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/NCT06017830</url>
    </required_header>
    <id_info>
      <org_study_id>48670771-514</org_study_id>
      <nct_id>NCT06017830</nct_id>
    </id_info>
    <brief_title>The Effect of Physical Therapy on Sexual Function</brief_title>
    <official_title>The Effectiveness of Physical Therapy on Sexual Function in Patients With Low Back Pain</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Sexual function in low back pain and after lumbar surgery has been evaluated in many studies&#xD;
        In a few studies, sexual function problems after surgery have also been reported. In the&#xD;
        literature, there is no study that investigates the effectiveness of physical therapy on&#xD;
        sexual function in patients with low back pain. In this study, the effectiveness of physical&#xD;
        therapy on sexual function in patients with low back pain will be evaluated.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        63 patients who had chronic low back pain who applied to City Hospital, Physical Medicine and&#xD;
        Rehabilitation Department between January 2021 and January 2023 were enrolled in the study.&#xD;
        Sexually active patients between the ages of 18 and 60, for whom physical therapy was planned&#xD;
        for low-back pain related to lumbar pathologies, were included in the study. Informed consent&#xD;
        was obtained from all patients. Exclusion criteria were defined as having contraindications&#xD;
        for any physical therapy agents, having cardiovascular, neurological, psychiatric disease, or&#xD;
        sexual disorders.&#xD;
  &#xD;
        Short Form-12 (SF-12), Oswestry Disability Index (ODI), and Hospital Anxiety and Depression&#xD;
        Scale (HAD) were recorded. International Index of Erectile Function (IIEF) and Female Sexual&#xD;
        Function Index (FSFI) were utilized to evaluate sexual function&#xD;
  &#xD;
        Fifteen sessions of physical therapy were planned for each patient. The physical therapy&#xD;
        program included 15 minutes of conventional transcutaneous electrical nerve stimulation, 10&#xD;
        minutes of ultrasound, and 15 minutes of superficial heaters such as hot packs or infrarouge.&#xD;
        All patients were evaluated the day before the first physical therapy session, the one-month&#xD;
        and three-month after the last physical therapy session.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Suspended</overall_status>
    <why_stopped>
      Covid-19 pandemi limited the number of patients who was applied physical therapy&#xD;
    </why_stopped>
    <start_date type="Actual">January 20, 2021</start_date>
    <completion_date type="Anticipated">September 2023</completion_date>
    <primary_completion_date type="Actual">January 20, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Screening</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>change from sexual function scores at just after physical therapy and 3 months</measure>
      <time_frame>Before, just after and 3 months later physical therapy</time_frame>
      <description>Female Sexual Function Index for women and International Index of Erectile Function for men will be used. There is no cut-off values. Better scores mean better results</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>change from disability scores at just after physical therapy and 3 months</measure>
      <time_frame>Before, just after and 3 months later physical therapy</time_frame>
      <description>Oswestry Disability Index will be used. min-max 0-100. better scores means worse results</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>change from quality of life at just after physical therapy and 3 months</measure>
      <time_frame>Before, just after and 3 months later physical therapy</time_frame>
      <description>Short Form-12 will be used. min-max 0-100. better score means better quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>change from mood at just after physical therapy and 3 months</measure>
      <time_frame>Before, just after and 3 months later physical therapy</time_frame>
      <description>Hospital Anxiety and Depression Scale will be used. min-max 0-21. better score means better result.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Sexual Dysfunction</condition>
    <condition>Low Back Pain</condition>
    <arm_group>
      <arm_group_label>Patients with low back pain</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Physical treatment agents</intervention_name>
      <description>Physical treatment agents such as TENS (transcutaneous electric nerve stimulation), hot pack and ultrasound will be applied to patients with low back pain. Sexual function will be assessed before, just after and 3 months later physical therapy.</description>
      <arm_group_label>Patients with low back pain</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  low back pain due to lumbar pathologies&#xD;
  &#xD;
            -  being sexually active&#xD;
  &#xD;
            -  have no contraindications for physical therapy agents&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  known sexual function problems,&#xD;
  &#xD;
            -  known psychiatric disease and/or are taking antidepressant&#xD;
  &#xD;
            -  diabetes mellitus,&#xD;
  &#xD;
            -  cardiovascular disease&#xD;
  &#xD;
            -  neurological diseases&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Gunay ER</last_name>
      <role>Principal Investigator</role>
      <affiliation>Prof Dr Cemil Taşçıoğlu Şehir Hastanesi</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Prof Dr Cemil Taşçıoğlu Şehir Hastanesi</name>
        <address>
          <city>Istanbul</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 25, 2021</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization</investigator_affiliation>
      <investigator_full_name>Gunay ER</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>
    <!-- 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/NCT06017830
  org study id: 48670771-514
  nct id: NCT06017830
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Sexual function in low back pain and after lumbar surgery has been evaluated in many studies
        In a few studies, sexual function problems after surgery have also been reported. In the
        literature, there is no study that investigates the effectiveness of physical therapy on
        sexual function in patients with low back pain. In this study, the effectiveness of physical
        therapy on sexual function in patients with low back pain will be evaluated.
  63 patients who had chronic low back pain who applied to City Hospital, Physical Medicine and
        Rehabilitation Department between January 2021 and January 2023 were enrolled in the study.
        Sexually active patients between the ages of 18 and 60, for whom physical therapy was planned
        for low-back pain related to lumbar pathologies, were included in the study. Informed consent
        was obtained from all patients. Exclusion criteria were defined as having contraindications
        for any physical therapy agents, having cardiovascular, neurological, psychiatric disease, or
        sexual disorders.
  
        Short Form-12 (SF-12), Oswestry Disability Index (ODI), and Hospital Anxiety and Depression
        Scale (HAD) were recorded. International Index of Erectile Function (IIEF) and Female Sexual
        Function Index (FSFI) were utilized to evaluate sexual function
  
        Fifteen sessions of physical therapy were planned for each patient. The physical therapy
        program included 15 minutes of conventional transcutaneous electrical nerve stimulation, 10
        minutes of ultrasound, and 15 minutes of superficial heaters such as hot packs or infrarouge.
        All patients were evaluated the day before the first physical therapy session, the one-month
        and three-month after the last physical therapy session.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Screening
  masking: None (Open Label)
  measure: change from sexual function scores at just after physical therapy and 3 months
  time frame: Before, just after and 3 months later physical therapy
  description: Female Sexual Function Index for women and International Index of Erectile Function for men will be used. There is no cut-off values. Better scores mean better results
  measure: change from disability scores at just after physical therapy and 3 months
  time frame: Before, just after and 3 months later physical therapy
  description: Oswestry Disability Index will be used. min-max 0-100. better scores means worse results
  measure: change from quality of life at just after physical therapy and 3 months
  time frame: Before, just after and 3 months later physical therapy
  description: Short Form-12 will be used. min-max 0-100. better score means better quality of life.
  measure: change from mood at just after physical therapy and 3 months
  time frame: Before, just after and 3 months later physical therapy
  description: Hospital Anxiety and Depression Scale will be used. min-max 0-21. better score means better result.
  arm group label: Patients with low back pain
  arm group type: Experimental
  intervention type: Device
  intervention name: Physical treatment agents
  description: Physical treatment agents such as TENS (transcutaneous electric nerve stimulation), hot pack and ultrasound will be applied to patients with low back pain. Sexual function will be assessed before, just after and 3 months later physical therapy.
  arm group label: Patients with low back pain
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: No
  last name: Gunay ER
  role: Principal Investigator
  affiliation: Prof Dr Cemil Taşçıoğlu Şehir Hastanesi
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
  investigator full name: Gunay ER
  investigator title: Principal Investigator
  mesh term: Back Pain
  mesh term: Low Back Pain