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/NCT06005948</url>
    </required_header>
    <id_info>
      <org_study_id>Uskudar75</org_study_id>
      <nct_id>NCT06005948</nct_id>
    </id_info>
    <brief_title>Investigation of the Effectiveness of Dynamic Neuromuscular Stabilization Exercises After Lumbar Disc Herniation Surgery</brief_title>
    <official_title>Investigation of the Effect of Dynamic Neuromuscular Stabilization on Pain, Functionality and Kinesiophobia in Individuals Undergoing Lumbar Disc Herniation Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Uskudar University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Uskudar 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 the study is to investigate the effects of dynamic neuromuscular stabilization&#xD;
        exercises on pain, functionality and fear in individuals who have undergone lumbar disc&#xD;
        herniation surgery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The research was planned as a randomized controlled trial, which is a quantitative study.&#xD;
        Participants will be divided into 2 groups as control and exercise groups by simple&#xD;
        randomization method. The individuals in the control group of the study will not be given any&#xD;
        exercise program after surgery. A home exercise program created with Dynamic Neuromuscular&#xD;
        Stabilization exercises after surgery will be applied to the individuals in the intervention&#xD;
        group. Data collection will be carried out through an online survey. The scales and forms to&#xD;
        be used before and after the treatment are respectively: 1. Oswestry Low Back Pain Disability&#xD;
        Questionnaire 2. International Physical Activity Questionnaire (Short Form) 3. Questionnaire&#xD;
        for Fear of Daily Living Activities The questionnaires will be uploaded to the Google Forms&#xD;
        database and the participants will be accessed via e-mail or mobile phone applications. .&#xD;
        They will be asked to fill out the questionnaires before starting the post-surgical exercise&#xD;
        program and the exercise program will be explained practically before discharge. The&#xD;
        exercises will be planned 3 times a week and for 8 weeks.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 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>The dynamic neuromuscular stabilization exercises</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The Oswestry Disability Index</measure>
      <time_frame>10 weeks</time_frame>
      <description>The questionnaire includes ten topics related to pain severity, weight lifting, self-care, walking, sitting, sexual function, standing, social life, sleep quality, and ability to travel. expression follows. The patient then checks for the expression that most closely resembles his condition. Each question is scored on a scale of 0-5, with the first statement being zero and indicating the least disability, and the last statement being scored as 5 indicating the most severe disability. The scores of all answered questions are added up, then multiplied by two to get the index (range 0 to 100). Zero equals no obstacle and 100 is the maximum possible obstacle.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>International Physical Activity Questionnaire Short Form (IPAQ-SF)</measure>
      <time_frame>10 weeks</time_frame>
      <description>It consists of 7 questions. The questions provide information about time spent walking, time spent in moderate and vigorous activities, and time spent sitting. Calculation of the short form's total score includes the sum of time (minutes) and frequency (days) of walking, moderate-intensity activity, and vigorous activity. The energy required for activities is calculated with the metabolic equivalent (MET) -minute score. Standard MET values have been established for these activities. These are; Sitting 1.5 MET, Walking 3.3 MET, Moderate-intensity physical activity 4.0 MET, Vigorous physical activity 8.0 MET. Daily and weekly physical activity using these values level is calculated.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fear of Daily Living Activities Questionnaire</measure>
      <time_frame>10 weeks</time_frame>
      <description>In the questionnaire consisting of 10 questions, the participant is asked to score each question between 0 and 100. No fear of the activity is set to 0 and excessive fear of the activity is 100. In addition, the participants are asked to add 2 different activities that are not included in the survey but cause fear.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Low Back Pain</condition>
    <condition>Kinesiophobia</condition>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>No exercise will be given after surgery</description>
    </arm_group>
    <arm_group>
      <arm_group_label>exercise group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Dynamic neuromuscular stabilization exercises will be performed for 8 weeks after surgery.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>exercise</intervention_name>
      <description>The dynamic neuromuscular stabilization group will receive developmental postures based on developmental kinesiology. It will involve a supine 3month Position, side-lying Position, Quadruped, oblique sitting, bear position, squat Position. Each position will be performed for 30-60 s for five reps, active exercise 5-10 reps under supervision for two days/week, and unsupervised for 3 days/week for 8 weeks</description>
      <arm_group_label>exercise group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>control</intervention_name>
      <description>No intervention will be made.</description>
      <arm_group_label>control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Be between 30 and 50 years old.&#xD;
  &#xD;
            -  Having undergone lumbar disc hernia surgery.&#xD;
  &#xD;
            -  Having access to a computer/tablet/phone and internet.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Having cognitive, mental or psychological problems.&#xD;
  &#xD;
            -  Having a visual or hearing impairment.&#xD;
  &#xD;
            -  Having a physical condition that causes significant loss of function&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Büşra ARISÜT</last_name>
      <role>Study Chair</role>
      <affiliation>Uskudar University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ömer ŞEVGİN</last_name>
      <phone>+905069787535</phone>
      <email>omer.sevgin@uskudar.edu.tr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Uskudar university</name>
        <address>
          <city>Istanbul</city>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ömer Şevgin</last_name>
        <email>omer.sevgin@uskudar.edu.tr</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Venkatesan P, K S, Kishen TJ, Janardhan S, Kumar Cr S. Comparison of yoga and dynamic neuromuscular stabilization exercise in chronic low back pain on magnetic resonance imaging of lumbar multifidus- protocol for a randomized controlled trial. Contemp Clin Trials Commun. 2022 May 28;28:100937. doi: 10.1016/j.conctc.2022.100937. eCollection 2022 Aug.</citation>
      <PMID>35789639</PMID>
    </reference>
    <reference>
      <citation>Baerga-Varela L, Abreu Ramos AM. Core strengthening exercises for low back pain. Bol Asoc Med P R. 2006 Jan-Mar;98(1):56-61.</citation>
      <PMID>19610550</PMID>
    </reference>
    <reference>
      <citation>Butowicz CM, Acasio JC, Silfies SP, Nussbaum MA, Hendershot BD. Chronic low back pain influences trunk neuromuscular control during unstable sitting among persons with lower-limb loss. Gait Posture. 2019 Oct;74:236-241. doi: 10.1016/j.gaitpost.2019.09.019. Epub 2019 Sep 18.</citation>
      <PMID>31563825</PMID>
    </reference>
    <reference>
      <citation>Kararti C, Ozsoy I, Ozyurt F, Basat HC, Ozsoy G, Ozudogru A. The effects of dynamic neuromuscular stabilization approach on clinical outcomes in older patients with chronic nonspecific low back pain: a randomized, controlled clinical trial. Somatosens Mot Res. 2023 Sep;40(3):116-125. doi: 10.1080/08990220.2023.2191705. Epub 2023 Mar 24.</citation>
      <PMID>36964655</PMID>
    </reference>
    <reference>
      <citation>Lariviere C, Gagnon DH, Henry SM, Preuss R, Dumas JP. The Effects of an 8-Week Stabilization Exercise Program on Lumbar Multifidus Muscle Thickness and Activation as Measured With Ultrasound Imaging in Patients With Low Back Pain: An Exploratory Study. PM R. 2018 May;10(5):483-493. doi: 10.1016/j.pmrj.2017.10.005. Epub 2017 Oct 31.</citation>
      <PMID>29097271</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Uskudar University</investigator_affiliation>
      <investigator_full_name>Dr. Öğr. Üyesi Ömer Şevgin</investigator_full_name>
      <investigator_title>Asst. Prof. Dr.</investigator_title>
    </responsible_party>
    <keyword>pain</keyword>
    <keyword>Neuromuscular Stabilization exercises</keyword>
    <keyword>Kinesiophobia</keyword>
    <keyword>surgical</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Intervertebral Disc Displacement</mesh_term>
      <mesh_term>Low Back Pain</mesh_term>
      <mesh_term>Kinesiophobia</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/NCT06005948
  org study id: Uskudar75
  nct id: NCT06005948
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the study is to investigate the effects of dynamic neuromuscular stabilization
        exercises on pain, functionality and fear in individuals who have undergone lumbar disc
        herniation surgery.
  The research was planned as a randomized controlled trial, which is a quantitative study.
        Participants will be divided into 2 groups as control and exercise groups by simple
        randomization method. The individuals in the control group of the study will not be given any
        exercise program after surgery. A home exercise program created with Dynamic Neuromuscular
        Stabilization exercises after surgery will be applied to the individuals in the intervention
        group. Data collection will be carried out through an online survey. The scales and forms to
        be used before and after the treatment are respectively: 1. Oswestry Low Back Pain Disability
        Questionnaire 2. International Physical Activity Questionnaire (Short Form) 3. Questionnaire
        for Fear of Daily Living Activities The questionnaires will be uploaded to the Google Forms
        database and the participants will be accessed via e-mail or mobile phone applications. .
        They will be asked to fill out the questionnaires before starting the post-surgical exercise
        program and the exercise program will be explained practically before discharge. The
        exercises will be planned 3 times a week and for 8 weeks.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The dynamic neuromuscular stabilization exercises
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: The Oswestry Disability Index
  time frame: 10 weeks
  description: The questionnaire includes ten topics related to pain severity, weight lifting, self-care, walking, sitting, sexual function, standing, social life, sleep quality, and ability to travel. expression follows. The patient then checks for the expression that most closely resembles his condition. Each question is scored on a scale of 0-5, with the first statement being zero and indicating the least disability, and the last statement being scored as 5 indicating the most severe disability. The scores of all answered questions are added up, then multiplied by two to get the index (range 0 to 100). Zero equals no obstacle and 100 is the maximum possible obstacle.
  measure: International Physical Activity Questionnaire Short Form (IPAQ-SF)
  time frame: 10 weeks
  description: It consists of 7 questions. The questions provide information about time spent walking, time spent in moderate and vigorous activities, and time spent sitting. Calculation of the short form's total score includes the sum of time (minutes) and frequency (days) of walking, moderate-intensity activity, and vigorous activity. The energy required for activities is calculated with the metabolic equivalent (MET) -minute score. Standard MET values have been established for these activities. These are; Sitting 1.5 MET, Walking 3.3 MET, Moderate-intensity physical activity 4.0 MET, Vigorous physical activity 8.0 MET. Daily and weekly physical activity using these values level is calculated.
  measure: Fear of Daily Living Activities Questionnaire
  time frame: 10 weeks
  description: In the questionnaire consisting of 10 questions, the participant is asked to score each question between 0 and 100. No fear of the activity is set to 0 and excessive fear of the activity is 100. In addition, the participants are asked to add 2 different activities that are not included in the survey but cause fear.
  arm group label: control group
  arm group type: Active Comparator
  description: No exercise will be given after surgery
  arm group label: exercise group
  arm group type: Experimental
  description: Dynamic neuromuscular stabilization exercises will be performed for 8 weeks after surgery.
  intervention type: Other
  intervention name: exercise
  description: The dynamic neuromuscular stabilization group will receive developmental postures based on developmental kinesiology. It will involve a supine 3month Position, side-lying Position, Quadruped, oblique sitting, bear position, squat Position. Each position will be performed for 30-60 s for five reps, active exercise 5-10 reps under supervision for two days/week, and unsupervised for 3 days/week for 8 weeks
  arm group label: exercise group
  intervention type: Other
  intervention name: control
  description: No intervention will be made.
  arm group label: control group
  criteria: 
  gender: All
  minimum age: 30 Years
  maximum age: 50 Years
  healthy volunteers: No
  last name: Büşra ARISÜT
  role: Study Chair
  affiliation: Uskudar University
  last name: Ömer ŞEVGİN
  phone: +905069787535
  email: omer.sevgin@uskudar.edu.tr
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  citation: Venkatesan P, K S, Kishen TJ, Janardhan S, Kumar Cr S. Comparison of yoga and dynamic neuromuscular stabilization exercise in chronic low back pain on magnetic resonance imaging of lumbar multifidus- protocol for a randomized controlled trial. Contemp Clin Trials Commun. 2022 May 28;28:100937. doi: 10.1016/j.conctc.2022.100937. eCollection 2022 Aug.
  PMID: 35789639
  citation: Baerga-Varela L, Abreu Ramos AM. Core strengthening exercises for low back pain. Bol Asoc Med P R. 2006 Jan-Mar;98(1):56-61.
  PMID: 19610550
  citation: Butowicz CM, Acasio JC, Silfies SP, Nussbaum MA, Hendershot BD. Chronic low back pain influences trunk neuromuscular control during unstable sitting among persons with lower-limb loss. Gait Posture. 2019 Oct;74:236-241. doi: 10.1016/j.gaitpost.2019.09.019. Epub 2019 Sep 18.
  PMID: 31563825
  citation: Kararti C, Ozsoy I, Ozyurt F, Basat HC, Ozsoy G, Ozudogru A. The effects of dynamic neuromuscular stabilization approach on clinical outcomes in older patients with chronic nonspecific low back pain: a randomized, controlled clinical trial. Somatosens Mot Res. 2023 Sep;40(3):116-125. doi: 10.1080/08990220.2023.2191705. Epub 2023 Mar 24.
  PMID: 36964655
  citation: Lariviere C, Gagnon DH, Henry SM, Preuss R, Dumas JP. The Effects of an 8-Week Stabilization Exercise Program on Lumbar Multifidus Muscle Thickness and Activation as Measured With Ultrasound Imaging in Patients With Low Back Pain: An Exploratory Study. PM R. 2018 May;10(5):483-493. doi: 10.1016/j.pmrj.2017.10.005. Epub 2017 Oct 31.
  PMID: 29097271
  responsible party type: Principal Investigator
  investigator affiliation: Uskudar University
  investigator full name: Dr. Öğr. Üyesi Ömer Şevgin
  investigator title: Asst. Prof. Dr.
  mesh term: Intervertebral Disc Displacement
  mesh term: Low Back Pain
  mesh term: Kinesiophobia
  sharing ipd: No