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/NCT06006377</url>
    </required_header>
    <id_info>
      <org_study_id>Uskudar56</org_study_id>
      <nct_id>NCT06006377</nct_id>
    </id_info>
    <brief_title>Investigation of the Efficacy of Treatments With Backup Device in Spine Pathologies</brief_title>
    <official_title>Investigation of the Efficacy of Treatments With Backup Device in Spine Pathologies</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>
        Our aim in this study is to examine the effectiveness of the Backup spine health device in&#xD;
        spinal problems and compare it with traditional physical therapy methods.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The investigators study was planned as a randomized controlled study. Participants will be&#xD;
        divided into 2 groups as conventional physiotherapy and Backup group by simple randomized&#xD;
        method. Participants will be taken to a treatment program for 10 weeks, 3 days a week.&#xD;
        Parameters such as pain, posture, sleep quality, quality of life, muscle shortening at the&#xD;
        beginning and end of the study. The results will be analyzed statistically.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 15, 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>conventional physiotherapy and backup device therapy</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pittsburgh Sleep Quality Index</measure>
      <time_frame>12 weeks</time_frame>
      <description>It is a 19-item self-report scale that evaluates sleep quality and impairment over the past month. It consists of 24 questions, 19 questions are self-report questions, 5 questions are questions to be answered by the spouse or roommate. The 18 scored questions of the scale consist of 7 components. Subjective Sleep Quality, Sleep Latency, Sleep Duration, Habitual Sleep Efficiency, Sleep Disorder, Sleeping Drug Use, and Daytime Dysfunction. Each component is evaluated over 0-3 points. The total score of the 7 components gives the scale total score. The total score ranges from 0 to 21. A total score greater than 5 indicates &quot;poor sleep quality&quot;.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>World Health Organization Quality of Life Scale Short Form</measure>
      <time_frame>12 weeks</time_frame>
      <description>The scale is a 26-item scale. Each section and area receives a maximum score of 20 points or 100 points. A high score indicates good quality of life.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Spine Disease</condition>
    <condition>Neck Pain</condition>
    <condition>Back Pain</condition>
    <condition>Disc Herniation</condition>
    <arm_group>
      <arm_group_label>conventional</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>conventional physiotherapy methods</description>
    </arm_group>
    <arm_group>
      <arm_group_label>backup</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Physiotherapy applied with backup device</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>conventional physiotherapy</intervention_name>
      <description>hotpack electrotherapy ultrasound exercises</description>
      <arm_group_label>backup</arm_group_label>
      <arm_group_label>conventional</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Backup therapy</intervention_name>
      <description>The backup spine health device is in the form of a mat and provides segmental electrical stimulation to the spines. At the same time, the mat can heat up to 40 degrees during the treatment process. Backup spine health device is very effective in both reducing pain and strengthening the muscles with electrical stimulations by reaching even the deep muscles around the spine. Sessions consist of 30 minutes</description>
      <arm_group_label>backup</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Being between the ages of 20-60&#xD;
  &#xD;
            -  sick individuals with spinal problems&#xD;
  &#xD;
            -  Persons who have filled out the consent form&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  People with spinal pathology for whom physiotherapy is contraindicated&#xD;
  &#xD;
            -  Having a neurological problem&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Asiye ÖNELGE</last_name>
      <role>Study Chair</role>
      <affiliation>Uskudar University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>ömer şevgin</last_name>
      <phone>+90506 978 75 35</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 ŞEVGİN</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Lurie J, Tomkins-Lane C. Management of lumbar spinal stenosis. BMJ. 2016 Jan 4;352:h6234. doi: 10.1136/bmj.h6234.</citation>
      <PMID>26727925</PMID>
    </reference>
    <reference>
      <citation>Childress MA, Becker BA. Nonoperative Management of Cervical Radiculopathy. Am Fam Physician. 2016 May 1;93(9):746-54.</citation>
      <PMID>27175952</PMID>
    </reference>
    <reference>
      <citation>Stoll T, Germann D, Hagmann H. [Physiotherapy in lumbar disc herniation ]. Ther Umsch. 2001 Aug;58(8):487-92. doi: 10.1024/0040-5930.58.8.487. German.</citation>
      <PMID>11552355</PMID>
    </reference>
    <reference>
      <citation>Andersen MO, Andresen AK, Lorenzen MD, Isenberg-Jorgensen A, Stottrup C. [Non-surgical treatment of lumbar radiculopathy]. Ugeskr Laeger. 2017 Nov 13;179(23):V05170397. Danish.</citation>
      <PMID>29139353</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 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>Backup</keyword>
    <keyword>physiotherapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Intervertebral Disc Displacement</mesh_term>
      <mesh_term>Spinal Diseases</mesh_term>
      <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>
  
  
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/NCT06006377
  org study id: Uskudar56
  nct id: NCT06006377
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Our aim in this study is to examine the effectiveness of the Backup spine health device in
        spinal problems and compare it with traditional physical therapy methods.
  The investigators study was planned as a randomized controlled study. Participants will be
        divided into 2 groups as conventional physiotherapy and Backup group by simple randomized
        method. Participants will be taken to a treatment program for 10 weeks, 3 days a week.
        Parameters such as pain, posture, sleep quality, quality of life, muscle shortening at the
        beginning and end of the study. The results will be analyzed statistically.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: conventional physiotherapy and backup device therapy
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Pittsburgh Sleep Quality Index
  time frame: 12 weeks
  description: It is a 19-item self-report scale that evaluates sleep quality and impairment over the past month. It consists of 24 questions, 19 questions are self-report questions, 5 questions are questions to be answered by the spouse or roommate. The 18 scored questions of the scale consist of 7 components. Subjective Sleep Quality, Sleep Latency, Sleep Duration, Habitual Sleep Efficiency, Sleep Disorder, Sleeping Drug Use, and Daytime Dysfunction. Each component is evaluated over 0-3 points. The total score of the 7 components gives the scale total score. The total score ranges from 0 to 21. A total score greater than 5 indicates "poor sleep quality".
  measure: World Health Organization Quality of Life Scale Short Form
  time frame: 12 weeks
  description: The scale is a 26-item scale. Each section and area receives a maximum score of 20 points or 100 points. A high score indicates good quality of life.
  arm group label: conventional
  arm group type: Active Comparator
  description: conventional physiotherapy methods
  arm group label: backup
  arm group type: Experimental
  description: Physiotherapy applied with backup device
  intervention type: Other
  intervention name: conventional physiotherapy
  description: hotpack electrotherapy ultrasound exercises
  arm group label: backup
  arm group label: conventional
  intervention type: Other
  intervention name: Backup therapy
  description: The backup spine health device is in the form of a mat and provides segmental electrical stimulation to the spines. At the same time, the mat can heat up to 40 degrees during the treatment process. Backup spine health device is very effective in both reducing pain and strengthening the muscles with electrical stimulations by reaching even the deep muscles around the spine. Sessions consist of 30 minutes
  arm group label: backup
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Asiye ÖNELGE
  role: Study Chair
  affiliation: Uskudar University
  last name: ömer şevgin
  phone: +90506 978 75 35
  email: omer.sevgin@uskudar.edu.tr
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  citation: Lurie J, Tomkins-Lane C. Management of lumbar spinal stenosis. BMJ. 2016 Jan 4;352:h6234. doi: 10.1136/bmj.h6234.
  PMID: 26727925
  citation: Childress MA, Becker BA. Nonoperative Management of Cervical Radiculopathy. Am Fam Physician. 2016 May 1;93(9):746-54.
  PMID: 27175952
  citation: Stoll T, Germann D, Hagmann H. [Physiotherapy in lumbar disc herniation ]. Ther Umsch. 2001 Aug;58(8):487-92. doi: 10.1024/0040-5930.58.8.487. German.
  PMID: 11552355
  citation: Andersen MO, Andresen AK, Lorenzen MD, Isenberg-Jorgensen A, Stottrup C. [Non-surgical treatment of lumbar radiculopathy]. Ugeskr Laeger. 2017 Nov 13;179(23):V05170397. Danish.
  PMID: 29139353
  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: Spinal Diseases
  mesh term: Neck Pain
  sharing ipd: No