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/NCT06014645</url>
    </required_header>
    <id_info>
      <org_study_id>Bursa NRŞ RKÇ</org_study_id>
      <nct_id>NCT06014645</nct_id>
    </id_info>
    <brief_title>Effectiveness of Home Programs After Lumbar Spinal Decompression Surgery</brief_title>
    <official_title>The Effect of Different Home Programs on Pain and Mobility Gain After Lumbar Spinal Decompression Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Muğla Sıtkı Koçman University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Muğla Sıtkı Koçman 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 study will be conducted with volunteer patients who are followed up by Bursa Çekirge&#xD;
        State Hospital Cekirge State Hospital Neurosurgery outpatient clinic and who have undergone&#xD;
        lumbar decompression surgery and who meet the study criteria. The cases will be divided into&#xD;
        2 groups by randomization software. The control group will receive post-operative cognitive&#xD;
        training and will be encouraged to move. The study group will receive a core stabilization&#xD;
        program in addition to education. The first evaluation will be performed 2 months&#xD;
        post-operatively and the second evaluation will be performed 2 months after treatment.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 14, 2023</start_date>
    <completion_date type="Anticipated">July 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 15, 2024</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>Visual Analog Scale (VAS)</measure>
      <time_frame>Change from Baseline VAS at 8 weeks</time_frame>
      <description>On a 10 cm straight line or numeric scale, the patient is asked to mark the pain they feel (0: no pain, 10: excruciating pain).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Tampa Scale for Kinesiophobia (TSK)</measure>
      <time_frame>Change from Baseline TSK at 8 weeks</time_frame>
      <description>The questionnaire is a 17-item scale developed to measure fear of movement/reinjury. The normal score range is between 17 and 68.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pain Catastrophising Scale (PCS)</measure>
      <time_frame>Change from Baseline PCS at 8 weeks</time_frame>
      <description>Scale is used to assess the patient's feelings and thoughts about pain and disaster. The total score ranges from 0 to 52 points. A high score indicates a bad situation.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Roland Morris Disability Questionnaire (RMDQ)</measure>
      <time_frame>Change from Baseline RMDQ at 8 weeks</time_frame>
      <description>The RMDQ is a self-administered questionnaire consisting of 24 items reflecting various activities of daily living. Each item is scored 1 if it is declared applicable to the participant and 0 otherwise, so that the total score can range from 0 (no disability) to 24 (severe disability).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Lumbar region flexibility in flexion extension lateral flexion directions</measure>
      <time_frame>Change from Baseline flexibilty tests at 8 weeks</time_frame>
      <description>The subject stands on a block and then performs lumlal flexion with knees straight. The distance above the block with the finger is recorded with a negative sign and the distance below the block is recorded with a positive sign. The subject stands in front of a wall. The pelvis and trunk should be in contact with the wall. The subject is asked to perform lumbar extension. The distance between the sternal notch and the wall is measured and noted. The subject stands in front of a wall with hands next to the trunk. The subject is asked to perform lumbar lateral flexion. The distance from the first position to the last position is measured using the middle finger as a base and noted.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Lumbar region endurance flexor and extensor</measure>
      <time_frame>Change from Baseline endurance tests at 8 weeks</time_frame>
      <description>The participant is placed prone on a treatment bed with the upper edge of the iliac crests flush with the edge of the bed. The lower body is secured to the bed with two straps. At the beginning of the test, participants cross their arms over their chest and remain in a neutral position for as long as possible. The time the position can be maintained is measured using a stopwatch. Participants are held in a supine position with both hips and knees flexed 90 degrees and the trunk flexed 60 degrees on a wedge. Stabilization is achieved with support from the back of the foot. After the wedge is moved back 10 cm, the participants maintain their body position for as long as possible. The time from the moment the wedge is moved back to the moment the participant re-establishes contact with the wedge is measured.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Functional Reach Test (FRT)</measure>
      <time_frame>Change from Baseline FRT at 8 weeks</time_frame>
      <description>The subject stands sideways next to a wall and flexes the shoulder 90 degrees. The 3rd metacarpal level is marked on the wall. The subject reaches as far as he/she can without taking a step. The 3rd metacarpal line is marked again. The difference between the marks is measured and noted.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Stair Climbing Test (SCT)</measure>
      <time_frame>Change from Baseline SCT at 8 weeks</time_frame>
      <description>The time (in seconds) taken to ascend and descend one flight of stairs is noted. A 9-step ladder with a 20 cm step height and a handrail is used. You are instructed to ascend and descend the stairs as quickly but safely as possible. The use of a handrail and walking aid is allowed if necessary. Timing starts with the start signal and ends when the participant has lowered both feet to ground level. The participant can stop and rest if necessary, but the timing continues.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Lumbar Spine Disease</condition>
    <arm_group>
      <arm_group_label>Intervention Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The study group will be given a core stabilization program in addition to the training. This program will include reeducation isometric contraction exercises for transversus obdominus, oblique abdominals, multifidus lumborum muscles and strengthening stretching exercises for other extremities. These interventions will be sent to the patients via telerehabitation method and the patients will always have access to the programs and training. In addition, both groups will be told that they can contact the researcher upon request.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The control group will receive post-operative cognitive training and will be encouraged to move as described by Moseley et al., 2004.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Rehabilitation</intervention_name>
      <description>The study group will be given a core stabilization program in addition to education.</description>
      <arm_group_label>Intervention Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Control</intervention_name>
      <description>The control group will receive post-operative cognitive training and will be encouraged to move.</description>
      <arm_group_label>Control Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Having undergone lumbar decompression surgery without fusion and 2 months of history&#xD;
  &#xD;
            -  Participate in all necessary follow-up assessments&#xD;
  &#xD;
            -  Being between 18-65 years old&#xD;
  &#xD;
            -  Understand simple commands&#xD;
  &#xD;
            -  Signing the consent form&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Presence of a previous spinal fusion surgery&#xD;
  &#xD;
            -  Presence of malignancy&#xD;
  &#xD;
            -  Having undergone spine surgery before&#xD;
  &#xD;
            -  Have any other orthopedic or neurological problem that may affect treatment and&#xD;
               assessments&#xD;
  &#xD;
            -  Situations that prevent communication&#xD;
  &#xD;
            -  Lack of cooperation during the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Fatih Özden, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Muğla Sıtkı Koçman University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>İsmet Tümtürk, MSc</last_name>
      <role>Principal Investigator</role>
      <affiliation>Süleyman Demirel University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Mustafa Yalçın, MSc</last_name>
      <role>Principal Investigator</role>
      <affiliation>Bursa Çekirge State Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Baki Umut Tuğay, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Muğla Sıtkı Koçman University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Fatih Özden, PhD</last_name>
      <phone>543 433 4593</phone>
      <phone_ext>+90</phone_ext>
      <email>fatihozden@mu.edu.tr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Bursa Çekirge State Hospital</name>
        <address>
          <city>Bursa</city>
          <state>Osmangazi</state>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Fatih Özden, PhD</last_name>
        <phone>543 433 4593</phone>
        <email>fatihozden90@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Muğla Sıtkı Koçman University</investigator_affiliation>
      <investigator_full_name>Fatih Ozden</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Spinal Diseases</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/NCT06014645
  org study id: Bursa NRŞ RKÇ
  nct id: NCT06014645
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study will be conducted with volunteer patients who are followed up by Bursa Çekirge
        State Hospital Cekirge State Hospital Neurosurgery outpatient clinic and who have undergone
        lumbar decompression surgery and who meet the study criteria. The cases will be divided into
        2 groups by randomization software. The control group will receive post-operative cognitive
        training and will be encouraged to move. The study group will receive a core stabilization
        program in addition to education. The first evaluation will be performed 2 months
        post-operatively and the second evaluation will be performed 2 months after treatment.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Visual Analog Scale (VAS)
  time frame: Change from Baseline VAS at 8 weeks
  description: On a 10 cm straight line or numeric scale, the patient is asked to mark the pain they feel (0: no pain, 10: excruciating pain).
  measure: Tampa Scale for Kinesiophobia (TSK)
  time frame: Change from Baseline TSK at 8 weeks
  description: The questionnaire is a 17-item scale developed to measure fear of movement/reinjury. The normal score range is between 17 and 68.
  measure: Pain Catastrophising Scale (PCS)
  time frame: Change from Baseline PCS at 8 weeks
  description: Scale is used to assess the patient's feelings and thoughts about pain and disaster. The total score ranges from 0 to 52 points. A high score indicates a bad situation.
  measure: Roland Morris Disability Questionnaire (RMDQ)
  time frame: Change from Baseline RMDQ at 8 weeks
  description: The RMDQ is a self-administered questionnaire consisting of 24 items reflecting various activities of daily living. Each item is scored 1 if it is declared applicable to the participant and 0 otherwise, so that the total score can range from 0 (no disability) to 24 (severe disability).
  measure: Lumbar region flexibility in flexion extension lateral flexion directions
  time frame: Change from Baseline flexibilty tests at 8 weeks
  description: The subject stands on a block and then performs lumlal flexion with knees straight. The distance above the block with the finger is recorded with a negative sign and the distance below the block is recorded with a positive sign. The subject stands in front of a wall. The pelvis and trunk should be in contact with the wall. The subject is asked to perform lumbar extension. The distance between the sternal notch and the wall is measured and noted. The subject stands in front of a wall with hands next to the trunk. The subject is asked to perform lumbar lateral flexion. The distance from the first position to the last position is measured using the middle finger as a base and noted.
  measure: Lumbar region endurance flexor and extensor
  time frame: Change from Baseline endurance tests at 8 weeks
  description: The participant is placed prone on a treatment bed with the upper edge of the iliac crests flush with the edge of the bed. The lower body is secured to the bed with two straps. At the beginning of the test, participants cross their arms over their chest and remain in a neutral position for as long as possible. The time the position can be maintained is measured using a stopwatch. Participants are held in a supine position with both hips and knees flexed 90 degrees and the trunk flexed 60 degrees on a wedge. Stabilization is achieved with support from the back of the foot. After the wedge is moved back 10 cm, the participants maintain their body position for as long as possible. The time from the moment the wedge is moved back to the moment the participant re-establishes contact with the wedge is measured.
  measure: Functional Reach Test (FRT)
  time frame: Change from Baseline FRT at 8 weeks
  description: The subject stands sideways next to a wall and flexes the shoulder 90 degrees. The 3rd metacarpal level is marked on the wall. The subject reaches as far as he/she can without taking a step. The 3rd metacarpal line is marked again. The difference between the marks is measured and noted.
  measure: Stair Climbing Test (SCT)
  time frame: Change from Baseline SCT at 8 weeks
  description: The time (in seconds) taken to ascend and descend one flight of stairs is noted. A 9-step ladder with a 20 cm step height and a handrail is used. You are instructed to ascend and descend the stairs as quickly but safely as possible. The use of a handrail and walking aid is allowed if necessary. Timing starts with the start signal and ends when the participant has lowered both feet to ground level. The participant can stop and rest if necessary, but the timing continues.
  arm group label: Intervention Group
  arm group type: Experimental
  description: The study group will be given a core stabilization program in addition to the training. This program will include reeducation isometric contraction exercises for transversus obdominus, oblique abdominals, multifidus lumborum muscles and strengthening stretching exercises for other extremities. These interventions will be sent to the patients via telerehabitation method and the patients will always have access to the programs and training. In addition, both groups will be told that they can contact the researcher upon request.
  arm group label: Control Group
  arm group type: Active Comparator
  description: The control group will receive post-operative cognitive training and will be encouraged to move as described by Moseley et al., 2004.
  intervention type: Other
  intervention name: Rehabilitation
  description: The study group will be given a core stabilization program in addition to education.
  arm group label: Intervention Group
  intervention type: Other
  intervention name: Control
  description: The control group will receive post-operative cognitive training and will be encouraged to move.
  arm group label: Control Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Fatih Özden, PhD
  role: Study Director
  affiliation: Muğla Sıtkı Koçman University
  last name: İsmet Tümtürk, MSc
  role: Principal Investigator
  affiliation: Süleyman Demirel University
  last name: Mustafa Yalçın, MSc
  role: Principal Investigator
  affiliation: Bursa Çekirge State Hospital
  last name: Baki Umut Tuğay, PhD
  role: Principal Investigator
  affiliation: Muğla Sıtkı Koçman University
  last name: Fatih Özden, PhD
  phone: 543 433 4593
  phone ext: +90
  email: fatihozden@mu.edu.tr
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Muğla Sıtkı Koçman University
  investigator full name: Fatih Ozden
  investigator title: Assistant Professor
  mesh term: Spinal Diseases