<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/NCT01703338</url>
  </required_header>
  <id_info>
    <org_study_id>201112117RIC</org_study_id>
    <nct_id>NCT01703338</nct_id>
  </id_info>
  <brief_title>Clinical and Biomechanics Research in Core Muscles After Lumbar Fusion Surgery</brief_title>
  <official_title>Clinical and Biomechanics Research in Core Muscles After Lumbar Fusion Surgery</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Lumbar fusion has been widely used for spinal disorders when conservative treatment has&#xD;
      failed. However, a number of studies have reported that the rate of re-operation is high for&#xD;
      lumbar fusion surgery. Swelling, atrophy or fat infiltration of the paraspinal muscles at the&#xD;
      surgery site can cause weakness and pain. After fusion, the range of motion is constrained at&#xD;
      the fused spine and might facilitate compensative movement of the adjacent levels and&#xD;
      increase degeneration rate of the spine.&#xD;
&#xD;
      Evidence has shown that core muscles play an important role to stabilize and support the&#xD;
      spine. Whether core stability exercise can enhance spinal stability after lumbar fusion&#xD;
      surgery remains unclear. Therefore, the overall goal of this proposed research is to&#xD;
      investigate how core muscles affect outcomes after lumbar spinal fusion. The investigators&#xD;
      will explore this issue hierarchically and systematically in 3-year duration.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">February 14, 2020</completion_date>
  <primary_completion_date type="Actual">December 24, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Lumbar Fusion</condition>
  <condition>Lumbar Spinal Fusion Surgery</condition>
  <arm_group>
    <arm_group_label>Lumbar spinal surgery</arm_group_label>
    <description>The study included participants who were diagnosed by a neurological surgeon and received lumbar surgery according to relevant imaging findings</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All subjects will be recruited from the National Taiwan University Hospital and Far Eastern&#xD;
        Memorial Hospital. The study is approved by the Institutional Medical Research Ethics&#xD;
        Committees in both National Taiwan University Hospital and Far Eastern Memorial Hospital.&#xD;
        Our neurological surgeon will response for subject screening and medical diagnose.&#xD;
        According to the power analysis, fifty subjects will be enrolled in this study. The&#xD;
        eligible subject will be given the subjects informed consent and sign it before the&#xD;
        enrollment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ages between 20 and 85 years,&#xD;
&#xD;
          2. back pain and/or sciatica exceeding 12 weeks for which conservative treatment had&#xD;
             failed to improve,&#xD;
&#xD;
          3. a primary diagnosis of spinal stenosis, spondylosis, degenerative or isthmic&#xD;
             spondylolisthesis or degenerative disc disease, and&#xD;
&#xD;
          4. the patient selected for lumbar surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. mechanical back pain due to posture changes and cannot maintain an upright posture&#xD;
             over 30 minutes;&#xD;
&#xD;
          2. segmental instability that includes isthmic spondylolisthesis, degenerative&#xD;
             spondylolisthesis over 0.4 cm;&#xD;
&#xD;
          3. intervertebral angle reversal on dynamic radiographs; and&#xD;
&#xD;
          4. previous lumbar fusion, rheumatoid arthritis, and ankylosing spondylitis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wei-Li Hsu, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>School &amp; Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University</name>
      <address>
        <city>Taipei</city>
        <zip>10055</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2020</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>September 9, 2020</last_update_submitted>
  <last_update_submitted_qc>September 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>assessment model</keyword>
  <keyword>biomechanical changes</keyword>
  <keyword>functional activities</keyword>
  <keyword>magnetic resonance imaging (MRI)</keyword>
  <keyword>causal relationship</keyword>
  <keyword>core muscles activation pattern</keyword>
  <keyword>pathological changes</keyword>
  <keyword>early rehabilitation</keyword>
  <keyword>core stability exercise</keyword>
  <keyword>minimally invasive lumbar spinal fusion surgery</keyword>
  <!-- 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/NCT01703338
org study id: 201112117RIC
nct id: NCT01703338
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Lumbar fusion has been widely used for spinal disorders when conservative treatment has
      failed. However, a number of studies have reported that the rate of re-operation is high for
      lumbar fusion surgery. Swelling, atrophy or fat infiltration of the paraspinal muscles at the
      surgery site can cause weakness and pain. After fusion, the range of motion is constrained at
      the fused spine and might facilitate compensative movement of the adjacent levels and
      increase degeneration rate of the spine.

      Evidence has shown that core muscles play an important role to stabilize and support the
      spine. Whether core stability exercise can enhance spinal stability after lumbar fusion
      surgery remains unclear. Therefore, the overall goal of this proposed research is to
      investigate how core muscles affect outcomes after lumbar spinal fusion. The investigators
      will explore this issue hierarchically and systematically in 3-year duration.
observational model: Case-Crossover
time perspective: Cross-Sectional
arm group label: Lumbar spinal surgery
description: The study included participants who were diagnosed by a neurological surgeon and received lumbar surgery according to relevant imaging findings
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Wei-Li Hsu, PhD
role: Principal Investigator
affiliation: National Taiwan University Hospital
facility: 
country: Taiwan
responsible party type: Sponsor