<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/NCT03025230</url>
  </required_header>
  <id_info>
    <org_study_id>M2012119/20130409</org_study_id>
    <nct_id>NCT03025230</nct_id>
  </id_info>
  <brief_title>Dry Needling Versus Intramuscular Stimulation in the Management of the Myofascial Trigger Points</brief_title>
  <official_title>Effectiveness of Dry Needling and Intramuscular Electrostimulation in the Treatment of Myofascial Trigger Points in Patients With Neck Pain</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>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>
      Hypothesis The application of intramuscular electrostimulation will be more effectiveness&#xD;
      than the dry needling in myofascial trigger points treatment.&#xD;
&#xD;
      Objetives:&#xD;
&#xD;
      To determine the effectiveness of intramuscular electrostimulation in the treatment of&#xD;
      trigger points of the levator scapula muscle for the improvement of pain in mechanical&#xD;
      cervicalgia.&#xD;
&#xD;
      Participants: Subjects with diagnosed of myofascial pain syndrome in cervical region and&#xD;
      active trigger points in levator scapulae muscle, randomly assigned to experimental or&#xD;
      control group.&#xD;
&#xD;
      Intervention: Control group: one session of dry needling in active trigger points;&#xD;
      experimental group: one session of intramuscular stimulation in active trigger points.&#xD;
&#xD;
      Main Outcomes Measures: Pain, pressure pain threshold (PPT), active cervical range of motion&#xD;
      and strength muscle . The measures will be taken before, after and one week after the&#xD;
      interventions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The muscle pain is one of the most common forms of musculoskeletal pain. Within muscular&#xD;
      pain, the presence of myofascial trigger points (PG) in the musculature is a important and&#xD;
      prevalent problem.&#xD;
&#xD;
      Currently one the techniques most used in the treatment of PG is dry needling. Dry needling&#xD;
      has been shown effective in the treatment of neck pain associated with PGs.&#xD;
&#xD;
      To our knowledge, there are no studies that they have compared the effectiveness of dry&#xD;
      needling and intramuscular stimulation by applying an electric current.&#xD;
&#xD;
      This study is a randomized clinical trial that aims to demonstrate that the application of an&#xD;
      electric current associated with dry needling in the treatment of PG.&#xD;
&#xD;
      In this study we will treat subjects with cervical pain who they have active PGs in the&#xD;
      levator scapulae muscle.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">March 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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pressure Pain Threshold (PPT)</measure>
    <time_frame>Change from baseline at one week</time_frame>
    <description>An algometer Wagner FPI 10-WA will be used to determine the PPT in levator scapulae trigger points</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Visual Analogue Scale</measure>
    <time_frame>Change from baseline at one week</time_frame>
    <description>The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations. The VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured from 0 (no pain) to 10 (maximum pain). All the subjects will showed their pain level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Strength in cervical latero-flexion</measure>
    <time_frame>Change from baseline at one week</time_frame>
    <description>Dynamic dynamometry with MicroFet-2 will be used while patients will positioned in seated. From this position, patients will performed lateral - flexion</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Trigger Point Pain, Myofascial</condition>
  <condition>Muscle Pain</condition>
  <condition>Myofascial Pain Syndrome</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dry needling technique and the application of a rectangular, biphasic, asymmetric analgesic electric current by selecting a frequency of 2 Hz with a pulse width 40 μs, with an intensity located at the tolerance threshold and for a time of 20 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Dry technique in PG.The needle will be moved in-and-out into different directions to encounter sensitive spots in PG region.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dry needling and electric stimulation</intervention_name>
    <description>Dry needling technique and the application of electric stimulation of levator scapulae PG</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dry needling</intervention_name>
    <description>Treatment of PG with a filiform needle in levator scapulae muscle</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cervical pain.&#xD;
&#xD;
          -  Active trigger points in levator scapulae muscle&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pain Irradiation toward upper limb&#xD;
&#xD;
          -  Psychological disorders&#xD;
&#xD;
          -  Whiplash.&#xD;
&#xD;
          -  Neuropathic symptoms&#xD;
&#xD;
          -  Cervical and / or Shoulder Spine Surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tomás Gallego-Izquierdo, Doctor</last_name>
    <role>Study Director</role>
    <affiliation>Alcala University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Patricia Martínez Merinero</name>
      <address>
        <city>Alcala de Henares</city>
        <state>Madrid</state>
        <zip>28806</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>February 23, 2021</last_update_submitted>
  <last_update_submitted_qc>February 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2021</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>
  <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>
    <mesh_term>Myalgia</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/NCT03025230
org study id: M2012119/20130409
nct id: NCT03025230
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Hypothesis The application of intramuscular electrostimulation will be more effectiveness
      than the dry needling in myofascial trigger points treatment.

      Objetives:

      To determine the effectiveness of intramuscular electrostimulation in the treatment of
      trigger points of the levator scapula muscle for the improvement of pain in mechanical
      cervicalgia.

      Participants: Subjects with diagnosed of myofascial pain syndrome in cervical region and
      active trigger points in levator scapulae muscle, randomly assigned to experimental or
      control group.

      Intervention: Control group: one session of dry needling in active trigger points;
      experimental group: one session of intramuscular stimulation in active trigger points.

      Main Outcomes Measures: Pain, pressure pain threshold (PPT), active cervical range of motion
      and strength muscle . The measures will be taken before, after and one week after the
      interventions.
The muscle pain is one of the most common forms of musculoskeletal pain. Within muscular
      pain, the presence of myofascial trigger points (PG) in the musculature is a important and
      prevalent problem.

      Currently one the techniques most used in the treatment of PG is dry needling. Dry needling
      has been shown effective in the treatment of neck pain associated with PGs.

      To our knowledge, there are no studies that they have compared the effectiveness of dry
      needling and intramuscular stimulation by applying an electric current.

      This study is a randomized clinical trial that aims to demonstrate that the application of an
      electric current associated with dry needling in the treatment of PG.

      In this study we will treat subjects with cervical pain who they have active PGs in the
      levator scapulae muscle.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Pressure Pain Threshold (PPT)
time frame: Change from baseline at one week
description: An algometer Wagner FPI 10-WA will be used to determine the PPT in levator scapulae trigger points
measure: Pain Visual Analogue Scale
time frame: Change from baseline at one week
description: The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations. The VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured from 0 (no pain) to 10 (maximum pain). All the subjects will showed their pain level.
measure: Strength in cervical latero-flexion
time frame: Change from baseline at one week
description: Dynamic dynamometry with MicroFet-2 will be used while patients will positioned in seated. From this position, patients will performed lateral - flexion
arm group label: Experimental group
arm group type: Experimental
description: Dry needling technique and the application of a rectangular, biphasic, asymmetric analgesic electric current by selecting a frequency of 2 Hz with a pulse width 40 μs, with an intensity located at the tolerance threshold and for a time of 20 minutes.
arm group label: Control group
arm group type: Active Comparator
description: Dry technique in PG.The needle will be moved in-and-out into different directions to encounter sensitive spots in PG region.
intervention type: Other
intervention name: Dry needling and electric stimulation
description: Dry needling technique and the application of electric stimulation of levator scapulae PG
arm group label: Experimental group
intervention type: Other
intervention name: Dry needling
description: Treatment of PG with a filiform needle in levator scapulae muscle
arm group label: Control group
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Tomás Gallego-Izquierdo, Doctor
role: Study Director
affiliation: Alcala University
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
mesh term: Myalgia