<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/NCT02219386</url>
  </required_header>
  <id_info>
    <org_study_id>44/11Comision of investigation</org_study_id>
    <nct_id>NCT02219386</nct_id>
  </id_info>
  <brief_title>Dry Needling of the Trapezius Muscle in Office Workers With Neck Pain</brief_title>
  <official_title>Dry Needling of the Trapezius Muscle in Office Workers With Neck Pain. Randomised, Single Blinded Clinical Trial</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Deep dry needling of active myofascial trigger points of trapezius muscle is effective in the&#xD;
      dimminution of pain of patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      EVALUATION:&#xD;
&#xD;
      A blind assesor does a complete evaluation of the patients to determine if they take part of&#xD;
      the study. An assesment of pain (by visual analogue scale), Pain pressure theshold (kg/cm2 by&#xD;
      algometry, Range of motion (CROM goniometer in degrees) and strength (digital dinamometry in&#xD;
      Newtons) are performed. In this evaluation inclusion criteria is checked too.&#xD;
&#xD;
      INTERVENTION:&#xD;
&#xD;
      -TREATMENT GROUP(Deep dry needling group (DDN)):&#xD;
&#xD;
      An experienced physical therapist performed this treatment. The intervention included DDN of&#xD;
      every active MTrP found in the trapezius muscle using a 4 cm x 0.32 mm acupuncture needle&#xD;
      with guided tube. ). In the case of upper trapezius active MTrPs, DDN was performed in the&#xD;
      prone position. For medium and lower trapezius muscle MTrPs, DDN was performed in a&#xD;
      side-lying position as described by Simons et al. (Simons et al., 1999). Once the needle was&#xD;
      inserted into the MTrP previously marked by the blinded assessor, local twitch responses&#xD;
      (LTRs) were obtained by using Hong's fast-in and fast-out technique, which involves rapid&#xD;
      movements of the needle in and out of the MTrP.&#xD;
&#xD;
      After that, the stretch is performed&#xD;
&#xD;
      - Passive stretch of the trapezius muscle (both groups)&#xD;
&#xD;
      Another experienced physical therapist, after taking part of training-sesions to do the same&#xD;
      stretch as in DDN group, performed the stretch.Participants in this group received the same&#xD;
      stretch as patients in treatment group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</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>Subjective Pain scored by Visual Analogue Scale (VAS.Participants were followed for the duration of the intervention, an average of 6 weeks)</measure>
    <time_frame>pretreatment, postreatment and follow-up(15 days)</time_frame>
    <description>pretreatment = at baseline; post-treatment= after 5 physical therapy sessions, 3 weeks after baseline; follow-up= 15 days after last intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Pressure Threshold (PPT. Participants were followed for the duration of the intervention, an average of 6 weeks)</measure>
    <time_frame>Pretreatment, post treatment and follow-up.</time_frame>
    <description>pretreatment = at baseline; post-treatment= after 5 physical therapy sessions, 3 weeks after baseline; follow-up= 15 days after last intervention.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Strenght scored by Digital dynamometer (Participants were followed for the duration of the intervention, an average of 6 weeks)</measure>
    <time_frame>Pretreatment, post treatment and follow-up.</time_frame>
    <description>pretreatment = at baseline; post-treatment= after 5 physical therapy sessions, 3 weeks after baseline; follow-up= 15 days after last intervention.</description>
  </other_outcome>
  <other_outcome>
    <measure>Cervical Range of Motion assesed with CROM goniometer (Participants were followed for the duration of the intervention, an average of 6 weeks)</measure>
    <time_frame>Pretreatment, post treatment and follow-up.</time_frame>
    <description>pretreatment = at baseline; post-treatment= after 5 physical therapy sessions, 3 weeks after baseline; follow-up= 15 days after last intervention. Participants were followed for the duration of the intervention, an average of 6 weeks)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Myofascial Trigger Point Pain</condition>
  <arm_group>
    <arm_group_label>Deep dry needling</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The group of DDN receive this treatment and stretch</description>
  </arm_group>
  <arm_group>
    <arm_group_label>muscle stretch</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The stretch applied was as described by Simons et al. (Simons et al., 1999). During the stretch the physiotherapist took up the slack, avoiding pain elicitation, maintaining the tension for four seconds and releasing the tension for eight seconds; this cycle was repeated three times</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Group 1. Deep dry needling</intervention_name>
    <description>Deep dry needling and stretch. The intervention included DDN of every active MTrP found in the trapezius muscle using a 4 cm x 0.32 mm acupuncture needle as described by Simons et al. (Simons et al., 1999). Once the needle was inserted into the MTrP previously marked by the blinded assessor, local twitch responses (LTRs) were obtained by using Hong's fast-in and fast-out technique, which involves rapid movements of the needle in and out of the MTrP. After four LTRs, the needle was withdrawn and the area was disinfected with alcohol again (Simons et al., 1999). Then, passive stretch was performed on the trapezius muscle.</description>
    <arm_group_label>Deep dry needling</arm_group_label>
    <arm_group_label>muscle stretch</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>group 2. Passive analitical stretch (performed in both groups)</intervention_name>
    <arm_group_label>muscle stretch</arm_group_label>
    <other_name>only the same stretch as performed in deep dry needling group.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  over 18&#xD;
&#xD;
          -  present myofascial trigger points in trapezius muscle&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  to be under anti-inflammatory, analgesic, anticoagulant, muscle relaxant or&#xD;
             antidepressant medication at the start of the study or one week before it (Simons,&#xD;
             2004)&#xD;
&#xD;
          -  to suffer from fibromyalgia syndrome, or to have any contraindication to conservative&#xD;
             or invasive physiotherapy (infection, fever, hypothyroidism, fear of needles, wounds&#xD;
             in the area of the puncture, metal allergy, cancer, systemic disease) (Baldry, 2005).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ester Cerezo-Téllez, PT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Alcalá University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UDAIF</name>
      <address>
        <city>Alcalá de Henares</city>
        <state>Madrid</state>
        <zip>28820</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>August 30, 2014</last_update_submitted>
  <last_update_submitted_qc>August 30, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 3, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alcala</investigator_affiliation>
    <investigator_full_name>Ester Cerezo-Téllez</investigator_full_name>
    <investigator_title>Physical Therapist.Master.</investigator_title>
  </responsible_party>
  <keyword>Myofascial pain syndromes,physiotherapy,muscle stretching exercises,neck pain,dry needling</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myofascial Pain Syndromes</mesh_term>
    <mesh_term>Neck Pain</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/NCT02219386
org study id: 44/11Comision of investigation
nct id: NCT02219386
lead sponsor: 
has dmc: Yes
Deep dry needling of active myofascial trigger points of trapezius muscle is effective in the
      dimminution of pain of patients
EVALUATION:

      A blind assesor does a complete evaluation of the patients to determine if they take part of
      the study. An assesment of pain (by visual analogue scale), Pain pressure theshold (kg/cm2 by
      algometry, Range of motion (CROM goniometer in degrees) and strength (digital dinamometry in
      Newtons) are performed. In this evaluation inclusion criteria is checked too.

      INTERVENTION:

      -TREATMENT GROUP(Deep dry needling group (DDN)):

      An experienced physical therapist performed this treatment. The intervention included DDN of
      every active MTrP found in the trapezius muscle using a 4 cm x 0.32 mm acupuncture needle
      with guided tube. ). In the case of upper trapezius active MTrPs, DDN was performed in the
      prone position. For medium and lower trapezius muscle MTrPs, DDN was performed in a
      side-lying position as described by Simons et al. (Simons et al., 1999). Once the needle was
      inserted into the MTrP previously marked by the blinded assessor, local twitch responses
      (LTRs) were obtained by using Hong's fast-in and fast-out technique, which involves rapid
      movements of the needle in and out of the MTrP.

      After that, the stretch is performed

      - Passive stretch of the trapezius muscle (both groups)

      Another experienced physical therapist, after taking part of training-sesions to do the same
      stretch as in DDN group, performed the stretch.Participants in this group received the same
      stretch as patients in treatment group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Subjective Pain scored by Visual Analogue Scale (VAS.Participants were followed for the duration of the intervention, an average of 6 weeks)
time frame: pretreatment, postreatment and follow-up(15 days)
description: pretreatment = at baseline; post-treatment= after 5 physical therapy sessions, 3 weeks after baseline; follow-up= 15 days after last intervention.
measure: Pain Pressure Threshold (PPT. Participants were followed for the duration of the intervention, an average of 6 weeks)
time frame: Pretreatment, post treatment and follow-up.
description: pretreatment = at baseline; post-treatment= after 5 physical therapy sessions, 3 weeks after baseline; follow-up= 15 days after last intervention.
measure: Strenght scored by Digital dynamometer (Participants were followed for the duration of the intervention, an average of 6 weeks)
time frame: Pretreatment, post treatment and follow-up.
description: pretreatment = at baseline; post-treatment= after 5 physical therapy sessions, 3 weeks after baseline; follow-up= 15 days after last intervention.
measure: Cervical Range of Motion assesed with CROM goniometer (Participants were followed for the duration of the intervention, an average of 6 weeks)
time frame: Pretreatment, post treatment and follow-up.
description: pretreatment = at baseline; post-treatment= after 5 physical therapy sessions, 3 weeks after baseline; follow-up= 15 days after last intervention. Participants were followed for the duration of the intervention, an average of 6 weeks)
arm group label: Deep dry needling
arm group type: Active Comparator
description: The group of DDN receive this treatment and stretch
arm group label: muscle stretch
arm group type: Other
description: The stretch applied was as described by Simons et al. (Simons et al., 1999). During the stretch the physiotherapist took up the slack, avoiding pain elicitation, maintaining the tension for four seconds and releasing the tension for eight seconds; this cycle was repeated three times
intervention type: Other
intervention name: Group 1. Deep dry needling
description: Deep dry needling and stretch. The intervention included DDN of every active MTrP found in the trapezius muscle using a 4 cm x 0.32 mm acupuncture needle as described by Simons et al. (Simons et al., 1999). Once the needle was inserted into the MTrP previously marked by the blinded assessor, local twitch responses (LTRs) were obtained by using Hong's fast-in and fast-out technique, which involves rapid movements of the needle in and out of the MTrP. After four LTRs, the needle was withdrawn and the area was disinfected with alcohol again (Simons et al., 1999). Then, passive stretch was performed on the trapezius muscle.
arm group label: Deep dry needling
arm group label: muscle stretch
intervention type: Other
intervention name: group 2. Passive analitical stretch (performed in both groups)
arm group label: muscle stretch
other name: only the same stretch as performed in deep dry needling group.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ester Cerezo-Téllez, PT
role: Principal Investigator
affiliation: Alcalá University
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: University of Alcala
investigator full name: Ester Cerezo-Téllez
investigator title: Physical Therapist.Master.
mesh term: Myofascial Pain Syndromes
mesh term: Neck Pain