xml: <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/NCT06023264</url>
    </required_header>
    <id_info>
      <org_study_id>03916375G</org_study_id>
      <nct_id>NCT06023264</nct_id>
    </id_info>
    <brief_title>Evaluate the Effect of Dry Needling on the Temporomandibular Joint in Subjects Who Have Suffered a Whiplash as a Result of a Traffic Accident</brief_title>
    <official_title>Randomized, Open Clinical Trial to Evaluate the Effect of Dry Needling on the Temporomandibular Joint in Subjects Who Have Suffered a Whiplash as a Result of a Traffic Accident</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz</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>
        The transportation industry is growing rapidly and the most popular mode is overland by road.&#xD;
        Traffic accidents are the most direct and serious risk to the lives of Western people. A&#xD;
        large number of traffic accidents occur on the roads each year, especially those caused by&#xD;
        motor vehicles on motorways and urban ring roads, often resulting in massive loss of life.&#xD;
        According to the World Health Organization (WHO), 1.35 million people die each year&#xD;
        worldwide.&#xD;
  &#xD;
        Whiplash is the most common injury in motor vehicle collisions, affecting 83% of injured&#xD;
        people.&#xD;
  &#xD;
        The temporomandibular joint (TMJ) is one of the most complex joints in the human body, since&#xD;
        in addition to performing functions in dental occlusion, it does so in the neuromuscular&#xD;
        system.&#xD;
  &#xD;
        Due to the relationship of the neck with the mandible, the main objective of the study is to&#xD;
        determine if there is an improvement in pain and functional limitation in general by applying&#xD;
        the dry needling technique in the temporomandibular joint musculature.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 4, 2023</start_date>
    <completion_date type="Anticipated">May 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 29, 2024</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>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Age</measure>
      <time_frame>Visit 1 (First day of treatment)</time_frame>
      <description>Years (Demographic variables)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Gender</measure>
      <time_frame>Visit 1 (First day of treatment)</time_frame>
      <description>Male, Female, Does not answer (Demographic variables)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Weight</measure>
      <time_frame>Visit 1 (First day of treatment)</time_frame>
      <description>Kilograms (Demographic variables)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Height</measure>
      <time_frame>Visit 1 (First day of treatment)</time_frame>
      <description>Meters (Demographic variables)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Mouth opening</measure>
      <time_frame>Visit 1(First day of treatment) and Visit 2 (One week after visit 1)</time_frame>
      <description>Millimeters (Basal conditions)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Jaw pain</measure>
      <time_frame>Visit 1(First day of treatment) and Visit 2 (One week after visit 1)</time_frame>
      <description>Visual Analog Scale (VAS) 1-10 (Basal conditions)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Headache</measure>
      <time_frame>Visit 1(First day of treatment) and Visit 2 (One week after visit 1)</time_frame>
      <description>Visual Analog Scale (VAS) 1-10 (Basal conditions)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Joint clicking</measure>
      <time_frame>Visit 1(First day of treatment) and Visit 2 (One week after visit 1)</time_frame>
      <description>Yes/No (Basal conditions)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pressure masseter, pterygoid, and temporalis</measure>
      <time_frame>Visit 1 (First day of treatment)</time_frame>
      <description>Determine pressure in kg in the masseter, temporal, and pterygoid muscles with an algometer to obtain 5/10 in Visual Analog Scale (VAS) to all participants</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pain masseter, pterygoid, and temporalis</measure>
      <time_frame>Visit 1(First day of treatment) and Visit 2 (One week after visit 1)</time_frame>
      <description>Obtain pain from 1 to 10 in the masseter, temporal, and pterygoid muscles according to the Visual Analog Scale (VAS) after applying the pressure obtained with the algometer in the previous step. *Patients in the experimental group are evaluated 10 minutes after the application of dry needling</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Whiplash</condition>
    <condition>Temporomandibular Joint Pain</condition>
    <condition>Dry Needling Technique</condition>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>dry needle</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Dry needling</intervention_name>
      <description>It is a minimally invasive treatment modality. Its effectiveness has been confirmed in numerous studies. It consists of applying an antiseptic in the puncture area and inserting the needle in the required aseptic conditions. During puncture, the patient's physical response is observed at all times, in order to control the local spasmodic responses in each muscle. After applying the technique, we assessed jaw pain, mouth opening, and the appearance of headaches. The adverse effects of the technique are the following: pain after puncture (1.7%), local bleeding at the puncture site (6.1%) and syncopal responses (0.7%).</description>
      <arm_group_label>dry needle</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Having suffered a traffic accident&#xD;
  &#xD;
            -  Having suffered a subsequent collision&#xD;
  &#xD;
            -  Having been diagnosed with whiplash in the hospital ''Fundación Jiménez Díaz (FJD)´´&#xD;
               emergency room in the first 72 hours after the collision.&#xD;
  &#xD;
            -  Age between 18-45 years, to avoid osteoarthritis and other degenerative problems.&#xD;
  &#xD;
            -  Minimum 3 in temporomandibular joint (TMJ) according to Visual Analog Scale (VAS)&#xD;
  &#xD;
            -  Consent to participate&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Temporomandibular joint (TMJ) or craniofacial surgeries&#xD;
  &#xD;
            -  Spinal surgery&#xD;
  &#xD;
            -  Direct trauma in temporomandibular joint (TMJ) or prior to the accident&#xD;
  &#xD;
            -  Botox, silicones or any type of cosmetic surgery in the facial region.&#xD;
  &#xD;
            -  Problems of migraines and tension headaches (pre-accident)&#xD;
  &#xD;
            -  Any degenerative musculoskeletal disease (fibromyalgia, rheumatoid arthritis,&#xD;
               osteoarthritis)&#xD;
  &#xD;
            -  Fear of needles&#xD;
  &#xD;
            -  Any neurological disorder (trigeminal neuralgia, epilepsy)&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Uncontrolled vascular or metabolic problems&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Patricia Recio Ramos, physiotherapist</last_name>
      <phone>915504800</phone>
      <phone_ext>3279</phone_ext>
      <email>patricia.recior@quironsalud.es</email>
    </overall_contact>
    <location>
      <facility>
        <name>Patricia Recio Ramos</name>
        <address>
          <city>Madrid</city>
          <country>Spain</country>
        </address>
      </facility>
      <contact>
        <last_name>Patricia Recio Ramos, physiotherapist</last_name>
        <phone>915504800</phone>
        <phone_ext>3279</phone_ext>
        <email>patricia.recior@quironsalud.es</email>
      </contact>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Arthralgia</mesh_term>
      <mesh_term>Whiplash Injuries</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06023264
  org study id: 03916375G
  nct id: NCT06023264
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The transportation industry is growing rapidly and the most popular mode is overland by road.
        Traffic accidents are the most direct and serious risk to the lives of Western people. A
        large number of traffic accidents occur on the roads each year, especially those caused by
        motor vehicles on motorways and urban ring roads, often resulting in massive loss of life.
        According to the World Health Organization (WHO), 1.35 million people die each year
        worldwide.
  
        Whiplash is the most common injury in motor vehicle collisions, affecting 83% of injured
        people.
  
        The temporomandibular joint (TMJ) is one of the most complex joints in the human body, since
        in addition to performing functions in dental occlusion, it does so in the neuromuscular
        system.
  
        Due to the relationship of the neck with the mandible, the main objective of the study is to
        determine if there is an improvement in pain and functional limitation in general by applying
        the dry needling technique in the temporomandibular joint musculature.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Age
  time frame: Visit 1 (First day of treatment)
  description: Years (Demographic variables)
  measure: Gender
  time frame: Visit 1 (First day of treatment)
  description: Male, Female, Does not answer (Demographic variables)
  measure: Weight
  time frame: Visit 1 (First day of treatment)
  description: Kilograms (Demographic variables)
  measure: Height
  time frame: Visit 1 (First day of treatment)
  description: Meters (Demographic variables)
  measure: Mouth opening
  time frame: Visit 1(First day of treatment) and Visit 2 (One week after visit 1)
  description: Millimeters (Basal conditions)
  measure: Jaw pain
  time frame: Visit 1(First day of treatment) and Visit 2 (One week after visit 1)
  description: Visual Analog Scale (VAS) 1-10 (Basal conditions)
  measure: Headache
  time frame: Visit 1(First day of treatment) and Visit 2 (One week after visit 1)
  description: Visual Analog Scale (VAS) 1-10 (Basal conditions)
  measure: Joint clicking
  time frame: Visit 1(First day of treatment) and Visit 2 (One week after visit 1)
  description: Yes/No (Basal conditions)
  measure: Pressure masseter, pterygoid, and temporalis
  time frame: Visit 1 (First day of treatment)
  description: Determine pressure in kg in the masseter, temporal, and pterygoid muscles with an algometer to obtain 5/10 in Visual Analog Scale (VAS) to all participants
  measure: Pain masseter, pterygoid, and temporalis
  time frame: Visit 1(First day of treatment) and Visit 2 (One week after visit 1)
  description: Obtain pain from 1 to 10 in the masseter, temporal, and pterygoid muscles according to the Visual Analog Scale (VAS) after applying the pressure obtained with the algometer in the previous step. *Patients in the experimental group are evaluated 10 minutes after the application of dry needling
  arm group label: Control
  arm group type: No Intervention
  arm group label: dry needle
  arm group type: Experimental
  intervention type: Procedure
  intervention name: Dry needling
  description: It is a minimally invasive treatment modality. Its effectiveness has been confirmed in numerous studies. It consists of applying an antiseptic in the puncture area and inserting the needle in the required aseptic conditions. During puncture, the patient's physical response is observed at all times, in order to control the local spasmodic responses in each muscle. After applying the technique, we assessed jaw pain, mouth opening, and the appearance of headaches. The adverse effects of the technique are the following: pain after puncture (1.7%), local bleeding at the puncture site (6.1%) and syncopal responses (0.7%).
  arm group label: dry needle
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: No
  last name: Patricia Recio Ramos, physiotherapist
  phone: 915504800
  phone ext: 3279
  email: patricia.recior@quironsalud.es
  facility: 
  contact: 
  country: Spain
  responsible party type: Sponsor
  mesh term: Arthralgia
  mesh term: Whiplash Injuries
  sharing ipd: No