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/NCT06034418</url>
    </required_header>
    <id_info>
      <org_study_id>AnkaraCHBilkent-FTR-FK-01</org_study_id>
      <nct_id>NCT06034418</nct_id>
    </id_info>
    <brief_title>Efficacy of Pulse Radiofrequency Treatment in Patients With Coxarthrosis</brief_title>
    <official_title>The Efficacy of Pulse Radiofrequency Treatment to Articular Branches of Femoral and Obturator Nerves in Patients With Coxarthrosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ankara City Hospital Bilkent</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ankara City Hospital Bilkent</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        Our aim in this interventional study is to investigate the effectiveness of pulsed&#xD;
        radiofrequency (PRF) treatment applied to the articular branches of the femoral and obturator&#xD;
        nerves on pain, functional level, functional capacity and quality of life in patients with&#xD;
        coxarthrosis. We will compare the effects of PRF treatment added to nerve block compared to&#xD;
        nerve block alone.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Hip pain caused by coxarthrosis is common in the general population and is one of the leading&#xD;
        causes of disability in the aging population. Conservative treatments may fail due to side&#xD;
        effects or ineffectiveness. Surgery is generally recommended for patients who do not respond&#xD;
        to conservative treatment. Surgery is not always an appropriate option for elderly patients&#xD;
        and patients with multiple comorbidities. For this reason, nerve block may be an appropriate&#xD;
        treatment option for patients who do not respond to conservative treatment, who are not&#xD;
        suitable for surgery or who do not want surgery. Pulsed radiofrequency (PRF) is a method of&#xD;
        temporarily preventing pain transmission through heat increase in the tissue with the help of&#xD;
        an electrode placed near the target nerve. Most of the pain sensation in the hip joint is&#xD;
        received by the articular branches of the femoral and obturator nerves. The application of&#xD;
        PRF to the nerves innervating the hip joint may be an effective method to reduce pain and&#xD;
        disability in these patients.&#xD;
  &#xD;
        This study was designed as a prospective, randomized, controlled trial. According to the&#xD;
        statistical analysis, 28 patients who met the eligibility criteria were planned to be&#xD;
        included in the study. The patients will be divided into 2 groups as the block group (n=14)&#xD;
        and the PRF group (n=14). In procedures performed under fluoroscopy, vascular structures will&#xD;
        be detected primarily by ultrasonography for safety purposes. Nerve block and PRF procedures&#xD;
        will be performed in sterile conditions according to their protocols. Patients will be&#xD;
        evaluated about pain, functional level, functional capacity and quality of life before&#xD;
        treatment, at week 2, week 4, and week 12. If complications develop, they will be recorded.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">November 25, 2022</start_date>
    <completion_date type="Anticipated">November 25, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 25, 2023</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Visual Analogue Scale (VAS)</measure>
      <time_frame>baseline, week 2, week 4 and week 12</time_frame>
      <description>Visual Analogue Scale (VAS) is one of the pain rating scales. The amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. The VAS consists of a 10 cm line, with two end points representing 0 (no pain) and 10 (extreme pain). At rest, with movement, nighttime VAS scores and averages of them will be recorded.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Active Range of Motion</measure>
      <time_frame>baseline, week 2, week 4 and week 12</time_frame>
      <description>Active ROM is a joint movement that can be achieved by active muscle contraction without the aid of external forces. It will be measured with a goniometer by physician.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Passive Range of Motion</measure>
      <time_frame>baseline, week 2, week 4 and week 12</time_frame>
      <description>Passive ROM is joint motion that can be achieved with the help of external forces. It will be measured with a goniometer by physician.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Harris Hip Score (HHS)</measure>
      <time_frame>baseline, week 2, week 4 and week 12</time_frame>
      <description>HHS is a measure of dysfunction for the hip joint. It consists of 4 parts including pain, function, absence of deformity and range of motion. Scores range from 0 to 100. Higher scores mean less dysfunction.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Six Minute Walk Test</measure>
      <time_frame>baseline, week 2, week 4 and week 12</time_frame>
      <description>6-minute walk test is used to measure the functional capacity of the person. A 30-meter-long, flat and hard-floored walking path is used. The start and end points are marked with cones. The distance that walked over 6 minutes will be recorded. Higher distance indicates better functional capacity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Short From-36 (SF-36)</measure>
      <time_frame>baseline, week 2, week 4 and week 12</time_frame>
      <description>Sf-36 is a questionare that measure health related quality of life. It includes 36 questions and assesses 8 health domains: physical functionality, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain and general health perceptions. Scores for each domain range from 0 to 100. A higher score identifies a better state of health.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of analgesics</measure>
      <time_frame>baseline, week 2, week 4 and week 12</time_frame>
      <description>The number of analgesic drugs used daily by the patient is recorded.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">28</enrollment>
    <condition>Coxarthrosis; Primary</condition>
    <arm_group>
      <arm_group_label>Pulse Radiofrequency Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Pulse radiofrequency therapy will be applied to each nerve in 2 cycles of 120 seconds for patients in the pulse radiofrequency group. After the pulse radiofrequency procedure, 1 cc betamethasone and 1 cc 1% lidocaine will be injected for each nerve.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Block Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>For the patients in the block group, nerve block will be performed by applying 1 cc betamethasone and 1 cc 1% lidocaine for each nerve.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Pulse radiofrequency treatment</intervention_name>
      <description>In the procedures to be performed under fluoroscopy, vascular structures will be detected primarily by ultrasonography for safety purposes. A standard RF device will be used for the process. A 22-gauge and 10 cm straight radiofrequency cannula with 1 cm active tip will be used. For each nerve, sensory stimulation will be performed at 50 Hz and the patient will be expected to feel numbness and tingling with a maximum 0.7 V. Motor stimulation will be at 2 Hz and no muscle contraction up to 2 V is expected. Following the appropriate cannula placement, pulse radiofrequency will be applied to each nerve in 2 cycles of 120 seconds for the patients in this group. The pulse radiofrequency current will be 20 milliseconds wide and 45 volts in size. The tip temperature shall not be more than 42℃.</description>
      <arm_group_label>Pulse Radiofrequency Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Nerve block with 1 cc betamethasone and 1 cc 1% lidocaine</intervention_name>
      <description>In the procedures to be performed under fluoroscopy, vascular structures will be detected primarily by ultrasonography for safety purposes. A standard RF device will be used for the process. A 22-gauge and 10 cm straight radiofrequency cannula with 1 cm active tip will be used. For each nerve, sensory stimulation will be performed at 50 Hz and the patient will be expected to feel numbness and tingling with a maximum 0.7 V. Motor stimulation will be at 2 Hz and no muscle contraction up to 2 V is expected. Following the appropriate cannula placement, patients will be injected with 1 cc betamethasone and 1 cc 1% lidocaine for each nerve. A total of 2 cc volume will be injected for each nerve.</description>
      <arm_group_label>Block Group</arm_group_label>
      <arm_group_label>Pulse Radiofrequency Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with unilateral and/or bilateral hip pain for more than 6 months who meet the&#xD;
               diagnosis of coxarthrosis according to the American College of Rheumatology(ACR)&#xD;
               criteria&#xD;
  &#xD;
            -  Pain intensity greater than 3 according to the visual analog pain scale&#xD;
  &#xD;
            -  Stage ≥2 hip osteoarthritis according to the Kellgren-Lawrence classification&#xD;
  &#xD;
            -  Ambulation with or without support&#xD;
  &#xD;
            -  Having the mental competence to express pain scores&#xD;
  &#xD;
            -  Signing an informed consent form stating consent to participate in the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Other non-degenerative causes of hip pain (Avascular necrosis, femoraacetebular&#xD;
               impingement syndrome, thoracenteric bursitis)&#xD;
  &#xD;
            -  Concomitant central nervous system and/or peripheral nervous system disease&#xD;
  &#xD;
            -  History of lower extremity fracture/surgery in the last 6 months&#xD;
  &#xD;
            -  Local infection on the hip or presence of systemic infection&#xD;
  &#xD;
            -  Conditions where fluoroscopy-guided injection is contraindicated like pregnancy,&#xD;
               contrast material allergy, local anesthetic allergy, coagulopathy&#xD;
  &#xD;
            -  Presence of unstable systemic diseases&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Fatıma Korkmaz, MD</last_name>
      <phone>+90 312 552 60 00</phone>
      <email>f_korkmaz95@hotmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Ankara Bilkent City Hospital</name>
        <address>
          <city>Ankara</city>
          <zip>06800</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ankara City Hospital Bilkent</investigator_affiliation>
      <investigator_full_name>Fatıma Korkmaz</investigator_full_name>
      <investigator_title>MD</investigator_title>
    </responsible_party>
    <keyword>coxarthrosis</keyword>
    <keyword>pain</keyword>
    <keyword>pulse radiofrequency</keyword>
    <keyword>nerve block</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Osteoarthritis, Hip</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Betamethasone</mesh_term>
      <mesh_term>Lidocaine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06034418
  org study id: AnkaraCHBilkent-FTR-FK-01
  nct id: NCT06034418
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Our aim in this interventional study is to investigate the effectiveness of pulsed
        radiofrequency (PRF) treatment applied to the articular branches of the femoral and obturator
        nerves on pain, functional level, functional capacity and quality of life in patients with
        coxarthrosis. We will compare the effects of PRF treatment added to nerve block compared to
        nerve block alone.
  Hip pain caused by coxarthrosis is common in the general population and is one of the leading
        causes of disability in the aging population. Conservative treatments may fail due to side
        effects or ineffectiveness. Surgery is generally recommended for patients who do not respond
        to conservative treatment. Surgery is not always an appropriate option for elderly patients
        and patients with multiple comorbidities. For this reason, nerve block may be an appropriate
        treatment option for patients who do not respond to conservative treatment, who are not
        suitable for surgery or who do not want surgery. Pulsed radiofrequency (PRF) is a method of
        temporarily preventing pain transmission through heat increase in the tissue with the help of
        an electrode placed near the target nerve. Most of the pain sensation in the hip joint is
        received by the articular branches of the femoral and obturator nerves. The application of
        PRF to the nerves innervating the hip joint may be an effective method to reduce pain and
        disability in these patients.
  
        This study was designed as a prospective, randomized, controlled trial. According to the
        statistical analysis, 28 patients who met the eligibility criteria were planned to be
        included in the study. The patients will be divided into 2 groups as the block group (n=14)
        and the PRF group (n=14). In procedures performed under fluoroscopy, vascular structures will
        be detected primarily by ultrasonography for safety purposes. Nerve block and PRF procedures
        will be performed in sterile conditions according to their protocols. Patients will be
        evaluated about pain, functional level, functional capacity and quality of life before
        treatment, at week 2, week 4, and week 12. If complications develop, they will be recorded.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Visual Analogue Scale (VAS)
  time frame: baseline, week 2, week 4 and week 12
  description: Visual Analogue Scale (VAS) is one of the pain rating scales. The amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. The VAS consists of a 10 cm line, with two end points representing 0 (no pain) and 10 (extreme pain). At rest, with movement, nighttime VAS scores and averages of them will be recorded.
  measure: Active Range of Motion
  time frame: baseline, week 2, week 4 and week 12
  description: Active ROM is a joint movement that can be achieved by active muscle contraction without the aid of external forces. It will be measured with a goniometer by physician.
  measure: Passive Range of Motion
  time frame: baseline, week 2, week 4 and week 12
  description: Passive ROM is joint motion that can be achieved with the help of external forces. It will be measured with a goniometer by physician.
  measure: Harris Hip Score (HHS)
  time frame: baseline, week 2, week 4 and week 12
  description: HHS is a measure of dysfunction for the hip joint. It consists of 4 parts including pain, function, absence of deformity and range of motion. Scores range from 0 to 100. Higher scores mean less dysfunction.
  measure: Six Minute Walk Test
  time frame: baseline, week 2, week 4 and week 12
  description: 6-minute walk test is used to measure the functional capacity of the person. A 30-meter-long, flat and hard-floored walking path is used. The start and end points are marked with cones. The distance that walked over 6 minutes will be recorded. Higher distance indicates better functional capacity.
  measure: Short From-36 (SF-36)
  time frame: baseline, week 2, week 4 and week 12
  description: Sf-36 is a questionare that measure health related quality of life. It includes 36 questions and assesses 8 health domains: physical functionality, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain and general health perceptions. Scores for each domain range from 0 to 100. A higher score identifies a better state of health.
  measure: Number of analgesics
  time frame: baseline, week 2, week 4 and week 12
  description: The number of analgesic drugs used daily by the patient is recorded.
  arm group label: Pulse Radiofrequency Group
  arm group type: Active Comparator
  description: Pulse radiofrequency therapy will be applied to each nerve in 2 cycles of 120 seconds for patients in the pulse radiofrequency group. After the pulse radiofrequency procedure, 1 cc betamethasone and 1 cc 1% lidocaine will be injected for each nerve.
  arm group label: Block Group
  arm group type: Active Comparator
  description: For the patients in the block group, nerve block will be performed by applying 1 cc betamethasone and 1 cc 1% lidocaine for each nerve.
  intervention type: Device
  intervention name: Pulse radiofrequency treatment
  description: In the procedures to be performed under fluoroscopy, vascular structures will be detected primarily by ultrasonography for safety purposes. A standard RF device will be used for the process. A 22-gauge and 10 cm straight radiofrequency cannula with 1 cm active tip will be used. For each nerve, sensory stimulation will be performed at 50 Hz and the patient will be expected to feel numbness and tingling with a maximum 0.7 V. Motor stimulation will be at 2 Hz and no muscle contraction up to 2 V is expected. Following the appropriate cannula placement, pulse radiofrequency will be applied to each nerve in 2 cycles of 120 seconds for the patients in this group. The pulse radiofrequency current will be 20 milliseconds wide and 45 volts in size. The tip temperature shall not be more than 42℃.
  arm group label: Pulse Radiofrequency Group
  intervention type: Drug
  intervention name: Nerve block with 1 cc betamethasone and 1 cc 1% lidocaine
  description: In the procedures to be performed under fluoroscopy, vascular structures will be detected primarily by ultrasonography for safety purposes. A standard RF device will be used for the process. A 22-gauge and 10 cm straight radiofrequency cannula with 1 cm active tip will be used. For each nerve, sensory stimulation will be performed at 50 Hz and the patient will be expected to feel numbness and tingling with a maximum 0.7 V. Motor stimulation will be at 2 Hz and no muscle contraction up to 2 V is expected. Following the appropriate cannula placement, patients will be injected with 1 cc betamethasone and 1 cc 1% lidocaine for each nerve. A total of 2 cc volume will be injected for each nerve.
  arm group label: Block Group
  arm group label: Pulse Radiofrequency Group
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: Fatıma Korkmaz, MD
  phone: +90 312 552 60 00
  email: f_korkmaz95@hotmail.com
  facility: 
  status: Recruiting
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Ankara City Hospital Bilkent
  investigator full name: Fatıma Korkmaz
  investigator title: MD
  mesh term: Osteoarthritis, Hip
  mesh term: Betamethasone
  mesh term: Lidocaine
  sharing ipd: No