<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/NCT03033212</url>
  </required_header>
  <id_info>
    <org_study_id>MORPFR001</org_study_id>
    <nct_id>NCT03033212</nct_id>
  </id_info>
  <brief_title>Single-Level TLIF: Post-Fusion Rehabilitation</brief_title>
  <official_title>Single-Level TLIF: Post-Fusion Rehabilitation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rush University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rush University Medical Center</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>
      This investigation will assess how the timing and type of rehabilitation after a&#xD;
      transforaminal lumbar interbody fusion will affect the efficacy of the surgical procedure.&#xD;
      The efficacy of the procedure will be evaluated through patients' quality of life, measured&#xD;
      by health-related quality of life questionnaires up to 24 months following the procedure.&#xD;
      These measures will be compared to the patients' baseline value.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will undergo transforaminal lumbar interbody fusion for degenerative pathology at&#xD;
      the L4-5 vertebral level. They will be randomized to one of three postoperative&#xD;
      rehabilitation groups. Group 1 will receive &quot;structured early rehabilitation&quot; beginning at 7&#xD;
      weeks. Group 2 will receive &quot;Delayed rehabilitation&quot; beginning at 13 weeks postoperatively.&#xD;
      Group 3 will undergo &quot;Self Rehabilitation&quot; beginning at 7 weeks postoperatively. Groups 1 and&#xD;
      2 will undergo rehabilitation under the supervision of a certified physical therapist for 10&#xD;
      total weeks. Group 3 will undergo non-supervised rehabilitation for 10 total weeks, and will&#xD;
      be given educational materials regarding which exercises to perform and at which intervals.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 21, 2017</start_date>
  <completion_date type="Actual">September 1, 2021</completion_date>
  <primary_completion_date type="Actual">September 1, 2021</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in Oswestry Disability Index [ODI] Score at 2-years</measure>
    <time_frame>Baseline, 2-year postoperative</time_frame>
    <description>Oswestry Disability Index</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Radiographic fusion</measure>
    <time_frame>Baseline, 1-year postoperative</time_frame>
    <description>Radiographic fusion at L4-5 levels as measured by computed tomography scan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in walking ability at 2-years</measure>
    <time_frame>Baseline, 2 years postoperative</time_frame>
    <description>Walking test performed for 6 minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in walking speed at 2-years</measure>
    <time_frame>Baseline, 2 years postoperative</time_frame>
    <description>Walking test performed for 6 minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Visual Analogue Scale [VAS] Pain Scores at 2-years</measure>
    <time_frame>Baseline, 2 year postoperative</time_frame>
    <description>Visual Analogue Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Short-Form 12 [SF-12] Scores at 2-years</measure>
    <time_frame>Baseline, 2 year postoperative</time_frame>
    <description>Short-Form 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline PROMIS Physical Function Scores at 2-years</measure>
    <time_frame>Baseline, 2 year postoperative</time_frame>
    <description>PROMIS Physical Function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Fear Avoidance Beliefs Metric at 2-years</measure>
    <time_frame>Baseline, 2 year postoperative</time_frame>
    <description>Fear Avoidance Beliefs Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Pain Catastrophization Metric at 2-years</measure>
    <time_frame>Baseline, 2 year postoperative</time_frame>
    <description>Pain Catastrophization Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Pain Neurophysiology Metric at 2-years</measure>
    <time_frame>Baseline, 2 year postoperative</time_frame>
    <description>Pain Neurophysiology Questionnaire</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Degenerative Spinal Cord Disease</condition>
  <arm_group>
    <arm_group_label>Early Structured Rehabilitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will begin Therapist-Guided Rehabilitation at 7 weeks postoperatively with a certified physical therapy. The patients will perform rehabilitation for 10 total weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed Rehabilitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will begin Therapist-Guided Rehabilitation at 13 weeks postoperatively with a certified physical therapy. The patients will perform rehabilitation for 10 total weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Self Rehabilitation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will begin Self-Guided Rehabilitation at 7 weeks postoperatively in a self-guided fashion. They will be provided with instructions for recommended exercises. They will undergo rehabilitation for a total of 10 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Therapist-Guided Rehabilitation</intervention_name>
    <description>Rehabilitation consists of exercises guided by a certified physical therapist. These exercises include: aerobics, walking tests, stability exercises, and strengthening exercises.</description>
    <arm_group_label>Delayed Rehabilitation</arm_group_label>
    <arm_group_label>Early Structured Rehabilitation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Self-Guided Rehabilitation</intervention_name>
    <description>Rehabilitation consists of self-guided exercises with provided instructions. These exercises include: aerobics, walking tests, stability exercises, and strengthening exercises.</description>
    <arm_group_label>Self Rehabilitation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        i. Single-level L4-L5 TLIF for degenerative pathology, including: radiculopathy, neurogenic&#xD;
        claudication, intervertebral disc disease, facet joint disease, degenerative&#xD;
        spondylolisthesis, degenerative myelopathy degenerative kyphosis and scoliosis ii. Back&#xD;
        and/or leg pain iii. Failed at least 3 months of conservative treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        i. Older than 65 years of age ii. Prior spinal surgery excluding laminectomy/discectomy&#xD;
        iii. Greater than Grade 2 spondylolisthesis iv. Greater than 10 degrees scoliosis v. Not&#xD;
        worked for greater than 6 months or unemployed as a result of lumbar condition vi. History&#xD;
        of spinal infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frank M Phillips, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rush University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Carla Edwards</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>September 8, 2021</last_update_submitted>
  <last_update_submitted_qc>September 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rush University Medical Center</investigator_affiliation>
    <investigator_full_name>Carla Edwards</investigator_full_name>
    <investigator_title>Clinical Research Manger</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03033212
org study id: MORPFR001
nct id: NCT03033212
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This investigation will assess how the timing and type of rehabilitation after a
      transforaminal lumbar interbody fusion will affect the efficacy of the surgical procedure.
      The efficacy of the procedure will be evaluated through patients' quality of life, measured
      by health-related quality of life questionnaires up to 24 months following the procedure.
      These measures will be compared to the patients' baseline value.
Patients will undergo transforaminal lumbar interbody fusion for degenerative pathology at
      the L4-5 vertebral level. They will be randomized to one of three postoperative
      rehabilitation groups. Group 1 will receive "structured early rehabilitation" beginning at 7
      weeks. Group 2 will receive "Delayed rehabilitation" beginning at 13 weeks postoperatively.
      Group 3 will undergo "Self Rehabilitation" beginning at 7 weeks postoperatively. Groups 1 and
      2 will undergo rehabilitation under the supervision of a certified physical therapist for 10
      total weeks. Group 3 will undergo non-supervised rehabilitation for 10 total weeks, and will
      be given educational materials regarding which exercises to perform and at which intervals.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Change from baseline in Oswestry Disability Index [ODI] Score at 2-years
time frame: Baseline, 2-year postoperative
description: Oswestry Disability Index
measure: Radiographic fusion
time frame: Baseline, 1-year postoperative
description: Radiographic fusion at L4-5 levels as measured by computed tomography scan
measure: Change from baseline in walking ability at 2-years
time frame: Baseline, 2 years postoperative
description: Walking test performed for 6 minutes
measure: Change from baseline in walking speed at 2-years
time frame: Baseline, 2 years postoperative
description: Walking test performed for 6 minutes
measure: Change from baseline in Visual Analogue Scale [VAS] Pain Scores at 2-years
time frame: Baseline, 2 year postoperative
description: Visual Analogue Scale
measure: Change from baseline in Short-Form 12 [SF-12] Scores at 2-years
time frame: Baseline, 2 year postoperative
description: Short-Form 12
measure: Change from baseline PROMIS Physical Function Scores at 2-years
time frame: Baseline, 2 year postoperative
description: PROMIS Physical Function
measure: Change from baseline in Fear Avoidance Beliefs Metric at 2-years
time frame: Baseline, 2 year postoperative
description: Fear Avoidance Beliefs Questionnaire
measure: Change from baseline in Pain Catastrophization Metric at 2-years
time frame: Baseline, 2 year postoperative
description: Pain Catastrophization Questionnaire
measure: Change from baseline in Pain Neurophysiology Metric at 2-years
time frame: Baseline, 2 year postoperative
description: Pain Neurophysiology Questionnaire
arm group label: Early Structured Rehabilitation
arm group type: Experimental
description: Patients will begin Therapist-Guided Rehabilitation at 7 weeks postoperatively with a certified physical therapy. The patients will perform rehabilitation for 10 total weeks.
arm group label: Delayed Rehabilitation
arm group type: Experimental
description: Patients will begin Therapist-Guided Rehabilitation at 13 weeks postoperatively with a certified physical therapy. The patients will perform rehabilitation for 10 total weeks.
arm group label: Self Rehabilitation
arm group type: Active Comparator
description: Patients will begin Self-Guided Rehabilitation at 7 weeks postoperatively in a self-guided fashion. They will be provided with instructions for recommended exercises. They will undergo rehabilitation for a total of 10 weeks.
intervention type: Other
intervention name: Therapist-Guided Rehabilitation
description: Rehabilitation consists of exercises guided by a certified physical therapist. These exercises include: aerobics, walking tests, stability exercises, and strengthening exercises.
arm group label: Delayed Rehabilitation
arm group label: Early Structured Rehabilitation
intervention type: Other
intervention name: Self-Guided Rehabilitation
description: Rehabilitation consists of self-guided exercises with provided instructions. These exercises include: aerobics, walking tests, stability exercises, and strengthening exercises.
arm group label: Self Rehabilitation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Frank M Phillips, MD
role: Principal Investigator
affiliation: Rush University Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Rush University Medical Center
investigator full name: Carla Edwards
investigator title: Clinical Research Manger
mesh term: Spinal Cord Diseases
sharing ipd: Undecided