<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/NCT01703403</url>
  </required_header>
  <id_info>
    <org_study_id>201205036RIC</org_study_id>
    <nct_id>NCT01703403</nct_id>
  </id_info>
  <brief_title>Physical Therapy Management in Degenerative Lumbar Diseases and Osteoporosis</brief_title>
  <official_title>Physical Therapy Management in Degenerative Lumbar Diseases and Osteoporosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Low back pain is a common health issue in elderly population. According to the statistics,&#xD;
      more than 80% of Taiwanese suffer low back pain in the life. The cause of low back pain&#xD;
      includes lumbar spondylosis, osteoporosis, compression fracture, muscle strain,&#xD;
      spondylolisthesis…etc. In addition to drugs and surgery, physical therapy is an alternative&#xD;
      choice for conservative treatment. Therefore, in this study, the investigators propose to&#xD;
      analyze the physical examination, diagnostic methods, X ray, physical therapy records,&#xD;
      physical therapy methods and clinical outcomes in patients with the diagnosis including&#xD;
      lumbar spondylosis, low back pain, osteoporosis, compression fracture, back pain treated at&#xD;
      National Taiwan University Hospital and received rehabilitation at the Physical Therapy&#xD;
      Center in recent ten years.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2012</start_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Low Back Pain</condition>
  <eligibility>
    <study_pop>
      <textblock>
        patients with the diagnosis including lumbar spondylosis, low back pain, osteoporosis,&#xD;
        compression fracture, back pain treated at National Taiwan University Hospital and received&#xD;
        rehabilitation at the Physical Therapy Center in recent ten years.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Experimental group:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with the diagnosis including lumbar spondylosis, low back pain, osteoporosis,&#xD;
             compression fracture, back pain treated at National Taiwan University Hospital&#xD;
&#xD;
          -  received rehabilitation at the Physical Therapy Center in recent ten years.&#xD;
&#xD;
        Control group:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with the diagnosis including lumbar spondylosis, low back pain, osteoporosis,&#xD;
             compression fracture, back pain treated at National Taiwan University Hospital&#xD;
&#xD;
          -  not received rehabilitation at the Physical Therapy Center in recent ten years.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wei-Li Hsu, PT,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>School of physical therapy, National Taiwan University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Wei-Li Hsu, PT,PhD</last_name>
    <phone>886-2-33668127</phone>
    <email>wlhsu@ntu.edu.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>School &amp; Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wei-Li Hsu, PT,PhD</last_name>
      <phone>886-2-3366-8127</phone>
      <email>wlhsu@ntu.edu.tw</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 5, 2012</study_first_submitted>
  <study_first_submitted_qc>October 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2012</study_first_posted>
  <last_update_submitted>October 9, 2012</last_update_submitted>
  <last_update_submitted_qc>October 9, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 10, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>physical therapy</keyword>
  <keyword>treated at NTUH and received rehabilitation at the PTC in recent ten years.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoporosis</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
  </condition_browse>
  <!-- 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/NCT01703403
org study id: 201205036RIC
nct id: NCT01703403
lead sponsor: 
has dmc: Yes
Low back pain is a common health issue in elderly population. According to the statistics,
      more than 80% of Taiwanese suffer low back pain in the life. The cause of low back pain
      includes lumbar spondylosis, osteoporosis, compression fracture, muscle strain,
      spondylolisthesis…etc. In addition to drugs and surgery, physical therapy is an alternative
      choice for conservative treatment. Therefore, in this study, the investigators propose to
      analyze the physical examination, diagnostic methods, X ray, physical therapy records,
      physical therapy methods and clinical outcomes in patients with the diagnosis including
      lumbar spondylosis, low back pain, osteoporosis, compression fracture, back pain treated at
      National Taiwan University Hospital and received rehabilitation at the Physical Therapy
      Center in recent ten years.
observational model: Case-Crossover
time perspective: Retrospective
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: 85 Years
healthy volunteers: No
last name: Wei-Li Hsu, PT,PhD
role: Principal Investigator
affiliation: School of physical therapy, National Taiwan University
last name: Wei-Li Hsu, PT,PhD
phone: 886-2-33668127
email: wlhsu@ntu.edu.tw
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Osteoporosis
mesh term: Low Back Pain