<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/NCT03249922</url>
  </required_header>
  <id_info>
    <org_study_id>Pro20170000766</org_study_id>
    <nct_id>NCT03249922</nct_id>
  </id_info>
  <brief_title>Quality of Life Outcomes in Spinal Cord Stimulation</brief_title>
  <official_title>A Prospective Analysis of Quality of Life Outcomes in Spinal Cord Stimulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rutgers, The State University of New Jersey</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rutgers, The State University of New Jersey</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators will be evaluating quality of life outcomes in patients who are undergoing&#xD;
      routine spinal cord stimulator implant for uncontrolled pain. Patients will be evaluated pre&#xD;
      and post-operatively for quality of life improvements, pain control, and functionality.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective cohort study for patients who will be undergoing implantation of spinal&#xD;
      cord stimulator for pain. All patient will have implantation done at University Hospital&#xD;
      Newark or Newark Beth Israel. The data points that will be collected will be the patient's&#xD;
      weight, BMI, and detailed questionnaires regarding disability, activity, quality of life, and&#xD;
      depression. The first data set will be taken pre-operatively at the DOC, 90 Bergen Street,&#xD;
      suite 8100. Those patients enrolled will have the same data taken again upon subsequent&#xD;
      postoperative visits at 3, 6, and 12 months. Being that spinal cord stimulation is a&#xD;
      well-documented safe procedure, the investigators do not anticipate any deviation from the&#xD;
      standard risks of surgery. With that being said the primary safety endpoint would be if there&#xD;
      is an increased complication rate, secondary to the procedure, greater than the current&#xD;
      anticipated risk rate. This is a purely observational study. Patients are not being recruited&#xD;
      for an intervention but are being recruited during routine clinical practice.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Inadequate enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">October 27, 2017</start_date>
  <completion_date type="Actual">July 22, 2018</completion_date>
  <primary_completion_date type="Actual">July 22, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The number of patients with at least 50% improvement in VAS Pain Score</measure>
    <time_frame>12 Months</time_frame>
    <description>The number of patients who had at least 50% improvement in VAS pain score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The number of patients with at least 50% improvement in Owenstry low back disability index</measure>
    <time_frame>12 Months</time_frame>
    <description>The number of patients who had at least 50% improvement in disability as determined by this questionnaire.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The number of patients with at least 50% improvement in WHODAS 12 disability index.</measure>
    <time_frame>12 Months</time_frame>
    <description>The number of patients who had at least 50% improvement in disability as determined by this questionnaire.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The number of patients with at least 50% improvement in SF-36 quality of life score</measure>
    <time_frame>12 months</time_frame>
    <description>The number of patients who had at least 50% improvement in quality of life as determined by this questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of patients with at least 50% improvement in beck depression inventory</measure>
    <time_frame>12 Months</time_frame>
    <description>The number of patients who had at least 50% improvement in depression as determined by this questionnaire.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>The Total number of surgical and post-operative Complications</measure>
    <time_frame>12 months</time_frame>
    <description>Total number of surgical and post-operative complications occurring during the study</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">6</enrollment>
  <condition>Neuropathic Pain</condition>
  <condition>Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Treatment Group</arm_group_label>
    <description>All patients who are considered candidates for spinal cord stimulator implant will be assigned to the &quot;Treatment Group&quot;. Participiants will be clinically evaluated and given the Owenstry low back disability index, WHODAS 12, Beck depression index and SF-36.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Spinal Cord Stimulation</intervention_name>
    <description>Implantation of a spinal cord stimulator for the control of axial back or neuropathic pain.</description>
    <arm_group_label>Treatment Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients of the functional neurosurgery and neuromodulation department at New Jersey&#xD;
        Medical School who present for indicated spinal cord stimulation therapy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with neuropathic pain or axial back pain that is not controlled by oral&#xD;
             analgesics, opioids, and has failed conservative management.&#xD;
&#xD;
          -  Ages 18-90 with no ethnicity or gender predilections.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have spinal cord injury, multiple stimulator revisions, DRG stimulators,&#xD;
             intrathecal pain pumps, complex regional pain syndrome, previous spinal cord&#xD;
             stimulator implant, mechanical instability requiring fusion, myelopathy, psychological&#xD;
             condition precluding them from complying with therapy, illegal drug abuse including&#xD;
             heroin, cocaine, and illegally obtained prescription pills, or have previously been or&#xD;
             are currently involved in litigation for medical malpractice.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Antonios Mammis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>mammisan@njms.rutgers.edu</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Neurologic Institute of New Jersey</name>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>July 22, 2018</last_update_submitted>
  <last_update_submitted_qc>July 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rutgers, The State University of New Jersey</investigator_affiliation>
    <investigator_full_name>Antonios Mammis MD</investigator_full_name>
    <investigator_title>Director, Center for Neuromodulation</investigator_title>
  </responsible_party>
  <keyword>spinal cord stimulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuralgia</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No IPD will be shared with other researchers.</ipd_description>
  </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/NCT03249922
org study id: Pro20170000766
nct id: NCT03249922
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The investigators will be evaluating quality of life outcomes in patients who are undergoing
      routine spinal cord stimulator implant for uncontrolled pain. Patients will be evaluated pre
      and post-operatively for quality of life improvements, pain control, and functionality.
This is a prospective cohort study for patients who will be undergoing implantation of spinal
      cord stimulator for pain. All patient will have implantation done at University Hospital
      Newark or Newark Beth Israel. The data points that will be collected will be the patient's
      weight, BMI, and detailed questionnaires regarding disability, activity, quality of life, and
      depression. The first data set will be taken pre-operatively at the DOC, 90 Bergen Street,
      suite 8100. Those patients enrolled will have the same data taken again upon subsequent
      postoperative visits at 3, 6, and 12 months. Being that spinal cord stimulation is a
      well-documented safe procedure, the investigators do not anticipate any deviation from the
      standard risks of surgery. With that being said the primary safety endpoint would be if there
      is an increased complication rate, secondary to the procedure, greater than the current
      anticipated risk rate. This is a purely observational study. Patients are not being recruited
      for an intervention but are being recruited during routine clinical practice.
observational model: Case-Only
time perspective: Prospective
measure: The number of patients with at least 50% improvement in VAS Pain Score
time frame: 12 Months
description: The number of patients who had at least 50% improvement in VAS pain score
measure: The number of patients with at least 50% improvement in Owenstry low back disability index
time frame: 12 Months
description: The number of patients who had at least 50% improvement in disability as determined by this questionnaire.
measure: The number of patients with at least 50% improvement in WHODAS 12 disability index.
time frame: 12 Months
description: The number of patients who had at least 50% improvement in disability as determined by this questionnaire.
measure: The number of patients with at least 50% improvement in SF-36 quality of life score
time frame: 12 months
description: The number of patients who had at least 50% improvement in quality of life as determined by this questionnaire.
measure: The number of patients with at least 50% improvement in beck depression inventory
time frame: 12 Months
description: The number of patients who had at least 50% improvement in depression as determined by this questionnaire.
measure: The Total number of surgical and post-operative Complications
time frame: 12 months
description: Total number of surgical and post-operative complications occurring during the study
arm group label: Treatment Group
description: All patients who are considered candidates for spinal cord stimulator implant will be assigned to the "Treatment Group". Participiants will be clinically evaluated and given the Owenstry low back disability index, WHODAS 12, Beck depression index and SF-36.
intervention type: Device
intervention name: Spinal Cord Stimulation
description: Implantation of a spinal cord stimulator for the control of axial back or neuropathic pain.
arm group label: Treatment Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
last name: Antonios Mammis, MD
role: Principal Investigator
affiliation: mammisan@njms.rutgers.edu
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Rutgers, The State University of New Jersey
investigator full name: Antonios Mammis MD
investigator title: Director, Center for Neuromodulation
mesh term: Neuralgia
mesh term: Low Back Pain
sharing ipd: No
ipd description: No IPD will be shared with other researchers.