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/NCT06007443</url>
    </required_header>
    <id_info>
      <org_study_id>CPM-TS-2PD</org_study_id>
      <nct_id>NCT06007443</nct_id>
    </id_info>
    <brief_title>Tactile Acuity and Pain Modulation</brief_title>
    <official_title>Association Between Tactile Acuity and Pain Modulation in Patients With Chronic Neck Pain</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hacettepe University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hacettepe University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Chronic neck pain is a common problem among the general population. Patients with chronic&#xD;
        neck pain used health care services twice as much as the population on average, mainly due to&#xD;
        intense pain intensity. It is well-known that pain intensity depends on the association of&#xD;
        pain processing in several levels of central pain processing.&#xD;
  &#xD;
        Identifying the association between conditioned pain modulation, temporal summation, and&#xD;
        somatosensory representation, all represent separate central pain processing, will provide an&#xD;
        opportunity to develop treatment strategies.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 28, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 28, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>pressure pain threshold</measure>
      <time_frame>'baseline'</time_frame>
      <description>The pressure pain threshold (PPTs) of the upper trapezius and dominant tibialis anterior muscles will be evaluated. For the upper trapezius muscle, assessment will be made approximately 5 to 8 cm superomedial to the superior angle of the scapula. For the tibialis anterior muscle, the assessment will be made muscle belly, which is approximately 2.5 cm lateral and 5 cm inferior to the tibial tubercle. Palpation during resisted active dorsiflexion ensured that the tibialis anterior muscle belly had been found.&#xD;
  Pressure pain thresholds will assessed using a pressure algometer (Algometer) with a stimulation area of 1 cm2. The increment rate of pressure will be kept at approximately 1 kg/cm2/s. The first time the pressure perceived as pain will be recorded as a PPTs. Two PPT assessments with a 30 second will be completed, and the average was used for statistical analysis.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>temporal summation</measure>
      <time_frame>'baseline'</time_frame>
      <description>Temporal summation (TS) of pressure pain will be elicited at the upper trapezius muscle by administering 10 consecutive pressure pulses using the algometer. For each pulse of the TS procedure, the pressure will be increased at approximately 2 kg/s until the previously determined PPT will be reached and maintained for one second. Pressure pulses will be presented with an inter-stimulus interval of one second. Participants will be instructed to rate their perceived pain intensity during the first, fifth, and tenth pressure pulse using a verbal numeric rating scale (VNRS). The TS pain score will be obtained by subtracting the first VNRS score from the last VNRS, with increased number indicates higher pain facilitation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>conditioned pain modulation</measure>
      <time_frame>'baseline'</time_frame>
      <description>An inflated occlusion cuff placed on the contralateral arm will be used as a conditioned stimulus. The occlusion cuff will be inflated at a rate of 20 mm Hg/s until &quot;the first sensation of pain&quot;. At that point, it will be maintained for 30 s. Pain intensity will then be rated on a VNRS. Next, cuff inflation will be increased or decreased until the VNRS will be rated as 3/10. PPTs assessment will be repeated during maintenance of the cuff inflation. CPM will be calculated as the first NRS score during cuff inflation minus the first VNRS score before cuff inflation, with more positive values indicating more pain inhibition and more negative values indicating more pain facilitation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>tactile acuity</measure>
      <time_frame>'baseline'</time_frame>
      <description>It will be assessed by using two-point discrimination threshold on both sides of the neck.&#xD;
  A sliding two-point Vernier Calliper with digital measurement will be placed under its own weight on the participant's skin, to provide two simultaneous tactile stimuli. For the spinal measures, the caliper will be aligned vertically 15 mm lateral to the spinous processes of C7. Assessment will be commenced with the two-points at a 20 mm separation, and will be increased by 2 mm increments until the participant reported feeling two points of contact. If two distinct points perceived in three consecutive trials this value will be recorded. A series of three ascending and descending assessments will be performed, with the mean of the six values will be used for analyses.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">55</enrollment>
    <condition>Chronic Neck Pain</condition>
    <condition>Musculoskeletal Pain</condition>
    <condition>Pain Modulation</condition>
    <condition>Cortical Plasticity</condition>
    <condition>Conditioned Pain Modulation</condition>
    <condition>Temporal Summation</condition>
    <arm_group>
      <arm_group_label>patients with neck pain</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>conditioned pain modulation, temporal summation and two-point discrimination will be evaluated in all included participants.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>pain modulation and cortical somatosensory representation assessment</intervention_name>
      <description>Pressure pain threshold, conditioned pain modulation, temporal summation, and two-point discrimination will be evaluated on the upper trapezius muscle.</description>
      <arm_group_label>patients with neck pain</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  pain in the back of the neck region&#xD;
  &#xD;
            -  pain longer than 3 months&#xD;
  &#xD;
            -  pain intensity at least 3 based on the visual analog scale&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  vertebra fracture&#xD;
  &#xD;
            -  fibromyalgia&#xD;
  &#xD;
            -  chronic fatigue syndrome&#xD;
  &#xD;
            -  surgery to the neck or shoulder&#xD;
  &#xD;
            -  radicular pain&#xD;
  &#xD;
            -  neurologic deficit due to disk hernia&#xD;
  &#xD;
            -  spinal stenosis&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Kübra canlı, MSc</last_name>
      <phone>903123052525</phone>
      <email>kbrac91@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hacettepe University</name>
        <address>
          <city>Ankara</city>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kübra canlı, MSc</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 27, 2023</last_update_submitted>
    <last_update_submitted_qc>August 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hacettepe University</investigator_affiliation>
      <investigator_full_name>Kübra Canli</investigator_full_name>
      <investigator_title>Principal investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Musculoskeletal Pain</mesh_term>
      <mesh_term>Neck Pain</mesh_term>
    </condition_browse>
    <!-- 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/NCT06007443
  org study id: CPM-TS-2PD
  nct id: NCT06007443
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Chronic neck pain is a common problem among the general population. Patients with chronic
        neck pain used health care services twice as much as the population on average, mainly due to
        intense pain intensity. It is well-known that pain intensity depends on the association of
        pain processing in several levels of central pain processing.
  
        Identifying the association between conditioned pain modulation, temporal summation, and
        somatosensory representation, all represent separate central pain processing, will provide an
        opportunity to develop treatment strategies.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: pressure pain threshold
  time frame: 'baseline'
  description: The pressure pain threshold (PPTs) of the upper trapezius and dominant tibialis anterior muscles will be evaluated. For the upper trapezius muscle, assessment will be made approximately 5 to 8 cm superomedial to the superior angle of the scapula. For the tibialis anterior muscle, the assessment will be made muscle belly, which is approximately 2.5 cm lateral and 5 cm inferior to the tibial tubercle. Palpation during resisted active dorsiflexion ensured that the tibialis anterior muscle belly had been found.
  Pressure pain thresholds will assessed using a pressure algometer (Algometer) with a stimulation area of 1 cm2. The increment rate of pressure will be kept at approximately 1 kg/cm2/s. The first time the pressure perceived as pain will be recorded as a PPTs. Two PPT assessments with a 30 second will be completed, and the average was used for statistical analysis.
  measure: temporal summation
  time frame: 'baseline'
  description: Temporal summation (TS) of pressure pain will be elicited at the upper trapezius muscle by administering 10 consecutive pressure pulses using the algometer. For each pulse of the TS procedure, the pressure will be increased at approximately 2 kg/s until the previously determined PPT will be reached and maintained for one second. Pressure pulses will be presented with an inter-stimulus interval of one second. Participants will be instructed to rate their perceived pain intensity during the first, fifth, and tenth pressure pulse using a verbal numeric rating scale (VNRS). The TS pain score will be obtained by subtracting the first VNRS score from the last VNRS, with increased number indicates higher pain facilitation
  measure: conditioned pain modulation
  time frame: 'baseline'
  description: An inflated occlusion cuff placed on the contralateral arm will be used as a conditioned stimulus. The occlusion cuff will be inflated at a rate of 20 mm Hg/s until "the first sensation of pain". At that point, it will be maintained for 30 s. Pain intensity will then be rated on a VNRS. Next, cuff inflation will be increased or decreased until the VNRS will be rated as 3/10. PPTs assessment will be repeated during maintenance of the cuff inflation. CPM will be calculated as the first NRS score during cuff inflation minus the first VNRS score before cuff inflation, with more positive values indicating more pain inhibition and more negative values indicating more pain facilitation.
  measure: tactile acuity
  time frame: 'baseline'
  description: It will be assessed by using two-point discrimination threshold on both sides of the neck.
  A sliding two-point Vernier Calliper with digital measurement will be placed under its own weight on the participant's skin, to provide two simultaneous tactile stimuli. For the spinal measures, the caliper will be aligned vertically 15 mm lateral to the spinous processes of C7. Assessment will be commenced with the two-points at a 20 mm separation, and will be increased by 2 mm increments until the participant reported feeling two points of contact. If two distinct points perceived in three consecutive trials this value will be recorded. A series of three ascending and descending assessments will be performed, with the mean of the six values will be used for analyses.
  arm group label: patients with neck pain
  arm group type: Experimental
  description: conditioned pain modulation, temporal summation and two-point discrimination will be evaluated in all included participants.
  intervention type: Other
  intervention name: pain modulation and cortical somatosensory representation assessment
  description: Pressure pain threshold, conditioned pain modulation, temporal summation, and two-point discrimination will be evaluated on the upper trapezius muscle.
  arm group label: patients with neck pain
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Kübra canlı, MSc
  phone: 903123052525
  email: kbrac91@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Hacettepe University
  investigator full name: Kübra Canli
  investigator title: Principal investigator
  mesh term: Musculoskeletal Pain
  mesh term: Neck Pain