<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/NCT03781843</url>
  </required_header>
  <id_info>
    <org_study_id>2018/42</org_study_id>
    <nct_id>NCT03781843</nct_id>
  </id_info>
  <brief_title>Effects of Genicular Nerve Block in Knee Osteoarthritis</brief_title>
  <official_title>Effects of Genicular Nerve Block for Patients With Knee Osteoarthritis Who Have Neuropathic or Nociceptive Pain: A Double-Blind, Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fatih Sultan Mehmet Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fatih Sultan Mehmet Training and Research 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Genicular nerve block is a safe and effective therapeutic procedure for intractable pain&#xD;
      associated with chronic knee osteoarthritis (OA). There is increasing support for the&#xD;
      neuropathic component to the knee OA pain. Investigators proposed that targeting treatment to&#xD;
      the underlying pain mechanism can improve pain management in knee OA. There is a debate on&#xD;
      injectable solutions used in nerve blocks. Investigators aimed to investigate the efficacy of&#xD;
      genicular nerve block and to determine which solution should be appropriate for patients with&#xD;
      knee osteoarthritis who have neuropathic or nociceptive pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The patients who participated in this study were selected from outpatients who attended our&#xD;
      hospital for knee pain. These 90 patients were who matched the following criteria. All&#xD;
      patients had knee pain for more than 3 months.&#xD;
&#xD;
      The ultrasound-guided genicular nerve block was performed at the site of the superior&#xD;
      lateral, the superior medial, and the inferior medial genicular nerves. Color Doppler was&#xD;
      used to identify the arterial structures which serve as landmarks for the corresponding&#xD;
      nerves. This method was used to inject a total of 6 mL of lidocaine or 6 mL dextrose or 6 mL&#xD;
      saline at 3 separate target sites: the superior lateral, superior medial, and inferior medial&#xD;
      genicular nerves.&#xD;
&#xD;
      Pain was evaluated with Analog Analogue Scale (VAS), daily living activities with Western&#xD;
      Ontario and McMaster Universities Arthritis Index (WOMAC), maximum distance walked with&#xD;
      Lequesne Score, and neuropathic pain was evaluated with painDETECT inquiry form. Outcome&#xD;
      measures were assessed at baseline and at 1st, 4th weeks, and 3rd months after the procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">September 3, 2018</start_date>
  <completion_date type="Anticipated">March 29, 2019</completion_date>
  <primary_completion_date type="Actual">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>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of genicular nerve block on neuropathic pain reduction in knee osteoarthritis</measure>
    <time_frame>3 months</time_frame>
    <description>Neuropathic pain reduction is measured by painDETECT questionnaire (PD-Q) which consists of 9 items that evaluate pain quality, pattern and radiation. Possible scores range from -1 to 38, with higher scores indicating more neuropathic-like symptoms. Clinical assessments:score ≤12: unlikely neuropathic pain; score 13-18: possibly neuropathic pain, and score ≥19:likely neuropathic pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy of genicular nerve block on nociceptive pain reduction in knee osteoarthritis.</measure>
    <time_frame>3 months</time_frame>
    <description>Nociceptive pain reduction is measured by Visual analogue scales (VAS). The score is determined by measuring the distance (mm) on the 10-cm line between the &quot;no pain&quot; anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy of genicular nerve block on physical function in knee osteoarthritis.</measure>
    <time_frame>6 months</time_frame>
    <description>Physical functional disability is measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The WOMAC index is a self-administered health questionnaire specifically designed for patients with osteoarthritis of the hip or knee. It consists of 24 multiple-choice items grouped into 3 categories: WOMAC pain, WOMAC stiffness, and WOMAC physical function. The questions are ranked on a 5-point Likert scale (1 point, best result; 5 points, worst result), and the scores are added up for each category. The WOMAC scores from 1 (best) to 5 (worst) points to a system of 0 (worst) to 100 (best) points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy of genicular nerve block on walking distance in knee osteoarthritis.</measure>
    <time_frame>6 months</time_frame>
    <description>Walking distance with or without walking aids is measured by Lequesne algofunctional index.The Lequesne OA index is a 11-question interview format questionnaire with three sections about pain or discomfort, maximum distance walked and possible necessity of crutches and activities of daily living . The Lequesne OA index is scored as the sum of all questions ranging from 0 to 24. Lower score indicates less dysfunction where 0 = no handicap, 1-4 = mild handicap, 5-7 = moderate handicap, 8-10 = severe handicap, 11-13 = very severe handicap, and ≥14 = extremely severe handicap.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Genicular nerve block with lidocaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The ultrasound-guided genicular nerve block was performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. Color Doppler was used to identify the arterial structures which serve as landmarks for the corresponding nerves.10 cm 21 G insulated block needle was inserted and aligned with the ultrasound scanning plane. Once satisfactory position of the needle is confirmed, 6 mL of a solution containing 6 mL of 2% lidocaine or 6 mL dextrose or 6 mL saline was slowly injected. Spread of local anesthetic was documented adjacent to the target nerve. This procedure was performed at the site of the three genicular nerves Interventions: Drug: 6 mL 2% lidocaine Procedure: Genicular nerve block</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Genicular nerve block with saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The ultrasound-guided genicular nerve block was performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. Color Doppler was used to identify the arterial structures which serve as landmarks for the corresponding nerves.&#xD;
10 cm 21 G insulated block needle was inserted and aligned with the ultrasound scanning plane. Once satisfactory position of the needle time is confirmed, 5 mL of a saline was slowly injected. Spread of local anesthetic was documented adjacent to the target nerve. This procedure was performed at the site of the three genicular nerves.&#xD;
Interventions:Drug: Saline Procedure: Genicular nerve block</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Genicular nerve block with dextrose</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The ultrasound-guided genicular nerve block was performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. Color Doppler was used to identify the arterial structures which serve as landmarks for the corresponding nerves.&#xD;
10 cm 21 G insulated block needle was inserted and aligned with the ultrasound scanning plane. Once satisfactory position of the needle time is confirmed, 5 mL of a dextrose was slowly injected. Spread of local anesthetic was documented adjacent to the target nerve. This procedure was performed at the site of the three genicular nerves.&#xD;
Interventions:Drug: Dextrose Procedure: Genicular nerve block</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Genicular nerve block with lidocaine</intervention_name>
    <description>The color doppler ultrasound-guided genicular nerve block at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves.</description>
    <arm_group_label>Genicular nerve block with lidocaine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Genicular nerve block with saline</intervention_name>
    <description>The color doppler ultrasound-guided genicular nerve block at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves.</description>
    <arm_group_label>Genicular nerve block with saline</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Genicular nerve block with dextrose</intervention_name>
    <description>The color doppler ultrasound-guided genicular nerve block at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves.</description>
    <arm_group_label>Genicular nerve block with dextrose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  knee pain for more than 3 month.&#xD;
&#xD;
          -  radiological tibiofemoral OA (Kellgren-Lawrence grade 2-4 )&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  acute knee pain, prior knee surgery, other connective tissue diseases that affected&#xD;
             the knee, serious neurological or psychiatric disorders, steroid or hyaluronic acid&#xD;
             injection therapy during the previous 3 months, sciatic pain, patients with&#xD;
             polyneuropathy, anticoagulant medication use, pacemaker use, prior electroacupuncture&#xD;
             treatment and physical treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pınar Akpınar, MD</last_name>
    <role>Study Director</role>
    <affiliation>FATİH SULTAN MEHMET EDUCATION AND RESEARCH HOSPITAL</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fatih Sultan Mehmet Education and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <zip>34752</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>January 18, 2019</last_update_submitted>
  <last_update_submitted_qc>January 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fatih Sultan Mehmet Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Berrak Tas</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Neuropathic Pain</keyword>
  <keyword>Nerve block</keyword>
  <keyword>Knee osteoarthritis</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03781843
org study id: 2018/42
nct id: NCT03781843
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Genicular nerve block is a safe and effective therapeutic procedure for intractable pain
      associated with chronic knee osteoarthritis (OA). There is increasing support for the
      neuropathic component to the knee OA pain. Investigators proposed that targeting treatment to
      the underlying pain mechanism can improve pain management in knee OA. There is a debate on
      injectable solutions used in nerve blocks. Investigators aimed to investigate the efficacy of
      genicular nerve block and to determine which solution should be appropriate for patients with
      knee osteoarthritis who have neuropathic or nociceptive pain.
The patients who participated in this study were selected from outpatients who attended our
      hospital for knee pain. These 90 patients were who matched the following criteria. All
      patients had knee pain for more than 3 months.

      The ultrasound-guided genicular nerve block was performed at the site of the superior
      lateral, the superior medial, and the inferior medial genicular nerves. Color Doppler was
      used to identify the arterial structures which serve as landmarks for the corresponding
      nerves. This method was used to inject a total of 6 mL of lidocaine or 6 mL dextrose or 6 mL
      saline at 3 separate target sites: the superior lateral, superior medial, and inferior medial
      genicular nerves.

      Pain was evaluated with Analog Analogue Scale (VAS), daily living activities with Western
      Ontario and McMaster Universities Arthritis Index (WOMAC), maximum distance walked with
      Lequesne Score, and neuropathic pain was evaluated with painDETECT inquiry form. Outcome
      measures were assessed at baseline and at 1st, 4th weeks, and 3rd months after the procedure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: Efficacy of genicular nerve block on neuropathic pain reduction in knee osteoarthritis
time frame: 3 months
description: Neuropathic pain reduction is measured by painDETECT questionnaire (PD-Q) which consists of 9 items that evaluate pain quality, pattern and radiation. Possible scores range from -1 to 38, with higher scores indicating more neuropathic-like symptoms. Clinical assessments:score ≤12: unlikely neuropathic pain; score 13-18: possibly neuropathic pain, and score ≥19:likely neuropathic pain.
measure: Efficacy of genicular nerve block on nociceptive pain reduction in knee osteoarthritis.
time frame: 3 months
description: Nociceptive pain reduction is measured by Visual analogue scales (VAS). The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm).
measure: Efficacy of genicular nerve block on physical function in knee osteoarthritis.
time frame: 6 months
description: Physical functional disability is measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The WOMAC index is a self-administered health questionnaire specifically designed for patients with osteoarthritis of the hip or knee. It consists of 24 multiple-choice items grouped into 3 categories: WOMAC pain, WOMAC stiffness, and WOMAC physical function. The questions are ranked on a 5-point Likert scale (1 point, best result; 5 points, worst result), and the scores are added up for each category. The WOMAC scores from 1 (best) to 5 (worst) points to a system of 0 (worst) to 100 (best) points.
measure: Efficacy of genicular nerve block on walking distance in knee osteoarthritis.
time frame: 6 months
description: Walking distance with or without walking aids is measured by Lequesne algofunctional index.The Lequesne OA index is a 11-question interview format questionnaire with three sections about pain or discomfort, maximum distance walked and possible necessity of crutches and activities of daily living . The Lequesne OA index is scored as the sum of all questions ranging from 0 to 24. Lower score indicates less dysfunction where 0 = no handicap, 1-4 = mild handicap, 5-7 = moderate handicap, 8-10 = severe handicap, 11-13 = very severe handicap, and ≥14 = extremely severe handicap.
arm group label: Genicular nerve block with lidocaine
arm group type: Active Comparator
description: The ultrasound-guided genicular nerve block was performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. Color Doppler was used to identify the arterial structures which serve as landmarks for the corresponding nerves.10 cm 21 G insulated block needle was inserted and aligned with the ultrasound scanning plane. Once satisfactory position of the needle is confirmed, 6 mL of a solution containing 6 mL of 2% lidocaine or 6 mL dextrose or 6 mL saline was slowly injected. Spread of local anesthetic was documented adjacent to the target nerve. This procedure was performed at the site of the three genicular nerves Interventions: Drug: 6 mL 2% lidocaine Procedure: Genicular nerve block
arm group label: Genicular nerve block with saline
arm group type: Placebo Comparator
description: The ultrasound-guided genicular nerve block was performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. Color Doppler was used to identify the arterial structures which serve as landmarks for the corresponding nerves.
10 cm 21 G insulated block needle was inserted and aligned with the ultrasound scanning plane. Once satisfactory position of the needle time is confirmed, 5 mL of a saline was slowly injected. Spread of local anesthetic was documented adjacent to the target nerve. This procedure was performed at the site of the three genicular nerves.
Interventions:Drug: Saline Procedure: Genicular nerve block
arm group label: Genicular nerve block with dextrose
arm group type: Placebo Comparator
description: The ultrasound-guided genicular nerve block was performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. Color Doppler was used to identify the arterial structures which serve as landmarks for the corresponding nerves.
10 cm 21 G insulated block needle was inserted and aligned with the ultrasound scanning plane. Once satisfactory position of the needle time is confirmed, 5 mL of a dextrose was slowly injected. Spread of local anesthetic was documented adjacent to the target nerve. This procedure was performed at the site of the three genicular nerves.
Interventions:Drug: Dextrose Procedure: Genicular nerve block
intervention type: Drug
intervention name: Genicular nerve block with lidocaine
description: The color doppler ultrasound-guided genicular nerve block at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves.
arm group label: Genicular nerve block with lidocaine
intervention type: Drug
intervention name: Genicular nerve block with saline
description: The color doppler ultrasound-guided genicular nerve block at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves.
arm group label: Genicular nerve block with saline
intervention type: Drug
intervention name: Genicular nerve block with dextrose
description: The color doppler ultrasound-guided genicular nerve block at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves.
arm group label: Genicular nerve block with dextrose
criteria: 
gender: All
minimum age: 50 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pınar Akpınar, MD
role: Study Director
affiliation: FATİH SULTAN MEHMET EDUCATION AND RESEARCH HOSPITAL
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Fatih Sultan Mehmet Training and Research Hospital
investigator full name: Berrak Tas
investigator title: Principal Investigator
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
mesh term: Lidocaine