<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/NCT03794024</url>
  </required_header>
  <id_info>
    <org_study_id>18-1115</org_study_id>
    <nct_id>NCT03794024</nct_id>
  </id_info>
  <brief_title>Comparison of Dorsal Column Stimulation to Dorsal Root Ganglion Stimulation for Complex Regional Pain Syndrome</brief_title>
  <official_title>Single Center, Randomized Prospective Comparative Effectiveness Study of Dorsal Column Spinal Cord Stimulation to Dorsal Root Ganglion Stimulation in the Treatment of Complex Regional Pain Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Cleveland Clinic</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>
      Complex Regional Pain Syndrome (CRPS) is a constellation of pain symptoms which are&#xD;
      associated with impairment in mood, social and physical function. Spinal Cord Stimulation&#xD;
      (SCS), a technique of placing electrodes into the epidural space is a validated treatment for&#xD;
      Complex Regional Pain Syndrome . Treatment of CRPS with SCS, in combination with physical&#xD;
      therapy, reduced pain to a greater degree than physical therapy alone. 40%-50% of CRPS&#xD;
      patients achieve &gt;50% pain relief with SCS using dorsal column stimulation . Dorsal Root&#xD;
      Ganglion (DRG) SCS has also recently demonstrated clinical efficacy in patients with CRPS and&#xD;
      peripheral causalgia . The hypothesis is that DRG stimulation is non-inferior to dorsal&#xD;
      column SCS in patients with CRPS who have failed to respond to a course of analgesics and&#xD;
      physical therapy. The aim to assess functional, quality of life, patient satisfaction and&#xD;
      medication requirements in subjects treated with neuromodulation for CRPS and contrast&#xD;
      outcomes amongst subjects treated with DRG SCS and dorsal column SCS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to compare outcomes between dorsal column spinal cord&#xD;
      stimulation and dorsal root ganglion spinal cord stimulation in patients with Complex&#xD;
      Regional Pain Syndrome at an infraumbilical location who have failed a course of conservative&#xD;
      management including analgesic pharmacotherapy and physical therapy.&#xD;
&#xD;
      This is a prospective randomized post-marketing clinical study. Patients will be randomized&#xD;
      in a 1:1 ratio to Dorsal Column or Dorsal Root Ganglion Spinal Cord Stimulation if they have&#xD;
      failed a course of conservative management including analgesics and physical therapy. All&#xD;
      patients are expected to undergo clinical, neurological, and imaging assessments, if&#xD;
      appropriate, at selected follow-up visits.&#xD;
&#xD;
      The study will be conducted a single center with a target maximum of 62 patients (31&#xD;
      randomized to each group).&#xD;
&#xD;
      Enrollment of subjects in this study is anticipated to take 24 months. Clinical follow-up&#xD;
      evaluations will be conducted at 10 days, 1, 3 and 6 months post-implant. The total study&#xD;
      duration is expected to be at least 30 months.&#xD;
&#xD;
      All patients presenting to the Investigators with Budapest criteria, research subset , for&#xD;
      the diagnosis of Complex Regional Pain Syndrome at an infraumbilical location who have not&#xD;
      had an adequate response to a course of conservative management including analgesics and&#xD;
      physical therapy will be screened for eligibility. A Screening/Enrollment Log will be&#xD;
      utilized in order to maintain a cumulative tracking of all screened patients.&#xD;
&#xD;
      Patients must meet all inclusion/exclusion criteria for enrollment in the clinical study.&#xD;
      Reasons for screening failure(s) will be documented.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Manufacturer of the device filed for bankruptcy&#xD;
  </why_stopped>
  <start_date type="Actual">January 8, 2019</start_date>
  <completion_date type="Actual">March 31, 2020</completion_date>
  <primary_completion_date type="Actual">March 3, 2020</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>Change in Numerical Rating Scale for Pain Intensity</measure>
    <time_frame>6 Months</time_frame>
    <description>To compare the outcomes of dorsal column stimulation with Dorsal Root Ganglion stimulation in patients with Complex Regional Pain Syndrome that persist despite a course of conservative management including physical therapy and analgesic pharmacotherapy using an 11-point [0-10] Numerical Rating Scale (NRS) for Pain Intensity at 6 months. A score of zero indicates no pain, and 10 indicates the worst possible pain imaginable.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Oswestry Disability Index for Pain Intensity</measure>
    <time_frame>6 Month</time_frame>
    <description>To compare the outcomes of dorsal column stimulation with Dorsal Root Ganglion stimulation in patients with Complex Regional Pain Syndrome that persist despite a course of conservative management including physical therapy and analgesic pharmacotherapy in function based on Oswestry Disability Index (ODI) for functional impairment. A score of 0 on the 101-point [0-100] Oswestry Disability Index indicates no disability while 100 indicates bed-bound.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in European Quality of Life 5 Dimension Scale</measure>
    <time_frame>6 Months</time_frame>
    <description>Change in Quality of Life as measured by the European Quality of Life 5 Dimension (EQ-5D) Scale. The EQ-5D-5L is composed of - the EQ-5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Each level corresponds to 1-digit number expressing the level selected for that dimension.</description>
  </other_outcome>
  <other_outcome>
    <measure>Health Status Measured by Short Form-36 (SF-36)</measure>
    <time_frame>6 Months</time_frame>
    <description>Change in Health Status measured by Short Form-36 (SF-36). This form measures patient's overall health. Scores range from 0 - 100 with lower scores indicating more disability while higher scores indicate less disability.</description>
  </other_outcome>
  <other_outcome>
    <measure>Pain Medication Usage</measure>
    <time_frame>6 Months</time_frame>
    <description>The opioid morphine equivalent conversion factor is used to standardized opioid usage having as a reference morphine as the main indicator for analgesic potency. Oral morphine equivalents are based on the idea that different doses of different opioids may give a similar analgesic effect. Where the doses of two different opioids are considered to give a comparable analgesic effect, they are deemed to be equianalgesic doses.</description>
  </other_outcome>
  <other_outcome>
    <measure>Satisfaction With the Pain Relief</measure>
    <time_frame>6 Months</time_frame>
    <description>There will be 3 separate questions on the form. Subjects will be asked to rate their satisfaction with the pain relief, satisfaction with the therapy in general and their likelihood undergoing the therapy again for a similar outcome as a percentage from 0-100% with 0% indicating no satisfaction/likelihood and 100% indicating completely satisfied and 100% likelihood of undergoing the therapy again for a similar outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Adverse Events Related to the Procedure or Devices</measure>
    <time_frame>6 Months</time_frame>
    <description>Descriptive safety data defined as adverse events related to the procedure or devices will be enumerated.</description>
  </other_outcome>
  <other_outcome>
    <measure>Patients' Global Impression of Change (PGIC)</measure>
    <time_frame>6 Months</time_frame>
    <description>Patients will be asked to rate their overall change in quality of health on a scale of 1 to 7 with 1 being no change in overall health and 7 being a great deal better in comparison to before implant. Another scale will on the same form ranging from 0-10 with 0 being much better, 5 being no change and 10 being much worse.</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">1</enrollment>
  <condition>Complex Regional Pain Syndrome</condition>
  <arm_group>
    <arm_group_label>Dorsal Column Stimulation</arm_group_label>
    <description>Subjects with Complex Regional Pain Syndrome receiving implant with the Nuvectra Algovita Dorsal Column Spinal Cord Stimulator</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dorsal Root Ganglion Stimulation</arm_group_label>
    <description>Subjects with Complex Regional Pain Syndrome receiving implant with the Axium Neurostimulator System</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator</intervention_name>
    <description>The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.</description>
    <arm_group_label>Dorsal Column Stimulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>The Axium Neurostimulator System</intervention_name>
    <description>The Axium Neurostimulator System is indicated for spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable pain of the lower limbs in adult patients with Complex Regional Pain Syndrome Types I and II</description>
    <arm_group_label>Dorsal Root Ganglion Stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with Budapest criteria (research diagnostic definition) of Complex Regional Pain&#xD;
        Syndrome occurring below the umbilicus who have not had an adequate response to&#xD;
        conservative management including analgesic and physical therapies.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Patient is greater than18 years of age&#xD;
&#xD;
               -  An infraumbilical location of the index pain&#xD;
&#xD;
               -  Symptoms have been present for greater than 6 months&#xD;
&#xD;
               -  Continuing pain which is disproportionate to any inciting event&#xD;
&#xD;
               -  Report hyperesthesia and/or allodynia&#xD;
&#xD;
               -  Report vasomotor changes including temperature asymmetry and/or skin color&#xD;
                  changes and/or skin color asymmetry&#xD;
&#xD;
               -  Report edema and/or sweating changes and/or sweating asymmetry&#xD;
&#xD;
               -  Report decreased range of motion and/or motor dysfunction (weakness, tremor,&#xD;
                  dystonia) and/or trophic changes (hair, nail, skin)&#xD;
&#xD;
               -  Display at least one sign in two or more of the following categories:&#xD;
&#xD;
                    -  Sensory: Evidence of hyperalgesia (to pinprick) and/or allodynia (to light&#xD;
                       touch and/or temperature sensation and/or deep somatic pressure and/or joint&#xD;
                       movement)&#xD;
&#xD;
                    -  Vasomotor: Evidence of temperature asymmetry (&gt;1°C) and/or skin color&#xD;
                       changes and/or asymmetry&#xD;
&#xD;
                    -  Sudomotor/Edema: Evidence of edema and/or sweating changes and/or sweating&#xD;
                       asymmetry&#xD;
&#xD;
                    -  Motor/Trophic: Evidence of decreased range of motion and/or motor&#xD;
                       dysfunction (weakness, tremor, dystonia) and/or trophic changes (hair, nail,&#xD;
                       skin)&#xD;
&#xD;
               -  Patient failed to have resolution of symptoms despite at least 4 weeks of&#xD;
                  conservative management including analgesic pharmacotherapy and physical therapy&#xD;
&#xD;
               -  Patient has index site pain &gt; spine pain&#xD;
&#xD;
               -  The subject is physically and mentally able to participate in the study&#xD;
&#xD;
               -  Patient is willing and able to provide informed consent&#xD;
&#xD;
               -  Patient is willing and able to comply with the study protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous surgery to the spine which could compromise placement of the study device&#xD;
&#xD;
          -  Anatomical spinal abnormality including severe central canal stenosis or bony&#xD;
             foraminal impingement which could preclude device placement&#xD;
&#xD;
          -  Foreseen need for MRI to monitor or evaluate another chronic condition&#xD;
&#xD;
          -  Previous experience with an implanted or trial neuromodulation system (spinal cord&#xD;
             stimulation, peripheral nerve stimulation) for the treatment of pain at the index&#xD;
             location&#xD;
&#xD;
          -  Active local or systemic infection&#xD;
&#xD;
          -  Actively in litigation for pain symptoms&#xD;
&#xD;
          -  Currently on Workman's Compensation&#xD;
&#xD;
          -  Women who are pregnant or intend to become pregnant during the study duration&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Robert Bolash, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Roberta Johnson</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>December 31, 2018</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <results_first_submitted>June 5, 2020</results_first_submitted>
  <results_first_submitted_qc>June 5, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">June 24, 2020</results_first_posted>
  <last_update_submitted>February 23, 2023</last_update_submitted>
  <last_update_submitted_qc>February 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2023</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>Complex Regional Pain Syndromes</mesh_term>
    <mesh_term>Reflex Sympathetic Dystrophy</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Somatoform Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 19, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/24/NCT03794024/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Dorsal Column Stimulation</title>
          <description>Subjects with Complex Regional Pain Syndrome receiving implant with the Nuvectra Algovita Dorsal Column Spinal Cord Stimulator&#xD;
The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator: The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.</description>
        </group>
        <group group_id="P2">
          <title>Dorsal Root Ganglion Stimulation</title>
          <description>Subjects with Complex Regional Pain Syndrome receiving implant with the Axium Neurostimulator System&#xD;
The Axium Neurostimulator System: The Axium Neurostimulator System is indicated for spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable pain of the lower limbs in adult patients with Complex Regional Pain Syndrome Types I and II</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>No patients enrolled were randomized into the Dorsal Root Ganglion Stimulation arm.</population>
      <group_list>
        <group group_id="B1">
          <title>Dorsal Column Stimulation</title>
          <description>Subjects with Complex Regional Pain Syndrome receiving implant with the Nuvectra Algovita Dorsal Column Spinal Cord Stimulator&#xD;
The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator: The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.</description>
        </group>
        <group group_id="B2">
          <title>Dorsal Root Ganglion Stimulation</title>
          <description>Subjects with Complex Regional Pain Syndrome receiving implant with the Axium Neurostimulator System&#xD;
The Axium Neurostimulator System: The Axium Neurostimulator System is indicated for spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable pain of the lower limbs in adult patients with Complex Regional Pain Syndrome Types I and II</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1"/>
            <count group_id="B2" value="0"/>
            <count group_id="B3" value="1"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Numerical Rating Scale for Pain Intensity</title>
        <description>To compare the outcomes of dorsal column stimulation with Dorsal Root Ganglion stimulation in patients with Complex Regional Pain Syndrome that persist despite a course of conservative management including physical therapy and analgesic pharmacotherapy using an 11-point [0-10] Numerical Rating Scale (NRS) for Pain Intensity at 6 months. A score of zero indicates no pain, and 10 indicates the worst possible pain imaginable.</description>
        <time_frame>6 Months</time_frame>
        <population>No patients achieved the 6 month endpoint</population>
        <group_list>
          <group group_id="O1">
            <title>Dorsal Column Stimulation</title>
            <description>Subjects with Complex Regional Pain Syndrome receiving implant with the Nuvectra Algovita Dorsal Column Spinal Cord Stimulator&#xD;
The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator: The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.</description>
          </group>
          <group group_id="O2">
            <title>Dorsal Root Ganglion Stimulation</title>
            <description>Subjects with Complex Regional Pain Syndrome receiving implant with the Axium Neurostimulator System&#xD;
The Axium Neurostimulator System: The Axium Neurostimulator System is indicated for spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable pain of the lower limbs in adult patients with Complex Regional Pain Syndrome Types I and II</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Numerical Rating Scale for Pain Intensity</title>
          <description>To compare the outcomes of dorsal column stimulation with Dorsal Root Ganglion stimulation in patients with Complex Regional Pain Syndrome that persist despite a course of conservative management including physical therapy and analgesic pharmacotherapy using an 11-point [0-10] Numerical Rating Scale (NRS) for Pain Intensity at 6 months. A score of zero indicates no pain, and 10 indicates the worst possible pain imaginable.</description>
          <population>No patients achieved the 6 month endpoint</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Oswestry Disability Index for Pain Intensity</title>
        <description>To compare the outcomes of dorsal column stimulation with Dorsal Root Ganglion stimulation in patients with Complex Regional Pain Syndrome that persist despite a course of conservative management including physical therapy and analgesic pharmacotherapy in function based on Oswestry Disability Index (ODI) for functional impairment. A score of 0 on the 101-point [0-100] Oswestry Disability Index indicates no disability while 100 indicates bed-bound.</description>
        <time_frame>6 Month</time_frame>
        <population>Data were not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Dorsal Column Stimulation</title>
            <description>Subjects with Complex Regional Pain Syndrome receiving implant with the Nuvectra Algovita Dorsal Column Spinal Cord Stimulator&#xD;
The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator: The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.</description>
          </group>
          <group group_id="O2">
            <title>Dorsal Root Ganglion Stimulation</title>
            <description>Subjects with Complex Regional Pain Syndrome receiving implant with the Axium Neurostimulator System&#xD;
The Axium Neurostimulator System: The Axium Neurostimulator System is indicated for spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable pain of the lower limbs in adult patients with Complex Regional Pain Syndrome Types I and II</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Oswestry Disability Index for Pain Intensity</title>
          <description>To compare the outcomes of dorsal column stimulation with Dorsal Root Ganglion stimulation in patients with Complex Regional Pain Syndrome that persist despite a course of conservative management including physical therapy and analgesic pharmacotherapy in function based on Oswestry Disability Index (ODI) for functional impairment. A score of 0 on the 101-point [0-100] Oswestry Disability Index indicates no disability while 100 indicates bed-bound.</description>
          <population>Data were not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change in European Quality of Life 5 Dimension Scale</title>
        <description>Change in Quality of Life as measured by the European Quality of Life 5 Dimension (EQ-5D) Scale. The EQ-5D-5L is composed of - the EQ-5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Each level corresponds to 1-digit number expressing the level selected for that dimension.</description>
        <time_frame>6 Months</time_frame>
        <population>Data were not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Dorsal Column Stimulation</title>
            <description>Subjects with Complex Regional Pain Syndrome receiving implant with the Nuvectra Algovita Dorsal Column Spinal Cord Stimulator&#xD;
The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator: The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.</description>
          </group>
          <group group_id="O2">
            <title>Dorsal Root Ganglion Stimulation</title>
            <description>Subjects with Complex Regional Pain Syndrome receiving implant with the Axium Neurostimulator System&#xD;
The Axium Neurostimulator System: The Axium Neurostimulator System is indicated for spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable pain of the lower limbs in adult patients with Complex Regional Pain Syndrome Types I and II</description>
          </group>
        </group_list>
        <measure>
          <title>Change in European Quality of Life 5 Dimension Scale</title>
          <description>Change in Quality of Life as measured by the European Quality of Life 5 Dimension (EQ-5D) Scale. The EQ-5D-5L is composed of - the EQ-5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Each level corresponds to 1-digit number expressing the level selected for that dimension.</description>
          <population>Data were not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Health Status Measured by Short Form-36 (SF-36)</title>
        <description>Change in Health Status measured by Short Form-36 (SF-36). This form measures patient's overall health. Scores range from 0 - 100 with lower scores indicating more disability while higher scores indicate less disability.</description>
        <time_frame>6 Months</time_frame>
        <population>Data were not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Dorsal Column Stimulation</title>
            <description>Subjects with Complex Regional Pain Syndrome receiving implant with the Nuvectra Algovita Dorsal Column Spinal Cord Stimulator&#xD;
The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator: The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.</description>
          </group>
          <group group_id="O2">
            <title>Dorsal Root Ganglion Stimulation</title>
            <description>Subjects with Complex Regional Pain Syndrome receiving implant with the Axium Neurostimulator System&#xD;
The Axium Neurostimulator System: The Axium Neurostimulator System is indicated for spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable pain of the lower limbs in adult patients with Complex Regional Pain Syndrome Types I and II</description>
          </group>
        </group_list>
        <measure>
          <title>Health Status Measured by Short Form-36 (SF-36)</title>
          <description>Change in Health Status measured by Short Form-36 (SF-36). This form measures patient's overall health. Scores range from 0 - 100 with lower scores indicating more disability while higher scores indicate less disability.</description>
          <population>Data were not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Pain Medication Usage</title>
        <description>The opioid morphine equivalent conversion factor is used to standardized opioid usage having as a reference morphine as the main indicator for analgesic potency. Oral morphine equivalents are based on the idea that different doses of different opioids may give a similar analgesic effect. Where the doses of two different opioids are considered to give a comparable analgesic effect, they are deemed to be equianalgesic doses.</description>
        <time_frame>6 Months</time_frame>
        <population>Data were not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Dorsal Column Stimulation</title>
            <description>Subjects with Complex Regional Pain Syndrome receiving implant with the Nuvectra Algovita Dorsal Column Spinal Cord Stimulator&#xD;
The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator: The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.</description>
          </group>
          <group group_id="O2">
            <title>Dorsal Root Ganglion Stimulation</title>
            <description>Subjects with Complex Regional Pain Syndrome receiving implant with the Axium Neurostimulator System&#xD;
The Axium Neurostimulator System: The Axium Neurostimulator System is indicated for spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable pain of the lower limbs in adult patients with Complex Regional Pain Syndrome Types I and II</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Medication Usage</title>
          <description>The opioid morphine equivalent conversion factor is used to standardized opioid usage having as a reference morphine as the main indicator for analgesic potency. Oral morphine equivalents are based on the idea that different doses of different opioids may give a similar analgesic effect. Where the doses of two different opioids are considered to give a comparable analgesic effect, they are deemed to be equianalgesic doses.</description>
          <population>Data were not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Satisfaction With the Pain Relief</title>
        <description>There will be 3 separate questions on the form. Subjects will be asked to rate their satisfaction with the pain relief, satisfaction with the therapy in general and their likelihood undergoing the therapy again for a similar outcome as a percentage from 0-100% with 0% indicating no satisfaction/likelihood and 100% indicating completely satisfied and 100% likelihood of undergoing the therapy again for a similar outcome.</description>
        <time_frame>6 Months</time_frame>
        <population>Data were not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Dorsal Column Stimulation</title>
            <description>Subjects with Complex Regional Pain Syndrome receiving implant with the Nuvectra Algovita Dorsal Column Spinal Cord Stimulator&#xD;
The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator: The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.</description>
          </group>
          <group group_id="O2">
            <title>Dorsal Root Ganglion Stimulation</title>
            <description>Subjects with Complex Regional Pain Syndrome receiving implant with the Axium Neurostimulator System&#xD;
The Axium Neurostimulator System: The Axium Neurostimulator System is indicated for spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable pain of the lower limbs in adult patients with Complex Regional Pain Syndrome Types I and II</description>
          </group>
        </group_list>
        <measure>
          <title>Satisfaction With the Pain Relief</title>
          <description>There will be 3 separate questions on the form. Subjects will be asked to rate their satisfaction with the pain relief, satisfaction with the therapy in general and their likelihood undergoing the therapy again for a similar outcome as a percentage from 0-100% with 0% indicating no satisfaction/likelihood and 100% indicating completely satisfied and 100% likelihood of undergoing the therapy again for a similar outcome.</description>
          <population>Data were not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Adverse Events Related to the Procedure or Devices</title>
        <description>Descriptive safety data defined as adverse events related to the procedure or devices will be enumerated.</description>
        <time_frame>6 Months</time_frame>
        <population>Data were not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Dorsal Column Stimulation</title>
            <description>Subjects with Complex Regional Pain Syndrome receiving implant with the Nuvectra Algovita Dorsal Column Spinal Cord Stimulator&#xD;
The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator: The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.</description>
          </group>
          <group group_id="O2">
            <title>Dorsal Root Ganglion Stimulation</title>
            <description>Subjects with Complex Regional Pain Syndrome receiving implant with the Axium Neurostimulator System&#xD;
The Axium Neurostimulator System: The Axium Neurostimulator System is indicated for spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable pain of the lower limbs in adult patients with Complex Regional Pain Syndrome Types I and II</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Events Related to the Procedure or Devices</title>
          <description>Descriptive safety data defined as adverse events related to the procedure or devices will be enumerated.</description>
          <population>Data were not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Patients' Global Impression of Change (PGIC)</title>
        <description>Patients will be asked to rate their overall change in quality of health on a scale of 1 to 7 with 1 being no change in overall health and 7 being a great deal better in comparison to before implant. Another scale will on the same form ranging from 0-10 with 0 being much better, 5 being no change and 10 being much worse.</description>
        <time_frame>6 Months</time_frame>
        <population>Data were not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Dorsal Column Stimulation</title>
            <description>Subjects with Complex Regional Pain Syndrome receiving implant with the Nuvectra Algovita Dorsal Column Spinal Cord Stimulator&#xD;
The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator: The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.</description>
          </group>
          <group group_id="O2">
            <title>Dorsal Root Ganglion Stimulation</title>
            <description>Subjects with Complex Regional Pain Syndrome receiving implant with the Axium Neurostimulator System&#xD;
The Axium Neurostimulator System: The Axium Neurostimulator System is indicated for spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable pain of the lower limbs in adult patients with Complex Regional Pain Syndrome Types I and II</description>
          </group>
        </group_list>
        <measure>
          <title>Patients' Global Impression of Change (PGIC)</title>
          <description>Patients will be asked to rate their overall change in quality of health on a scale of 1 to 7 with 1 being no change in overall health and 7 being a great deal better in comparison to before implant. Another scale will on the same form ranging from 0-10 with 0 being much better, 5 being no change and 10 being much worse.</description>
          <population>Data were not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <desc>The definitions parallel those listed on clinicaltrials.gov</desc>
      <group_list>
        <group group_id="E1">
          <title>Dorsal Column Stimulation</title>
          <description>Subjects with Complex Regional Pain Syndrome receiving implant with the Nuvectra Algovita Dorsal Column Spinal Cord Stimulator&#xD;
The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator: The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.</description>
        </group>
        <group group_id="E2">
          <title>Dorsal Root Ganglion Stimulation</title>
          <description>Subjects with Complex Regional Pain Syndrome receiving implant with the Axium Neurostimulator System&#xD;
The Axium Neurostimulator System: The Axium Neurostimulator System is indicated for spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable pain of the lower limbs in adult patients with Complex Regional Pain Syndrome Types I and II</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Robert Bolash</name_or_title>
      <organization>Cleveland Clinic</organization>
      <phone>216-444-3134</phone>
      <email>bolashr@ccf.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03794024
org study id: 18-1115
nct id: NCT03794024
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Complex Regional Pain Syndrome (CRPS) is a constellation of pain symptoms which are
      associated with impairment in mood, social and physical function. Spinal Cord Stimulation
      (SCS), a technique of placing electrodes into the epidural space is a validated treatment for
      Complex Regional Pain Syndrome . Treatment of CRPS with SCS, in combination with physical
      therapy, reduced pain to a greater degree than physical therapy alone. 40%-50% of CRPS
      patients achieve >50% pain relief with SCS using dorsal column stimulation . Dorsal Root
      Ganglion (DRG) SCS has also recently demonstrated clinical efficacy in patients with CRPS and
      peripheral causalgia . The hypothesis is that DRG stimulation is non-inferior to dorsal
      column SCS in patients with CRPS who have failed to respond to a course of analgesics and
      physical therapy. The aim to assess functional, quality of life, patient satisfaction and
      medication requirements in subjects treated with neuromodulation for CRPS and contrast
      outcomes amongst subjects treated with DRG SCS and dorsal column SCS.
The purpose of this study is to compare outcomes between dorsal column spinal cord
      stimulation and dorsal root ganglion spinal cord stimulation in patients with Complex
      Regional Pain Syndrome at an infraumbilical location who have failed a course of conservative
      management including analgesic pharmacotherapy and physical therapy.

      This is a prospective randomized post-marketing clinical study. Patients will be randomized
      in a 1:1 ratio to Dorsal Column or Dorsal Root Ganglion Spinal Cord Stimulation if they have
      failed a course of conservative management including analgesics and physical therapy. All
      patients are expected to undergo clinical, neurological, and imaging assessments, if
      appropriate, at selected follow-up visits.

      The study will be conducted a single center with a target maximum of 62 patients (31
      randomized to each group).

      Enrollment of subjects in this study is anticipated to take 24 months. Clinical follow-up
      evaluations will be conducted at 10 days, 1, 3 and 6 months post-implant. The total study
      duration is expected to be at least 30 months.

      All patients presenting to the Investigators with Budapest criteria, research subset , for
      the diagnosis of Complex Regional Pain Syndrome at an infraumbilical location who have not
      had an adequate response to a course of conservative management including analgesics and
      physical therapy will be screened for eligibility. A Screening/Enrollment Log will be
      utilized in order to maintain a cumulative tracking of all screened patients.

      Patients must meet all inclusion/exclusion criteria for enrollment in the clinical study.
      Reasons for screening failure(s) will be documented.
observational model: Cohort
time perspective: Prospective
measure: Change in Numerical Rating Scale for Pain Intensity
time frame: 6 Months
description: To compare the outcomes of dorsal column stimulation with Dorsal Root Ganglion stimulation in patients with Complex Regional Pain Syndrome that persist despite a course of conservative management including physical therapy and analgesic pharmacotherapy using an 11-point [0-10] Numerical Rating Scale (NRS) for Pain Intensity at 6 months. A score of zero indicates no pain, and 10 indicates the worst possible pain imaginable.
measure: Change in Oswestry Disability Index for Pain Intensity
time frame: 6 Month
description: To compare the outcomes of dorsal column stimulation with Dorsal Root Ganglion stimulation in patients with Complex Regional Pain Syndrome that persist despite a course of conservative management including physical therapy and analgesic pharmacotherapy in function based on Oswestry Disability Index (ODI) for functional impairment. A score of 0 on the 101-point [0-100] Oswestry Disability Index indicates no disability while 100 indicates bed-bound.
measure: Change in European Quality of Life 5 Dimension Scale
time frame: 6 Months
description: Change in Quality of Life as measured by the European Quality of Life 5 Dimension (EQ-5D) Scale. The EQ-5D-5L is composed of - the EQ-5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Each level corresponds to 1-digit number expressing the level selected for that dimension.
measure: Health Status Measured by Short Form-36 (SF-36)
time frame: 6 Months
description: Change in Health Status measured by Short Form-36 (SF-36). This form measures patient's overall health. Scores range from 0 - 100 with lower scores indicating more disability while higher scores indicate less disability.
measure: Pain Medication Usage
time frame: 6 Months
description: The opioid morphine equivalent conversion factor is used to standardized opioid usage having as a reference morphine as the main indicator for analgesic potency. Oral morphine equivalents are based on the idea that different doses of different opioids may give a similar analgesic effect. Where the doses of two different opioids are considered to give a comparable analgesic effect, they are deemed to be equianalgesic doses.
measure: Satisfaction With the Pain Relief
time frame: 6 Months
description: There will be 3 separate questions on the form. Subjects will be asked to rate their satisfaction with the pain relief, satisfaction with the therapy in general and their likelihood undergoing the therapy again for a similar outcome as a percentage from 0-100% with 0% indicating no satisfaction/likelihood and 100% indicating completely satisfied and 100% likelihood of undergoing the therapy again for a similar outcome.
measure: Adverse Events Related to the Procedure or Devices
time frame: 6 Months
description: Descriptive safety data defined as adverse events related to the procedure or devices will be enumerated.
measure: Patients' Global Impression of Change (PGIC)
time frame: 6 Months
description: Patients will be asked to rate their overall change in quality of health on a scale of 1 to 7 with 1 being no change in overall health and 7 being a great deal better in comparison to before implant. Another scale will on the same form ranging from 0-10 with 0 being much better, 5 being no change and 10 being much worse.
arm group label: Dorsal Column Stimulation
description: Subjects with Complex Regional Pain Syndrome receiving implant with the Nuvectra Algovita Dorsal Column Spinal Cord Stimulator
arm group label: Dorsal Root Ganglion Stimulation
description: Subjects with Complex Regional Pain Syndrome receiving implant with the Axium Neurostimulator System
intervention type: Device
intervention name: The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator
description: The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.
arm group label: Dorsal Column Stimulation
intervention type: Device
intervention name: The Axium Neurostimulator System
description: The Axium Neurostimulator System is indicated for spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable pain of the lower limbs in adult patients with Complex Regional Pain Syndrome Types I and II
arm group label: Dorsal Root Ganglion Stimulation
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Robert Bolash, MD
role: Principal Investigator
affiliation: The Cleveland Clinic
facility: 
country: United States
responsible party type: Sponsor
mesh term: Complex Regional Pain Syndromes
mesh term: Reflex Sympathetic Dystrophy
mesh term: Syndrome
mesh term: Somatoform Disorders
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 