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/NCT05964517</url>
    </required_header>
    <id_info>
      <org_study_id>2022/392</org_study_id>
      <nct_id>NCT05964517</nct_id>
    </id_info>
    <brief_title>Fascial Distortion Model in Tension Type Headache</brief_title>
    <official_title>The Effects of the Fascial Distortion Model on Pain Intensity, Cervical Posture, and Joint Position Sense in Patients With Tension-type Headache.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Gaziantep</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Gaziantep</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>
        Tension-type headache is a headache that starts from the cervical and suboccipital regions,&#xD;
        spreads from the back of the head to the parietal, frontal and temporal regions, and is felt&#xD;
        in the form of compression, pressure and heaviness.&#xD;
  &#xD;
        Increased muscle and fascia tone in the cervical and cranial region, together with active&#xD;
        trigger points and factors that trigger pain, cause tension-type headache. Head and neck&#xD;
        fascia serves as an important proprioceptive structure in our body. Abnormal inputs from&#xD;
        mechanoreceptors and structures around the joint cause deterioration in joint position sense.&#xD;
        This study was planned to investigate the effects of the new facial distortion model on pain&#xD;
        intensity, cervical posture and joint position sense, unlike the manual techniques used in&#xD;
        previous studies in tension-type headache.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study was planned as a randomized controlled trial to investigate the effect of fascial&#xD;
        distortion model on pain severity, cervical posture and joint position sense in patients with&#xD;
        tension headache. Individuals with tension-type headache will be divided into control (n=15)&#xD;
        and study group (n=15) by simple random method. Fascial distortion modeling will be applied&#xD;
        to the study group for a total of 4 weeks, one session a week for 30 minutes. No application&#xD;
        was made to the control group. Evaluations will made for all individuals twice, at baseline&#xD;
        and after 4 weeks. Pain severity of individuals was evaluated with VAS and McGill-Melzack&#xD;
        Pain Scale, cervical posture with Posturescreen Mobile application, joint position sense with&#xD;
        laser cursor-assisted angle repetition test.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 7, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2023</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>
      <intervention_model_description>Control and study group&#xD;
  Facial distortion modeling was applied to the study group for 30 minutes, once a week, for 4 weeks. The control group was followed for 4 weeks and the same evaluations were made to the patients twice.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>Participants dont know in which group enrolled.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Pain Evaluation</measure>
      <time_frame>Change from McGill scale at one month</time_frame>
      <description>The McGill Pain Scale will be used to assess the pain of individuals. The questionnaire consists of four different parts. In the first part, in order to determine the localization of pain. In the second part, there are 20 word groups to be marked to determine the nature of the pain. In the fourth part of the scale, the patient is asked to choose appropriate words to determine the severity of pain. The higher the score, the greater the severity of the pain.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pain Intensity</measure>
      <time_frame>Change from VAS at one month</time_frame>
      <description>Pain intensity will be evaluated with the Visual analog scale (VAS). VAS consists of a 10 cm long horizontal line. '0' means no pain, '10' means unbearable pain. For evaluation, the patients were asked to mark the level of pain they felt on this line, and the distance to the starting point was measured with a ruler and the severity of the pain was recorded. The higher the score, the greater the severity of the pain.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cervical Joint Position sense</measure>
      <time_frame>Change from joint position sense at one month</time_frame>
      <description>Laser cursor assisted angle repetition test will be used to evaluate cervical joint position sense. The patient is positioned to coincide with the origin point of the laser target table. The patient is first asked to aim at the origin of the target pane with his eyes open. The distance from the point where the patient is standing to the origin is measured in cm. As the deviation distance increases, the sense of joint position worsens.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Posture analysis</measure>
      <time_frame>Change from posture at one month</time_frame>
      <description>Posturescreen mobile (PostureCo Inc., Trinity, FL, USA) application will be used for cervical posture assessment. Posturescreen Mobile (PSM) is a new photographic mobile application for detecting deviations from ideal posture.The validity and reliability study of the (PSM) application was conducted (118). As a reference point, the canthus of the eye, tragus, 7th cervical vertebra, and acromion will be marked on the photograph by the physiotherapist. Craniovertebral angle and shoulder position angle obtained automatically from the application will be recorded. Forward head posture increases with decreasing craniovertebral angle. The increase in shoulder position angle shows that protraction also increases.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Postural; Defect</condition>
    <condition>Tension-Type Headache</condition>
    <condition>Pain, Neck</condition>
    <condition>Craniovertebral; Syndrome</condition>
    <condition>Proprioceptive Disorders</condition>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The control group refers to patients with tension-type headache who will not be treated. These patients are only evaluated during follow-up.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Study Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients with tension-type headache in the study group are treated. Evaluations are made before and after treatment.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Fascial Distortion Model</intervention_name>
      <description>Facial Distortion is a manual therapy technique applied by model physiotherapists. It is a deep tissue massage to the fascial tissue.</description>
      <arm_group_label>Study Group</arm_group_label>
      <other_name>Manual therapy</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  diagnosis of tension-type headache,&#xD;
  &#xD;
            -  the ages of 20-50 years,&#xD;
  &#xD;
            -  must be headache complaint for at least 6 months,&#xD;
  &#xD;
            -  Pain is at least 4 on the visual pain scale.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  diagnosis of ervical disc herniation,&#xD;
  &#xD;
            -  diagnosis of sinusitis, migraine and vertigo,&#xD;
  &#xD;
            -  diagnosis of scoliosis,&#xD;
  &#xD;
            -  diagnosis of radiculopathy,&#xD;
  &#xD;
            -  Having a history of surgery Tumor, cyst or similar findings, Having received any&#xD;
               physical therapy for the cervical region before, Having any psychological disorder It&#xD;
               is the use of any painkillers during the treatment.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Tuba Maden</last_name>
      <phone>05319340249</phone>
      <email>tuba.kmaden@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Tuba Maden</name>
        <address>
          <city>Gaziantep</city>
          <state>Sahinbey</state>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Tuba Maden, PhD</last_name>
        <phone>05319340249</phone>
        <email>tuba.kmaden@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Gaziantep</investigator_affiliation>
      <investigator_full_name>Ogr Uyesi Tuba MADEN</investigator_full_name>
      <investigator_title>Assisstanf Profesor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tension-Type Headache</mesh_term>
      <mesh_term>Somatosensory Disorders</mesh_term>
      <mesh_term>Headache</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/NCT05964517
  org study id: 2022/392
  nct id: NCT05964517
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Tension-type headache is a headache that starts from the cervical and suboccipital regions,
        spreads from the back of the head to the parietal, frontal and temporal regions, and is felt
        in the form of compression, pressure and heaviness.
  
        Increased muscle and fascia tone in the cervical and cranial region, together with active
        trigger points and factors that trigger pain, cause tension-type headache. Head and neck
        fascia serves as an important proprioceptive structure in our body. Abnormal inputs from
        mechanoreceptors and structures around the joint cause deterioration in joint position sense.
        This study was planned to investigate the effects of the new facial distortion model on pain
        intensity, cervical posture and joint position sense, unlike the manual techniques used in
        previous studies in tension-type headache.
  This study was planned as a randomized controlled trial to investigate the effect of fascial
        distortion model on pain severity, cervical posture and joint position sense in patients with
        tension headache. Individuals with tension-type headache will be divided into control (n=15)
        and study group (n=15) by simple random method. Fascial distortion modeling will be applied
        to the study group for a total of 4 weeks, one session a week for 30 minutes. No application
        was made to the control group. Evaluations will made for all individuals twice, at baseline
        and after 4 weeks. Pain severity of individuals was evaluated with VAS and McGill-Melzack
        Pain Scale, cervical posture with Posturescreen Mobile application, joint position sense with
        laser cursor-assisted angle repetition test.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Control and study group
  Facial distortion modeling was applied to the study group for 30 minutes, once a week, for 4 weeks. The control group was followed for 4 weeks and the same evaluations were made to the patients twice.
  primary purpose: Treatment
  masking: Single (Participant)
  masking description: Participants dont know in which group enrolled.
  measure: Pain Evaluation
  time frame: Change from McGill scale at one month
  description: The McGill Pain Scale will be used to assess the pain of individuals. The questionnaire consists of four different parts. In the first part, in order to determine the localization of pain. In the second part, there are 20 word groups to be marked to determine the nature of the pain. In the fourth part of the scale, the patient is asked to choose appropriate words to determine the severity of pain. The higher the score, the greater the severity of the pain.
  measure: Pain Intensity
  time frame: Change from VAS at one month
  description: Pain intensity will be evaluated with the Visual analog scale (VAS). VAS consists of a 10 cm long horizontal line. '0' means no pain, '10' means unbearable pain. For evaluation, the patients were asked to mark the level of pain they felt on this line, and the distance to the starting point was measured with a ruler and the severity of the pain was recorded. The higher the score, the greater the severity of the pain.
  measure: Cervical Joint Position sense
  time frame: Change from joint position sense at one month
  description: Laser cursor assisted angle repetition test will be used to evaluate cervical joint position sense. The patient is positioned to coincide with the origin point of the laser target table. The patient is first asked to aim at the origin of the target pane with his eyes open. The distance from the point where the patient is standing to the origin is measured in cm. As the deviation distance increases, the sense of joint position worsens.
  measure: Posture analysis
  time frame: Change from posture at one month
  description: Posturescreen mobile (PostureCo Inc., Trinity, FL, USA) application will be used for cervical posture assessment. Posturescreen Mobile (PSM) is a new photographic mobile application for detecting deviations from ideal posture.The validity and reliability study of the (PSM) application was conducted (118). As a reference point, the canthus of the eye, tragus, 7th cervical vertebra, and acromion will be marked on the photograph by the physiotherapist. Craniovertebral angle and shoulder position angle obtained automatically from the application will be recorded. Forward head posture increases with decreasing craniovertebral angle. The increase in shoulder position angle shows that protraction also increases.
  arm group label: Control Group
  arm group type: No Intervention
  description: The control group refers to patients with tension-type headache who will not be treated. These patients are only evaluated during follow-up.
  arm group label: Study Group
  arm group type: Active Comparator
  description: Patients with tension-type headache in the study group are treated. Evaluations are made before and after treatment.
  intervention type: Other
  intervention name: Fascial Distortion Model
  description: Facial Distortion is a manual therapy technique applied by model physiotherapists. It is a deep tissue massage to the fascial tissue.
  arm group label: Study Group
  other name: Manual therapy
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 50 Years
  healthy volunteers: No
  last name: Tuba Maden
  phone: 05319340249
  email: tuba.kmaden@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: University of Gaziantep
  investigator full name: Ogr Uyesi Tuba MADEN
  investigator title: Assisstanf Profesor
  mesh term: Tension-Type Headache
  mesh term: Somatosensory Disorders
  mesh term: Headache
  mesh term: Neck Pain