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/NCT06000709</url>
    </required_header>
    <id_info>
      <org_study_id>HS25899</org_study_id>
      <nct_id>NCT06000709</nct_id>
    </id_info>
    <brief_title>Comparison Between Ultrasound-Guided Genicular Nerve Phenol Neurolysis and Intra-articular Steroid Injections</brief_title>
    <official_title>Randomized, Double-blinded, Comparison Between Ultrasound-Guided Genicular Nerve Phenol Neurolysis and Intra-articular Steroid Injections</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Manitoba</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Manitoba</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Genicular nerve neurolysis (GN) constitutes a relatively novel technique, whereby different&#xD;
        chemical compounds (i.e. alcohol, phenol) are injected in close proximity to the genicular&#xD;
        nerves of the knee joint, with the intention to exert a neurolytic effect by denaturing&#xD;
        proteins resulting in Wallerian degeneration distal to the lesion. Based on the preliminary&#xD;
        evidence and considering the potential benefits of the technique, we hypothesized that&#xD;
        ultrasound-guided genicular chemical neurolysis with phenol is superior in terms of pain&#xD;
        relief at 3 months, when compared to intra-articular steroid (IAS) injection.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study will allow us to determine if ultrasound-guided phenol genicular neurolys is&#xD;
        superior to intra-articular steroid injection in terms of analgesia and functional outcomes,&#xD;
        providing a more effective and long-lasting alternative for patients with chronic knee pain&#xD;
        secondary to osteoarthritis&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 28, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 31, 2024</primary_completion_date>
    <phase>Phase 4</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pain scores (Numeric Rating Scale) at 3 months</measure>
      <time_frame>3 months</time_frame>
      <description>Knee pain intensity using Numeric Rating Scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pain scores (Numeric Rating Scale) at baseline, 1 and 6 months</measure>
      <time_frame>baseline, 1 month, 6 months</time_frame>
      <description>Knee pain intensity using Numeric Rating Scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients experiencing a 50% or greater decrease in baseline knee pain scores (NRS)</measure>
      <time_frame>1 months, 3 months, 6 months</time_frame>
      <description>Knee pain intensity using Numeric Rating Scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Brief Pain Inventory Score (BPI)</measure>
      <time_frame>baseline, 1 month, 3 months, 6 months</time_frame>
      <description>Functional activity measurement using the Brief Pain Inventory (short form)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>WOMAC index</measure>
      <time_frame>baseline, 1 month, 3 months, 6 months</time_frame>
      <description>The WOMAC index consists of three subscales: pain, stiffness, and physical function (17 questions overall)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of adverse events</measure>
      <time_frame>from injection up to 1 month after intervention</time_frame>
      <description>Determined by the presence of hypoesthesia, paresthesia, puncture site hematoma, and worsening pain or infection</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Osteoarthritis, Knee</condition>
    <condition>Chronic Knee Pain</condition>
    <arm_group>
      <arm_group_label>Ultrasound-guided Genicular Nerve Phenol Neurolysis</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>One time injection of 1.5 mL of phenol 6% at 3 target locations: superomedial, superolateral and inferomedial genicular nerves</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Ultrasound-guided Intraarticular Steroid Injection</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Intraarticular knee injection of 40 mg of methylprednisolone acetate in a volume of 5 mL of saline</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>6% aqueous phenol</intervention_name>
      <description>1.5 mL of aqueous phenol will be injected at each target genicular nerve under ultrasound guidance</description>
      <arm_group_label>Ultrasound-guided Genicular Nerve Phenol Neurolysis</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>MethylPREDNISolone 40 MG</intervention_name>
      <description>40 mg of methylprednisolone diluted in 5 mL of 0.9% normal saline will be injected inside the knee joint capsule under ultrasound guidance</description>
      <arm_group_label>Ultrasound-guided Intraarticular Steroid Injection</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Intraarticular Knee Placebo</intervention_name>
      <description>Single injection 1.5 mL of 0.9% normal saline outside the knee joint capsule under ultrasound guidance</description>
      <arm_group_label>Ultrasound-guided Genicular Nerve Phenol Neurolysis</arm_group_label>
      <other_name>0.9% normal saline</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Genicular Nerve Placebo</intervention_name>
      <description>1.5 mL of 0.9% normal saline will be injected subcutaneously at each target genicular nerve under ultrasound guidance</description>
      <arm_group_label>Ultrasound-guided Intraarticular Steroid Injection</arm_group_label>
      <other_name>0.9% normal saline</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Severe knee pain for more than 6 months, defined as Numeric rating scale (NRS) score&#xD;
               of 6 and greater, unresponsive to conservative medical treatment&#xD;
  &#xD;
            -  Radiological OA grade 2 to 4 (Kellgren-Lawrence scale)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Previous total knee replacement on the index knee&#xD;
  &#xD;
            -  Prior knee radiofrequency ablation on the index knee&#xD;
  &#xD;
            -  Connective tissue diseases with knee involvement (e.g. rheumatoid arthritis)&#xD;
  &#xD;
            -  Body mass index ≥ 40 kg/m2&#xD;
  &#xD;
            -  Uncontrolled coagulopathy, defined as supratherapeutic dose of anticoagulation&#xD;
               medication&#xD;
  &#xD;
            -  Allergy to local anesthetics&#xD;
  &#xD;
            -  Unstable opioid consumption, defined as an increase &gt;10% in dosage during the last 3&#xD;
               months prior to recruitment.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Javier Webar, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Manitoba</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Javier Webar, MD</last_name>
      <phone>2047873018</phone>
      <email>javier.webar@umanitoba.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sebastian Layera, MD</last_name>
      <phone>2047873018</phone>
      <email>layerars@myumanitoba.ca</email>
    </overall_contact_backup>
    <reference>
      <citation>Walega DR, McCormick ZL. Chemical Neurolysis of the Genicular Nerves for Chronic Knee Pain: Reviving an Old Dog and an Old Trick. Pain Med. 2018 Sep 1;19(9):1882-1884. doi: 10.1093/pm/pny023. No abstract available.</citation>
      <PMID>29514315</PMID>
    </reference>
    <reference>
      <citation>Risso RC, Ferraro LHC, Nouer Frederico T, Peng PWH, Luzo MV, Debieux P, Sakata RK. Chemical Ablation of Genicular Nerve with Phenol for Pain Relief in Patients with Knee Osteoarthritis: A Prospective Study. Pain Pract. 2021 Apr;21(4):438-444. doi: 10.1111/papr.12972. Epub 2020 Dec 29.</citation>
      <PMID>33277760</PMID>
    </reference>
    <reference>
      <citation>Park Y, Lee SC, Nam HS, Lee J, Nam SH. Comparison of sonographically guided intra-articular injections at 3 different sites of the knee. J Ultrasound Med. 2011 Dec;30(12):1669-76. doi: 10.7863/jum.2011.30.12.1669.</citation>
      <PMID>22124002</PMID>
    </reference>
    <reference>
      <citation>Davis T, Loudermilk E, DePalma M, Hunter C, Lindley D, Patel N, Choi D, Soloman M, Gupta A, Desai M, Buvanendran A, Kapural L. Prospective, Multicenter, Randomized, Crossover Clinical Trial Comparing the Safety and Effectiveness of Cooled Radiofrequency Ablation With Corticosteroid Injection in the Management of Knee Pain From Osteoarthritis. Reg Anesth Pain Med. 2018 Jan;43(1):84-91. doi: 10.1097/AAP.0000000000000690.</citation>
      <PMID>29095245</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Manitoba</investigator_affiliation>
      <investigator_full_name>Javier Webar</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>Phenol</keyword>
    <keyword>Injections, Intra-Articular</keyword>
    <keyword>Steroids</keyword>
    <keyword>Nerve Block</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Osteoarthritis, Knee</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Phenol</mesh_term>
      <mesh_term>Methylprednisolone</mesh_term>
      <mesh_term>Methylprednisolone Acetate</mesh_term>
      <mesh_term>Methylprednisolone Hemisuccinate</mesh_term>
      <mesh_term>Prednisolone</mesh_term>
      <mesh_term>Prednisolone acetate</mesh_term>
      <mesh_term>Prednisolone hemisuccinate</mesh_term>
      <mesh_term>Prednisolone phosphate</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06000709
  org study id: HS25899
  nct id: NCT06000709
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Genicular nerve neurolysis (GN) constitutes a relatively novel technique, whereby different
        chemical compounds (i.e. alcohol, phenol) are injected in close proximity to the genicular
        nerves of the knee joint, with the intention to exert a neurolytic effect by denaturing
        proteins resulting in Wallerian degeneration distal to the lesion. Based on the preliminary
        evidence and considering the potential benefits of the technique, we hypothesized that
        ultrasound-guided genicular chemical neurolysis with phenol is superior in terms of pain
        relief at 3 months, when compared to intra-articular steroid (IAS) injection.
  This study will allow us to determine if ultrasound-guided phenol genicular neurolys is
        superior to intra-articular steroid injection in terms of analgesia and functional outcomes,
        providing a more effective and long-lasting alternative for patients with chronic knee pain
        secondary to osteoarthritis
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Pain scores (Numeric Rating Scale) at 3 months
  time frame: 3 months
  description: Knee pain intensity using Numeric Rating Scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
  measure: Pain scores (Numeric Rating Scale) at baseline, 1 and 6 months
  time frame: baseline, 1 month, 6 months
  description: Knee pain intensity using Numeric Rating Scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
  measure: Proportion of patients experiencing a 50% or greater decrease in baseline knee pain scores (NRS)
  time frame: 1 months, 3 months, 6 months
  description: Knee pain intensity using Numeric Rating Scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
  measure: Brief Pain Inventory Score (BPI)
  time frame: baseline, 1 month, 3 months, 6 months
  description: Functional activity measurement using the Brief Pain Inventory (short form)
  measure: WOMAC index
  time frame: baseline, 1 month, 3 months, 6 months
  description: The WOMAC index consists of three subscales: pain, stiffness, and physical function (17 questions overall)
  measure: Incidence of adverse events
  time frame: from injection up to 1 month after intervention
  description: Determined by the presence of hypoesthesia, paresthesia, puncture site hematoma, and worsening pain or infection
  arm group label: Ultrasound-guided Genicular Nerve Phenol Neurolysis
  arm group type: Experimental
  description: One time injection of 1.5 mL of phenol 6% at 3 target locations: superomedial, superolateral and inferomedial genicular nerves
  arm group label: Ultrasound-guided Intraarticular Steroid Injection
  arm group type: Active Comparator
  description: Intraarticular knee injection of 40 mg of methylprednisolone acetate in a volume of 5 mL of saline
  intervention type: Drug
  intervention name: 6% aqueous phenol
  description: 1.5 mL of aqueous phenol will be injected at each target genicular nerve under ultrasound guidance
  arm group label: Ultrasound-guided Genicular Nerve Phenol Neurolysis
  intervention type: Drug
  intervention name: MethylPREDNISolone 40 MG
  description: 40 mg of methylprednisolone diluted in 5 mL of 0.9% normal saline will be injected inside the knee joint capsule under ultrasound guidance
  arm group label: Ultrasound-guided Intraarticular Steroid Injection
  intervention type: Drug
  intervention name: Intraarticular Knee Placebo
  description: Single injection 1.5 mL of 0.9% normal saline outside the knee joint capsule under ultrasound guidance
  arm group label: Ultrasound-guided Genicular Nerve Phenol Neurolysis
  other name: 0.9% normal saline
  intervention type: Drug
  intervention name: Genicular Nerve Placebo
  description: 1.5 mL of 0.9% normal saline will be injected subcutaneously at each target genicular nerve under ultrasound guidance
  arm group label: Ultrasound-guided Intraarticular Steroid Injection
  other name: 0.9% normal saline
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Javier Webar, MD
  role: Principal Investigator
  affiliation: University of Manitoba
  last name: Javier Webar, MD
  phone: 2047873018
  email: javier.webar@umanitoba.ca
  last name: Sebastian Layera, MD
  phone: 2047873018
  email: layerars@myumanitoba.ca
  citation: Walega DR, McCormick ZL. Chemical Neurolysis of the Genicular Nerves for Chronic Knee Pain: Reviving an Old Dog and an Old Trick. Pain Med. 2018 Sep 1;19(9):1882-1884. doi: 10.1093/pm/pny023. No abstract available.
  PMID: 29514315
  citation: Risso RC, Ferraro LHC, Nouer Frederico T, Peng PWH, Luzo MV, Debieux P, Sakata RK. Chemical Ablation of Genicular Nerve with Phenol for Pain Relief in Patients with Knee Osteoarthritis: A Prospective Study. Pain Pract. 2021 Apr;21(4):438-444. doi: 10.1111/papr.12972. Epub 2020 Dec 29.
  PMID: 33277760
  citation: Park Y, Lee SC, Nam HS, Lee J, Nam SH. Comparison of sonographically guided intra-articular injections at 3 different sites of the knee. J Ultrasound Med. 2011 Dec;30(12):1669-76. doi: 10.7863/jum.2011.30.12.1669.
  PMID: 22124002
  citation: Davis T, Loudermilk E, DePalma M, Hunter C, Lindley D, Patel N, Choi D, Soloman M, Gupta A, Desai M, Buvanendran A, Kapural L. Prospective, Multicenter, Randomized, Crossover Clinical Trial Comparing the Safety and Effectiveness of Cooled Radiofrequency Ablation With Corticosteroid Injection in the Management of Knee Pain From Osteoarthritis. Reg Anesth Pain Med. 2018 Jan;43(1):84-91. doi: 10.1097/AAP.0000000000000690.
  PMID: 29095245
  responsible party type: Principal Investigator
  investigator affiliation: University of Manitoba
  investigator full name: Javier Webar
  investigator title: Assistant Professor
  mesh term: Osteoarthritis, Knee
  mesh term: Phenol
  mesh term: Methylprednisolone
  mesh term: Methylprednisolone Acetate
  mesh term: Methylprednisolone Hemisuccinate
  mesh term: Prednisolone
  mesh term: Prednisolone acetate
  mesh term: Prednisolone hemisuccinate
  mesh term: Prednisolone phosphate
  sharing ipd: No