<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/NCT03758300</url>
  </required_header>
  <id_info>
    <org_study_id>2018-3664</org_study_id>
    <nct_id>NCT03758300</nct_id>
  </id_info>
  <brief_title>RF TKA Prehabilitation</brief_title>
  <official_title>Radiofrequency Facilitates the Prehabilitation Process in Patients Undergoing Total Knee Arthroplasty: Effects on Preoperative and Postoperative Functional Capacity. A Double Blind Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McGill University Health Centre/Research Institute of the McGill University Health Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>McGill University Health Centre/Research Institute of the McGill University Health Centre</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the effects of the radiofrequency applied to the&#xD;
      sensory innervation of the knee, with respect to a control group (standard therapy), in a&#xD;
      prehabilitation program aiming to improve the functional recovery of patients undergoing TKA.&#xD;
&#xD;
      In the present study, the investigators hypothesize that participants treated with&#xD;
      radiofrequency 4-6 weeks before the surgery, should be able to effectively accomplish the&#xD;
      prehabilitation program and, therefore, have a faster recovery of their functional status in&#xD;
      the post operative period , compared with the control group (That use the present state of&#xD;
      the art approach)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postoperative functional capacity following TKA surgery has been strongly associated with&#xD;
      preoperative functional status. Presence of pain, poor strength and flexibility, and limited&#xD;
      ability to complete physiological tasks have been shown to be consistent predictors of poor&#xD;
      recovery from knee surgery.&#xD;
&#xD;
      The postoperative period is associated with 30-40% decrease in functional capacity, and&#xD;
      efforts have been made to facilitate the recovery by implementing rehabilitative measures&#xD;
      over the period of weeks and months. However, the postoperative period might not be the best&#xD;
      time to engage patients in intensive physiotherapy as they are easily tired and in pain.&#xD;
      Preparing patients for the stress of surgery, called also prehabilitation, is emerging as a&#xD;
      mean to optimize pre-operative status and increase functional reserve thus, increasing&#xD;
      surgical stress tolerance. Observational and randomized controlled studies in patients&#xD;
      scheduled for colorectal, thoracic, and spinal surgeries have suggested that a 4-6 weeks of&#xD;
      moderate preoperative physical activity can lead to significant postoperative improvements in&#xD;
      cardiorespiratory reserve and functional capacity. However, preliminary trials on the effect&#xD;
      of a 6-8 weeks prehabilitation program with structured exercises prior to knee arthroplasty&#xD;
      have reported contrasting results, and one of the reasons might be the high levels of pain&#xD;
      encountered by these patients while exercising, therefore making it difficult to engage them&#xD;
      in achieving effective prehabilitation. It would therefore, make sense if efforts were&#xD;
      directed towards relieving pain thus, facilitating broader fitness enhancement strategies and&#xD;
      improving the surgical experience and the recovery process.&#xD;
&#xD;
      Common pharmacological methods to relieve osteoarthritic pain while waiting for surgery,&#xD;
      include acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDS and Cox-2 inhibitors)&#xD;
      and occasionally opioids. Non-surgical interventions, such as intra-articular injection with&#xD;
      steroids or hyaluronic acids, acupuncture and periosteal stimulation therapy, are often used&#xD;
      as complementary therapies of limited benefit. The use of pulsed and Continuous&#xD;
      radiofrequency (PRF and CRF) to the saphenous nerve and the genicular nerves branches of the&#xD;
      knee, have been shown to decrease significantly pain scores in 44% of patients with chronic&#xD;
      OA of the knee for up to one year after the treatment. Akbasa et al. using the Western&#xD;
      Ontario and McMaster Osteoarthritis Index (WOMAC), reported significant reduction of pain at&#xD;
      rest, movement and flexion of the knee and increase in patient's satisfaction 6 months after&#xD;
      the PRF treatment. Our group has recently demonstrated the benefits of radiofrequency&#xD;
      treatment in patients waiting for total knee replacement TKA 9. More so, the investigators&#xD;
      recent results reported to the American Society of Regional Anesthesia and Pain, showed in a&#xD;
      randomized controlled trial promising results in terms of faster recovery of patients&#xD;
      undergoing TKA, when they received RF instead of the standard postoperative analgesia&#xD;
      technique 10.&#xD;
&#xD;
      The present study is, as mentioned above, related to an already approved and finished study&#xD;
      in this institution: 15-209-MUHC &quot;Functional outcome and postoperative analgesia following&#xD;
      total knee arthroplasty: a prospective, randomized, double blind comparison between&#xD;
      continuous adductor canal block and pulsed radiofrequency of saphenous and genicular nerves&#xD;
      of the knee&quot;. In that study, our research group was investigating the effects of the&#xD;
      Radiofrequency treatment preoperatively on the postoperative pain and functional recovery, in&#xD;
      patients who did not participate in a prehabilitation program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 31, 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>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change of 15% of the total distance walked during a 6MWT</measure>
    <time_frame>18 weeks</time_frame>
    <description>change of 15% or more in total distance in six minute walk test from baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in WOMAC score</measure>
    <time_frame>Baseline and 18 weeks</time_frame>
    <description>Change in score of WOMAC questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in knee pain levels assessed by VAS (Dynamic/Static)</measure>
    <time_frame>Baseline and 18 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in amount of daily pain relief medication consumption</measure>
    <time_frame>Baseline and 18 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in total time of the time up and go (TUG) test</measure>
    <time_frame>Baseline and 18 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">48</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Radiofrequency group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this group patients will receive in a sterile fashion continuous radiofrequency for 4 minutes to the 3 genicular nerves in the operative knee as well as Pulsed Radiofrequency at 42 degrees celsius, for 4 minutes (60-70 volts) to the saphenous nerve and the nerve to the Vastus Medialis, at the level of the adductor canal. The procedure is done under local anesthesia on an ambulatory basis. After the radiofrequency, Ropivacaine 0.5% 5 ml is injected to each one of the nerves, along with 5 milligrams of Methylprednisolone to each nerve. Once the procedure is completed (takes about 20 minutes), patients will be observed in the preoperative program facility for 30 minutes and then discharged home.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control (Sham Radiofrequency) group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>In this group patients will receive injections of the local anesthetic and steroids in the same anatomical locations, without activating the radiofrequency generator.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Radiofrequency</intervention_name>
    <description>See previous page</description>
    <arm_group_label>Control (Sham Radiofrequency) group</arm_group_label>
    <arm_group_label>Radiofrequency group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic knee pain, with Dynamic VAS ≥ 5&#xD;
&#xD;
          -  Scheduled for elective total knee arthroplasty&#xD;
&#xD;
          -  Functional impairment due to pain because of knee osteoarthritis&#xD;
&#xD;
          -  Taking medications to control the pain.&#xD;
&#xD;
          -  Ability to perform the 6 MWT.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ASA physical status &gt; 3&#xD;
&#xD;
          -  Morbid obesity (BMI &gt;40)&#xD;
&#xD;
          -  Revision of total knee arthroplasty&#xD;
&#xD;
          -  Mayor neuropsychiatric disease&#xD;
&#xD;
          -  Mayor cardiac, renal or hepatic failure&#xD;
&#xD;
          -  Anemia (hematocrit &lt;30%)&#xD;
&#xD;
          -  Immunosuppression&#xD;
&#xD;
          -  Rheumatoid arthritis&#xD;
&#xD;
          -  Allergy to opioids, to local anesthetics or other medications used in the study,&#xD;
&#xD;
          -  Chronic regular use of large doses of opioids (&gt;20mg equivalent of morphine/day) or&#xD;
             sedatives&#xD;
&#xD;
          -  Unwillingness to have spinal anesthesia&#xD;
&#xD;
          -  History of recent drug abuse&#xD;
&#xD;
          -  Contraindication to receive regional anesthesia (e.g. coagulation defect)&#xD;
&#xD;
          -  Inability to walk before the surgery&#xD;
&#xD;
          -  Inability to perform physical tasks&#xD;
&#xD;
          -  Contraindications to physical exercise and training&#xD;
&#xD;
          -  Prior mayor knee surgery&#xD;
&#xD;
          -  Connective tissue diseases affecting the knee&#xD;
&#xD;
          -  Serious neurologic disorders&#xD;
&#xD;
          -  Injection with steroids or hyaluronic acids during the previous 3 months&#xD;
&#xD;
          -  Active sciatic pain&#xD;
&#xD;
          -  Anticoagulant medications&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Montreal General Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3A 1A1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>JF Asenjo, MD</last_name>
      <phone>514) 934-1934</phone>
      <phone_ext>43261</phone_ext>
      <email>jfasenjog@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>JF Asenjo, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>August 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>November 28, 2018</last_update_submitted>
  <last_update_submitted_qc>November 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McGill University Health Centre/Research Institute of the McGill University Health Centre</investigator_affiliation>
    <investigator_full_name>JF Asenjo</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <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>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03758300
org study id: 2018-3664
nct id: NCT03758300
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare the effects of the radiofrequency applied to the
      sensory innervation of the knee, with respect to a control group (standard therapy), in a
      prehabilitation program aiming to improve the functional recovery of patients undergoing TKA.

      In the present study, the investigators hypothesize that participants treated with
      radiofrequency 4-6 weeks before the surgery, should be able to effectively accomplish the
      prehabilitation program and, therefore, have a faster recovery of their functional status in
      the post operative period , compared with the control group (That use the present state of
      the art approach)
Postoperative functional capacity following TKA surgery has been strongly associated with
      preoperative functional status. Presence of pain, poor strength and flexibility, and limited
      ability to complete physiological tasks have been shown to be consistent predictors of poor
      recovery from knee surgery.

      The postoperative period is associated with 30-40% decrease in functional capacity, and
      efforts have been made to facilitate the recovery by implementing rehabilitative measures
      over the period of weeks and months. However, the postoperative period might not be the best
      time to engage patients in intensive physiotherapy as they are easily tired and in pain.
      Preparing patients for the stress of surgery, called also prehabilitation, is emerging as a
      mean to optimize pre-operative status and increase functional reserve thus, increasing
      surgical stress tolerance. Observational and randomized controlled studies in patients
      scheduled for colorectal, thoracic, and spinal surgeries have suggested that a 4-6 weeks of
      moderate preoperative physical activity can lead to significant postoperative improvements in
      cardiorespiratory reserve and functional capacity. However, preliminary trials on the effect
      of a 6-8 weeks prehabilitation program with structured exercises prior to knee arthroplasty
      have reported contrasting results, and one of the reasons might be the high levels of pain
      encountered by these patients while exercising, therefore making it difficult to engage them
      in achieving effective prehabilitation. It would therefore, make sense if efforts were
      directed towards relieving pain thus, facilitating broader fitness enhancement strategies and
      improving the surgical experience and the recovery process.

      Common pharmacological methods to relieve osteoarthritic pain while waiting for surgery,
      include acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDS and Cox-2 inhibitors)
      and occasionally opioids. Non-surgical interventions, such as intra-articular injection with
      steroids or hyaluronic acids, acupuncture and periosteal stimulation therapy, are often used
      as complementary therapies of limited benefit. The use of pulsed and Continuous
      radiofrequency (PRF and CRF) to the saphenous nerve and the genicular nerves branches of the
      knee, have been shown to decrease significantly pain scores in 44% of patients with chronic
      OA of the knee for up to one year after the treatment. Akbasa et al. using the Western
      Ontario and McMaster Osteoarthritis Index (WOMAC), reported significant reduction of pain at
      rest, movement and flexion of the knee and increase in patient's satisfaction 6 months after
      the PRF treatment. Our group has recently demonstrated the benefits of radiofrequency
      treatment in patients waiting for total knee replacement TKA 9. More so, the investigators
      recent results reported to the American Society of Regional Anesthesia and Pain, showed in a
      randomized controlled trial promising results in terms of faster recovery of patients
      undergoing TKA, when they received RF instead of the standard postoperative analgesia
      technique 10.

      The present study is, as mentioned above, related to an already approved and finished study
      in this institution: 15-209-MUHC "Functional outcome and postoperative analgesia following
      total knee arthroplasty: a prospective, randomized, double blind comparison between
      continuous adductor canal block and pulsed radiofrequency of saphenous and genicular nerves
      of the knee". In that study, our research group was investigating the effects of the
      Radiofrequency treatment preoperatively on the postoperative pain and functional recovery, in
      patients who did not participate in a prehabilitation program.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: change of 15% of the total distance walked during a 6MWT
time frame: 18 weeks
description: change of 15% or more in total distance in six minute walk test from baseline
measure: Change in WOMAC score
time frame: Baseline and 18 weeks
description: Change in score of WOMAC questionnaire
measure: Change in knee pain levels assessed by VAS (Dynamic/Static)
time frame: Baseline and 18 weeks
measure: Change in amount of daily pain relief medication consumption
time frame: Baseline and 18 weeks
measure: Change in total time of the time up and go (TUG) test
time frame: Baseline and 18 weeks
arm group label: Radiofrequency group
arm group type: Experimental
description: In this group patients will receive in a sterile fashion continuous radiofrequency for 4 minutes to the 3 genicular nerves in the operative knee as well as Pulsed Radiofrequency at 42 degrees celsius, for 4 minutes (60-70 volts) to the saphenous nerve and the nerve to the Vastus Medialis, at the level of the adductor canal. The procedure is done under local anesthesia on an ambulatory basis. After the radiofrequency, Ropivacaine 0.5% 5 ml is injected to each one of the nerves, along with 5 milligrams of Methylprednisolone to each nerve. Once the procedure is completed (takes about 20 minutes), patients will be observed in the preoperative program facility for 30 minutes and then discharged home.
arm group label: Control (Sham Radiofrequency) group
arm group type: Sham Comparator
description: In this group patients will receive injections of the local anesthetic and steroids in the same anatomical locations, without activating the radiofrequency generator.
intervention type: Other
intervention name: Radiofrequency
description: See previous page
arm group label: Control (Sham Radiofrequency) group
arm group label: Radiofrequency group
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
investigator full name: JF Asenjo
investigator title: Professor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: Undecided