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/NCT05982964</url>
    </required_header>
    <id_info>
      <org_study_id>E-85646034-604.02.02-62452</org_study_id>
      <nct_id>NCT05982964</nct_id>
    </id_info>
    <brief_title>Impact of Scapula Position on Functionality and Balance in People With Chronic Low Back Pain</brief_title>
    <official_title>Impact of Scapula Position on Functionality and Balance in People With Chronic Low Back Pain</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Istanbul Medipol University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Istanbul Medipol University Hospital</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>
        Chronic low back pain is defined as pain that lasts for more than 3 months or exceeds the&#xD;
        expected recovery time.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Chronic low back pain is defined as pain that lasts for more than 3 months or exceeds the&#xD;
        expected recovery time.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 31, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2023</completion_date>
    <primary_completion_date type="Actual">July 31, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Pressure Pain Threshold Algometer</measure>
      <time_frame>1 day</time_frame>
      <description>The pressure algometer is a tool used to assess the pain threshold. The algometer used in this study is connected to a dial measuring the pressure in kilograms and pounds, and consists of a metal piston with a diameter of 1 centimeter at the tip, the smallest gap of which is 100 gr and 10 kg/cm².</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Examining the Scapular Position</measure>
      <time_frame>1 day</time_frame>
      <description>The lateral scapular glide test was used to evaluate the scapula position. In the first position, the arms were relaxed at the sides, the shoulder was in the neutral position, in the second position the patient's hands were positioned around the waist and the humerus was brought to medial rotation and abduction of 45 degrees, and in the third position, the humerus was placed in maximal medial rotation and 90-degree abduction.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Evaluation of Balance</measure>
      <time_frame>1 day</time_frame>
      <description>The static and dynamic postural stability of all individuals included in the study were evaluated with the Biodex Balance System (BDS).&#xD;
  For dynamic stability measurement, a total of 3 tests were conducted, with the platform in dynamic position, with each period lasting 20 seconds, giving the participant a rest period of 10 seconds in between. Afterwards, the average of these 3 tests was obtained automatically by the device. In the results obtained, it is possible to interpret that as the score approaches 0, the balance is maintained, and as it moves away from 0, the balance is deteriorated.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Proprioception Evaluation</measure>
      <time_frame>1 day</time_frame>
      <description>An inclinometer is an instrument that records angular movements with respect to gravity. The inclinometer has many advantages such as precise measurement, digital display, and ease of use.&#xD;
  In our study, inclinometer was used in the evaluation of proprioception. Measurements will be recorded in degrees.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Evaluation of Functionality</measure>
      <time_frame>1 day</time_frame>
      <description>The Oswestry Low Back Pain Disability Questionnaire (OBAEA) was used to examine functionality in patients with chronic low back pain. This survey consists of 10 questions in total. Each question has 6 options and ranges from 0 to 5. Participants are asked to mark the option that best fits their individual situation. While 50 is the highest score, it is evaluated as mild functional disability between 1 and 10 points, moderate functional disability between 11 and 30 points, and severe functional disability between 31 and 50 points.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Waist Awareness Assessment</measure>
      <time_frame>1 day</time_frame>
      <description>Fremantle Waist Awareness Questionnaire was used to evaluate low back awareness in the study. The Fremantle Waist Awareness Questionnaire is the only one that assesses body awareness about the waist. It consists of 9 questions in total and each question has a score ranging from 0-4. In total, the lowest 0 and the highest 36 points can be obtained. High scores indicate low back awareness.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">81</enrollment>
    <condition>Back Pain</condition>
    <arm_group>
      <arm_group_label>back pain group</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Healthy volunteers</arm_group_label>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Our study was carried out on healthy and non-specific low back pain individuals who came to&#xD;
          Bahçeşehir University.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion criteria:&#xD;
  &#xD;
            -  Individuals between the ages of 18-65&#xD;
  &#xD;
            -  Individuals with low back pain for at least 3 months for the first group&#xD;
  &#xD;
            -  Not undergoing surgery related to the lumbar region&#xD;
  &#xD;
            -  Cases without lumbar steroid injection in the last 3 months&#xD;
  &#xD;
            -  Not having visual and hearing loss&#xD;
  &#xD;
            -  Having low back pain&#xD;
  &#xD;
            -  Cases without neurological problems&#xD;
  &#xD;
            -  Cases without tumor and infection in the lumbar region&#xD;
  &#xD;
            -  Exclusion criteria:&#xD;
  &#xD;
            -  Individuals under the age of 18&#xD;
  &#xD;
            -  Individuals with low back pain for less than 3 months for the first group&#xD;
  &#xD;
            -  Not having a musculoskeletal or neuromuscular disease that limits mobility,&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>HAZAL genç, PhD</last_name>
      <phone>05413204291</phone>
      <email>hazaloksuz@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>HAZAL genç</name>
        <address>
          <city>Istanbul</city>
          <state>None Selected</state>
          <zip>34353</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>HAZAL genç, phd</last_name>
        <phone>05413204291</phone>
        <email>hazaloksuz@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Istanbul Medipol University Hospital</investigator_affiliation>
      <investigator_full_name>hazal genc</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>Back Pain</mesh_term>
      <mesh_term>Low Back Pain</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/NCT05982964
  org study id: E-85646034-604.02.02-62452
  nct id: NCT05982964
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Chronic low back pain is defined as pain that lasts for more than 3 months or exceeds the
        expected recovery time.
  Chronic low back pain is defined as pain that lasts for more than 3 months or exceeds the
        expected recovery time.
  observational model: Other
  time perspective: Other
  measure: Pressure Pain Threshold Algometer
  time frame: 1 day
  description: The pressure algometer is a tool used to assess the pain threshold. The algometer used in this study is connected to a dial measuring the pressure in kilograms and pounds, and consists of a metal piston with a diameter of 1 centimeter at the tip, the smallest gap of which is 100 gr and 10 kg/cm².
  measure: Examining the Scapular Position
  time frame: 1 day
  description: The lateral scapular glide test was used to evaluate the scapula position. In the first position, the arms were relaxed at the sides, the shoulder was in the neutral position, in the second position the patient's hands were positioned around the waist and the humerus was brought to medial rotation and abduction of 45 degrees, and in the third position, the humerus was placed in maximal medial rotation and 90-degree abduction.
  measure: Evaluation of Balance
  time frame: 1 day
  description: The static and dynamic postural stability of all individuals included in the study were evaluated with the Biodex Balance System (BDS).
  For dynamic stability measurement, a total of 3 tests were conducted, with the platform in dynamic position, with each period lasting 20 seconds, giving the participant a rest period of 10 seconds in between. Afterwards, the average of these 3 tests was obtained automatically by the device. In the results obtained, it is possible to interpret that as the score approaches 0, the balance is maintained, and as it moves away from 0, the balance is deteriorated.
  measure: Proprioception Evaluation
  time frame: 1 day
  description: An inclinometer is an instrument that records angular movements with respect to gravity. The inclinometer has many advantages such as precise measurement, digital display, and ease of use.
  In our study, inclinometer was used in the evaluation of proprioception. Measurements will be recorded in degrees.
  measure: Evaluation of Functionality
  time frame: 1 day
  description: The Oswestry Low Back Pain Disability Questionnaire (OBAEA) was used to examine functionality in patients with chronic low back pain. This survey consists of 10 questions in total. Each question has 6 options and ranges from 0 to 5. Participants are asked to mark the option that best fits their individual situation. While 50 is the highest score, it is evaluated as mild functional disability between 1 and 10 points, moderate functional disability between 11 and 30 points, and severe functional disability between 31 and 50 points.
  measure: Waist Awareness Assessment
  time frame: 1 day
  description: Fremantle Waist Awareness Questionnaire was used to evaluate low back awareness in the study. The Fremantle Waist Awareness Questionnaire is the only one that assesses body awareness about the waist. It consists of 9 questions in total and each question has a score ranging from 0-4. In total, the lowest 0 and the highest 36 points can be obtained. High scores indicate low back awareness.
  arm group label: back pain group
  arm group label: Healthy volunteers
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: HAZAL genç, PhD
  phone: 05413204291
  email: hazaloksuz@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Istanbul Medipol University Hospital
  investigator full name: hazal genc
  investigator title: Principal Investigator
  mesh term: Back Pain
  mesh term: Low Back Pain
  sharing ipd: No