<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/NCT03788161</url>
  </required_header>
  <id_info>
    <org_study_id>URJC1509201810418</org_study_id>
    <nct_id>NCT03788161</nct_id>
  </id_info>
  <brief_title>Virtual Reality and Post-dry Needling Soreness</brief_title>
  <official_title>Effects of Virtual Reality on Post-Needling Soreness After Dry Needling of Trigger Points in the Extensor Carpi Radialis Brevis</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>
      Application of trigger point dry needling can induce post-dry needling soreness. This is not&#xD;
      a negative experience, but sometimes some patients want to reduce it as much as possible.&#xD;
      Different therapeutic strategies targeting to decrease post-dry needling soreness need to be&#xD;
      investigated. Previous studies have investigated spray and stretch, ischemic compression or&#xD;
      low-load eccentric exercise as post-needling intervention procedures. There is increasing&#xD;
      evidence supporting the role of descending pain inhibition mechanisms for paon control. The&#xD;
      application of virtual reality as a distraction technique could active brain mechanisms&#xD;
      during dry needling. Therefore, the objective of this study will be to investigate the&#xD;
      effects of playing virtual reality during the application of dry needling on post-needling&#xD;
      soreness over trigger points in the extensor carpi radialis brevis muscle. A secondary aim&#xD;
      will be to determine the prognostic role of baseline scores of pressure pain sensitivity,&#xD;
      related-disability, anxiety and catastrophizing levels.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2019</start_date>
  <completion_date type="Actual">April 26, 2021</completion_date>
  <primary_completion_date type="Actual">March 15, 2021</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 post-dry needling pain assessed with a numerical pain rate scale before and after the intervention</measure>
    <time_frame>Baseline, 5 minutes after, 12 hours after, 24 hours after, 36 hours after, 48 hours after, and 72 hours after treatment</time_frame>
    <description>A numerical Pain Rate Scale (NPRS, 0-10) will be used to record post-dry needling soreness and pain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Baseline score of upper extremity related-disability assessed with the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire</measure>
    <time_frame>Baseline</time_frame>
    <description>The DASH questionaire consists of 30-items assessing: 1, degree of difficulty during the preceding week in performing physical activities because of problems in the upper extremity (21 items); 2, severity of each pain symptom, activity-related pain, tingling, weakness, and stiffness (5 items); and, 3, the problem's effect on social activities, work, and sleep, and its psychological impact (4 items). Each item is answered on a 5-points scale ranging from 1 (no difficulty to perform, no symptom, or no impact) to 5 (unable to do, very severe symptom, or high impact). Responses are summed to form a raw score that is converted to a 0 to 100 scale where higher scores reflect greater related-disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline data on pressure pain sensitivity assessed with a pressure algometer</measure>
    <time_frame>Baseline</time_frame>
    <description>Pressure pain thresholds over the cervical spine, the lateral epicondyle and the tibialis anterior muscle will be assessed with a pressure algometer at baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline anxiety levels as assessed with the State-Trait Anxiety Inventory (STAI) questionnaire</measure>
    <time_frame>Baseline</time_frame>
    <description>The STAI is a 40 items scale assessing separate dimensions of state anxiety (items l-20, STAI-S) and trait anxiety (items 21-40, STAI-T). The STAI-S items assess relatively enduring symptoms of anxiety. Participants use a 4-points response scale ranging from &quot;not at all&quot; to &quot;very much&quot;, to indicate the extent to which they experience each emotion. The STAI-T scale measures a stable propensity to experience anxiety, and tendencies to perceive stressful situations as threatening. It consists of 20 statements requiring individuals to rate how they generally feel on a 4-points scale. In both scales, higher scores indicate greater state or trait anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Catastrophizing belief as assessed with the Pain Catastrophizing Scale</measure>
    <time_frame>Baseline</time_frame>
    <description>The Pain Catastrophizing Scale will be used for determining baseline participant's propensity to catastrophize about pain. It consists of 13-items evaluating the three components of catastrophizing: rumination, magnification and helplessness.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Healthy</condition>
  <condition>Epicondylitis of the Elbow</condition>
  <arm_group>
    <arm_group_label>Real Virtual Reality</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a distraction by playing a game of virtual reality with a 3D application</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Virtual Reality</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive a placebo distraction with a game of virtual reality with a 3D application without functioning</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Real Virtual Reality</intervention_name>
    <description>Participants will receive a distraction by playing a game of virtual reality with a 3D application</description>
    <arm_group_label>Real Virtual Reality</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo Virtual Reality</intervention_name>
    <description>Participants will receive a placebo distraction with a game of virtual reality with a 3D application without functioning</description>
    <arm_group_label>Placebo Virtual Reality</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for pain-free participants:&#xD;
&#xD;
          -  no history of upper quadrant pain symptoms the year preceding the study&#xD;
&#xD;
          -  no history of upper quadrant surgery&#xD;
&#xD;
          -  presence of a latent trigger point in the extensor carpi radialis brevis muscle&#xD;
&#xD;
        Inclusion criteria for patients with elbow pain:&#xD;
&#xD;
          -  pain over the lateral side of the elbow;&#xD;
&#xD;
          -  pain on palpation over the lateral epicondyle or the associated common wrist extensor&#xD;
             tendon;&#xD;
&#xD;
          -  elbow pain with either resisted static contraction or stretching of the wrist extensor&#xD;
             muscles.&#xD;
&#xD;
          -  presence of an active trigger point in the extensor carpi radialis brevis muscle&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  bilateral symptoms;&#xD;
&#xD;
          -  older than 50 years of age;&#xD;
&#xD;
          -  previous surgery or steroid injections;&#xD;
&#xD;
          -  other diagnoses of upper extremity (shoulder pathology, cervical radiculopathy,&#xD;
             cervical whiplash);&#xD;
&#xD;
          -  history of cervical or upper extremity trauma;&#xD;
&#xD;
          -  history of musculoskeletal medical conditions (rheumatoid arthritis, fibromyalgia);&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cesar Fernandez-de-Las-Peñas</name>
      <address>
        <city>Alcorcon</city>
        <state>Madrid</state>
        <zip>28921</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>December 22, 2018</study_first_submitted>
  <study_first_submitted_qc>December 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 27, 2018</study_first_posted>
  <last_update_submitted>April 26, 2021</last_update_submitted>
  <last_update_submitted_qc>April 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2021</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>Director of Department</investigator_title>
  </responsible_party>
  <keyword>trigger points</keyword>
  <keyword>virtual reality</keyword>
  <keyword>Dry needling</keyword>
  <!-- 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/NCT03788161
org study id: URJC1509201810418
nct id: NCT03788161
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Application of trigger point dry needling can induce post-dry needling soreness. This is not
      a negative experience, but sometimes some patients want to reduce it as much as possible.
      Different therapeutic strategies targeting to decrease post-dry needling soreness need to be
      investigated. Previous studies have investigated spray and stretch, ischemic compression or
      low-load eccentric exercise as post-needling intervention procedures. There is increasing
      evidence supporting the role of descending pain inhibition mechanisms for paon control. The
      application of virtual reality as a distraction technique could active brain mechanisms
      during dry needling. Therefore, the objective of this study will be to investigate the
      effects of playing virtual reality during the application of dry needling on post-needling
      soreness over trigger points in the extensor carpi radialis brevis muscle. A secondary aim
      will be to determine the prognostic role of baseline scores of pressure pain sensitivity,
      related-disability, anxiety and catastrophizing levels.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Changes in post-dry needling pain assessed with a numerical pain rate scale before and after the intervention
time frame: Baseline, 5 minutes after, 12 hours after, 24 hours after, 36 hours after, 48 hours after, and 72 hours after treatment
description: A numerical Pain Rate Scale (NPRS, 0-10) will be used to record post-dry needling soreness and pain
measure: Baseline score of upper extremity related-disability assessed with the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
time frame: Baseline
description: The DASH questionaire consists of 30-items assessing: 1, degree of difficulty during the preceding week in performing physical activities because of problems in the upper extremity (21 items); 2, severity of each pain symptom, activity-related pain, tingling, weakness, and stiffness (5 items); and, 3, the problem's effect on social activities, work, and sleep, and its psychological impact (4 items). Each item is answered on a 5-points scale ranging from 1 (no difficulty to perform, no symptom, or no impact) to 5 (unable to do, very severe symptom, or high impact). Responses are summed to form a raw score that is converted to a 0 to 100 scale where higher scores reflect greater related-disability.
measure: Baseline data on pressure pain sensitivity assessed with a pressure algometer
time frame: Baseline
description: Pressure pain thresholds over the cervical spine, the lateral epicondyle and the tibialis anterior muscle will be assessed with a pressure algometer at baseline
measure: Baseline anxiety levels as assessed with the State-Trait Anxiety Inventory (STAI) questionnaire
time frame: Baseline
description: The STAI is a 40 items scale assessing separate dimensions of state anxiety (items l-20, STAI-S) and trait anxiety (items 21-40, STAI-T). The STAI-S items assess relatively enduring symptoms of anxiety. Participants use a 4-points response scale ranging from "not at all" to "very much", to indicate the extent to which they experience each emotion. The STAI-T scale measures a stable propensity to experience anxiety, and tendencies to perceive stressful situations as threatening. It consists of 20 statements requiring individuals to rate how they generally feel on a 4-points scale. In both scales, higher scores indicate greater state or trait anxiety.
measure: Catastrophizing belief as assessed with the Pain Catastrophizing Scale
time frame: Baseline
description: The Pain Catastrophizing Scale will be used for determining baseline participant's propensity to catastrophize about pain. It consists of 13-items evaluating the three components of catastrophizing: rumination, magnification and helplessness.
arm group label: Real Virtual Reality
arm group type: Experimental
description: Participants will receive a distraction by playing a game of virtual reality with a 3D application
arm group label: Placebo Virtual Reality
arm group type: Placebo Comparator
description: Participants will receive a placebo distraction with a game of virtual reality with a 3D application without functioning
intervention type: Other
intervention name: Real Virtual Reality
description: Participants will receive a distraction by playing a game of virtual reality with a 3D application
arm group label: Real Virtual Reality
intervention type: Other
intervention name: Placebo Virtual Reality
description: Participants will receive a placebo distraction with a game of virtual reality with a 3D application without functioning
arm group label: Placebo Virtual Reality
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad Rey Juan Carlos
investigator full name: César Fernández-de-las-Peñas
investigator title: Director of Department