xml: <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/NCT06016127</url>
    </required_header>
    <id_info>
      <org_study_id>CRS-107</org_study_id>
      <nct_id>NCT06016127</nct_id>
    </id_info>
    <brief_title>Cryoneurolysis for Facet Mediated Chronic Low Back Pain</brief_title>
    <official_title>A Single-center, Randomized, Pilot Study to Assess Iovera° Lumbar Medial Branch Cryoneurolysis vs Lumbar Radiofrequency Ablation for Facet Mediated Chronic Low Back Pain</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Medical Pain Management Services, PLLC</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Pacira Pharmaceuticals, Inc</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Medical Pain Management Services, PLLC</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>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a single-center, randomized, pilot study in adult subjects with facet mediated CLBP.&#xD;
        Thirty (30) subjects are planned for initial enrollment and will be randomized 1:1 to receive&#xD;
        ioveraº medial branch cryoneurolysis or radiofrequency ablation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a single-center, randomized, pilot study in adult subjects with facet mediated CLBP.&#xD;
        Thirty (30) subjects are planned for initial enrollment and will be randomized 1:1 to receive&#xD;
        ioveraº medial branch cryoneurolysis or radiofrequency ablation.&#xD;
  &#xD;
        This study is designed to determine if a full efficacy RCT can be successfully conducted&#xD;
        using the procedures and protocols described in the current pilot study protocol, or if&#xD;
        protocol modifications are necessary before moving forward with a full efficacy RCT.&#xD;
        Furthermore, the study will assess the feasibility of the outcome measurements employed,&#xD;
        construct a foundation for sample size calculation, and the acceptability/practicality of&#xD;
        conducting the full efficacy RCT.&#xD;
  &#xD;
        Randomization to treatment groups according to the randomization assignment will be performed&#xD;
        on the day of treatment. The treatment groups are:&#xD;
  &#xD;
          -  Group 1: subjects will receive iovera° cryoneurolysis to the medial branch nerves of the&#xD;
             lumbar spine&#xD;
  &#xD;
          -  Group 2: subjects will receive RFA to the medial branch nerves of the lumbar spine&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">June 18, 2022</start_date>
    <completion_date type="Anticipated">October 23, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 23, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Randomization to treatment groups according to the randomization assignment</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>Open label</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Safety of cryoneurolysis as compared to radiofrequency ablation (RFA)</measure>
      <time_frame>0-12 months</time_frame>
      <description>Safety will be assessed as the number of subjects with reported treatment-related adverse related to cryoneurolysis or RFA.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in pain intensity as measured by 11-point Numeric Rating Scale (NRs)</measure>
      <time_frame>0-12 months</time_frame>
      <description>Subjects will evaluate their pain in the low back region using an 11-point Numeric Rating Scale (NRS), where 0=no pain and 10=worst possible pain.&#xD;
  Subjects will evaluate how much pain they are currently experiencing and their worst and average level of pain over the past 24 hours.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Change in functional disability</measure>
      <time_frame>0-12 months</time_frame>
      <description>Function disability will be measured by the Oswestry Disability Index. The score ranges from 0-50, with lower scores reflecting milder disability.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in Patients' Global Impression of Change</measure>
      <time_frame>0-12 months</time_frame>
      <description>The Patients' Global Impression of Change (PGIC) is a 7-point patient self-reporting scale of overall change in activity limitations, symptoms, emotions, and quality of life ranging from 1) no change 2) hardly any change 3) no noticeable change 4) change has not made any real difference 5) a slight but noticeable change 6) a definite improvement 7) considerable improvement.&#xD;
  The scale also assesses degree of change since beginning care (0=much better, 10=much worse).</description>
    </other_outcome>
    <other_outcome>
      <measure>Satisfaction with pain management</measure>
      <time_frame>0-12 months</time_frame>
      <description>Subject satisfaction with pain management as measured on a scale ranging from 1) extremely dissatisfied 2) dissatisfied 3) neither satisfied nor dissatisfied 4) satisfied 5) extremely satisfied.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">30</enrollment>
    <condition>Low Back Pain</condition>
    <condition>Facet Joint Pain</condition>
    <arm_group>
      <arm_group_label>Cryoneurolysis</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Subjects will receive iovera° cryoneurolysis to the medial branch nerves of the lumbar spine</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Radiofrequency ablation</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Subjects will receive RFA to the medial branch nerves of the lumbar spine</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>iovera system</intervention_name>
      <description>The iovera° system consists of a reusable, portable Handpiece, along with single patient use sterile Smart Tips (i.e., cryoprobes) and disposable nitrous oxide (N2O) cartridges. The iovera° system produces the desired effect through initiation of a cooling cycle. Each cooling cycle is initiated by fully inserting the Smart Tip into the selected procedure site and activating the cryogen flow. The Smart Tip needles are made of stainless steel and have a closed tip, fully enclosing the cryogen. The &quot;190&quot; Smart Tip will be used in this study.</description>
      <arm_group_label>Cryoneurolysis</arm_group_label>
      <other_name>iovera</other_name>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Radiofrequency ablation</intervention_name>
      <description>The RFA system consists of a Cosman, G4 Generator. The needles used are 20-gauge, 10cm long with a 10mm active tip manufactured by Cosman. A grounding pad, also manufactured by Cosman, is placed on the upper thigh for each procedure and connected to the G4 Generator.</description>
      <arm_group_label>Radiofrequency ablation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Male or female volunteers, at least 18 years of age at screening&#xD;
  &#xD;
            2. Primary complaint of axial low-back pain suggestive of unilateral or bilateral facet&#xD;
               joint involvement (i.e., facet mediated CLBP)&#xD;
  &#xD;
            3. Low back pain is chronic (i.e., &gt; 3 months' duration)&#xD;
  &#xD;
            4. Low back pain score of ≥ 4 (i.e., moderate pain) on the 0 to 10 NRS or functional&#xD;
               impairment at screening&#xD;
  &#xD;
            5. Successful trial of two diagnostic medial branch blocks consisting of two positive&#xD;
               blocks with local anesthetic only (i.e., no steroids) that results in at least 50%&#xD;
               relief of primary (index) pain for the duration of the local anesthetic used or&#xD;
               history of a positive response to prior radiofrequency treatment (i.e., ≥ 6 months&#xD;
               prior to enrollment)&#xD;
  &#xD;
            6. Failure of at least three months of conservative non-operative therapy (e.g., physical&#xD;
               therapy, chiropractic care, spinal injections, NSAIDs or other appropriate&#xD;
               analgesics),&#xD;
  &#xD;
            7. Able to provide informed consent, adhere to the study visit schedule, and complete all&#xD;
               study assessments&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Active workers' compensation, personal injury, Social Security disability insurance&#xD;
               (SSDI), or other litigation/compensation related to the spine&#xD;
  &#xD;
            2. Serious spinal disorders (verified on magnetic resonance imaging (MRI)) that may&#xD;
               impact outcomes, including any of the following:&#xD;
  &#xD;
                 1. Suspected cauda equina syndrome (e.g., bowel/bladder dysfunction)&#xD;
  &#xD;
                 2. Infection&#xD;
  &#xD;
                 3. Tumor&#xD;
  &#xD;
                 4. Traumatic fracture&#xD;
  &#xD;
                 5. Systemic inflammatory spondyloarthropathy&#xD;
  &#xD;
                 6. Lumbar radiculopathy/radiculitis (i.e., root irritation and deficit)&#xD;
  &#xD;
                 7. Neurogenic claudication&#xD;
  &#xD;
            3. Prior lumbar spinal fusion surgery&#xD;
  &#xD;
            4. Comorbidity that, in the judgment of the Investigator, may affect the subject's&#xD;
               ability to participate in the study including lumbar radiculopathy and neuropathic&#xD;
               pain disorder&#xD;
  &#xD;
            5. Currently pregnant, nursing, or planning to become pregnant during the study&#xD;
  &#xD;
            6. Known contraindication to study devices, including any of the following:&#xD;
  &#xD;
                 1. Cryoglobulinemia&#xD;
  &#xD;
                 2. Paroxysmal cold hemoglobinuria&#xD;
  &#xD;
                 3. Cold urticaria&#xD;
  &#xD;
                 4. Raynaud's disease&#xD;
  &#xD;
                 5. Open and/or infected wounds at or near the treatment site&#xD;
  &#xD;
                 6. Coagulopathy&#xD;
  &#xD;
            7. 3.5-inch needle cannot be used in the low back region because of habitus&#xD;
  &#xD;
            8. Severe chronic pain disorder that in the opinion of the investigator may impact&#xD;
               postsurgical outcomes&#xD;
  &#xD;
            9. Presence of any of the following:&#xD;
  &#xD;
                 1. Spinal neurostimulator&#xD;
  &#xD;
                 2. Intrathecal analgesic drug pump&#xD;
  &#xD;
           10. Current manifestation of poorly controlled mental illness that in the opinion of the&#xD;
               investigator may meaningfully impact treatment outcomes, including any of the&#xD;
               following:&#xD;
  &#xD;
                 1. Mood disorder (e.g., major depression, bipolar)&#xD;
  &#xD;
                 2. Psychotic disorder (e.g., schizophrenia)&#xD;
  &#xD;
           11. Subject received other spine intervention/therapies in the 30 days prior to block&#xD;
               administration (e.g., spinal injections, minimally invasive therapies, surgical&#xD;
               therapies)&#xD;
  &#xD;
           12. Subject received radiofrequency ablation in the low back region ≤ 6 months before&#xD;
               study enrollment&#xD;
  &#xD;
           13. History, suspicion, or clinical manifestation of:&#xD;
  &#xD;
                 1. Alcohol abuse or dependence&#xD;
  &#xD;
                 2. Illicit drug use&#xD;
  &#xD;
                 3. Opioid abuse or dependence (≥40 mg MED PO/day in past 30 days) Given the COVID-19&#xD;
                    pandemic, the subject must be medically fit/cleared for treatment by the&#xD;
                    investigator. If there is a concern about a subject's recent or potential&#xD;
                    exposure to COVID-19, or if the subject is not medically fit/cleared for&#xD;
                    treatment due to suspected COVID-19 illness/symptoms (or other serious illness),&#xD;
                    the subject must be excluded per Exclusion criterion #4.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>The Albany &amp; Saratoga Centers For Pain Management</name>
        <address>
          <city>Saratoga Springs</city>
          <state>New York</state>
          <zip>12866</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>low back pain</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Arthralgia</mesh_term>
      <mesh_term>Back Pain</mesh_term>
      <mesh_term>Low Back Pain</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Contact PI</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06016127
  org study id: CRS-107
  nct id: NCT06016127
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  This is a single-center, randomized, pilot study in adult subjects with facet mediated CLBP.
        Thirty (30) subjects are planned for initial enrollment and will be randomized 1:1 to receive
        ioveraº medial branch cryoneurolysis or radiofrequency ablation.
  This is a single-center, randomized, pilot study in adult subjects with facet mediated CLBP.
        Thirty (30) subjects are planned for initial enrollment and will be randomized 1:1 to receive
        ioveraº medial branch cryoneurolysis or radiofrequency ablation.
  
        This study is designed to determine if a full efficacy RCT can be successfully conducted
        using the procedures and protocols described in the current pilot study protocol, or if
        protocol modifications are necessary before moving forward with a full efficacy RCT.
        Furthermore, the study will assess the feasibility of the outcome measurements employed,
        construct a foundation for sample size calculation, and the acceptability/practicality of
        conducting the full efficacy RCT.
  
        Randomization to treatment groups according to the randomization assignment will be performed
        on the day of treatment. The treatment groups are:
  
          -  Group 1: subjects will receive iovera° cryoneurolysis to the medial branch nerves of the
             lumbar spine
  
          -  Group 2: subjects will receive RFA to the medial branch nerves of the lumbar spine
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomization to treatment groups according to the randomization assignment
  primary purpose: Treatment
  masking: None (Open Label)
  masking description: Open label
  measure: Safety of cryoneurolysis as compared to radiofrequency ablation (RFA)
  time frame: 0-12 months
  description: Safety will be assessed as the number of subjects with reported treatment-related adverse related to cryoneurolysis or RFA.
  measure: Change in pain intensity as measured by 11-point Numeric Rating Scale (NRs)
  time frame: 0-12 months
  description: Subjects will evaluate their pain in the low back region using an 11-point Numeric Rating Scale (NRS), where 0=no pain and 10=worst possible pain.
  Subjects will evaluate how much pain they are currently experiencing and their worst and average level of pain over the past 24 hours.
  measure: Change in functional disability
  time frame: 0-12 months
  description: Function disability will be measured by the Oswestry Disability Index. The score ranges from 0-50, with lower scores reflecting milder disability.
  measure: Change in Patients' Global Impression of Change
  time frame: 0-12 months
  description: The Patients' Global Impression of Change (PGIC) is a 7-point patient self-reporting scale of overall change in activity limitations, symptoms, emotions, and quality of life ranging from 1) no change 2) hardly any change 3) no noticeable change 4) change has not made any real difference 5) a slight but noticeable change 6) a definite improvement 7) considerable improvement.
  The scale also assesses degree of change since beginning care (0=much better, 10=much worse).
  measure: Satisfaction with pain management
  time frame: 0-12 months
  description: Subject satisfaction with pain management as measured on a scale ranging from 1) extremely dissatisfied 2) dissatisfied 3) neither satisfied nor dissatisfied 4) satisfied 5) extremely satisfied.
  arm group label: Cryoneurolysis
  arm group type: Active Comparator
  description: Subjects will receive iovera° cryoneurolysis to the medial branch nerves of the lumbar spine
  arm group label: Radiofrequency ablation
  arm group type: Active Comparator
  description: Subjects will receive RFA to the medial branch nerves of the lumbar spine
  intervention type: Device
  intervention name: iovera system
  description: The iovera° system consists of a reusable, portable Handpiece, along with single patient use sterile Smart Tips (i.e., cryoprobes) and disposable nitrous oxide (N2O) cartridges. The iovera° system produces the desired effect through initiation of a cooling cycle. Each cooling cycle is initiated by fully inserting the Smart Tip into the selected procedure site and activating the cryogen flow. The Smart Tip needles are made of stainless steel and have a closed tip, fully enclosing the cryogen. The "190" Smart Tip will be used in this study.
  arm group label: Cryoneurolysis
  other name: iovera
  intervention type: Device
  intervention name: Radiofrequency ablation
  description: The RFA system consists of a Cosman, G4 Generator. The needles used are 20-gauge, 10cm long with a 10mm active tip manufactured by Cosman. A grounding pad, also manufactured by Cosman, is placed on the upper thigh for each procedure and connected to the G4 Generator.
  arm group label: Radiofrequency ablation
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Arthralgia
  mesh term: Back Pain
  mesh term: Low Back Pain
  sharing ipd: No
  ipd description: Contact PI