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/NCT06017674</url>
    </required_header>
    <id_info>
      <org_study_id>2022.03.89</org_study_id>
      <nct_id>NCT06017674</nct_id>
    </id_info>
    <brief_title>Intra-articular Pulsed Radiofrequency in Chronic Knee Pain</brief_title>
    <official_title>The Effectiveness of Intra-articular Pulsed Radiofrequency in Patients With Painful Knee Osteoarthritis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Basaksehir Cam &amp; Sakura Şehir Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Basaksehir Cam &amp; Sakura Şehir Hospital</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>
        The aim of this study is to investigate the additional effect of Intra-articular Pulsed&#xD;
        Radiofrequency (IAPRF) on pain and functional activities in addition to intra-articular&#xD;
        steroids in patients with grade II and III knee osteoarthritis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This randomized controlled trial included patients over 18 years of age with knee pain&#xD;
        persisting for more than 3 months and stage II-III knee OA according to the Kellgren-Lawrence&#xD;
        scale. The participants were randomized into two groups: the IAPRF + steroid injection (Group&#xD;
        1) and only steroid injection (Group 2) groups. The injections were administered under&#xD;
        fluoroscopic guidance in both groups, and the needle was advanced to the midline of the&#xD;
        tibiofemoral joint in the anteroposterior and lateral views. Group 1 received 8 mg of&#xD;
        intra-articular dexamethasone after IAPRF application for 360 s at 45 V voltage, with the&#xD;
        temperature not exceeding 42°C. Group 2 received 8 mg of intra-articular dexamethasone only.&#xD;
        Pain intensity and participation in daily activities were evaluated using the numerical&#xD;
        rating scale (NRS) and Western Ontario and McMaster Universities arthritis index (WOMAC),&#xD;
        respectively, before the procedure and 1, 4, and 12 weeks after the procedure.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">May 1, 2022</start_date>
    <completion_date type="Actual">December 31, 2022</completion_date>
    <primary_completion_date type="Actual">September 30, 2022</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>Single-center, single-blinded, randomized prospective trial</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Investigator)</masking>
      <masking_description>Procedures and evaluations were performed by different practitioners</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Numeric Rating Scale</measure>
      <time_frame>0, 1, 4 and 12 weeks</time_frame>
      <description>Pain levels before and 1, 4, 12 weeks after the procedure were evaluated with Numeric Rating Scale (NRS). The patients were instructed to score their pain intensity on a scale of 0 to 10, where &quot;0&quot; represents &quot;no pain at all&quot; and &quot;10&quot; represents &quot;worst pain ever possible.&quot;</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Western Ontario and McMaster Universities Arthritis Index</measure>
      <time_frame>0, 1, 4 and 12 weeks</time_frame>
      <description>The Western Ontario and McMaster Universities Arthritis Index (WOMAC) was used to assess daily living activities at all evaluation points.The WOMAC consists of 24 items on three subscales: pain, stiffness, and physical function. All items were scored on a scale of 0 to 4, where &quot;0&quot; represents none, &quot;1&quot; represents mild, &quot;2&quot; represents moderate, &quot;3&quot; represents severe, and &quot;4&quot; represents extreme. The total score ranges from 0 to 96, with a higher score indicating poorer function in daily living activities.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">54</enrollment>
    <condition>Osteoarthritis, Knee</condition>
    <condition>Osteoarthritis</condition>
    <condition>Pain, Chronic</condition>
    <arm_group>
      <arm_group_label>Group 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Intra-articular Pulsed Radiofrequency and Steroid Injection</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Only Intra-articular Steroid Injection</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Intra-articular Pulsed Radiofrequency</intervention_name>
      <description>A 22-gauge 10 cm radiofrequency cannula with a 10-mm active tip was advanced to the mid-tibiofemoral joint under fluoroscopic guidance. After needle insertion, paresthesia-pain and motor stimulation tests were performed using sensory (50 Hz) and motor (2 Hz, 1 V) stimulation to confirm the absence of stimulation. Intra-articular Pulsed Radiofrequency (IAPRF) was applied at 45 V voltage for 20 ms pulse width for 360 s, followed by a 480 ms silent phase. The tissue temperature was adjusted to not exceed 42°C.</description>
      <arm_group_label>Group 1</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Steroid Injection</intervention_name>
      <description>8 mg dexamethasone was applied into the tibio-femoral joint with a 22-gauge, 10 cm needle under fluoroscopy.</description>
      <arm_group_label>Group 1</arm_group_label>
      <arm_group_label>Group 2</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age &gt; 18 years,&#xD;
  &#xD;
            -  Having knee pain persisting for more than 3 months due to knee osteoarthritis (OA),&#xD;
  &#xD;
            -  Kellgren-Lawrence Classification grades II and III OA,&#xD;
  &#xD;
            -  Giving written and verbal informed consents.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with a history of undergoing knee surgery and/or receiving any&#xD;
               intra-articular knee injection within the previous 6 months,&#xD;
  &#xD;
            -  Having a local or systemic infection or a coagulation disorder,&#xD;
  &#xD;
            -  Patients who refused to participate in the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Burak Erken, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Basaksehir Cam &amp; Sakura Şehir Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Başakşehir Cam and Sakura Şehir Hospital</name>
        <address>
          <city>Istanbul</city>
          <zip>34488</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <results_reference>
      <citation>Filippiadis D, Tsochatzis A, Petsatodis E, Galanis S, Velonakis G, Giankoulof C, Kelekis A. Intra-Articular Application of Sluijter-Teixera Poisson Pulsed Radiofrequency in Symptomatic Patients with Knee Osteoarthritis: Focus upon Clinical Efficacy and Safety. Pain Res Manag. 2021 Feb 20;2021:5554631. doi: 10.1155/2021/5554631. eCollection 2021.</citation>
      <PMID>34518775</PMID>
    </results_reference>
    <results_reference>
      <citation>Masala S, Fiori R, Raguso M, Morini M, Calabria E, Simonetti G. Pulse-dose radiofrequency for knee osteoartrithis. Cardiovasc Intervent Radiol. 2014 Apr;37(2):482-7. doi: 10.1007/s00270-013-0694-z. Epub 2013 Aug 14.</citation>
      <PMID>23942592</PMID>
    </results_reference>
    <results_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>
    </results_reference>
    <results_reference>
      <citation>Sluijter ME, Teixeira A, Serra V, Balogh S, Schianchi P. Intra-articular application of pulsed radiofrequency for arthrogenic pain--report of six cases. Pain Pract. 2008 Jan-Feb;8(1):57-61. doi: 10.1111/j.1533-2500.2007.00172.x. No abstract available.</citation>
      <PMID>18211593</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Basaksehir Cam &amp; Sakura Şehir Hospital</investigator_affiliation>
      <investigator_full_name>Burak Erken</investigator_full_name>
      <investigator_title>Medical Doctor</investigator_title>
    </responsible_party>
    <keyword>intra-articular pulsed radiofrequency</keyword>
    <keyword>knee osteoarthritis</keyword>
    <keyword>intra-articular steroid injection</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Osteoarthritis</mesh_term>
      <mesh_term>Osteoarthritis, Knee</mesh_term>
      <mesh_term>Chronic Pain</mesh_term>
    </condition_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/NCT06017674
  org study id: 2022.03.89
  nct id: NCT06017674
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The aim of this study is to investigate the additional effect of Intra-articular Pulsed
        Radiofrequency (IAPRF) on pain and functional activities in addition to intra-articular
        steroids in patients with grade II and III knee osteoarthritis.
  This randomized controlled trial included patients over 18 years of age with knee pain
        persisting for more than 3 months and stage II-III knee OA according to the Kellgren-Lawrence
        scale. The participants were randomized into two groups: the IAPRF + steroid injection (Group
        1) and only steroid injection (Group 2) groups. The injections were administered under
        fluoroscopic guidance in both groups, and the needle was advanced to the midline of the
        tibiofemoral joint in the anteroposterior and lateral views. Group 1 received 8 mg of
        intra-articular dexamethasone after IAPRF application for 360 s at 45 V voltage, with the
        temperature not exceeding 42°C. Group 2 received 8 mg of intra-articular dexamethasone only.
        Pain intensity and participation in daily activities were evaluated using the numerical
        rating scale (NRS) and Western Ontario and McMaster Universities arthritis index (WOMAC),
        respectively, before the procedure and 1, 4, and 12 weeks after the procedure.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Single-center, single-blinded, randomized prospective trial
  primary purpose: Treatment
  masking: Single (Investigator)
  masking description: Procedures and evaluations were performed by different practitioners
  measure: Numeric Rating Scale
  time frame: 0, 1, 4 and 12 weeks
  description: Pain levels before and 1, 4, 12 weeks after the procedure were evaluated with Numeric Rating Scale (NRS). The patients were instructed to score their pain intensity on a scale of 0 to 10, where "0" represents "no pain at all" and "10" represents "worst pain ever possible."
  measure: Western Ontario and McMaster Universities Arthritis Index
  time frame: 0, 1, 4 and 12 weeks
  description: The Western Ontario and McMaster Universities Arthritis Index (WOMAC) was used to assess daily living activities at all evaluation points.The WOMAC consists of 24 items on three subscales: pain, stiffness, and physical function. All items were scored on a scale of 0 to 4, where "0" represents none, "1" represents mild, "2" represents moderate, "3" represents severe, and "4" represents extreme. The total score ranges from 0 to 96, with a higher score indicating poorer function in daily living activities.
  arm group label: Group 1
  arm group type: Experimental
  description: Intra-articular Pulsed Radiofrequency and Steroid Injection
  arm group label: Group 2
  arm group type: Experimental
  description: Only Intra-articular Steroid Injection
  intervention type: Procedure
  intervention name: Intra-articular Pulsed Radiofrequency
  description: A 22-gauge 10 cm radiofrequency cannula with a 10-mm active tip was advanced to the mid-tibiofemoral joint under fluoroscopic guidance. After needle insertion, paresthesia-pain and motor stimulation tests were performed using sensory (50 Hz) and motor (2 Hz, 1 V) stimulation to confirm the absence of stimulation. Intra-articular Pulsed Radiofrequency (IAPRF) was applied at 45 V voltage for 20 ms pulse width for 360 s, followed by a 480 ms silent phase. The tissue temperature was adjusted to not exceed 42°C.
  arm group label: Group 1
  intervention type: Drug
  intervention name: Steroid Injection
  description: 8 mg dexamethasone was applied into the tibio-femoral joint with a 22-gauge, 10 cm needle under fluoroscopy.
  arm group label: Group 1
  arm group label: Group 2
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Burak Erken, MD
  role: Principal Investigator
  affiliation: Basaksehir Cam & Sakura Şehir Hospital
  facility: 
  country: Turkey
  citation: Filippiadis D, Tsochatzis A, Petsatodis E, Galanis S, Velonakis G, Giankoulof C, Kelekis A. Intra-Articular Application of Sluijter-Teixera Poisson Pulsed Radiofrequency in Symptomatic Patients with Knee Osteoarthritis: Focus upon Clinical Efficacy and Safety. Pain Res Manag. 2021 Feb 20;2021:5554631. doi: 10.1155/2021/5554631. eCollection 2021.
  PMID: 34518775
  citation: Masala S, Fiori R, Raguso M, Morini M, Calabria E, Simonetti G. Pulse-dose radiofrequency for knee osteoartrithis. Cardiovasc Intervent Radiol. 2014 Apr;37(2):482-7. doi: 10.1007/s00270-013-0694-z. Epub 2013 Aug 14.
  PMID: 23942592
  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: Sluijter ME, Teixeira A, Serra V, Balogh S, Schianchi P. Intra-articular application of pulsed radiofrequency for arthrogenic pain--report of six cases. Pain Pract. 2008 Jan-Feb;8(1):57-61. doi: 10.1111/j.1533-2500.2007.00172.x. No abstract available.
  PMID: 18211593
  responsible party type: Principal Investigator
  investigator affiliation: Basaksehir Cam & Sakura Şehir Hospital
  investigator full name: Burak Erken
  investigator title: Medical Doctor
  mesh term: Osteoarthritis
  mesh term: Osteoarthritis, Knee
  mesh term: Chronic Pain
  sharing ipd: No