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/NCT05986656</url>
    </required_header>
    <id_info>
      <org_study_id>13072023</org_study_id>
      <nct_id>NCT05986656</nct_id>
    </id_info>
    <brief_title>X-ray Evaluation of the Effectiveness of the Atlas Correction in Patients With Chronic Subluxation of the Atlas</brief_title>
    <acronym>AtlaStandard</acronym>
    <official_title>X-ray Assessment of the Effectiveness of Hardware Medical Acupressure of the Suboccipital Muscles According to the &quot;Atlas-Standard&quot; Method in Patients With Chronic Subluxation of the First Cervical Vertebra</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia</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 aim of the study is to evaluate the effect of the procedure of medical acupressure of the&#xD;
        suboccipital muscles according to the Atlas-Standard method on the normalization of the&#xD;
        position of the first cervical vertebra and the angles of the spinal column in patients with&#xD;
        diagnosed chronic subluxation with objectification of the results by radiography and&#xD;
        inclinometry.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 8, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 30, 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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Distance between righr and left inner surface of the lateral mass of the atlas and the outer surface of the odontoid process of the axis on x-ray</measure>
      <time_frame>1 month.</time_frame>
      <description>Elimination of asymmetry between the right and left atlantodental intervals</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pain level</measure>
      <time_frame>1 month</time_frame>
      <description>Change in the pain level in the spine according to VAS (Visual Analog Scale from 0 to 10 where 0 is &quot;no pain&quot;, 10 is &quot;worst pain imaginable&quot;)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Painkillers</measure>
      <time_frame>1 month</time_frame>
      <description>Number of participants who use painkillers before and after procedure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The functional disability</measure>
      <time_frame>1 month</time_frame>
      <description>Evaluated with the Oswestry Disability Index (ODI: 0 = minimal [better outcome] to 100% = maximal disability [worse outcome])</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in the angles of deviation of the spinous processes</measure>
      <time_frame>1 month</time_frame>
      <description>Measurement of the angles of deviation of the spinous processes in degrees of the frontal and sagittal cavities from C7 to S3 in the position of full flexion, extension of the spine and in the vertical position measured by Spinal Mouse device</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in the range of motion of the spine</measure>
      <time_frame>1 month</time_frame>
      <description>Changes in the range of motion of the spine in degrees in the frontal and sagittal planes in the range from C7 to S3 in the position of full flexion and extension of the spine measured by Spinal Mouse device</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Subluxation and Dislocation of C0/C1 Cervical Vertebrae</condition>
    <arm_group>
      <arm_group_label>Atlas correction</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Basic group.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Atlas-Standard method</intervention_name>
      <description>Hardware acupressure of the suboccipital muscles according to the Atlas-Standard method for the reduction of chronic subluxation of the first cervical vertebra.</description>
      <arm_group_label>Atlas correction</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with chronic subluxation of the first cervical vertebra with complaints of&#xD;
               pain in the occiput/cervical/thoracic/lumbar spine/limitation of head rotation in one&#xD;
               or both directions.&#xD;
  &#xD;
            -  Scoliotic deformity of the spine 1-2 degrees.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Fractures of the first / second cervical vertebra in history&#xD;
  &#xD;
            -  Fractures of the spine in any of the departments in the anmenesis&#xD;
  &#xD;
            -  Assimilation of the atlas with the occipital bone or the second cervical vertebra&#xD;
  &#xD;
            -  Operations on the spine using metal structures&#xD;
  &#xD;
            -  Scoliosis 3-4 degree&#xD;
  &#xD;
            -  Botulinum toxin injections in the suboccipital region within the last year&#xD;
  &#xD;
            -  Taking muscle relaxants&#xD;
  &#xD;
            -  Corrective surgery on muscles and bones&#xD;
  &#xD;
            -  Braces&#xD;
  &#xD;
            -  Active period of dental implants installation&#xD;
  &#xD;
            -  Postoperative period (any operation, including on the eyes) less than 6 months&#xD;
  &#xD;
            -  Acute infectious diseases - less than 2 weeks from the start of recovery&#xD;
  &#xD;
            -  Skin diseases with inflammatory manifestations in the neck&#xD;
  &#xD;
            -  Oncological diseases&#xD;
  &#xD;
            -  Recovery period after injury (cervical and brain injury) or stroke less than a year&#xD;
  &#xD;
            -  Established mental illness&#xD;
  &#xD;
            -  Extreme malnutrition (cachexia)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Denis Borsuk</last_name>
      <role>Study Chair</role>
      <affiliation>South Ural Medical University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Denis Borsuk</last_name>
      <phone>+79630777333</phone>
      <email>borsuk-angio@mail.ru</email>
    </overall_contact>
    <location>
      <facility>
        <name>Astrakhan Regional Clinical Hospital</name>
        <address>
          <city>Astrakhan</city>
          <country>Russian Federation</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Alexandr Yanpolskii</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Russian Federation</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>September 9, 2023</last_update_submitted>
    <last_update_submitted_qc>September 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia</investigator_affiliation>
      <investigator_full_name>Denis Borsuk</investigator_full_name>
      <investigator_title>Director</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Joint Dislocations</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/NCT05986656
  org study id: 13072023
  nct id: NCT05986656
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the study is to evaluate the effect of the procedure of medical acupressure of the
        suboccipital muscles according to the Atlas-Standard method on the normalization of the
        position of the first cervical vertebra and the angles of the spinal column in patients with
        diagnosed chronic subluxation with objectification of the results by radiography and
        inclinometry.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Distance between righr and left inner surface of the lateral mass of the atlas and the outer surface of the odontoid process of the axis on x-ray
  time frame: 1 month.
  description: Elimination of asymmetry between the right and left atlantodental intervals
  measure: Pain level
  time frame: 1 month
  description: Change in the pain level in the spine according to VAS (Visual Analog Scale from 0 to 10 where 0 is "no pain", 10 is "worst pain imaginable")
  measure: Painkillers
  time frame: 1 month
  description: Number of participants who use painkillers before and after procedure
  measure: The functional disability
  time frame: 1 month
  description: Evaluated with the Oswestry Disability Index (ODI: 0 = minimal [better outcome] to 100% = maximal disability [worse outcome])
  measure: Changes in the angles of deviation of the spinous processes
  time frame: 1 month
  description: Measurement of the angles of deviation of the spinous processes in degrees of the frontal and sagittal cavities from C7 to S3 in the position of full flexion, extension of the spine and in the vertical position measured by Spinal Mouse device
  measure: Changes in the range of motion of the spine
  time frame: 1 month
  description: Changes in the range of motion of the spine in degrees in the frontal and sagittal planes in the range from C7 to S3 in the position of full flexion and extension of the spine measured by Spinal Mouse device
  arm group label: Atlas correction
  arm group type: Experimental
  description: Basic group.
  intervention type: Procedure
  intervention name: Atlas-Standard method
  description: Hardware acupressure of the suboccipital muscles according to the Atlas-Standard method for the reduction of chronic subluxation of the first cervical vertebra.
  arm group label: Atlas correction
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Denis Borsuk
  role: Study Chair
  affiliation: South Ural Medical University
  last name: Denis Borsuk
  phone: +79630777333
  email: borsuk-angio@mail.ru
  facility: 
  status: Recruiting
  contact: 
  country: Russian Federation
  responsible party type: Principal Investigator
  investigator affiliation: Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia
  investigator full name: Denis Borsuk
  investigator title: Director
  mesh term: Joint Dislocations
  sharing ipd: No