<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/NCT02215551</url>
  </required_header>
  <id_info>
    <org_study_id>O0798-R</org_study_id>
    <nct_id>NCT02215551</nct_id>
  </id_info>
  <brief_title>Predictors of Decompressive Laminectomy Outcomes</brief_title>
  <official_title>Toward Optimizing Decompressive Laminectomy Outcomes: Looking Outside the Spine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Decompressive laminectomy (DL) is the most common type of back surgery performed in older&#xD;
      adults; DL treats lumbar spinal stenosis (LSS), a degenerative narrowing of the spinal canal&#xD;
      causes pain and trouble walking. An estimated one in three people who undergo DL do not get&#xD;
      well and often undergo repeated surgery.1,3-6 Some studies indicate that conditions outside&#xD;
      of the spine (e.g., depression, hip arthritis) cause people who undergo DL to do&#xD;
      poorly,27,30-36 but no one has comprehensively examined these conditions or the impact of&#xD;
      treating them on DL outcomes. Thus LSS treatment continues to focus on the spine alone.61 The&#xD;
      aim of this study is to identify conditions other than LSS that place Veterans at risk of&#xD;
      poor DL outcomes so that future comparative effectiveness studies can be designed that&#xD;
      examine the impact of a more comprehensive approach to treatment. Investigators believe that&#xD;
      a patient-centered rather than a disease-centered approach will lead to superior outcomes,&#xD;
      less suffering, and more appropriate use of health care resources.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary aim of this 6-site prospective cohort study is to develop algorithms usable in&#xD;
      the clinical setting that predict decompressive laminectomy (DL) outcomes (i.e., success vs.&#xD;
      failure) in older adults with lumbar spinal stenosis (LSS), the most common indication for&#xD;
      spine surgery in older patients. The clinical algorithms developed will be based primarily on&#xD;
      factors outside of LSS that are important aging-related predictors of pain and disability&#xD;
      (e.g., hip osteoarthritis (OA), fibromyalgia syndrome, depression, anxiety, fear-avoidance&#xD;
      beliefs, dysfunctional coping). Preliminary data support the impact of some of these factors&#xD;
      on DL outcomes, but no study has included comprehensive assessment of rigorously collected&#xD;
      data in the context of a prospective cohort. Thus LSS treatment remains focused exclusively&#xD;
      on the lumbar spine and treatment outcomes suboptimal with, on average, &lt; 20% reduction in&#xD;
      pain. An estimated one in three DL patients does not improve at all. Further, anatomical&#xD;
      evidence of LSS (i.e., based on advanced imaging) exists in many older patients without pain&#xD;
      or functional compromise. Two hundred fifty patients with symptomatic LSS scheduled to&#xD;
      undergo DL without fusion and who have no dementia, spinal instability, or prior lumbar&#xD;
      surgery will be recruited from spine surgery practices at each of the 6 participating sites&#xD;
      (VA Pittsburgh Healthcare System, Durham VA Medical Center [MC], Richmond VAMC, Ann Arbor&#xD;
      VAMC, Denver VAMC, San Antonio VAMC). Within 30 days prior to DL (i.e., at baseline),&#xD;
      participants will undergo comprehensive and rigorous assessment of pain and&#xD;
      disability-generating factors including: 1) SS symptoms with the Brigham Spinal Stenosis&#xD;
      questionnaire (BSS, the most specific available LSS measurement tool); 2) musculoskeletal&#xD;
      comorbidities (scoliosis, kyphosis, hip osteoarthritis, fibromyalgia symptoms, severity of&#xD;
      spinal stenosis, degenerative disc and facet disease); 3) mood (depression [with the Centre&#xD;
      for Epidemiology Studies Depression Scale (CES-D)], anxiety [with the GAD-7]); 4) cognitive&#xD;
      function (normal vs. mild cognitive impairment with the computer-based assessment of mild&#xD;
      cognitive impairment); 5) psychological function (fear-avoidance beliefs [with the Fear&#xD;
      Avoidance Beliefs Questionnaire], chronic pain self-efficacy [with the Chronic Pain&#xD;
      Self-Efficacy Scales], dysfunctional pain coping skills [with the Cognitive Strategies&#xD;
      Questionnaire], treatment expectancy, illicit substance use, alcohol use, smoking status,&#xD;
      PTSD symptoms); 6) medical comorbidity (including BMI); 7) demographic factors (age, gender,&#xD;
      race, educational/marital status). The BSS will be collected at baseline, at the first&#xD;
      postoperative visit, and every 3 months for one year. Prediction rules, based on the&#xD;
      comprehensive set of factors measured and DL success/failure determined by the BSS, will be&#xD;
      created using multiple methods to maximize predictive accuracy and validated subsequently in&#xD;
      a separate cohort of 100 individuals. Investigators will apply these rules to future&#xD;
      comparative effectiveness trials that test personalized LSS treatment approaches (i.e., that&#xD;
      involve targeting extra-LSS factors as part of the total treatment package) as compared with&#xD;
      DL alone. An exploratory aim of the proposed study is to evaluate the use of Goal Attainment&#xD;
      Scaling (GAS) as a DL outcome. This patient-centered outcomes measurement approach is used&#xD;
      commonly in the rehabilitation setting, but never before in DL patients. To prepare for&#xD;
      future comparative effectiveness trials, investigators want to develop GAS as an outcome&#xD;
      measure because it can be used to track outcomes in SS patients across surgical and&#xD;
      non-surgical interventions, and investigators anticipate that both will be employed as part&#xD;
      of personalized treatment. Investigators will explore (through 10-12 patient interviews) and&#xD;
      refine (with a modified Delphi panel of experts) GAS goals in patients with SS, and measure&#xD;
      goal achievement in a subset of 20 participants. What might happen if older adults with LSS&#xD;
      were treated in the context of a comprehensive pre-operative program before undergoing DL?&#xD;
      Might long-term outcomes associated with DL improve? Might patient satisfaction improve?&#xD;
      Might some patients avoid DL? These are questions that ultimately investigators hope to&#xD;
      answer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2014</start_date>
  <completion_date type="Actual">January 10, 2023</completion_date>
  <primary_completion_date type="Actual">July 1, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Brigham Spinal Stenosis Questionnaire</measure>
    <time_frame>1 Year</time_frame>
    <description>The BSS has three scales that measure pain, function, and satisfaction. The pain and satisfaction scales can be administered before and after DL; the satisfaction scale measures satisfaction with surgery and is only administered following DL. Threshold values have been defined for success versus failure on each of the three subscales based on receiver operating characteristic (ROC) analyses - 0.46 for the Symptom Severity Scale, 0.42 for the Physical Function Scale, and 2.42 for the Patient Satisfaction Scale. The most balanced definition of overall success requires that the patient achieve success in at least two of the three scales. Investigators use this definition, which has the greatest sensitivity and specificity, as the primary outcome in our statistical analyses.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Goal Attainment Scaling (GAS)</measure>
    <time_frame>1 Year</time_frame>
    <description>Goal Attainment Scaling is a structured interview that allows for standardized measurement of physical function goals in terms of the degree to which they have been attained for each individual person.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">239</enrollment>
  <condition>Lumbar Spinal Stenosis</condition>
  <arm_group>
    <arm_group_label>Study Group</arm_group_label>
    <description>Younger than 90 years old. no communication barriers (e.g., English speaking, household telephone) Affirmative response to each of the three following questions: a) Do patients have pain, weakness, numbness, or tingling in their legs when walking standing? b) Does this pain, weakness, numbness or tingling in their legs interfere with their daily activities? c) Have patients tried at least one non-surgical treatment for their leg symptoms (e.g., physical therapy, pain medications, spinal injection)? Have been scheduled for surgery on lower back for a condition called lumbar spinal stenosis.&#xD;
Whom have non degenerative causes of LSS such as tumor, infection, trauma, hemorrhage, or epidural lipomatosis, Prior lumbar spinal surgery, spondylolisthesis with spinal instability, significant cognitive impairment.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        350 Veterans with degenerative lumbar spinal stenosis (LSS) who are scheduled to undergo&#xD;
        decompressive laminectomy (DL) will be recruited. No one will be excluded on the basis of&#xD;
        age, race, gender or ethnicity. There is no age restriction as investigators are targeting&#xD;
        patients with degenerative lumbar spinal stenosis, most of who are in their 50's and 60's.&#xD;
        Investigators exclude participants with non-degenerative causes of LSS, as noted below.&#xD;
        Investigators anticipate that the demographics of the participants will reflect that of the&#xD;
        three participating VA sites and their affiliated University spine surgery practices. Our&#xD;
        goal is to recruit at least 70% Veteran participants and Investigators have added three&#xD;
        additional VA sites that will help to ensure this.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Younger than 90 years old.&#xD;
&#xD;
          -  no communication barriers (e.g., English speaking, household telephone)&#xD;
&#xD;
          -  Affirmative response to each of the three following questions:&#xD;
&#xD;
               -  a) Do patients have pain, weakness, numbness, or tingling in their legs when&#xD;
                  walking standing?&#xD;
&#xD;
               -  b) Does this pain, weakness, numbness or tingling in their legs interfere with&#xD;
                  their daily activities?&#xD;
&#xD;
               -  c) Have patients tried at least one non-surgical treatment for their leg symptoms&#xD;
                  (e.g., physical therapy, pain medications, spinal injection)?&#xD;
&#xD;
          -  Have been scheduled for surgery on lower back for a condition called lumbar spinal&#xD;
             stenosis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  non degenerative causes of LSS such as&#xD;
&#xD;
               -  tumor,&#xD;
&#xD;
               -  infection,&#xD;
&#xD;
               -  trauma,&#xD;
&#xD;
               -  hemorrhage,&#xD;
&#xD;
               -  or epidural lipomatosis&#xD;
&#xD;
          -  Prior lumbar spinal surgery&#xD;
&#xD;
          -  spondylolisthesis with spinal instability&#xD;
&#xD;
          -  significant cognitive impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Debra K. Weiner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VA Eastern Colorado Health Care System, Denver, CO</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta VA Medical and Rehab Center, Decatur, GA</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Ann Arbor Healthcare System, Ann Arbor, MI</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minneapolis VA Health Care System, Minneapolis, MN</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55417</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15240</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Texas Health Care System, San Antonio, TX</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hunter Holmes McGuire VA Medical Center, Richmond, VA</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23249</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>January 11, 2023</last_update_submitted>
  <last_update_submitted_qc>January 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>laminectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Stenosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02215551
org study id: O0798-R
nct id: NCT02215551
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Decompressive laminectomy (DL) is the most common type of back surgery performed in older
      adults; DL treats lumbar spinal stenosis (LSS), a degenerative narrowing of the spinal canal
      causes pain and trouble walking. An estimated one in three people who undergo DL do not get
      well and often undergo repeated surgery.1,3-6 Some studies indicate that conditions outside
      of the spine (e.g., depression, hip arthritis) cause people who undergo DL to do
      poorly,27,30-36 but no one has comprehensively examined these conditions or the impact of
      treating them on DL outcomes. Thus LSS treatment continues to focus on the spine alone.61 The
      aim of this study is to identify conditions other than LSS that place Veterans at risk of
      poor DL outcomes so that future comparative effectiveness studies can be designed that
      examine the impact of a more comprehensive approach to treatment. Investigators believe that
      a patient-centered rather than a disease-centered approach will lead to superior outcomes,
      less suffering, and more appropriate use of health care resources.
The primary aim of this 6-site prospective cohort study is to develop algorithms usable in
      the clinical setting that predict decompressive laminectomy (DL) outcomes (i.e., success vs.
      failure) in older adults with lumbar spinal stenosis (LSS), the most common indication for
      spine surgery in older patients. The clinical algorithms developed will be based primarily on
      factors outside of LSS that are important aging-related predictors of pain and disability
      (e.g., hip osteoarthritis (OA), fibromyalgia syndrome, depression, anxiety, fear-avoidance
      beliefs, dysfunctional coping). Preliminary data support the impact of some of these factors
      on DL outcomes, but no study has included comprehensive assessment of rigorously collected
      data in the context of a prospective cohort. Thus LSS treatment remains focused exclusively
      on the lumbar spine and treatment outcomes suboptimal with, on average, < 20% reduction in
      pain. An estimated one in three DL patients does not improve at all. Further, anatomical
      evidence of LSS (i.e., based on advanced imaging) exists in many older patients without pain
      or functional compromise. Two hundred fifty patients with symptomatic LSS scheduled to
      undergo DL without fusion and who have no dementia, spinal instability, or prior lumbar
      surgery will be recruited from spine surgery practices at each of the 6 participating sites
      (VA Pittsburgh Healthcare System, Durham VA Medical Center [MC], Richmond VAMC, Ann Arbor
      VAMC, Denver VAMC, San Antonio VAMC). Within 30 days prior to DL (i.e., at baseline),
      participants will undergo comprehensive and rigorous assessment of pain and
      disability-generating factors including: 1) SS symptoms with the Brigham Spinal Stenosis
      questionnaire (BSS, the most specific available LSS measurement tool); 2) musculoskeletal
      comorbidities (scoliosis, kyphosis, hip osteoarthritis, fibromyalgia symptoms, severity of
      spinal stenosis, degenerative disc and facet disease); 3) mood (depression [with the Centre
      for Epidemiology Studies Depression Scale (CES-D)], anxiety [with the GAD-7]); 4) cognitive
      function (normal vs. mild cognitive impairment with the computer-based assessment of mild
      cognitive impairment); 5) psychological function (fear-avoidance beliefs [with the Fear
      Avoidance Beliefs Questionnaire], chronic pain self-efficacy [with the Chronic Pain
      Self-Efficacy Scales], dysfunctional pain coping skills [with the Cognitive Strategies
      Questionnaire], treatment expectancy, illicit substance use, alcohol use, smoking status,
      PTSD symptoms); 6) medical comorbidity (including BMI); 7) demographic factors (age, gender,
      race, educational/marital status). The BSS will be collected at baseline, at the first
      postoperative visit, and every 3 months for one year. Prediction rules, based on the
      comprehensive set of factors measured and DL success/failure determined by the BSS, will be
      created using multiple methods to maximize predictive accuracy and validated subsequently in
      a separate cohort of 100 individuals. Investigators will apply these rules to future
      comparative effectiveness trials that test personalized LSS treatment approaches (i.e., that
      involve targeting extra-LSS factors as part of the total treatment package) as compared with
      DL alone. An exploratory aim of the proposed study is to evaluate the use of Goal Attainment
      Scaling (GAS) as a DL outcome. This patient-centered outcomes measurement approach is used
      commonly in the rehabilitation setting, but never before in DL patients. To prepare for
      future comparative effectiveness trials, investigators want to develop GAS as an outcome
      measure because it can be used to track outcomes in SS patients across surgical and
      non-surgical interventions, and investigators anticipate that both will be employed as part
      of personalized treatment. Investigators will explore (through 10-12 patient interviews) and
      refine (with a modified Delphi panel of experts) GAS goals in patients with SS, and measure
      goal achievement in a subset of 20 participants. What might happen if older adults with LSS
      were treated in the context of a comprehensive pre-operative program before undergoing DL?
      Might long-term outcomes associated with DL improve? Might patient satisfaction improve?
      Might some patients avoid DL? These are questions that ultimately investigators hope to
      answer.
observational model: Cohort
time perspective: Prospective
measure: Brigham Spinal Stenosis Questionnaire
time frame: 1 Year
description: The BSS has three scales that measure pain, function, and satisfaction. The pain and satisfaction scales can be administered before and after DL; the satisfaction scale measures satisfaction with surgery and is only administered following DL. Threshold values have been defined for success versus failure on each of the three subscales based on receiver operating characteristic (ROC) analyses - 0.46 for the Symptom Severity Scale, 0.42 for the Physical Function Scale, and 2.42 for the Patient Satisfaction Scale. The most balanced definition of overall success requires that the patient achieve success in at least two of the three scales. Investigators use this definition, which has the greatest sensitivity and specificity, as the primary outcome in our statistical analyses.
measure: Goal Attainment Scaling (GAS)
time frame: 1 Year
description: Goal Attainment Scaling is a structured interview that allows for standardized measurement of physical function goals in terms of the degree to which they have been attained for each individual person.
arm group label: Study Group
description: Younger than 90 years old. no communication barriers (e.g., English speaking, household telephone) Affirmative response to each of the three following questions: a) Do patients have pain, weakness, numbness, or tingling in their legs when walking standing? b) Does this pain, weakness, numbness or tingling in their legs interfere with their daily activities? c) Have patients tried at least one non-surgical treatment for their leg symptoms (e.g., physical therapy, pain medications, spinal injection)? Have been scheduled for surgery on lower back for a condition called lumbar spinal stenosis.
Whom have non degenerative causes of LSS such as tumor, infection, trauma, hemorrhage, or epidural lipomatosis, Prior lumbar spinal surgery, spondylolisthesis with spinal instability, significant cognitive impairment.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Debra K. Weiner, MD
role: Principal Investigator
affiliation: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Spinal Stenosis
sharing ipd: No