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/NCT06004882</url>
    </required_header>
    <id_info>
      <org_study_id>2023-0041</org_study_id>
      <secondary_id>NCI-2023-06513</secondary_id>
      <nct_id>NCT06004882</nct_id>
    </id_info>
    <brief_title>Peripheral Nerve Stimulation of Genicular Nerves Versus Conventional Therapy With Intra-articular Steroid Injection for Chronic Knee Pain: A Prospective, Randomized Pilot Study</brief_title>
    <official_title>Peripheral Nerve Stimulation of Genicular Nerves Versus Conventional Therapy With Intra-articular Steroid Injection for Chronic Knee Pain: A Prospective, Randomized Pilot Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>M.D. Anderson Cancer Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>M.D. Anderson Cancer Center</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        To compare the effects of the following types of therapy on knee range of motion when given&#xD;
        to patients with chronic knee pain:&#xD;
  &#xD;
          -  A standard steroid injection&#xD;
  &#xD;
          -  Peripheral nerve stimulation (PNS) therapy in combination with a standard steroid&#xD;
             injection&#xD;
  &#xD;
          -  PNS therapy in combination with a placebo injection&#xD;
  &#xD;
        Steroid injections are given directly into the knee joints and are considered to be the&#xD;
        standard therapy for chronic knee pain. In this study, the injection will be made of the&#xD;
        steroid drugs triamcinolone and bupivacaine.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Primary Objectives:&#xD;
  &#xD;
          -  To compare the mean change in knee range of motion using goniometry from at 30 days&#xD;
             (visit 2) from baseline among the three treatment arms.&#xD;
  &#xD;
        Secondary Objectives:&#xD;
  &#xD;
          -  To compare the mean change in knee range of motion using goniometry at 60 days (visit 3)&#xD;
             and 90 days (visit 4) from baseline among the three treatment arms.&#xD;
  &#xD;
          -  To compare changes in knee pain scores (NRS), WOMAC index, use of opioids (measured in&#xD;
             morphine milliequivalent), and incidence of complications and adverse effects at 30&#xD;
             days, 60 days, and 90 days from baseline among the three treatment arms&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 10, 2023</start_date>
    <completion_date type="Anticipated">January 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">January 31, 2024</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>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.0</measure>
      <time_frame>through study completion; an average of 1 year</time_frame>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">45</enrollment>
    <condition>Peripheral Nerve Stimulation</condition>
    <condition>Genicular Nerves</condition>
    <condition>Chronic Knee Pain</condition>
    <arm_group>
      <arm_group_label>Group 1 (standard steroid injection)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive 1 standard steroid injection.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2 (PNS therapy plus 1 standard steroid injection).</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive PNS therapy plus 1 standard steroid injection.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 3 (PNS therapy plus 1 placebo injection)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive PNS therapy plus 1 placebo injection.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>PNS therapy</intervention_name>
      <description>PNS therapy-NS is a 60-day therapy targeting chronic pain. The procedure involves implanting a small piece of wire next to the nerve causing pain, and the wire is connected to an external device that is then used to apply electric pulses to the nerve, blocking pain signals, for 60 days</description>
      <arm_group_label>Group 2 (PNS therapy plus 1 standard steroid injection).</arm_group_label>
      <arm_group_label>Group 3 (PNS therapy plus 1 placebo injection)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Triamcinolone</intervention_name>
      <description>Given by Injection</description>
      <arm_group_label>Group 1 (standard steroid injection)</arm_group_label>
      <arm_group_label>Group 2 (PNS therapy plus 1 standard steroid injection).</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Bupivacaine</intervention_name>
      <description>Given by Injection</description>
      <arm_group_label>Group 1 (standard steroid injection)</arm_group_label>
      <arm_group_label>Group 2 (PNS therapy plus 1 standard steroid injection).</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Given by Injection</description>
      <arm_group_label>Group 3 (PNS therapy plus 1 placebo injection)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients diagnosed with chronic knee pain (baseline pain score &gt;=4), seen at Pain&#xD;
               Management Center at MD Anderson Cancer Center; if patient has bilateral knee pain,&#xD;
               the side with the more severe knee pain will be treated first and counted towards the&#xD;
               primary and secondary endpoints&#xD;
  &#xD;
            -  Patients between ages 18-85 years old&#xD;
  &#xD;
            -  Patient signed informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with cognitive dysfunction or without capacity to consent&#xD;
  &#xD;
            -  Patient with recent history (&lt;6 months) of drug or alcohol abuse&#xD;
  &#xD;
            -  Patients with open skin lesion or undergoing antibiotic therapy for local for systemic&#xD;
               infection&#xD;
  &#xD;
            -  Patients with allergies to local anesthesia, steroids, or adhesives&#xD;
  &#xD;
            -  Patients who are on opioids for reasons other than knee pain&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Saba Javed, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>M.D. Anderson Cancer Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Saba Javed, MD</last_name>
      <phone>(713) 792-9530</phone>
      <email>sjaved@mdanderson.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>M D Anderson Cancer Center</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77030</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Saba Javed, MD</last_name>
        <phone>713-792-9530</phone>
        <email>sjaved@mdanderson.org</email>
      </contact>
      <investigator>
        <last_name>Saba Javed, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>http://www.mdanderson.org</url>
      <description>M D Anderson Cancer Center</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Triamcinolone</mesh_term>
      <mesh_term>Bupivacaine</mesh_term>
    </intervention_browse>
    <!-- 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/NCT06004882
  org study id: 2023-0041
  secondary id: NCI-2023-06513
  nct id: NCT06004882
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  To compare the effects of the following types of therapy on knee range of motion when given
        to patients with chronic knee pain:
  
          -  A standard steroid injection
  
          -  Peripheral nerve stimulation (PNS) therapy in combination with a standard steroid
             injection
  
          -  PNS therapy in combination with a placebo injection
  
        Steroid injections are given directly into the knee joints and are considered to be the
        standard therapy for chronic knee pain. In this study, the injection will be made of the
        steroid drugs triamcinolone and bupivacaine.
  Primary Objectives:
  
          -  To compare the mean change in knee range of motion using goniometry from at 30 days
             (visit 2) from baseline among the three treatment arms.
  
        Secondary Objectives:
  
          -  To compare the mean change in knee range of motion using goniometry at 60 days (visit 3)
             and 90 days (visit 4) from baseline among the three treatment arms.
  
          -  To compare changes in knee pain scores (NRS), WOMAC index, use of opioids (measured in
             morphine milliequivalent), and incidence of complications and adverse effects at 30
             days, 60 days, and 90 days from baseline among the three treatment arms
  allocation: Randomized
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.0
  time frame: through study completion; an average of 1 year
  arm group label: Group 1 (standard steroid injection)
  arm group type: Experimental
  description: Participants will receive 1 standard steroid injection.
  arm group label: Group 2 (PNS therapy plus 1 standard steroid injection).
  arm group type: Experimental
  description: Participants will receive PNS therapy plus 1 standard steroid injection.
  arm group label: Group 3 (PNS therapy plus 1 placebo injection)
  arm group type: Experimental
  description: Participants will receive PNS therapy plus 1 placebo injection.
  intervention type: Other
  intervention name: PNS therapy
  description: PNS therapy-NS is a 60-day therapy targeting chronic pain. The procedure involves implanting a small piece of wire next to the nerve causing pain, and the wire is connected to an external device that is then used to apply electric pulses to the nerve, blocking pain signals, for 60 days
  arm group label: Group 2 (PNS therapy plus 1 standard steroid injection).
  arm group label: Group 3 (PNS therapy plus 1 placebo injection)
  intervention type: Drug
  intervention name: Triamcinolone
  description: Given by Injection
  arm group label: Group 1 (standard steroid injection)
  arm group label: Group 2 (PNS therapy plus 1 standard steroid injection).
  intervention type: Drug
  intervention name: Bupivacaine
  description: Given by Injection
  arm group label: Group 1 (standard steroid injection)
  arm group label: Group 2 (PNS therapy plus 1 standard steroid injection).
  intervention type: Other
  intervention name: Placebo
  description: Given by Injection
  arm group label: Group 3 (PNS therapy plus 1 placebo injection)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Saba Javed, MD
  role: Principal Investigator
  affiliation: M.D. Anderson Cancer Center
  last name: Saba Javed, MD
  phone: (713) 792-9530
  email: sjaved@mdanderson.org
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  url: http://www.mdanderson.org
  description: M D Anderson Cancer Center
  responsible party type: Sponsor
  mesh term: Triamcinolone
  mesh term: Bupivacaine