<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/NCT02982291</url>
  </required_header>
  <id_info>
    <org_study_id>2015-182</org_study_id>
    <nct_id>NCT02982291</nct_id>
  </id_info>
  <brief_title>Focused Spinal Stenosis Rehabilitation Program for Lumbar Spinal Stenosis</brief_title>
  <official_title>Focused Spinal Stenosis Rehabilitation Program vs. Generic Williams Flexion Protocol</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital for Special Surgery, New York</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital for Special Surgery, New York</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Lumbar spinal stenosis with neurogenic claudication is a common condition in the elderly&#xD;
      population and is characterized by bilateral buttock, thigh, or calf discomfort and/or pain,&#xD;
      as well as by weakness precipitated by walking and prolonged standing. Self-management&#xD;
      options include physical therapy, which includes exercise as a core component for improving&#xD;
      the flexibility and mobility of the spine and hips. A Williams flexion protocol has&#xD;
      historically been used to treat low-back pain following degenerative changes to the posterior&#xD;
      elements of the lumbar spine. However, few studies have been done to validate the efficacy of&#xD;
      this protocol. A more focused treatment protocol may be more efficacious. Patients in this&#xD;
      study will be randomized to receive either the generic physical therapy protocol (15&#xD;
      sessions) or the focused rehabilitation program (5 sessions). The sessions will take place&#xD;
      over the course of 6 months. Outcomes will be assessed using validated questionnaires and&#xD;
      physical function tests.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Difficulty recruiting patients&#xD;
  </why_stopped>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Actual">February 1, 2018</completion_date>
  <primary_completion_date type="Actual">February 1, 2018</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in functional ability</measure>
    <time_frame>Up to 1 year after initial physical therapy visit</time_frame>
    <description>Change in functional ability will be assessed using the Oswestry Disability Index. The minimum clinically important difference of the ODI has been documented in the literature as a 13-point change.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain</measure>
    <time_frame>Up to 1 year after initial physical therapy visit</time_frame>
    <description>Pain will be measured by the Numerical Pain Rating Scale, on a 0-10 scale, where 0=no pain and 10=worst pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>Up to 1 year after initial physical therapy visit</time_frame>
    <description>Quality of life will be measured using the PROMIS Physical Function 10a Questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerance to exercise</measure>
    <time_frame>Up to 1 year after initial physical therapy visit</time_frame>
    <description>The Timed Treadmill Test, which requires patients to walk on a treadmill at 1.2 miles per hour and a 1% grade and report when they begin experiencing typical exercise-induced symptoms, will be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical ability</measure>
    <time_frame>Up to 1 year after initial physical therapy visit</time_frame>
    <description>Physical ability will be assessed upon exams that measure balance, hip abductor strength, range of motion, etc.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Spinal Stenosis Lumbar</condition>
  <arm_group>
    <arm_group_label>Standard</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Individualized</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Williams flexion protocol</intervention_name>
    <description>The Williams flexion protocol group will participate in 15 treatment sessions.</description>
    <arm_group_label>Standard</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Focused spinal stenosis rehabilitation</intervention_name>
    <description>The focused spinal stenosis rehabilitation group will participate in 5 treatment sessions.</description>
    <arm_group_label>Individualized</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Lumbar spinal stenosis with neurogenic claudication&#xD;
&#xD;
          -  Symptoms present for at least 3 months&#xD;
&#xD;
          -  Moderate to severe acquired or congenital LSS based on radiological evaluation&#xD;
&#xD;
          -  Lumbar MRI obtained within the past 12 months prior to initial physical therapy visit&#xD;
&#xD;
          -  40 years of age or older&#xD;
&#xD;
          -  Body mass index less than or equal to 35&#xD;
&#xD;
          -  Can tolerate a 6-min treadmill test&#xD;
&#xD;
          -  Willing to comply with home exercises as prescribed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute disc herniation&#xD;
&#xD;
          -  Grade 3 or greater spondylolisthesis&#xD;
&#xD;
          -  Rheumatoid or autoimmune conditions (e.g., ankylosing spondylitis)&#xD;
&#xD;
          -  Active spinal compression fractures&#xD;
&#xD;
          -  Knee surgery in the previous 6 months (e.g., total knee arthroplasty)&#xD;
&#xD;
          -  Previous spinal fusion&#xD;
&#xD;
          -  Absence of pedal pulses&#xD;
&#xD;
          -  Inflammation/infectious process&#xD;
&#xD;
          -  Myelopathy&#xD;
&#xD;
          -  Psychiatric disorder preventing informed consent or participation in assigned physical&#xD;
             therapy sessions&#xD;
&#xD;
          -  Patients with pending litigation or workers compensation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Turner</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital for Special Surgery, New York</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital for Special Surgery</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>February 1, 2018</last_update_submitted>
  <last_update_submitted_qc>February 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Stenosis</mesh_term>
    <mesh_term>Constriction, Pathologic</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/NCT02982291
org study id: 2015-182
nct id: NCT02982291
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Lumbar spinal stenosis with neurogenic claudication is a common condition in the elderly
      population and is characterized by bilateral buttock, thigh, or calf discomfort and/or pain,
      as well as by weakness precipitated by walking and prolonged standing. Self-management
      options include physical therapy, which includes exercise as a core component for improving
      the flexibility and mobility of the spine and hips. A Williams flexion protocol has
      historically been used to treat low-back pain following degenerative changes to the posterior
      elements of the lumbar spine. However, few studies have been done to validate the efficacy of
      this protocol. A more focused treatment protocol may be more efficacious. Patients in this
      study will be randomized to receive either the generic physical therapy protocol (15
      sessions) or the focused rehabilitation program (5 sessions). The sessions will take place
      over the course of 6 months. Outcomes will be assessed using validated questionnaires and
      physical function tests.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change in functional ability
time frame: Up to 1 year after initial physical therapy visit
description: Change in functional ability will be assessed using the Oswestry Disability Index. The minimum clinically important difference of the ODI has been documented in the literature as a 13-point change.
measure: Pain
time frame: Up to 1 year after initial physical therapy visit
description: Pain will be measured by the Numerical Pain Rating Scale, on a 0-10 scale, where 0=no pain and 10=worst pain.
measure: Quality of life
time frame: Up to 1 year after initial physical therapy visit
description: Quality of life will be measured using the PROMIS Physical Function 10a Questionnaire.
measure: Tolerance to exercise
time frame: Up to 1 year after initial physical therapy visit
description: The Timed Treadmill Test, which requires patients to walk on a treadmill at 1.2 miles per hour and a 1% grade and report when they begin experiencing typical exercise-induced symptoms, will be used.
measure: Physical ability
time frame: Up to 1 year after initial physical therapy visit
description: Physical ability will be assessed upon exams that measure balance, hip abductor strength, range of motion, etc.
arm group label: Standard
arm group type: Active Comparator
arm group label: Individualized
arm group type: Experimental
intervention type: Procedure
intervention name: Williams flexion protocol
description: The Williams flexion protocol group will participate in 15 treatment sessions.
arm group label: Standard
intervention type: Procedure
intervention name: Focused spinal stenosis rehabilitation
description: The focused spinal stenosis rehabilitation group will participate in 5 treatment sessions.
arm group label: Individualized
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Robert Turner
role: Principal Investigator
affiliation: Hospital for Special Surgery, New York
facility: 
country: United States
responsible party type: Sponsor
mesh term: Spinal Stenosis
mesh term: Constriction, Pathologic