<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/NCT03792386</url>
  </required_header>
  <id_info>
    <org_study_id>R/17.06.52</org_study_id>
    <nct_id>NCT03792386</nct_id>
  </id_info>
  <brief_title>Combined Ultrasound and Fluoroscopy Guided Cervical Transforaminal Injection</brief_title>
  <official_title>Clinical Visibility of Combined Ultrasound and Fluoroscopy Guided Cervical Transforaminal Injection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</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>
      The combined use of Doppler ultrasound and fluoroscopy may increase efficacy and safety&#xD;
      during cervical transforaminal epidural injection of steroid and local anaesthetic&#xD;
&#xD;
      The study will detect by which technique we have to start and confirm by the other to reach&#xD;
      the favourable outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In a previous Ultrasound study involving the C5C6 levels, a performance time of 248.8 ± 82.7&#xD;
      seconds was reported. On the basis of these findings, a 30% difference in performance time&#xD;
      would represent an effect size of 0.82 and would require 20 patients per group to achieve an&#xD;
      alpha error of 0.05 and beta error of 0.1. For dropped cases; 5% will be added. So a total&#xD;
      sample size of 64 patients (32 per group) will be required.&#xD;
&#xD;
      Statistical Analysis: will be performed using SPSS version 22 statistical software. For&#xD;
      quantitative data, normality will be first assessed with the Shapiro test and then analyzed&#xD;
      with the Student t-test. Data that will not have a normal distribution, as well as ordinal&#xD;
      data, will be analyzed with the Mann-Whitney U test. For binomial data, Fisher exact test&#xD;
      will be used. All P values presented will be 2-sided and values of less than 0.05 will be&#xD;
      considered significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2019</start_date>
  <completion_date type="Actual">July 15, 2019</completion_date>
  <primary_completion_date type="Actual">June 15, 2019</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>performance time in minutes</measure>
    <time_frame>starting by direction of the spinal needle towards the nerve root till confirmation of correct placement of the needle and injection over a period of 15 minutes</time_frame>
    <description>Defined as time needed for correct transforaminal needle placement through ultrasound guidance followed by fluoroscopic confirmation or fluoroscopic guidance followed by ultrasound confirmation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feasibility of the radiologic target</measure>
    <time_frame>starting by direction of the spinal needle towards the nerve root till confirmation of correct placement of the needle and injection over a period of 15 minutes</time_frame>
    <description>number of needle corrections till confirmation of correct placement of the needle</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual analogue score</measure>
    <time_frame>pre-procedure then every 3 months till 6 months after the procedure</time_frame>
    <description>Visual analogue score (VAS, 11-point scale): using 100mm visual analogue score in which 0 mm represents no pain and 100mm worst pain imaginable</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neck disability index</measure>
    <time_frame>pre-procedure then every 3 months till 6 months after the procedure</time_frame>
    <description>Neck disability index (NDI, 35-point scale); 0-4points (0-8%) no disability, 5-14points (10 - 28%) mild disability, 15-24points (30-48% ) moderate disability, 25-34points (50- 64%) severe disability, 35-50points (70-100%) complete disability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of patient satisfaction</measure>
    <time_frame>pre-procedure then every 3 months till 6 months after the procedure</time_frame>
    <description>Level of patient satisfaction (5-point scale); Very dissatisfied Dissatisfied Neutral Satisfied Very satisfied</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Chronic Cervical Radicular Pain</condition>
  <arm_group>
    <arm_group_label>Ultrasound guidance with fluoroscopic confirmation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in which the intervention will be performed using ultrasound guidance with fluoroscopic confirmation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fluoroscopic guidance with ultrasonographic confirmation.</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in which intervention will be performed using fluoroscopic guidance with ultrasonographic confirmation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ultrasound guidance with fluoroscopic confirmation</intervention_name>
    <description>the cervical spine will be sonographically examined to determine the C7 transverse process then after lidocaine skin infiltration, a 22G spinal needle is directed towards the hypoechoic shadow of the nerve root using the in-plane technique. then 1ml of non-ionic contrast will be injected and AP and the oblique foraminal fluoroscopic view will be obtained. After confirmation of correct placement of the needle,(2ml, 8mg dexamethasone plus 1ml Lidocaine 1%) will be injected.</description>
    <arm_group_label>Ultrasound guidance with fluoroscopic confirmation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Fluoroscopic guidance with ultrasonographic confirmation.</intervention_name>
    <description>After AP view, alignment or squaring of the target lower end plate, an oblique foraminal view is obtained. Following lidocaine 1% skin infiltration, a 22G spinal needle is directed towards the target foramen then, the superficial ultrasound probe will be applied to delineate the foramen. The needle will be advanced ~3mm towards the dorsal root ganglia under fluoroscopic guidance. After contrast confirmation of needle placement, 2ml,8mg dexamethasone plus 1ml Lidocaine 1%) will be injected.</description>
    <arm_group_label>Fluoroscopic guidance with ultrasonographic confirmation.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients suffering from radicular discogenic pain&#xD;
&#xD;
          -  Patients suffering from radicular foraminal pain Patients suffering from radicular&#xD;
             pain secondary to spinal canal stenosis&#xD;
&#xD;
          -  Patients suffering from radicular pain after failed cervical disc surgery&#xD;
&#xD;
          -  Not responding to conservative management for at least 3 months&#xD;
&#xD;
          -  Patients with recalcitrant symptoms after transforaminal steroid injection.&#xD;
&#xD;
          -  American Society of Anesthesiology (ASA) from I to III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of local or systemic infection&#xD;
&#xD;
          -  Coagulopathy&#xD;
&#xD;
          -  Body mass index &gt; 35&#xD;
&#xD;
          -  Cervical spine fracture&#xD;
&#xD;
          -  Myelopathy&#xD;
&#xD;
          -  Malignancy&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Patients unable to communicate with the operator during the procedure or report their&#xD;
             pain diary after it.&#xD;
&#xD;
          -  Patients not responding to previous cervical transforaminal steroid injection or had&#xD;
             any untoward effects.&#xD;
&#xD;
          -  Allergy to any one of the used medications.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Enas A Abd el Motlb, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Associate Professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Enas A Abd el Motlb</name>
      <address>
        <city>Mansourah</city>
        <state>DK</state>
        <zip>050</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>January 1, 2019</study_first_submitted>
  <study_first_submitted_qc>January 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>September 6, 2020</last_update_submitted>
  <last_update_submitted_qc>September 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03792386
org study id: R/17.06.52
nct id: NCT03792386
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The combined use of Doppler ultrasound and fluoroscopy may increase efficacy and safety
      during cervical transforaminal epidural injection of steroid and local anaesthetic

      The study will detect by which technique we have to start and confirm by the other to reach
      the favourable outcome.
In a previous Ultrasound study involving the C5C6 levels, a performance time of 248.8 ± 82.7
      seconds was reported. On the basis of these findings, a 30% difference in performance time
      would represent an effect size of 0.82 and would require 20 patients per group to achieve an
      alpha error of 0.05 and beta error of 0.1. For dropped cases; 5% will be added. So a total
      sample size of 64 patients (32 per group) will be required.

      Statistical Analysis: will be performed using SPSS version 22 statistical software. For
      quantitative data, normality will be first assessed with the Shapiro test and then analyzed
      with the Student t-test. Data that will not have a normal distribution, as well as ordinal
      data, will be analyzed with the Mann-Whitney U test. For binomial data, Fisher exact test
      will be used. All P values presented will be 2-sided and values of less than 0.05 will be
      considered significant.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: performance time in minutes
time frame: starting by direction of the spinal needle towards the nerve root till confirmation of correct placement of the needle and injection over a period of 15 minutes
description: Defined as time needed for correct transforaminal needle placement through ultrasound guidance followed by fluoroscopic confirmation or fluoroscopic guidance followed by ultrasound confirmation
measure: Feasibility of the radiologic target
time frame: starting by direction of the spinal needle towards the nerve root till confirmation of correct placement of the needle and injection over a period of 15 minutes
description: number of needle corrections till confirmation of correct placement of the needle
measure: Visual analogue score
time frame: pre-procedure then every 3 months till 6 months after the procedure
description: Visual analogue score (VAS, 11-point scale): using 100mm visual analogue score in which 0 mm represents no pain and 100mm worst pain imaginable
measure: Neck disability index
time frame: pre-procedure then every 3 months till 6 months after the procedure
description: Neck disability index (NDI, 35-point scale); 0-4points (0-8%) no disability, 5-14points (10 - 28%) mild disability, 15-24points (30-48% ) moderate disability, 25-34points (50- 64%) severe disability, 35-50points (70-100%) complete disability
measure: Level of patient satisfaction
time frame: pre-procedure then every 3 months till 6 months after the procedure
description: Level of patient satisfaction (5-point scale); Very dissatisfied Dissatisfied Neutral Satisfied Very satisfied
arm group label: Ultrasound guidance with fluoroscopic confirmation
arm group type: Active Comparator
description: Patients in which the intervention will be performed using ultrasound guidance with fluoroscopic confirmation
arm group label: Fluoroscopic guidance with ultrasonographic confirmation.
arm group type: Active Comparator
description: Patients in which intervention will be performed using fluoroscopic guidance with ultrasonographic confirmation.
intervention type: Procedure
intervention name: Ultrasound guidance with fluoroscopic confirmation
description: the cervical spine will be sonographically examined to determine the C7 transverse process then after lidocaine skin infiltration, a 22G spinal needle is directed towards the hypoechoic shadow of the nerve root using the in-plane technique. then 1ml of non-ionic contrast will be injected and AP and the oblique foraminal fluoroscopic view will be obtained. After confirmation of correct placement of the needle,(2ml, 8mg dexamethasone plus 1ml Lidocaine 1%) will be injected.
arm group label: Ultrasound guidance with fluoroscopic confirmation
intervention type: Procedure
intervention name: Fluoroscopic guidance with ultrasonographic confirmation.
description: After AP view, alignment or squaring of the target lower end plate, an oblique foraminal view is obtained. Following lidocaine 1% skin infiltration, a 22G spinal needle is directed towards the target foramen then, the superficial ultrasound probe will be applied to delineate the foramen. The needle will be advanced ~3mm towards the dorsal root ganglia under fluoroscopic guidance. After contrast confirmation of needle placement, 2ml,8mg dexamethasone plus 1ml Lidocaine 1%) will be injected.
arm group label: Fluoroscopic guidance with ultrasonographic confirmation.
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Enas A Abd el Motlb, MD
role: Study Chair
affiliation: Associate Professor
facility: 
country: Egypt
responsible party type: Sponsor
sharing ipd: Undecided