm group label: Application 90 minutes pressure release
arm group type: Experimental
description: Subjects will receive a pressure release technique for 90 seconds in the levator scapula muscle
arm group label: Application 60 minutes pressure release
arm group type: Experimental
description: Subjects will receive a pressure release technique for 60 seconds in the levator scapula muscle
arm group label: Application 30 minutes pressure release
arm group type: Experimental
description: Subjects will receive a pressure release technique for 30 seconds in the levator scapula muscle
intervention type: Other
intervention name: Pressure release 90
description: This is a massage technique that aims is eliminate myofascial trigger points for to treat muscle pain.
arm group label: Application 90 minutes pressure release
other name: soft tissue massage
other name: Compression ischemic massage technique
intervention type: Other
intervention name: Pressure release 60
description: This is a massage technique that aims is eliminate myofascial trigger points for to treat muscle pain.
arm group label: Application 60 minutes pressure release
other name: Compression ischemic massage technique
other name: soft tissue massage
intervention type: Other
intervention name: Pressure release 30
description: This is a massage technique that aims is eliminate myofascial trigger points for to treat muscle pain.
arm group label: Application 30 minutes pressure release
other name: Compression ischemic massage technique
other name: soft tissue massage
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Daniel Pecos-Martin, Doctor
role: Study Director
affiliation: Alcalá University (Physical Therapy and pain group)
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: University of Alcala
investigator full name: Prof. Dr. Daniel Pecos Martín
investigator title: Dr. Pecos-Martin, Daniel (Principal Investigator)
mesh term: Myofascial Pain Syndromes
mesh term: Fibromyalgia
sharing ipd: No