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/NCT05962463</url>
    </required_header>
    <id_info>
      <org_study_id>0120-464/2022/6</org_study_id>
      <nct_id>NCT05962463</nct_id>
    </id_info>
    <brief_title>Pulsed Radiofrequency Therapy vs Canal Adductor Blockade in Knee Osteoarthritis</brief_title>
    <official_title>Comparison of the Effectiveness of Pulsed Radiofrequency Therapy and Canal Adductor Blockade for Chronic Pain and Functioning in Knee Osteoarthritis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Medical Centre Ljubljana</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Medical Centre Ljubljana</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>
        This study is intended to prove the efficacy and safety of ultrasound-guided pulsed&#xD;
        radiofrequency therapy on adductor canal nerves by patients with Knee osteoarthritis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Knee osteoarthritis is a serious epidemiologic problem. Non-surgical methods are shown&#xD;
        limited efficacy in relieving chronic knee pain in patients in advanced stages of knee&#xD;
        osteoarthritis. The knee prosthesis is a successful treatment for many patients with advanced&#xD;
        knee osteoarthritis. Still, there are important numbers of patients, which are not&#xD;
        appropriate candidates for such surgery treatment or refused surgery for any reason. For&#xD;
        them, any treatment which could relieve pain in their knee would have a good impact on their&#xD;
        quality of life. Interventions like adductor canal block(ACB) and pulsed radiofrequency&#xD;
        therapy (PRF) have demonstrated good results. In this study, investigators compare the&#xD;
        effectiveness of these two methods. Official approval from the ethics committee of the&#xD;
        Republic of Slovenia was obtained for this study. After being informed about the research and&#xD;
        potential risks, all patients giving written informed consent will undergo an orthopedic&#xD;
        examination and those with a confirmed diagnosis of knee osteoarthritis that lasted more than&#xD;
        6 months will be included in the study. All participants were randomly divided into two&#xD;
        groups. Participants in the first group receive single shot ACB and participants in the&#xD;
        second group receive PRF therapy at the same point. Before starting all patients filled the&#xD;
        Knee injury and osteoarthritis outcome(KOOS) form and estimated the maximal and minimal&#xD;
        intensity of pain in the knee. They repeat self-assessment of pain, in the same manner, using&#xD;
        11 points numeric rating score(NRS) 1 month, 3, and six months after the blockade or PRF&#xD;
        therapy. Measurement of maximum voluntary isometric contraction of the quadriceps muscle&#xD;
        (MVIC), time up and go test(TUG), and 30s stand-up chair test are performed by a&#xD;
        physiotherapist before a block of adductor canal on both legs,1 hour, 1 month, 3 months and 6&#xD;
        months after a block or PRF therapy.The adductor canal blockl is performed by the same&#xD;
        trained anesthesiologist at the proximal part of the leg using 14 ml of Levobupivacaine and&#xD;
        100 mcg of Clonidine mixed in the same syringeAfterof the study participants filled the Knee&#xD;
        injury and osteoarthritis outcome(KOOS) form once again.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">April 2024</completion_date>
    <primary_completion_date type="Anticipated">January 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Pain intensity</measure>
      <time_frame>Baseline ,1 hour,1 month, 3 month and 6 months</time_frame>
      <description>Change From Baseline in Maximal and minimal Pain on the 11-point Numeric rating score Pain Scale (NRS 0-11) ;Numeric 11-point rating score is widely accepted self-reported score for measurement of chronic and acute pain in researches.Possible scores range are between 0-free of pain and 10-the worst imaginable pain.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>KOOS</measure>
      <time_frame>Baseline ,1 hour,1 month, 3 month and 6 months</time_frame>
      <description>The Knee injury and osteoarthritis outcome(KOOS) score change in percentage from baseline and 1 month following adductor canal block [ Time Frame: Baseline and 1 month following adductor canal block ] KOOS is valid,reliable outcome measure in patients with knee osteoarthritis. usually used following knee surgery.This method is recognised as useful also in other and nonsurgical knee treatment.Shortened version widely used in North America is western Ontario and McMaster Universities Index(WOMAC)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Maximum voluntary isometric contraction of quadriceps muscle (MVIC)</measure>
      <time_frame>Baseline ,1 hour,1 month, 3 month and 6 months</time_frame>
      <description>Maximum voluntary isometric contraction of quadriceps muscle (MVIC) measured by handheld dynamometer ] This method is used to check impact of block on contraction of quadriceps muscle.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Timed up to go test (TUG)</measure>
      <time_frame>Baseline ,1 hour,1 month, 3 month and 6 months</time_frame>
      <description>Time that patient need to stand up from a standard height armchair,walk 3 meters,go back to the chair and takes a seat.Used to assess a patients balance,risk of falling and global mobility</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Satisfaction of patient</measure>
      <time_frame>Baseline ,1 hour,1 month, 3 month and 6 months</time_frame>
      <description>We determine whether the patient is satisfied with the result of treatment by asking the following question: &quot;what is the least amount of success that the treatment would have to achieve by the end of the study and/or treatment for the patient to conclude that the treatment was worth it and the patient is satisfied?&quot; The patient is asked to describe the minimum goal to be satisfied with the treatment in her own words, such as: &quot;50% reduction in pain, to go to the store without assistance, to use only one cane, to not wake up with pain, to perform regular housekeeping duties at home with minimal breaks, to walk a certain distance, or to play tennis&quot;. At the end of the study the patient indicates whether that goal was achieved with a &quot;yes&quot; or &quot;no&quot; answer.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Range of knee motion (ROM)</measure>
      <time_frame>Baseline ,1 hour,1 month, 3 month and 6 months</time_frame>
      <description>Passive knee joint ROM of extension and flexion was measured in the control and blocked leg in the supine position using a goniometer.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>30 seconds stand up chair test (30 s SCT)</measure>
      <time_frame>Baseline ,1 hour,1 month, 3 month and 6 months</time_frame>
      <description>In the 30 s CST, number of times the participant rises from a chair in 30 s is counted.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">128</enrollment>
    <condition>Knee Osteoarthritis</condition>
    <arm_group>
      <arm_group_label>Canal adductor blockade</arm_group_label>
      <description>After surgical cleaning of the anteromedial thigh, all participants in this group received single shot ultrasound guided canal adductor blockade with 14 ml 0,25% levobupivacaine and 100 mcg clonidine mixed in the same syringe. Investigators previously scanned the adductor canal and chose the middle of the canal as the entry point of the 10 cm echogenic ultrasound needle. After the blockade, all participants were monitored in our ambulance for the next hour.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Pulsed radiofrequency therapy</arm_group_label>
      <description>After surgical cleaning of the anteromedial thigh, all participants in this group received ultrasound-guided pulsed radiofrequency therapy. Investigators previously scanned the adductor canal and chose the middle of the canal as the entry point of the RF 10 cm needle with a 1 cm free tip. After sensory and motor checking all patients have gotten 6 minutes of therapy divided into 3 sequences of 2 minutes of 50 V current and 42. Before starting the PRF therapy all participants have gotten 2 ml 0,25% levobupivacaine through the needle for preventing discomfort during the procedure. After the treatment, all participants were monitored in our ambulance for the next hour.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Canal adductor blockade</intervention_name>
      <description>The same experienced anesthesiologist has performed all blocks. Always after surgical cleaning of the anteromedial thigh, all participants in this group received single shot ultrasound guided canal adductor blockade. After the blockade, all participants were monitored in our ambulance for the next hour.</description>
      <arm_group_label>Canal adductor blockade</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Canal adductor pulsed radio-frequency therapy</intervention_name>
      <description>The same experienced anesthesiologist has performed all PRF therapy After surgical cleaning of the anteromedial thigh, all participants in this group received ultrasound-guided pulsed radiofrequency therapy. We've previously scanned the adductor canal and chose the middle of the canal as the entry point of the RF 10 cm needle with a 1 cm free tip. After sensory and motor checking all patients have gotten 6 minutes of therapy divided into 3 sequences of 2 minutes of 50 V current and 42ºC. After the treatment, all participants were monitored in our ambulance for the next hour.</description>
      <arm_group_label>Pulsed radiofrequency therapy</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          All participants included in this study were sent by family physicians to our Pain&#xD;
          ambulance and all have already been diagnosed with knee osteoarthritis chronic pain. The&#xD;
          diagnosis was confirmed by Orthopedist engaged in our study. Anesthesiologist decides if&#xD;
          the patient is appropriate for the study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnose of the Knee osteoarthritis confirmed by orthopedic examination&#xD;
  &#xD;
            -  K-L grades 3 and 4&#xD;
  &#xD;
            -  A sufficient level of education to understand study procedures&#xD;
  &#xD;
            -  Be able to communicate with site personnel&#xD;
  &#xD;
            -  Age &gt;45 years&#xD;
  &#xD;
          Exclusion Criteria :&#xD;
  &#xD;
            -  Any cardiovascular, hepatic, or renal conditions that would compromise participation,&#xD;
               in the opinion of the investigator&#xD;
  &#xD;
            -  Severe neurologic conditions interfere with a knee condition&#xD;
  &#xD;
            -  Narcotic dependent (opioid intake of more than 3 months and more than 30 mg of daily&#xD;
               oral morphine equivalents)&#xD;
  &#xD;
            -  Coexisting severe hematological disorder or deranged coagulation parameters&#xD;
  &#xD;
            -  Psychiatric illnesses&#xD;
  &#xD;
            -  Allergy to any of the drugs used in the study&#xD;
  &#xD;
            -  Infection or malignancy at the site of the block&#xD;
  &#xD;
            -  Any active systemic infection&#xD;
  &#xD;
            -  Implanted electronic devices like spinal cord stimulators, cardiac pacemakers or&#xD;
               similar&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>45 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mensur Salihovic</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Medical Centre Ljubljana</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Mensur Salihovic, MD</last_name>
      <phone>+38640208892</phone>
      <email>mensur.salihovic@kclj.si</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mensur Salihovic</last_name>
      <phone>+38640208892</phone>
      <email>mensur.salihovic@kclj.si</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University Medical Centre</name>
        <address>
          <city>Ljubljana</city>
          <zip>1000</zip>
          <country>Slovenia</country>
        </address>
      </facility>
      <contact>
        <last_name>Mensur Salihovic</last_name>
        <phone>0038640208892</phone>
        <email>mensur.salihovic@kclj.si</email>
      </contact>
      <investigator>
        <last_name>Boris Rijavec</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Urska Puh</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Janez Benedik</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Peter Poredoš</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Slovenia</country>
    </location_countries>
    <reference>
      <citation>Arendt-Nielsen L, Nie H, Laursen MB, Laursen BS, Madeleine P, Simonsen OH, Graven-Nielsen T. Sensitization in patients with painful knee osteoarthritis. Pain. 2010 Jun;149(3):573-581. doi: 10.1016/j.pain.2010.04.003. Epub 2010 Apr 24.</citation>
      <PMID>20418016</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>Salihovic M, Rijavec B, Muratagic A, Blagus R, Puh U. Effectiveness of Ultrasound-Guided Canal Adductor Blockade for Chronic Pain and Functioning in Knee Osteoarthritis: A Prospective Longitudinal Observational Study. Biomed Res Int. 2022 Jan 22;2022:5270662. doi: 10.1155/2022/5270662. eCollection 2022.</citation>
      <PMID>35103237</PMID>
    </reference>
    <reference>
      <citation>Burckett-St Laurant D, Peng P, Giron Arango L, Niazi AU, Chan VW, Agur A, Perlas A. The Nerves of the Adductor Canal and the Innervation of the Knee: An Anatomic Study. Reg Anesth Pain Med. 2016 May-Jun;41(3):321-7. doi: 10.1097/AAP.0000000000000389.</citation>
      <PMID>27015545</PMID>
    </reference>
    <reference>
      <citation>Akbas M, Luleci N, Dere K, Luleci E, Ozdemir U, Toman H. Efficacy of pulsed radiofrequency treatment on the saphenous nerve in patients with chronic knee pain. J Back Musculoskelet Rehabil. 2011;24(2):77-82. doi: 10.3233/BMR-2011-0277.</citation>
      <PMID>21558611</PMID>
    </reference>
    <reference>
      <citation>Carpenedo R, Al-Wardat M, Vizzolo L, Germani G, Chine E, Ridolfo S, Dauri M, Natoli S. Ultrasound-guided pulsed radiofrequency of the saphenous nerve for knee osteoarthritis pain: a pilot randomized trial. Pain Manag. 2022 Mar;12(2):181-193. doi: 10.2217/pmt-2021-0035. Epub 2021 Aug 25.</citation>
      <PMID>34431329</PMID>
    </reference>
    <reference>
      <citation>Zhang H, Wang B, He J, Du Z. Efficacy and safety of radiofrequency ablation for treatment of knee osteoarthritis: a meta-analysis of randomized controlled trials. J Int Med Res. 2021 Apr;49(4):3000605211006647. doi: 10.1177/03000605211006647.</citation>
      <PMID>33887985</PMID>
    </reference>
    <reference>
      <citation>Uematsu H, Osako S, Hakata S, Kabata D, Shintani A, Kawazoe D, Mizuno K, Fujino Y, Matsuda Y. A Double-Blind, Placebo-Controlled Study of Ultrasound-Guided Pulsed Radiofrequency Treatment of the Saphenous Nerve for Refractory Osteoarthritis-Associated Knee Pain. Pain Physician. 2021 Sep;24(6):E761-E769.</citation>
      <PMID>34554694</PMID>
    </reference>
    <reference>
      <citation>Gupta A, Huettner DP, Dukewich M. Comparative Effectiveness Review of Cooled Versus Pulsed Radiofrequency Ablation for the Treatment of Knee Osteoarthritis: A Systematic Review. Pain Physician. 2017 Mar;20(3):155-171.</citation>
      <PMID>28339430</PMID>
    </reference>
    <results_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>
    </results_reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 2, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University Medical Centre Ljubljana</investigator_affiliation>
      <investigator_full_name>Mensur Salihovic</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Adductor canal blockade</keyword>
    <keyword>Radiofrequency therapy</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>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>All IPD that underlie results in a publication will be shared with all other researchers.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>After the end of the study and the publishing results.</ipd_time_frame>
      <ipd_access_criteria>The request needs to be addressed to the principal investigator. It should come from an official address or from a student or researcher personally.</ipd_access_criteria>
    </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/NCT05962463
  org study id: 0120-464/2022/6
  nct id: NCT05962463
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This study is intended to prove the efficacy and safety of ultrasound-guided pulsed
        radiofrequency therapy on adductor canal nerves by patients with Knee osteoarthritis.
  Knee osteoarthritis is a serious epidemiologic problem. Non-surgical methods are shown
        limited efficacy in relieving chronic knee pain in patients in advanced stages of knee
        osteoarthritis. The knee prosthesis is a successful treatment for many patients with advanced
        knee osteoarthritis. Still, there are important numbers of patients, which are not
        appropriate candidates for such surgery treatment or refused surgery for any reason. For
        them, any treatment which could relieve pain in their knee would have a good impact on their
        quality of life. Interventions like adductor canal block(ACB) and pulsed radiofrequency
        therapy (PRF) have demonstrated good results. In this study, investigators compare the
        effectiveness of these two methods. Official approval from the ethics committee of the
        Republic of Slovenia was obtained for this study. After being informed about the research and
        potential risks, all patients giving written informed consent will undergo an orthopedic
        examination and those with a confirmed diagnosis of knee osteoarthritis that lasted more than
        6 months will be included in the study. All participants were randomly divided into two
        groups. Participants in the first group receive single shot ACB and participants in the
        second group receive PRF therapy at the same point. Before starting all patients filled the
        Knee injury and osteoarthritis outcome(KOOS) form and estimated the maximal and minimal
        intensity of pain in the knee. They repeat self-assessment of pain, in the same manner, using
        11 points numeric rating score(NRS) 1 month, 3, and six months after the blockade or PRF
        therapy. Measurement of maximum voluntary isometric contraction of the quadriceps muscle
        (MVIC), time up and go test(TUG), and 30s stand-up chair test are performed by a
        physiotherapist before a block of adductor canal on both legs,1 hour, 1 month, 3 months and 6
        months after a block or PRF therapy.The adductor canal blockl is performed by the same
        trained anesthesiologist at the proximal part of the leg using 14 ml of Levobupivacaine and
        100 mcg of Clonidine mixed in the same syringeAfterof the study participants filled the Knee
        injury and osteoarthritis outcome(KOOS) form once again.
  observational model: Cohort
  time perspective: Prospective
  measure: Pain intensity
  time frame: Baseline ,1 hour,1 month, 3 month and 6 months
  description: Change From Baseline in Maximal and minimal Pain on the 11-point Numeric rating score Pain Scale (NRS 0-11) ;Numeric 11-point rating score is widely accepted self-reported score for measurement of chronic and acute pain in researches.Possible scores range are between 0-free of pain and 10-the worst imaginable pain.
  measure: KOOS
  time frame: Baseline ,1 hour,1 month, 3 month and 6 months
  description: The Knee injury and osteoarthritis outcome(KOOS) score change in percentage from baseline and 1 month following adductor canal block [ Time Frame: Baseline and 1 month following adductor canal block ] KOOS is valid,reliable outcome measure in patients with knee osteoarthritis. usually used following knee surgery.This method is recognised as useful also in other and nonsurgical knee treatment.Shortened version widely used in North America is western Ontario and McMaster Universities Index(WOMAC)
  measure: Maximum voluntary isometric contraction of quadriceps muscle (MVIC)
  time frame: Baseline ,1 hour,1 month, 3 month and 6 months
  description: Maximum voluntary isometric contraction of quadriceps muscle (MVIC) measured by handheld dynamometer ] This method is used to check impact of block on contraction of quadriceps muscle.
  measure: Timed up to go test (TUG)
  time frame: Baseline ,1 hour,1 month, 3 month and 6 months
  description: Time that patient need to stand up from a standard height armchair,walk 3 meters,go back to the chair and takes a seat.Used to assess a patients balance,risk of falling and global mobility
  measure: Satisfaction of patient
  time frame: Baseline ,1 hour,1 month, 3 month and 6 months
  description: We determine whether the patient is satisfied with the result of treatment by asking the following question: "what is the least amount of success that the treatment would have to achieve by the end of the study and/or treatment for the patient to conclude that the treatment was worth it and the patient is satisfied?" The patient is asked to describe the minimum goal to be satisfied with the treatment in her own words, such as: "50% reduction in pain, to go to the store without assistance, to use only one cane, to not wake up with pain, to perform regular housekeeping duties at home with minimal breaks, to walk a certain distance, or to play tennis". At the end of the study the patient indicates whether that goal was achieved with a "yes" or "no" answer.
  measure: Range of knee motion (ROM)
  time frame: Baseline ,1 hour,1 month, 3 month and 6 months
  description: Passive knee joint ROM of extension and flexion was measured in the control and blocked leg in the supine position using a goniometer.
  measure: 30 seconds stand up chair test (30 s SCT)
  time frame: Baseline ,1 hour,1 month, 3 month and 6 months
  description: In the 30 s CST, number of times the participant rises from a chair in 30 s is counted.
  arm group label: Canal adductor blockade
  description: After surgical cleaning of the anteromedial thigh, all participants in this group received single shot ultrasound guided canal adductor blockade with 14 ml 0,25% levobupivacaine and 100 mcg clonidine mixed in the same syringe. Investigators previously scanned the adductor canal and chose the middle of the canal as the entry point of the 10 cm echogenic ultrasound needle. After the blockade, all participants were monitored in our ambulance for the next hour.
  arm group label: Pulsed radiofrequency therapy
  description: After surgical cleaning of the anteromedial thigh, all participants in this group received ultrasound-guided pulsed radiofrequency therapy. Investigators previously scanned the adductor canal and chose the middle of the canal as the entry point of the RF 10 cm needle with a 1 cm free tip. After sensory and motor checking all patients have gotten 6 minutes of therapy divided into 3 sequences of 2 minutes of 50 V current and 42. Before starting the PRF therapy all participants have gotten 2 ml 0,25% levobupivacaine through the needle for preventing discomfort during the procedure. After the treatment, all participants were monitored in our ambulance for the next hour.
  intervention type: Procedure
  intervention name: Canal adductor blockade
  description: The same experienced anesthesiologist has performed all blocks. Always after surgical cleaning of the anteromedial thigh, all participants in this group received single shot ultrasound guided canal adductor blockade. After the blockade, all participants were monitored in our ambulance for the next hour.
  arm group label: Canal adductor blockade
  intervention type: Procedure
  intervention name: Canal adductor pulsed radio-frequency therapy
  description: The same experienced anesthesiologist has performed all PRF therapy After surgical cleaning of the anteromedial thigh, all participants in this group received ultrasound-guided pulsed radiofrequency therapy. We've previously scanned the adductor canal and chose the middle of the canal as the entry point of the RF 10 cm needle with a 1 cm free tip. After sensory and motor checking all patients have gotten 6 minutes of therapy divided into 3 sequences of 2 minutes of 50 V current and 42ºC. After the treatment, all participants were monitored in our ambulance for the next hour.
  arm group label: Pulsed radiofrequency therapy
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 45 Years
  maximum age: 100 Years
  healthy volunteers: No
  last name: Mensur Salihovic
  role: Principal Investigator
  affiliation: University Medical Centre Ljubljana
  last name: Mensur Salihovic, MD
  phone: +38640208892
  email: mensur.salihovic@kclj.si
  last name: Mensur Salihovic
  phone: +38640208892
  email: mensur.salihovic@kclj.si
  facility: 
  contact: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Slovenia
  citation: Arendt-Nielsen L, Nie H, Laursen MB, Laursen BS, Madeleine P, Simonsen OH, Graven-Nielsen T. Sensitization in patients with painful knee osteoarthritis. Pain. 2010 Jun;149(3):573-581. doi: 10.1016/j.pain.2010.04.003. Epub 2010 Apr 24.
  PMID: 20418016
  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: Salihovic M, Rijavec B, Muratagic A, Blagus R, Puh U. Effectiveness of Ultrasound-Guided Canal Adductor Blockade for Chronic Pain and Functioning in Knee Osteoarthritis: A Prospective Longitudinal Observational Study. Biomed Res Int. 2022 Jan 22;2022:5270662. doi: 10.1155/2022/5270662. eCollection 2022.
  PMID: 35103237
  citation: Burckett-St Laurant D, Peng P, Giron Arango L, Niazi AU, Chan VW, Agur A, Perlas A. The Nerves of the Adductor Canal and the Innervation of the Knee: An Anatomic Study. Reg Anesth Pain Med. 2016 May-Jun;41(3):321-7. doi: 10.1097/AAP.0000000000000389.
  PMID: 27015545
  citation: Akbas M, Luleci N, Dere K, Luleci E, Ozdemir U, Toman H. Efficacy of pulsed radiofrequency treatment on the saphenous nerve in patients with chronic knee pain. J Back Musculoskelet Rehabil. 2011;24(2):77-82. doi: 10.3233/BMR-2011-0277.
  PMID: 21558611
  citation: Carpenedo R, Al-Wardat M, Vizzolo L, Germani G, Chine E, Ridolfo S, Dauri M, Natoli S. Ultrasound-guided pulsed radiofrequency of the saphenous nerve for knee osteoarthritis pain: a pilot randomized trial. Pain Manag. 2022 Mar;12(2):181-193. doi: 10.2217/pmt-2021-0035. Epub 2021 Aug 25.
  PMID: 34431329
  citation: Zhang H, Wang B, He J, Du Z. Efficacy and safety of radiofrequency ablation for treatment of knee osteoarthritis: a meta-analysis of randomized controlled trials. J Int Med Res. 2021 Apr;49(4):3000605211006647. doi: 10.1177/03000605211006647.
  PMID: 33887985
  citation: Uematsu H, Osako S, Hakata S, Kabata D, Shintani A, Kawazoe D, Mizuno K, Fujino Y, Matsuda Y. A Double-Blind, Placebo-Controlled Study of Ultrasound-Guided Pulsed Radiofrequency Treatment of the Saphenous Nerve for Refractory Osteoarthritis-Associated Knee Pain. Pain Physician. 2021 Sep;24(6):E761-E769.
  PMID: 34554694
  citation: Gupta A, Huettner DP, Dukewich M. Comparative Effectiveness Review of Cooled Versus Pulsed Radiofrequency Ablation for the Treatment of Knee Osteoarthritis: A Systematic Review. Pain Physician. 2017 Mar;20(3):155-171.
  PMID: 28339430
  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
  responsible party type: Principal Investigator
  investigator affiliation: University Medical Centre Ljubljana
  investigator full name: Mensur Salihovic
  investigator title: Principal Investigator
  mesh term: Osteoarthritis
  mesh term: Osteoarthritis, Knee
  sharing ipd: Yes
  ipd description: All IPD that underlie results in a publication will be shared with all other researchers.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd time frame: After the end of the study and the publishing results.
  ipd access criteria: The request needs to be addressed to the principal investigator. It should come from an official address or from a student or researcher personally.