<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/NCT03262623</url>
  </required_header>
  <id_info>
    <org_study_id>1082017</org_study_id>
    <nct_id>NCT03262623</nct_id>
  </id_info>
  <brief_title>Radial Nerve Block for Treatment of Tennis Elbow</brief_title>
  <official_title>Localized Radial Nerve Block for Treatment of Tennis Elbow: a Prospective, Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Makassed General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Makassed General 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>
      Background: Lateral epicondylitis, or tennis elbow, is a common musculoskeletal disorder that&#xD;
      causes pain and functional limitation. Although different nonsurgical conservative therapies&#xD;
      such as bracing, physical therapy, nonsteroidal anti-inflammatory drugs, and corticosteroid&#xD;
      injections in addition to surgical approaches have been used, yet there is no standard&#xD;
      treatment for lateral epicondylitis.&#xD;
&#xD;
      Objectives: The primary objective of this study is to assess the effectiveness of nerve&#xD;
      stimulator guided radial nerve block for treatment of lateral epicondylitis. The primary&#xD;
      outcome measure is pain measured through the Visual Analogue Scale (VAS) at 1 and 2 weeks.&#xD;
&#xD;
      Methods: This is a prospective randomized, double blind clinical trial. Patients will be&#xD;
      randomly allocated into two groups. Group I will receive radial nerve block guided by a nerve&#xD;
      stimulator. Group II patients will receive placebo through radial nerve block. Patients will&#xD;
      be followed up for 2 weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lateral epicondylitis, or tennis elbow, is a common musculoskeletal disorder that causes pain&#xD;
      and functional limitation. It is a major arm disorder which occurs commonly in adults between&#xD;
      30 and 50 years, with an estimated prevalence of 1% to 3% in the general population. Lateral&#xD;
      epicondylitis results from the overuse of the extensor muscles, causing inflammation or&#xD;
      irritation of the tendon insertion. It is common in workers whose job requires manual and&#xD;
      repetitive work .&#xD;
&#xD;
      Although different nonsurgical conservative therapies such as bracing, physical therapy,&#xD;
      nonsteroidal anti-inflammatory drugs, and corticosteroid injections in addition to surgical&#xD;
      approaches have been used, yet there is no standard treatment for lateral epicondylitis.&#xD;
&#xD;
      To our knowledge, there are no studies that used nerve-stimulator-guided radial nerve block&#xD;
      for the treatment of lateral epicondylitis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Anticipated">April 2022</completion_date>
  <primary_completion_date type="Anticipated">April 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain score</measure>
    <time_frame>2 weeks</time_frame>
    <description>Pain will be measured through the Visual Analogue Scale (VAS). The scale ranges between 0 and 10, with 0 being no pain and 10 maximum possible pain</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Pain, Elbow</condition>
  <arm_group>
    <arm_group_label>Radial nerve block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive radial nerve block guided by a nerve stimulator.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients will receive placebo through radial nerve block</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Radial nerve block</intervention_name>
    <description>A nerve stimulator will be used to localize the radial nerve. Then radial block will be performed. At this point 3-5 ml of the anesthetic mixture is injected. Each 10 ml of the anesthetic mixture contained: 3ml lidocaine 2%, 3ml lidocaine 2% with epinephrine, 1:2000,000, 3ml bupivicaine 0.5% and 1ml clonidine 150 µg/ml.</description>
    <arm_group_label>Radial nerve block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>A nerve stimulator will be used to localize the radial nerve. Then radial block will be performed containing normal saline</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years and above&#xD;
&#xD;
          -  presenting with refractory elbow pain&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        patients with:&#xD;
&#xD;
          -  osteoarthritis,&#xD;
&#xD;
          -  rheumatoid arthritis,&#xD;
&#xD;
          -  olecranon bursitis,&#xD;
&#xD;
          -  radial nerve entrapment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zoher Naja, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Makassed General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zoher Naja, MD</last_name>
    <phone>+9611636000</phone>
    <phone_ext>6405</phone_ext>
    <email>zouhnaja@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Makassed General Hospital</name>
      <address>
        <city>Beirut</city>
        <country>Lebanon</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zoher Naja, MD</last_name>
      <phone>+9611636000</phone>
      <phone_ext>6941</phone_ext>
      <email>zouhnaja@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Lebanon</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>January 14, 2022</last_update_submitted>
  <last_update_submitted_qc>January 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Makassed General Hospital</investigator_affiliation>
    <investigator_full_name>Zoher Naja</investigator_full_name>
    <investigator_title>Chairperson of Anesthesia and Pain Management Department</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tennis Elbow</mesh_term>
  </condition_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/NCT03262623
org study id: 1082017
nct id: NCT03262623
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: Lateral epicondylitis, or tennis elbow, is a common musculoskeletal disorder that
      causes pain and functional limitation. Although different nonsurgical conservative therapies
      such as bracing, physical therapy, nonsteroidal anti-inflammatory drugs, and corticosteroid
      injections in addition to surgical approaches have been used, yet there is no standard
      treatment for lateral epicondylitis.

      Objectives: The primary objective of this study is to assess the effectiveness of nerve
      stimulator guided radial nerve block for treatment of lateral epicondylitis. The primary
      outcome measure is pain measured through the Visual Analogue Scale (VAS) at 1 and 2 weeks.

      Methods: This is a prospective randomized, double blind clinical trial. Patients will be
      randomly allocated into two groups. Group I will receive radial nerve block guided by a nerve
      stimulator. Group II patients will receive placebo through radial nerve block. Patients will
      be followed up for 2 weeks.
Lateral epicondylitis, or tennis elbow, is a common musculoskeletal disorder that causes pain
      and functional limitation. It is a major arm disorder which occurs commonly in adults between
      30 and 50 years, with an estimated prevalence of 1% to 3% in the general population. Lateral
      epicondylitis results from the overuse of the extensor muscles, causing inflammation or
      irritation of the tendon insertion. It is common in workers whose job requires manual and
      repetitive work .

      Although different nonsurgical conservative therapies such as bracing, physical therapy,
      nonsteroidal anti-inflammatory drugs, and corticosteroid injections in addition to surgical
      approaches have been used, yet there is no standard treatment for lateral epicondylitis.

      To our knowledge, there are no studies that used nerve-stimulator-guided radial nerve block
      for the treatment of lateral epicondylitis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Pain score
time frame: 2 weeks
description: Pain will be measured through the Visual Analogue Scale (VAS). The scale ranges between 0 and 10, with 0 being no pain and 10 maximum possible pain
arm group label: Radial nerve block
arm group type: Experimental
description: Patients will receive radial nerve block guided by a nerve stimulator.
arm group label: Placebo
arm group type: Placebo Comparator
description: Patients will receive placebo through radial nerve block
intervention type: Other
intervention name: Radial nerve block
description: A nerve stimulator will be used to localize the radial nerve. Then radial block will be performed. At this point 3-5 ml of the anesthetic mixture is injected. Each 10 ml of the anesthetic mixture contained: 3ml lidocaine 2%, 3ml lidocaine 2% with epinephrine, 1:2000,000, 3ml bupivicaine 0.5% and 1ml clonidine 150 µg/ml.
arm group label: Radial nerve block
intervention type: Other
intervention name: Placebo
description: A nerve stimulator will be used to localize the radial nerve. Then radial block will be performed containing normal saline
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Zoher Naja, MD
role: Principal Investigator
affiliation: Makassed General Hospital
last name: Zoher Naja, MD
phone: +9611636000
phone ext: 6405
email: zouhnaja@yahoo.com
facility: 
status: Recruiting
contact: 
country: Lebanon
responsible party type: Principal Investigator
investigator affiliation: Makassed General Hospital
investigator full name: Zoher Naja
investigator title: Chairperson of Anesthesia and Pain Management Department
mesh term: Tennis Elbow