<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/NCT04475445</url>
  </required_header>
  <id_info>
    <org_study_id>CE/20-04-08</org_study_id>
    <nct_id>NCT04475445</nct_id>
  </id_info>
  <brief_title>Fluoroscopic Guided Interlaminar Epidural Versus Ultrasound Guided Transforaminal Epidural in the Treatment of Unilateral Cervicobrachialgia.</brief_title>
  <official_title>Fluoroscopic Guided Interlaminar Epidural Versus Ultrasound Guided Transforaminal Epidural in the Treatment of Unilateral Cervicobrachialgia : a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Saint Pierre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Saint Pierre</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>
      Chronic cervicobrachialgia is a public health problem. Epidural injections of corticosteroids&#xD;
      and local anesthesics via transforaminal and interlaminar routes both have shown their&#xD;
      potential in its treatment. The interlaminar approach offers the advantage of an epidural&#xD;
      injection (i.e., direct contact with the nerve root in the epidural space). However, it&#xD;
      requires fluoroscopy and can lead to potentially serious complications (compression of the&#xD;
      nerve root, spinal cord injury...). The ultrasound-guided injection of corticosteroids via&#xD;
      the transforaminal route, which offers the advantage of selectively targeting the symptomatic&#xD;
      nerve root, may have the same therapeutic advantages as the interlaminar approach in&#xD;
      decreasing unilateral cervicobrachial pain (i.e. a decrease in pain after infiltration) and&#xD;
      reduce its risks.The aim of this study is to compare the efficacy of transforaminal vs&#xD;
      interlaminar cervical corticosteroid injection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 30, 2020</start_date>
  <completion_date type="Anticipated">July 2021</completion_date>
  <primary_completion_date type="Anticipated">July 2021</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 Score change at 30 minutes post infiltration when compared to baseline</measure>
    <time_frame>up to 30 minutes</time_frame>
    <description>Pain will be evaluated by Visual Analog Scale (VAS) before and 30 minutes after corticosteroid infiltration.&#xD;
Visual Analog pain score (scale = 0 no pain; 10= worst pain imaginable)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue Score change at 1 month post infiltration when compared to baseline</measure>
    <time_frame>up to 1 month</time_frame>
    <description>Pain will be evaluated by Visual Analog Scale (VAS) before and 1 month after corticosteroid infiltration.&#xD;
Visual Analog pain score (scale = 0 no pain; 10= worst pain imaginable)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction during procedure</measure>
    <time_frame>at the end of infiltration</time_frame>
    <description>Pain will be evaluated by Satisfaction scale after procedure (0= unsatisfied, 5= very satisfied)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neck disability index (NDI) score (questionnaire)</measure>
    <time_frame>up to 1 month</time_frame>
    <description>Neck disability index (NDI) score will be calculated before, 30 minutes and 1 month after corticosteroid infiltration&#xD;
The NDI is a standard instrument for measuring self-rated disability due to neck pain.&#xD;
Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. Points summed to a total score. The test can be interpreted as a raw score, with a maximum score of 50, Interpretation for scoring intervals : 0 - 4 = no disability; 5 - 14 = mild disability; 15 - 24 = moderate disability; 25 - 34 = severe disability, above 34 = complete disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Procedure failure</measure>
    <time_frame>up to 30 minutes</time_frame>
    <description>The procedure will be considered as a failure if the infiltration is not performed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Adverse effects (lipothymia, nausea, vomiting)</measure>
    <time_frame>up to 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of complications (stroke, hematoma, paralysis)</measure>
    <time_frame>up to 1 month</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Cervicobrachial Neuralgia</condition>
  <arm_group>
    <arm_group_label>Ultrasound guided transforaminal epidural steroid injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Interlaminar epidural steroid injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ultrasound-guided transforaminal epidural steroid injection</intervention_name>
    <description>Ultrasound identification of the nerve root, fluoroscopic control of the position and injection of a mixture of 10 mg of dexamethasone and 20 mg of lidocaine.</description>
    <arm_group_label>Ultrasound guided transforaminal epidural steroid injection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Interlaminar epidural steroid injection</intervention_name>
    <description>Fluoroscopic location of the epidural space C5C6 or C6C7, injection of a mixture of 10 mg of dexamethasone and 20 mg of lidocaine.</description>
    <arm_group_label>Interlaminar epidural steroid injection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists physical status (ASA) I-III&#xD;
&#xD;
          -  Chronic unilateral cervicobrachial pain&#xD;
&#xD;
          -  Allowed Steroid infiltration&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Lactation&#xD;
&#xD;
          -  Allergy or intolerance to any of the drugs/materials used in this study,&#xD;
&#xD;
          -  Participation in another interventional study&#xD;
&#xD;
          -  Systemic anticoagulation,&#xD;
&#xD;
          -  Infection at the puncture site&#xD;
&#xD;
          -  Patient refusal.&#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>Panayota Kapessidou, MD,PhD</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mohamed Ali Bali, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>mohamed_bali@stpierre-bru.be</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Panayota Kapessidou, MD,PhD</last_name>
    <phone>+32.2.535</phone>
    <phone_ext>3750</phone_ext>
    <email>pkapessi@ulb.ac.be</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mohamed Ali Bali, MD</last_name>
    <phone>+ 32.2.535</phone>
    <phone_ext>3758</phone_ext>
    <email>mohamed_bali@stpierre-bru.be</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHU Saint-Pierre</name>
      <address>
        <city>Bruxelles</city>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mohamed Ali Bali, MD</last_name>
      <phone>+32.2.535</phone>
      <phone_ext>3758</phone_ext>
      <email>mohamed_bali@stpierre-bru.be</email>
    </contact>
    <contact_backup>
      <last_name>Panayota Kapessidou, MD</last_name>
      <phone>+32.2.535</phone>
      <phone_ext>3750</phone_ext>
      <email>pkapessi@ulb.ac.be</email>
    </contact_backup>
    <investigator>
      <last_name>Mohamed Bali, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <reference>
    <citation>Kaye AD, Manchikanti L, Abdi S, Atluri S, Bakshi S, Benyamin R, Boswell MV, Buenaventura R, Candido KD, Cordner HJ, Datta S, Doulatram G, Gharibo CG, Grami V, Gupta S, Jha S, Kaplan ED, Malla Y, Mann DP, Nampiaparampil DE, Racz G, Raj P, Rana MV, Sharma ML, Singh V, Soin A, Staats PS, Vallejo R, Wargo BW, Hirsch JA. Efficacy of Epidural Injections in Managing Chronic Spinal Pain: A Best Evidence Synthesis. Pain Physician. 2015 Nov;18(6):E939-1004.</citation>
    <PMID>26606031</PMID>
  </reference>
  <reference>
    <citation>Banik RK, Chen Chen CC. Spinal Epidural Hematoma after Interlaminar Cervical Epidural Steroid Injection. Anesthesiology. 2019 Dec;131(6):1342-1343. doi: 10.1097/ALN.0000000000002896. No abstract available.</citation>
    <PMID>31365368</PMID>
  </reference>
  <reference>
    <citation>Bush K, Mandegaran R, Robinson E, Zavareh A. The safety and efficiency of performing cervical transforaminal epidural steroid injections under fluoroscopic control on an ambulatory/outpatient basis. Eur Spine J. 2020 May;29(5):994-1000. doi: 10.1007/s00586-019-06147-2. Epub 2019 Sep 18.</citation>
    <PMID>31535205</PMID>
  </reference>
  <reference>
    <citation>Narouze SN, Vydyanathan A, Kapural L, Sessler DI, Mekhail N. Ultrasound-guided cervical selective nerve root block: a fluoroscopy-controlled feasibility study. Reg Anesth Pain Med. 2009 Jul-Aug;34(4):343-8. doi: 10.1097/AAP.0b013e3181ac7e5c.</citation>
    <PMID>19574867</PMID>
  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>August 17, 2020</last_update_submitted>
  <last_update_submitted_qc>August 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Neuropathic Cervicobrachial</keyword>
  <keyword>Ultrasound-guided transforaminal infiltration</keyword>
  <keyword>Cervical Interlaminar epidural infiltration</keyword>
  <keyword>Cervical Chronic Pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuralgia</mesh_term>
    <mesh_term>Brachial Plexus Neuritis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04475445
org study id: CE/20-04-08
nct id: NCT04475445
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Chronic cervicobrachialgia is a public health problem. Epidural injections of corticosteroids
      and local anesthesics via transforaminal and interlaminar routes both have shown their
      potential in its treatment. The interlaminar approach offers the advantage of an epidural
      injection (i.e., direct contact with the nerve root in the epidural space). However, it
      requires fluoroscopy and can lead to potentially serious complications (compression of the
      nerve root, spinal cord injury...). The ultrasound-guided injection of corticosteroids via
      the transforaminal route, which offers the advantage of selectively targeting the symptomatic
      nerve root, may have the same therapeutic advantages as the interlaminar approach in
      decreasing unilateral cervicobrachial pain (i.e. a decrease in pain after infiltration) and
      reduce its risks.The aim of this study is to compare the efficacy of transforaminal vs
      interlaminar cervical corticosteroid injection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Visual Analogue Score change at 30 minutes post infiltration when compared to baseline
time frame: up to 30 minutes
description: Pain will be evaluated by Visual Analog Scale (VAS) before and 30 minutes after corticosteroid infiltration.
Visual Analog pain score (scale = 0 no pain; 10= worst pain imaginable)
measure: Visual Analogue Score change at 1 month post infiltration when compared to baseline
time frame: up to 1 month
description: Pain will be evaluated by Visual Analog Scale (VAS) before and 1 month after corticosteroid infiltration.
Visual Analog pain score (scale = 0 no pain; 10= worst pain imaginable)
measure: Patient satisfaction during procedure
time frame: at the end of infiltration
description: Pain will be evaluated by Satisfaction scale after procedure (0= unsatisfied, 5= very satisfied)
measure: Neck disability index (NDI) score (questionnaire)
time frame: up to 1 month
description: Neck disability index (NDI) score will be calculated before, 30 minutes and 1 month after corticosteroid infiltration
The NDI is a standard instrument for measuring self-rated disability due to neck pain.
Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. Points summed to a total score. The test can be interpreted as a raw score, with a maximum score of 50, Interpretation for scoring intervals : 0 - 4 = no disability; 5 - 14 = mild disability; 15 - 24 = moderate disability; 25 - 34 = severe disability, above 34 = complete disability.
measure: Rate of Procedure failure
time frame: up to 30 minutes
description: The procedure will be considered as a failure if the infiltration is not performed.
measure: Incidence of Adverse effects (lipothymia, nausea, vomiting)
time frame: up to 1 month
measure: Incidence of complications (stroke, hematoma, paralysis)
time frame: up to 1 month
arm group label: Ultrasound guided transforaminal epidural steroid injection
arm group type: Experimental
arm group label: Interlaminar epidural steroid injection
arm group type: Experimental
intervention type: Other
intervention name: Ultrasound-guided transforaminal epidural steroid injection
description: Ultrasound identification of the nerve root, fluoroscopic control of the position and injection of a mixture of 10 mg of dexamethasone and 20 mg of lidocaine.
arm group label: Ultrasound guided transforaminal epidural steroid injection
intervention type: Other
intervention name: Interlaminar epidural steroid injection
description: Fluoroscopic location of the epidural space C5C6 or C6C7, injection of a mixture of 10 mg of dexamethasone and 20 mg of lidocaine.
arm group label: Interlaminar epidural steroid injection
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Panayota Kapessidou, MD,PhD
role: Study Director
affiliation: University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
last name: Mohamed Ali Bali, MD
role: Principal Investigator
affiliation: mohamed_bali@stpierre-bru.be
last name: Panayota Kapessidou, MD,PhD
phone: +32.2.535
phone ext: 3750
email: pkapessi@ulb.ac.be
last name: Mohamed Ali Bali, MD
phone: + 32.2.535
phone ext: 3758
email: mohamed_bali@stpierre-bru.be
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Belgium
citation: Kaye AD, Manchikanti L, Abdi S, Atluri S, Bakshi S, Benyamin R, Boswell MV, Buenaventura R, Candido KD, Cordner HJ, Datta S, Doulatram G, Gharibo CG, Grami V, Gupta S, Jha S, Kaplan ED, Malla Y, Mann DP, Nampiaparampil DE, Racz G, Raj P, Rana MV, Sharma ML, Singh V, Soin A, Staats PS, Vallejo R, Wargo BW, Hirsch JA. Efficacy of Epidural Injections in Managing Chronic Spinal Pain: A Best Evidence Synthesis. Pain Physician. 2015 Nov;18(6):E939-1004.
PMID: 26606031
citation: Banik RK, Chen Chen CC. Spinal Epidural Hematoma after Interlaminar Cervical Epidural Steroid Injection. Anesthesiology. 2019 Dec;131(6):1342-1343. doi: 10.1097/ALN.0000000000002896. No abstract available.
PMID: 31365368
citation: Bush K, Mandegaran R, Robinson E, Zavareh A. The safety and efficiency of performing cervical transforaminal epidural steroid injections under fluoroscopic control on an ambulatory/outpatient basis. Eur Spine J. 2020 May;29(5):994-1000. doi: 10.1007/s00586-019-06147-2. Epub 2019 Sep 18.
PMID: 31535205
citation: Narouze SN, Vydyanathan A, Kapural L, Sessler DI, Mekhail N. Ultrasound-guided cervical selective nerve root block: a fluoroscopy-controlled feasibility study. Reg Anesth Pain Med. 2009 Jul-Aug;34(4):343-8. doi: 10.1097/AAP.0b013e3181ac7e5c.
PMID: 19574867
responsible party type: Sponsor
mesh term: Neuralgia
mesh term: Brachial Plexus Neuritis
sharing ipd: No