<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/NCT03782584</url>
  </required_header>
  <id_info>
    <org_study_id>DEU.HSI.MSc-2015970022</org_study_id>
    <nct_id>NCT03782584</nct_id>
  </id_info>
  <brief_title>Efficiency of Modified Pilates Exercises in Patients With Chronic Neck Pain</brief_title>
  <official_title>Efficiency of Modified Pilates Exercises in Patients With Chronic Neck Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dokuz Eylul University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dokuz Eylul University</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 this study is to investigate the effects of modified pilates exercises on neck&#xD;
      pain, deep neck flexor muscles edurance, joint position sense and functionality in patients&#xD;
      with chronic neck pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      50 individuals with Chronic Neck Pain not working will be included to our study. We will&#xD;
      evaluate pain (with visual analog scale), deep neck flexors' endurance (with cranio-cervical&#xD;
      flexure test using the pressure stabilizing feedback device), cervical range of motion and&#xD;
      cervical proprioception (wit cervical range of motion device). Besides we will conduct a&#xD;
      questionnaire (neck disability index) to get further knowledge about their functionality.&#xD;
      Participants will be randomly allocated 2 groups consisting of 25 participants and these 2&#xD;
      groups will receive different interventions. Modified Pilates Exercise Group (MPEG) will be&#xD;
      involved in a modified pilates exercise training for a total of 6 weeks a day, 2 days a week&#xD;
      in the presence of a physiotherapist. The Control Group (KG) will receive daily routine&#xD;
      advises to prevent neck pain and they will be asked about to apply these advises and not to&#xD;
      make other changes in their life. The evaluations will be repeated and analyzed 2 times,&#xD;
      pre-treatment and 6 weeks after treatment , and the effectiveness of the modified pilates&#xD;
      exercises will be examined in the chronic neck pain. Our hypothesis is ''Modified pilates&#xD;
      exercises have a positive effect on neck pain, range of motion, deep neck flexor muscles,&#xD;
      joint position sense and function in patients with chronic neck pain.''&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2018</start_date>
  <completion_date type="Actual">November 30, 2018</completion_date>
  <primary_completion_date type="Actual">August 30, 2018</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Evaluation</measure>
    <time_frame>6 weeks</time_frame>
    <description>This test will be measured by Visual Analog Scale (VAS) score. VAS has 10-centimeter line corresponding to the amount of pain they experienced. &quot;0&quot; means &quot;no pain&quot; and &quot;10&quot; means &quot;pain as bad as possible&quot;.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neck Disability Index</measure>
    <time_frame>6 weeks</time_frame>
    <description>Neck disability index is a survey that has 10 different sections including Pain intensity, personal care, weight lifting, reading, headache, concentration, work, driving, sleeping and resting activitie.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Posture Evaluation</measure>
    <time_frame>6 weeks</time_frame>
    <description>Sagital plan photographs of the people will be taken and head and shoulder posture will be evaluated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neck Range Of Motion</measure>
    <time_frame>6 weeks</time_frame>
    <description>Range of motion will be measured by cervical range of motion device (CROM device)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Deep Neck Flexor Endurance</measure>
    <time_frame>6 weeks</time_frame>
    <description>Score of cranio-cervical flexion test will be measured by Stabilizer Pressure Biofeedback Unit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neck Position Sense</measure>
    <time_frame>6 weeks</time_frame>
    <description>Joint position error of 6-direction (flexion, extension, right-left lateral flexion and right-left rotation) will be measured by cervical range of motion device (CROM device).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Neck Pain</condition>
  <arm_group>
    <arm_group_label>Modified Pilates Exercise Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>they will be involved in a modified pilates exercise training for a total of 6 weeks a day, 2 days a week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>they will be given daily life advises to prevent neck pain</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>modified pilates exercise</intervention_name>
    <description>modified exercises from original pilates exercises.</description>
    <arm_group_label>Modified Pilates Exercise Group</arm_group_label>
    <other_name>daily routine advises</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>daily life advises</intervention_name>
    <description>they will be given daily life advises to prevent neck pain</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Having neck pain more than 3 months&#xD;
&#xD;
          -  No physical therapy in last year&#xD;
&#xD;
          -  No background with pilates exercises&#xD;
&#xD;
          -  Being able to understand Turkish, treatment and evaluations.&#xD;
&#xD;
          -  Being able to complete all the evaluations and treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Fracture or surgery background with shoulder, cervical area or other extremities.&#xD;
&#xD;
          -  Any systemic musculoskeletal diseases&#xD;
&#xD;
          -  Existing chest deformities or scoliosis&#xD;
&#xD;
          -  Cervical hernia, neuropathy or whiplash.&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Having pain above 7 in VAS&#xD;
&#xD;
          -  Any other pain that could prevent people from doing exercises&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>sevgi sevi yeşilyaprak, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>9 eylül university</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Izmir University of Economics</name>
      <address>
        <city>İzmir</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>March 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>November 20, 2020</last_update_submitted>
  <last_update_submitted_qc>November 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dokuz Eylul University</investigator_affiliation>
    <investigator_full_name>Gonca Şahiner Pıçak</investigator_full_name>
    <investigator_title>associate professor</investigator_title>
  </responsible_party>
  <keyword>exercise</keyword>
  <keyword>pilates</keyword>
  <keyword>modified pilates</keyword>
  <keyword>chronic neck pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neck 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>


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/NCT03782584
org study id: DEU.HSI.MSc-2015970022
nct id: NCT03782584
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to investigate the effects of modified pilates exercises on neck
      pain, deep neck flexor muscles edurance, joint position sense and functionality in patients
      with chronic neck pain.
50 individuals with Chronic Neck Pain not working will be included to our study. We will
      evaluate pain (with visual analog scale), deep neck flexors' endurance (with cranio-cervical
      flexure test using the pressure stabilizing feedback device), cervical range of motion and
      cervical proprioception (wit cervical range of motion device). Besides we will conduct a
      questionnaire (neck disability index) to get further knowledge about their functionality.
      Participants will be randomly allocated 2 groups consisting of 25 participants and these 2
      groups will receive different interventions. Modified Pilates Exercise Group (MPEG) will be
      involved in a modified pilates exercise training for a total of 6 weeks a day, 2 days a week
      in the presence of a physiotherapist. The Control Group (KG) will receive daily routine
      advises to prevent neck pain and they will be asked about to apply these advises and not to
      make other changes in their life. The evaluations will be repeated and analyzed 2 times,
      pre-treatment and 6 weeks after treatment , and the effectiveness of the modified pilates
      exercises will be examined in the chronic neck pain. Our hypothesis is ''Modified pilates
      exercises have a positive effect on neck pain, range of motion, deep neck flexor muscles,
      joint position sense and function in patients with chronic neck pain.''
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pain Evaluation
time frame: 6 weeks
description: This test will be measured by Visual Analog Scale (VAS) score. VAS has 10-centimeter line corresponding to the amount of pain they experienced. "0" means "no pain" and "10" means "pain as bad as possible".
measure: Neck Disability Index
time frame: 6 weeks
description: Neck disability index is a survey that has 10 different sections including Pain intensity, personal care, weight lifting, reading, headache, concentration, work, driving, sleeping and resting activitie.
measure: Posture Evaluation
time frame: 6 weeks
description: Sagital plan photographs of the people will be taken and head and shoulder posture will be evaluated.
measure: Neck Range Of Motion
time frame: 6 weeks
description: Range of motion will be measured by cervical range of motion device (CROM device)
measure: Deep Neck Flexor Endurance
time frame: 6 weeks
description: Score of cranio-cervical flexion test will be measured by Stabilizer Pressure Biofeedback Unit.
measure: Neck Position Sense
time frame: 6 weeks
description: Joint position error of 6-direction (flexion, extension, right-left lateral flexion and right-left rotation) will be measured by cervical range of motion device (CROM device).
arm group label: Modified Pilates Exercise Group
arm group type: Experimental
description: they will be involved in a modified pilates exercise training for a total of 6 weeks a day, 2 days a week.
arm group label: Control Group
arm group type: Other
description: they will be given daily life advises to prevent neck pain
intervention type: Other
intervention name: modified pilates exercise
description: modified exercises from original pilates exercises.
arm group label: Modified Pilates Exercise Group
other name: daily routine advises
intervention type: Other
intervention name: daily life advises
description: they will be given daily life advises to prevent neck pain
arm group label: Control Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: sevgi sevi yeşilyaprak, PHD
role: Principal Investigator
affiliation: 9 eylül university
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Dokuz Eylul University
investigator full name: Gonca Şahiner Pıçak
investigator title: associate professor
mesh term: Neck Pain
sharing ipd: No