<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/NCT04417491</url>
  </required_header>
  <id_info>
    <org_study_id>URJC5006</org_study_id>
    <nct_id>NCT04417491</nct_id>
  </id_info>
  <brief_title>Patient Expectations and Dry Needling</brief_title>
  <official_title>Influence of Patient Expectations on Dry Needling Effects on Pain Outcomes in Mechanical Neck Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Rey Juan Carlos</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Rey Juan Carlos</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>
      Dry needling (DN) is a treatment technique used for treating musculoskeletal pain conditions.&#xD;
      DN has shown to be effective on pain and function in patients with mechanical neck pain.&#xD;
      Potential effects of DN can be related to several mechanisms, including physical, cognitive&#xD;
      and emotional factors. This study will evaluate the role of the patient expectances related&#xD;
      to the evolution (progress) of the condition, in this case, mechanical neck pain, in the&#xD;
      effects of real or sham dry needling in sensitivity outcomes such as pain intensity or&#xD;
      pressure pain sensitivity. Expectation of each patient in both groups will be considered&#xD;
      positive, neutral or negative based on the outcomes of the Patient Shoulder Expectancies&#xD;
      (PSOE) questionnaire which was adapted to the cervical spine.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 5, 2020</start_date>
  <completion_date type="Actual">November 28, 2020</completion_date>
  <primary_completion_date type="Actual">November 2, 2020</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Neck Pain Intensity between baseline and follow-up periods</measure>
    <time_frame>Baseline, immediately after and 1 week after intervention</time_frame>
    <description>The intensity of neck pain at rest and during active movement of the cervical spine in rotation will be assessed with a visual analogue scale (VAS).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Pressure pain sensitivity between baseline and follow-up periods</measure>
    <time_frame>Baseline, immediately after and 1 week after intervention</time_frame>
    <description>Pressure pain thresholds (PPT) will be assessed at the upper trapezius muscle, spinous process of C7 and distant pain-free area of the lower extremity (heel)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in patients self-perceived improvement between baseline and follow-up periods</measure>
    <time_frame>Baseline and 1 week after intervention</time_frame>
    <description>Patients self-perceived improvement will be assessed using a Global Rating of Change (GROC) consisting of a 15-point scale ranging from -7 (a very great deal worse) to +7 (a very great deal better).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Neck Pain</condition>
  <arm_group>
    <arm_group_label>Dry Needling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention group will receive real dry needling (fast in and fast out needling technique) in an active MTrP within upper trapezius muscle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Needling</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The placebo group will receive sham needling in an active MTrP within the upper trapezius muscle. A sham needle will be used as placebo. This needle has a blunt tip and retractable handle that created the illusion of a needle penetrating the skin.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dry Needling</intervention_name>
    <description>Real dry needling will be conducted according to the fast-in and fast-out principle. The intervention will be applied until a total of four local twitch responses will be elicited</description>
    <arm_group_label>Dry Needling</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham Needling</intervention_name>
    <description>Sham dry needling with be conducted with a sham needle device. This needle has a blunt tip and retractable handle that created the illusion of a needle penetrating the skin. When this needle touches the skin, a pricking sensation will be created. However, when pressure will be increased, the shaft of the needle disappears into the handle creating a sensation on the patient</description>
    <arm_group_label>Sham Needling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Non-specific mechanical neck pain of at least 3 months of duration&#xD;
&#xD;
          -  At least one active trigger point in the upper trapezius muscle which referred pain&#xD;
             reproduces the neck pain symptoms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  whiplash injury;&#xD;
&#xD;
          -  previous cervical or thoracic surgery;&#xD;
&#xD;
          -  cervical radiculopathy or myelopathy;&#xD;
&#xD;
          -  diagnosis of fibromyalgia syndrome;&#xD;
&#xD;
          -  having undergone physical therapy in the previous 6 months;&#xD;
&#xD;
          -  fear to needles&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Months</minimum_age>
    <maximum_age>65 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>César Fernández-de-las-Peñas</name>
      <address>
        <city>Alcorcón</city>
        <state>Rest Of The World</state>
        <zip>28922</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>November 29, 2020</last_update_submitted>
  <last_update_submitted_qc>November 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Rey Juan Carlos</investigator_affiliation>
    <investigator_full_name>César Fernández-de-las-Peñas</investigator_full_name>
    <investigator_title>Full Proffessor</investigator_title>
  </responsible_party>
  <keyword>Neck Pain</keyword>
  <keyword>Needling</keyword>
  <keyword>Expectance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neck Pain</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/NCT04417491
org study id: URJC5006
nct id: NCT04417491
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Dry needling (DN) is a treatment technique used for treating musculoskeletal pain conditions.
      DN has shown to be effective on pain and function in patients with mechanical neck pain.
      Potential effects of DN can be related to several mechanisms, including physical, cognitive
      and emotional factors. This study will evaluate the role of the patient expectances related
      to the evolution (progress) of the condition, in this case, mechanical neck pain, in the
      effects of real or sham dry needling in sensitivity outcomes such as pain intensity or
      pressure pain sensitivity. Expectation of each patient in both groups will be considered
      positive, neutral or negative based on the outcomes of the Patient Shoulder Expectancies
      (PSOE) questionnaire which was adapted to the cervical spine.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Changes in Neck Pain Intensity between baseline and follow-up periods
time frame: Baseline, immediately after and 1 week after intervention
description: The intensity of neck pain at rest and during active movement of the cervical spine in rotation will be assessed with a visual analogue scale (VAS).
measure: Changes in Pressure pain sensitivity between baseline and follow-up periods
time frame: Baseline, immediately after and 1 week after intervention
description: Pressure pain thresholds (PPT) will be assessed at the upper trapezius muscle, spinous process of C7 and distant pain-free area of the lower extremity (heel)
measure: Changes in patients self-perceived improvement between baseline and follow-up periods
time frame: Baseline and 1 week after intervention
description: Patients self-perceived improvement will be assessed using a Global Rating of Change (GROC) consisting of a 15-point scale ranging from -7 (a very great deal worse) to +7 (a very great deal better).
arm group label: Dry Needling
arm group type: Experimental
description: The intervention group will receive real dry needling (fast in and fast out needling technique) in an active MTrP within upper trapezius muscle.
arm group label: Sham Needling
arm group type: Sham Comparator
description: The placebo group will receive sham needling in an active MTrP within the upper trapezius muscle. A sham needle will be used as placebo. This needle has a blunt tip and retractable handle that created the illusion of a needle penetrating the skin.
intervention type: Device
intervention name: Dry Needling
description: Real dry needling will be conducted according to the fast-in and fast-out principle. The intervention will be applied until a total of four local twitch responses will be elicited
arm group label: Dry Needling
intervention type: Device
intervention name: Sham Needling
description: Sham dry needling with be conducted with a sham needle device. This needle has a blunt tip and retractable handle that created the illusion of a needle penetrating the skin. When this needle touches the skin, a pricking sensation will be created. However, when pressure will be increased, the shaft of the needle disappears into the handle creating a sensation on the patient
arm group label: Sham Needling
criteria: 
gender: All
minimum age: 18 Months
maximum age: 65 Months
healthy volunteers: No
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad Rey Juan Carlos
investigator full name: César Fernández-de-las-Peñas
investigator title: Full Proffessor
mesh term: Neck Pain
sharing ipd: No