<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/NCT02260869</url>
  </required_header>
  <id_info>
    <org_study_id>MPC-2014-GNK</org_study_id>
    <nct_id>NCT02260869</nct_id>
  </id_info>
  <brief_title>Efficacy of Cooled and Monopolar Radiofrequency Ablation of the Geniculate Nerves for the Treatment of Chronic Osteoarthritic Knee Pain</brief_title>
  <official_title>A Prospective Double Blind, Randomized Control Trial to Compare the Efficacy of Cool Radiofrequency Ablation vs. Conventional Monopolar Radiofrequency Ablation of the Geniculate Nerves for the Treatment of Chronic Osteoarthritic Knee Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Millennium Pain Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Millennium Pain Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single center randomized controlled trial. Approximately 102 patients will be&#xD;
      randomized to one of two treatment groups: cooled radiofrequency or conventional monopolar&#xD;
      radiofrequency ablation. Patients with chronic knee pain, with moderate to severe&#xD;
      osteoarthritis according to the Kellgren-Lawrence scale for at least 6 months who have failed&#xD;
      conservative therapy will be screened for the study.&#xD;
&#xD;
      Then, patients will be enrolled based on reporting ≥50% pain relief after a fluoroscopic&#xD;
      guided single diagnostic block of the geniculate nerves (superior medial, superior lateral,&#xD;
      and inferior medial) with 0.5 ml of local anesthetic (2% Lidocaine).&#xD;
&#xD;
      Baseline data will be collected for all enrolled patients. Outcomes will be measured at 1, 4,&#xD;
      12, 24 and 52 weeks.&#xD;
&#xD;
      Outcome measures will be: Visual analogue scale (VAS) both while at rest and during&#xD;
      ambulation, Oxford knee scores, WOMAC, and global perceived effect.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Due to financial constraints, sponsor could not complete the study.&#xD;
  </why_stopped>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Actual">June 26, 2019</completion_date>
  <primary_completion_date type="Actual">October 15, 2018</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evidence of Change in Knee Pain</measure>
    <time_frame>24 weeks</time_frame>
    <description>A 100mm visual analog scale (VAS) score at 24 weeks post-treatment will be compared to baseline score to measure change in pain level.&#xD;
Change in Pain = (VAS at 24 weeks) - (VAS at baseline) The VAS consists of a 100 mm long line without marks between the 0 and 100 mm edges. Range of scale is 0 to 100 mm, where 0 means no pain and 100 mm means the worst pain imaginable.&#xD;
A negative change in VAS means a reduction in pain level after 24-weeks of treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evidence of Functional Changes</measure>
    <time_frame>24 weeks</time_frame>
    <description>Standard score system (Oxford Knee Score) was used to assess functional changes at 24 weeks of treatment relative to baseline. The Oxford Knee Score (OKS) measures the level of function, activities of daily living and how they have been affected by knee pain. The OKS is a obtained from a 12-item patient reported questionnaire. Each item has 5 categories, scored from 0 to 4, with 0 being the worst outcome and 4 the best outcome of each item. The OKS is the sum of all item scores. Therefore, it ranges from 0 to 48, with 0 being the worst functional outcome possible and 48 is the best functional outcome possible.&#xD;
Change in OKS = (OKS at 24 weeks) - (OKS at baseline) A positive Change in OKS indicates an improvement in extent of function.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">79</enrollment>
  <condition>Osteoarthritis, Knee</condition>
  <arm_group>
    <arm_group_label>Cooled radiofrequency ablation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient is placed in supine position on a fluoroscopic table with a pillow under the popliteal fossa. An anterio-posterior fluoroscopic view of the tibio-femoral joint is obtained. Skin and subcutaneous tissues are anesthetized and a 17 g introducer needle is advanced percutaneously towards the junction of shaft with epicondyle until bone contact is made. The needle is then laterally displaced away from the bone. This process is performed at the superior medial and superior lateral aspects of the femur, and the inferior medial aspect of the tibia. The fluoroscope is placed in lateral view to guide the needle depth to be at the medial third of the femur or tibia. A cooled radiofrequency probe from a Pain Management Radiofrequency kit is advanced through the introducer. Following sensory and motor stimulation, cooled genicular nerve radiofrequency ablation is carried out at 60 Celsius for 150 seconds.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Monopolar radiofrequency ablation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient is placed in supine position on a fluoroscopic table with a pillow under the popliteal fossa. An anterio-posterior fluoroscopic view of the tibio-femoral joint is obtained. Skin and subcutaneous tissues are anesthetized and a 16 g introducer needle is advanced percutaneously towards the junction of shaft with epicondyle until bone contact is made. The needle is then laterally displaced away from the bone. This process is performed at the superior medial and superior lateral aspects of the femur, and the inferior medial aspect of the tibia. The fluoroscope is placed in lateral view to guide the needle depth to be at the medial third of the femur or tibia. A conventional radiofrequency probe from a Pain Management Radiofrequency kit is advanced through the introducer. Following sensory and motor stimulation, genicular nerve radiofrequency ablation will be carried out at 80 Celsius for 90 seconds.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Genicular nerve radiofrequency ablation</intervention_name>
    <description>Radiofrequency ablation uses the electrical field generated by a radiofrequency probe inserted near a nerve responsible for pain. Chronic pain sensation in the knee is generated at the genicular nerves. The physician locates the affected genicular nerve by injecting an anesthetic (lidocaine) that produces a sensory nerve block (i.e. anesthetic pain relief). A radiofrequency probe is inserted percutaneously near the affected nerve using a cannula/introducer and is then connected to a radiofrequency generator. This is set to stimulate sensory and motor response, which allows the physician to adjust the probe position for effective and safe treatment. Then radiofrequency is applied to the tissue for a short time (up to 150 seconds) in order to generate a target temperature (no more than 80 degrees Celsius). The increase in the temperature of the tissue ablates the affected nerve producing pain relief.</description>
    <arm_group_label>Cooled radiofrequency ablation</arm_group_label>
    <arm_group_label>Monopolar radiofrequency ablation</arm_group_label>
    <other_name>genicular neurotomy using radiofrequency</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pain Management Radiofrequency Kit</intervention_name>
    <description>The pain management radiofrequency consists of a radiofrequency generator, a radiofrequency probe and an introducer/cannula. The introducer cannula is used to percutaneously position the probe in the appropriate location for treatment. The radiofrequency probe is an electrode that delivers the electric field that heats up the tissue. In cooled radiofrequency the electrode is surrounded by a water jacket that cools it while heat is generated. The generator is the instrument that provides the radiofrequency according to a particular temperature and time program. Temperature, tissue impedance and radiofrequency power are lalso monitored by the generator.</description>
    <arm_group_label>Cooled radiofrequency ablation</arm_group_label>
    <arm_group_label>Monopolar radiofrequency ablation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who have given their written informed consent to participate in this clinical&#xD;
             study based on voluntary agreement after a thorough explanation of the patient's&#xD;
             participation is provided to them.&#xD;
&#xD;
          -  Female patients who are not pregnant and do not plan to become pregnant during the&#xD;
             study. Females of child bearing potential must provide a negative pregnancy test&#xD;
             provided by the study physician and must be using reliable contraception and must&#xD;
             continue to use reliable contraception until study completion at 52 weeks.&#xD;
             Non-childbearing potential is defined as postmenopausal for at least 2 years or&#xD;
             surgical sterilization or hysterectomy at least 3 months before study start.&#xD;
&#xD;
          -  Must be older than 18 years old..&#xD;
&#xD;
          -  Must have chronic knee pain for at least 6 months.&#xD;
&#xD;
          -  Must have radiologic evidence of OA of the knee, grade 2-4 based on the&#xD;
             Kellgreen-Lawrence scale.&#xD;
&#xD;
          -  Persistent pain despite the use of conservative treatment (physical therapy, oral&#xD;
             analgesic, steroid injections).&#xD;
&#xD;
          -  Must have a VAS score of at least 5 with ambulation.&#xD;
&#xD;
          -  Subjects must be on a stable dose of pain medication regimen for at least 2 months.&#xD;
&#xD;
          -  Greater than or equal to 50% improvement from blocks in target knee for duration of&#xD;
             the anesthetic.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Knee pain must not be acute.&#xD;
&#xD;
          -  Previous total knee replacement.&#xD;
&#xD;
          -  Evidence of connective tissue disease.&#xD;
&#xD;
          -  Patients who have a BMI greater than 40.&#xD;
&#xD;
          -  Evidence of serious neurological or psychiatric disorders.&#xD;
&#xD;
          -  Current opioid use must not be greater than or equal to 90 mg morphine equivalent per&#xD;
             24 hour period.&#xD;
&#xD;
          -  Must not have radicular pain in the affected limb.&#xD;
&#xD;
          -  Patients with uncorrected coagulation disorders or who are on anticoagulation therapy&#xD;
             and cannot interrupt the therapy.&#xD;
&#xD;
          -  Patients who have pacemakers or generators.&#xD;
&#xD;
          -  Patient who are pregnant, breast-feeding or women of childbearing potential with&#xD;
             positive pregnancy tests.&#xD;
&#xD;
          -  Sexually active female patients of childbearing potential who are not willing to use&#xD;
             adequate contraceptive measures to avoid pregnancy until week 52 of the study.&#xD;
             Sexually active male patients who are not willing to use adequate contraceptive&#xD;
             measures until week 52 of the study. Adequate methods of birth control include the&#xD;
             following: Hormonal contraception (female patients) or use of at least one acceptable&#xD;
             double-barrier method (for example: diaphragm plus spermicidal agent or condoms (male&#xD;
             or female) plus spermicidal agent.), vasectomy, intrauterine device, and/or exclusive&#xD;
             sexual partner for whom one of the above acceptable methods applies.&#xD;
&#xD;
          -  Patients who have cancer or a past history of any cancer within 5 years prior to the&#xD;
             time of informed consent, with the exception of basal cell or squamous cell carcinoma&#xD;
             of the skin.&#xD;
&#xD;
          -  Human immunodeficiency virus (HIV) infection or a clinically significant infection.&#xD;
&#xD;
          -  A clinically significant disorder such as cerebrovascular disease, pulmonary&#xD;
             infarction, ischemic heart disease, cardiac dysrhythmia, myocardial infarction, or&#xD;
             congestive heart failure.&#xD;
&#xD;
          -  Uncontrolled diabetes, uncontrolled pulmonary disease, or uncontrolled hypertension.&#xD;
&#xD;
          -  Patients who have evidence of major psychiatric disease, mental disorder, drug&#xD;
             dependency, alcohol dependency, or substance abuse disorders.&#xD;
&#xD;
          -  Any patient with a medical condition and/or disease that the Investigator believes&#xD;
             could affect the study results or the safe conduct of the study.&#xD;
&#xD;
          -  Patients who are receiving compensation according to Workers' Compensation Act or are&#xD;
             involved in personal injury litigation.&#xD;
&#xD;
          -  Patients who participated in another clinical study within 3 months prior to the time&#xD;
             of informed consent, or who are expected to participate in another study during the&#xD;
             period of this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ricardo Vallejo, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Millennium Pain Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Millennium Pain Center</name>
      <address>
        <city>Bloomington</city>
        <state>Illinois</state>
        <zip>61704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Millennium Pain Center at Decatur Memorial Hospital</name>
      <address>
        <city>Decatur</city>
        <state>Illinois</state>
        <zip>62526</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Methodist Comprehensive Spine and Pain Center - Millennium Pain Center</name>
      <address>
        <city>Peoria</city>
        <state>Illinois</state>
        <zip>61602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Murphy L, Helmick CG. The impact of osteoarthritis in the United States: a population-health perspective: A population-based review of the fourth most common cause of hospitalization in U.S. adults. Orthop Nurs. 2012 Mar-Apr;31(2):85-91. doi: 10.1097/NOR.0b013e31824fcd42.</citation>
    <PMID>22446800</PMID>
  </reference>
  <reference>
    <citation>Jordan JM, Helmick CG, Renner JB, Luta G, Dragomir AD, Woodard J, Fang F, Schwartz TA, Abbate LM, Callahan LF, Kalsbeek WD, Hochberg MC. Prevalence of knee symptoms and radiographic and symptomatic knee osteoarthritis in African Americans and Caucasians: the Johnston County Osteoarthritis Project. J Rheumatol. 2007 Jan;34(1):172-80.</citation>
    <PMID>17216685</PMID>
  </reference>
  <reference>
    <citation>Peat G, McCarney R, Croft P. Knee pain and osteoarthritis in older adults: a review of community burden and current use of primary health care. Ann Rheum Dis. 2001 Feb;60(2):91-7. doi: 10.1136/ard.60.2.91.</citation>
    <PMID>11156538</PMID>
  </reference>
  <reference>
    <citation>Karaman H, Tufek A, Kavak GO, Yildirim ZB, Uysal E, Celik F, Kaya S. Intra-articularly applied pulsed radiofrequency can reduce chronic knee pain in patients with osteoarthritis. J Chin Med Assoc. 2011 Aug;74(8):336-40. doi: 10.1016/j.jcma.2011.06.004. Epub 2011 Jul 23.</citation>
    <PMID>21872812</PMID>
  </reference>
  <reference>
    <citation>Choi WJ, Hwang SJ, Song JG, Leem JG, Kang YU, Park PH, Shin JW. Radiofrequency treatment relieves chronic knee osteoarthritis pain: a double-blind randomized controlled trial. Pain. 2011 Mar;152(3):481-487. doi: 10.1016/j.pain.2010.09.029. Epub 2010 Nov 4.</citation>
    <PMID>21055873</PMID>
  </reference>
  <reference>
    <citation>Ikeuchi M, Ushida T, Izumi M, Tani T. Percutaneous radiofrequency treatment for refractory anteromedial pain of osteoarthritic knees. Pain Med. 2011 Apr;12(4):546-51. doi: 10.1111/j.1526-4637.2011.01086.x. Epub 2011 Apr 4.</citation>
    <PMID>21463469</PMID>
  </reference>
  <reference>
    <citation>Vallejo R, Benyamin R, Tilley DM, Kelley CA, Cedeno DL. An ex vivo comparison of cooled-radiofrequency and bipolar-radiofrequency lesion size and the effect of injected fluids. Reg Anesth Pain Med. 2014 Jul-Aug;39(4):312-21. doi: 10.1097/AAP.0000000000000090.</citation>
    <PMID>24781285</PMID>
  </reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>October 6, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <results_first_submitted>September 23, 2020</results_first_submitted>
  <results_first_submitted_qc>April 3, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">April 26, 2022</results_first_posted>
  <last_update_submitted>April 3, 2022</last_update_submitted>
  <last_update_submitted_qc>April 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2022</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>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <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>January 24, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/69/NCT02260869/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Cooled Radiofrequency Ablation</title>
          <description>Radiofrequency ablation of the genicular nerves of osteoarthritic knee(s) using a cooled radiofrequency ablation probe</description>
        </group>
        <group group_id="P2">
          <title>Monopolar Radiofrequency Ablation</title>
          <description>Radiofrequency ablation of the genicular nerves of osteoarthritic knee(s) using a monopolar radiofrequency ablation probe (16-gauge)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
                <participants group_id="P2" count="37"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cooled Radiofrequency Ablation</title>
          <description>Radiofrequency ablation of the genicular nerves of osteoarthritic knee(s) using a cooled radiofrequency ablation probe</description>
        </group>
        <group group_id="B2">
          <title>Monopolar Radiofrequency Ablation</title>
          <description>Radiofrequency ablation of the genicular nerves of osteoarthritic knee(s) using a monopolar radiofrequency ablation probe (16-gauge)</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="38"/>
            <count group_id="B2" value="37"/>
            <count group_id="B3" value="75"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="38"/>
                    <count group_id="B2" value="37"/>
                    <count group_id="B3" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62.2" spread="10.3"/>
                    <measurement group_id="B2" value="56.8" spread="12.3"/>
                    <measurement group_id="B3" value="60.0" spread="11.8"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="38"/>
                    <count group_id="B2" value="37"/>
                    <count group_id="B3" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="38"/>
                    <count group_id="B2" value="37"/>
                    <count group_id="B3" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33.0" spread="5.2"/>
                    <measurement group_id="B2" value="31.9" spread="4.6"/>
                    <measurement group_id="B3" value="32.5" spread="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Knee Pain VAS Score</title>
          <description>The 100 mm Visual Analog Scale (VAS) was used to assess pain level by subjects. The scale consists of a 100 mm long line without marks between the 0 and 100 mm edges. Range of scale is 0 to 100 mm, where 0 means no pain and 100 mm means the worst pain imaginable.</description>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="38"/>
                    <count group_id="B2" value="37"/>
                    <count group_id="B3" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="74.4" spread="12.2"/>
                    <measurement group_id="B2" value="73.0" spread="11.3"/>
                    <measurement group_id="B3" value="73.7" spread="11.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Oxford Knee Score</title>
          <description>The Oxford Knee Score (OKS) measures the level of function, activities of daily living and how they have been affected by knee pain over the preceding four weeks. The OKS is a obtained from a 12-item patient reported questionnaire. Each item has 5 categories, scored from 0 to 4, with 0 being the worst outcome and 4 the best outcome of each item. The OKS is the sum of all item scores. Therefore, it ranges from 0 to 48, with 0 being the worst functional outcome possible and 48 is the best functional outcome possible.</description>
          <units>oxford knee score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="38"/>
                    <count group_id="B2" value="37"/>
                    <count group_id="B3" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19.9" spread="7.4"/>
                    <measurement group_id="B2" value="17.7" spread="5.2"/>
                    <measurement group_id="B3" value="18.8" spread="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Evidence of Change in Knee Pain</title>
        <description>A 100mm visual analog scale (VAS) score at 24 weeks post-treatment will be compared to baseline score to measure change in pain level.&#xD;
Change in Pain = (VAS at 24 weeks) - (VAS at baseline) The VAS consists of a 100 mm long line without marks between the 0 and 100 mm edges. Range of scale is 0 to 100 mm, where 0 means no pain and 100 mm means the worst pain imaginable.&#xD;
A negative change in VAS means a reduction in pain level after 24-weeks of treatment.</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cooled Radiofrequency Ablation</title>
            <description>Radiofrequency ablation of the genicular nerves of osteoarthritic knee(s) using a cooled radiofrequency ablation probe</description>
          </group>
          <group group_id="O2">
            <title>Monopolar Radiofrequency Ablation</title>
            <description>Radiofrequency ablation of the genicular nerves of osteoarthritic knee(s) using a monopolar radiofrequency ablation probe (16-gauge)</description>
          </group>
        </group_list>
        <measure>
          <title>Evidence of Change in Knee Pain</title>
          <description>A 100mm visual analog scale (VAS) score at 24 weeks post-treatment will be compared to baseline score to measure change in pain level.&#xD;
Change in Pain = (VAS at 24 weeks) - (VAS at baseline) The VAS consists of a 100 mm long line without marks between the 0 and 100 mm edges. Range of scale is 0 to 100 mm, where 0 means no pain and 100 mm means the worst pain imaginable.&#xD;
A negative change in VAS means a reduction in pain level after 24-weeks of treatment.</description>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>knees</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="37"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>knees</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-40.7" spread="26.8"/>
                    <measurement group_id="O2" value="-38.6" spread="27.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evidence of Functional Changes</title>
        <description>Standard score system (Oxford Knee Score) was used to assess functional changes at 24 weeks of treatment relative to baseline. The Oxford Knee Score (OKS) measures the level of function, activities of daily living and how they have been affected by knee pain. The OKS is a obtained from a 12-item patient reported questionnaire. Each item has 5 categories, scored from 0 to 4, with 0 being the worst outcome and 4 the best outcome of each item. The OKS is the sum of all item scores. Therefore, it ranges from 0 to 48, with 0 being the worst functional outcome possible and 48 is the best functional outcome possible.&#xD;
Change in OKS = (OKS at 24 weeks) - (OKS at baseline) A positive Change in OKS indicates an improvement in extent of function.</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cooled Radiofrequency Ablation</title>
            <description>Radiofrequency ablation of the genicular nerves of osteoarthritic knee(s) using a cooled radiofrequency ablation probe</description>
          </group>
          <group group_id="O2">
            <title>Monopolar Radiofrequency Ablation</title>
            <description>Radiofrequency ablation of the genicular nerves of osteoarthritic knee(s) using a monopolar radiofrequency ablation probe (16-gauge)</description>
          </group>
        </group_list>
        <measure>
          <title>Evidence of Functional Changes</title>
          <description>Standard score system (Oxford Knee Score) was used to assess functional changes at 24 weeks of treatment relative to baseline. The Oxford Knee Score (OKS) measures the level of function, activities of daily living and how they have been affected by knee pain. The OKS is a obtained from a 12-item patient reported questionnaire. Each item has 5 categories, scored from 0 to 4, with 0 being the worst outcome and 4 the best outcome of each item. The OKS is the sum of all item scores. Therefore, it ranges from 0 to 48, with 0 being the worst functional outcome possible and 48 is the best functional outcome possible.&#xD;
Change in OKS = (OKS at 24 weeks) - (OKS at baseline) A positive Change in OKS indicates an improvement in extent of function.</description>
          <units>Oxford Knee Score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>knees</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="37"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>knees</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.7" spread="9.1"/>
                    <measurement group_id="O2" value="12.7" spread="10.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected since the start of enrollment and randomization until the 52 weeks follow up visit.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Cooled Radiofrequency Ablation</title>
          <description>Radiofrequency ablation of the genicular nerves of osteoarthritic knee(s) using a cooled radiofrequency ablation probe</description>
        </group>
        <group group_id="E2">
          <title>Monopolar Radiofrequency Ablation</title>
          <description>Radiofrequency ablation of the genicular nerves of osteoarthritic knee(s) using a monopolar radiofrequency ablation probe (16-gauge)</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Worsening of reflux esophagitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypokalemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Broken Left Femur</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Respiratory tract infections</sub_title>
                <counts group_id="E1" events="10" subjects_affected="7" subjects_at_risk="38"/>
                <counts group_id="E2" events="12" subjects_affected="9" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Knee Pain or Swelling</sub_title>
                <counts group_id="E1" events="8" subjects_affected="6" subjects_at_risk="38"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Other pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="38"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Bruised body parts</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Muscular issues</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="37"/>
              </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>
    <limitations_and_caveats>Early termination led to a number of subjects analyzed below the required statistical power to measure a significant difference between the means</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>David Cedeno</name_or_title>
      <organization>Lumbrera LLC</organization>
      <phone>3098266974</phone>
      <email>dclumbrera@gmail.com</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/NCT02260869
org study id: MPC-2014-GNK
nct id: NCT02260869
lead sponsor: 
has dmc: No
This is a single center randomized controlled trial. Approximately 102 patients will be
      randomized to one of two treatment groups: cooled radiofrequency or conventional monopolar
      radiofrequency ablation. Patients with chronic knee pain, with moderate to severe
      osteoarthritis according to the Kellgren-Lawrence scale for at least 6 months who have failed
      conservative therapy will be screened for the study.

      Then, patients will be enrolled based on reporting ≥50% pain relief after a fluoroscopic
      guided single diagnostic block of the geniculate nerves (superior medial, superior lateral,
      and inferior medial) with 0.5 ml of local anesthetic (2% Lidocaine).

      Baseline data will be collected for all enrolled patients. Outcomes will be measured at 1, 4,
      12, 24 and 52 weeks.

      Outcome measures will be: Visual analogue scale (VAS) both while at rest and during
      ambulation, Oxford knee scores, WOMAC, and global perceived effect.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Evidence of Change in Knee Pain
time frame: 24 weeks
description: A 100mm visual analog scale (VAS) score at 24 weeks post-treatment will be compared to baseline score to measure change in pain level.
Change in Pain = (VAS at 24 weeks) - (VAS at baseline) The VAS consists of a 100 mm long line without marks between the 0 and 100 mm edges. Range of scale is 0 to 100 mm, where 0 means no pain and 100 mm means the worst pain imaginable.
A negative change in VAS means a reduction in pain level after 24-weeks of treatment.
measure: Evidence of Functional Changes
time frame: 24 weeks
description: Standard score system (Oxford Knee Score) was used to assess functional changes at 24 weeks of treatment relative to baseline. The Oxford Knee Score (OKS) measures the level of function, activities of daily living and how they have been affected by knee pain. The OKS is a obtained from a 12-item patient reported questionnaire. Each item has 5 categories, scored from 0 to 4, with 0 being the worst outcome and 4 the best outcome of each item. The OKS is the sum of all item scores. Therefore, it ranges from 0 to 48, with 0 being the worst functional outcome possible and 48 is the best functional outcome possible.
Change in OKS = (OKS at 24 weeks) - (OKS at baseline) A positive Change in OKS indicates an improvement in extent of function.
arm group label: Cooled radiofrequency ablation
arm group type: Active Comparator
description: Patient is placed in supine position on a fluoroscopic table with a pillow under the popliteal fossa. An anterio-posterior fluoroscopic view of the tibio-femoral joint is obtained. Skin and subcutaneous tissues are anesthetized and a 17 g introducer needle is advanced percutaneously towards the junction of shaft with epicondyle until bone contact is made. The needle is then laterally displaced away from the bone. This process is performed at the superior medial and superior lateral aspects of the femur, and the inferior medial aspect of the tibia. The fluoroscope is placed in lateral view to guide the needle depth to be at the medial third of the femur or tibia. A cooled radiofrequency probe from a Pain Management Radiofrequency kit is advanced through the introducer. Following sensory and motor stimulation, cooled genicular nerve radiofrequency ablation is carried out at 60 Celsius for 150 seconds.
arm group label: Monopolar radiofrequency ablation
arm group type: Active Comparator
description: Patient is placed in supine position on a fluoroscopic table with a pillow under the popliteal fossa. An anterio-posterior fluoroscopic view of the tibio-femoral joint is obtained. Skin and subcutaneous tissues are anesthetized and a 16 g introducer needle is advanced percutaneously towards the junction of shaft with epicondyle until bone contact is made. The needle is then laterally displaced away from the bone. This process is performed at the superior medial and superior lateral aspects of the femur, and the inferior medial aspect of the tibia. The fluoroscope is placed in lateral view to guide the needle depth to be at the medial third of the femur or tibia. A conventional radiofrequency probe from a Pain Management Radiofrequency kit is advanced through the introducer. Following sensory and motor stimulation, genicular nerve radiofrequency ablation will be carried out at 80 Celsius for 90 seconds.
intervention type: Procedure
intervention name: Genicular nerve radiofrequency ablation
description: Radiofrequency ablation uses the electrical field generated by a radiofrequency probe inserted near a nerve responsible for pain. Chronic pain sensation in the knee is generated at the genicular nerves. The physician locates the affected genicular nerve by injecting an anesthetic (lidocaine) that produces a sensory nerve block (i.e. anesthetic pain relief). A radiofrequency probe is inserted percutaneously near the affected nerve using a cannula/introducer and is then connected to a radiofrequency generator. This is set to stimulate sensory and motor response, which allows the physician to adjust the probe position for effective and safe treatment. Then radiofrequency is applied to the tissue for a short time (up to 150 seconds) in order to generate a target temperature (no more than 80 degrees Celsius). The increase in the temperature of the tissue ablates the affected nerve producing pain relief.
arm group label: Cooled radiofrequency ablation
arm group label: Monopolar radiofrequency ablation
other name: genicular neurotomy using radiofrequency
intervention type: Device
intervention name: Pain Management Radiofrequency Kit
description: The pain management radiofrequency consists of a radiofrequency generator, a radiofrequency probe and an introducer/cannula. The introducer cannula is used to percutaneously position the probe in the appropriate location for treatment. The radiofrequency probe is an electrode that delivers the electric field that heats up the tissue. In cooled radiofrequency the electrode is surrounded by a water jacket that cools it while heat is generated. The generator is the instrument that provides the radiofrequency according to a particular temperature and time program. Temperature, tissue impedance and radiofrequency power are lalso monitored by the generator.
arm group label: Cooled radiofrequency ablation
arm group label: Monopolar radiofrequency ablation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Ricardo Vallejo, MD, PhD
role: Principal Investigator
affiliation: Millennium Pain Center
facility: 
facility: 
facility: 
country: United States
citation: Murphy L, Helmick CG. The impact of osteoarthritis in the United States: a population-health perspective: A population-based review of the fourth most common cause of hospitalization in U.S. adults. Orthop Nurs. 2012 Mar-Apr;31(2):85-91. doi: 10.1097/NOR.0b013e31824fcd42.
PMID: 22446800
citation: Jordan JM, Helmick CG, Renner JB, Luta G, Dragomir AD, Woodard J, Fang F, Schwartz TA, Abbate LM, Callahan LF, Kalsbeek WD, Hochberg MC. Prevalence of knee symptoms and radiographic and symptomatic knee osteoarthritis in African Americans and Caucasians: the Johnston County Osteoarthritis Project. J Rheumatol. 2007 Jan;34(1):172-80.
PMID: 17216685
citation: Peat G, McCarney R, Croft P. Knee pain and osteoarthritis in older adults: a review of community burden and current use of primary health care. Ann Rheum Dis. 2001 Feb;60(2):91-7. doi: 10.1136/ard.60.2.91.
PMID: 11156538
citation: Karaman H, Tufek A, Kavak GO, Yildirim ZB, Uysal E, Celik F, Kaya S. Intra-articularly applied pulsed radiofrequency can reduce chronic knee pain in patients with osteoarthritis. J Chin Med Assoc. 2011 Aug;74(8):336-40. doi: 10.1016/j.jcma.2011.06.004. Epub 2011 Jul 23.
PMID: 21872812
citation: Choi WJ, Hwang SJ, Song JG, Leem JG, Kang YU, Park PH, Shin JW. Radiofrequency treatment relieves chronic knee osteoarthritis pain: a double-blind randomized controlled trial. Pain. 2011 Mar;152(3):481-487. doi: 10.1016/j.pain.2010.09.029. Epub 2010 Nov 4.
PMID: 21055873
citation: Ikeuchi M, Ushida T, Izumi M, Tani T. Percutaneous radiofrequency treatment for refractory anteromedial pain of osteoarthritic knees. Pain Med. 2011 Apr;12(4):546-51. doi: 10.1111/j.1526-4637.2011.01086.x. Epub 2011 Apr 4.
PMID: 21463469
citation: Vallejo R, Benyamin R, Tilley DM, Kelley CA, Cedeno DL. An ex vivo comparison of cooled-radiofrequency and bipolar-radiofrequency lesion size and the effect of injected fluids. Reg Anesth Pain Med. 2014 Jul-Aug;39(4):312-21. doi: 10.1097/AAP.0000000000000090.
PMID: 24781285
responsible party type: Sponsor
mesh term: Osteoarthritis, Knee
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Early termination led to a number of subjects analyzed below the required statistical power to measure a significant difference between the means
point of contact: 