<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/NCT04454541</url>
  </required_header>
  <id_info>
    <org_study_id>UBLOCK</org_study_id>
    <nct_id>NCT04454541</nct_id>
  </id_info>
  <brief_title>Efficacy of Ultrasound-Guided Multifidus Cervicis Plan Block Vs Greater Occipital Nerve Block for Cervicogenic Headache</brief_title>
  <acronym>UBLOC</acronym>
  <official_title>The Efficacy of Ultrasound -Guided Multifidus Cervicis Plan Block Versus Greater Occipital Nerve Block for Cervicogenic Headache</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abha International Private Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abha International Private Hospital</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>
      Background: Cervicogenic headache (CH) described as a chronic hemi-cranial pain resulted from&#xD;
      a disorder of the cervical spine and its anatomic structures innervated by the C1, C2, and C3&#xD;
      cervical spinal nerves. Traditionally noninvasive and invasive techniques were used for&#xD;
      treatment. Greater occipital nerve block is the most frequent peripheral nerve block invasive&#xD;
      technique used for the management of cervicogenic headache Objectives: The study was done to&#xD;
      compare the efficacy of two different techniques: multifidus cervicus plan block and greater&#xD;
      occipital nerve block in treatment of refractory cervicogenic headache using ultrasound&#xD;
      guided.&#xD;
&#xD;
      Patients and Methods: sixty patients with cervicogenic headache were recruited and diagnosed&#xD;
      according to ICHD-ш Beta version. Divided into two group, one for greater occipital nerve&#xD;
      block and the other for multifidus cervicis plane block with ultrasound guided.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was done to compare the efficacy of two different techniques: multifidus cervicus&#xD;
      plane block and greater occipital nerve block in treatment of cervicogenic headache using&#xD;
      ultrasound guided.&#xD;
&#xD;
      This prospective study that was approved by Institutional Review Board (IRB), Mansoura&#xD;
      Faculty of Medicine, Mansoura University, Cairo Egypt (Code Number: R/19.04.483) and all&#xD;
      participants gave written informed consent. The procedures followed were in accordance with&#xD;
      our protocol.&#xD;
&#xD;
      This study included patients with cervicogenic headache disorders that diagnosed according to&#xD;
      International Classification of Headache Disorder version III (ICHD-III beta version)&#xD;
      criteria (18)&#xD;
&#xD;
      Full clinical neurological examination was done for all patients. Blood samples for routine&#xD;
      laboratory investigations (Complete blood count, creatinine, liver function tests, PT, APTT)&#xD;
      were taken from all patients, electrocardiography (ECG) were done for all patients. Pain&#xD;
      intensity was evaluated via visual analog scale (VAS) scores (0 -10). Pain intensity&#xD;
      evaluation will be done at initial presentation then after 2 and 4 weeks, using the VAS scale&#xD;
      for affected side of cervicogenic headache. Saturation of pulse oxygen (SpO2), all Procedures&#xD;
      performed using ultrasound system with a 7 - 13 MHz multi-frequency transducer (LOGIQ P5; GE&#xD;
      Healthcare).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2019</start_date>
  <completion_date type="Actual">December 1, 2019</completion_date>
  <primary_completion_date type="Actual">November 1, 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>
    <intervention_model_description>Arm A-Greater occipital nerve block The ultrasound-guided GONB was performed to more accurately locate the nerve. The patient was asked to lie prone on the table. To locate the nerve, we searched for the occipital artery in the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process.&#xD;
Arm B- Multifidus cervicus plan block group (MCPB) Patients will receive continuing low-flow non humidified nasal cannula oxygen (2 L/min) and continued intravenous infusion of Ringer's solution while respiratory signs were closely monitored during the procedure.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Headache free</measure>
    <time_frame>30 minute post intervention</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual analog scale (VAS)</measure>
    <time_frame>2 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual analog scale (VAS)</measure>
    <time_frame>4 Weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Cervicogenic Headache</condition>
  <arm_group>
    <arm_group_label>Greater occipital nerve block with ultrasound</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A-Greater occipital nerve block The ultrasound-guided GONB was performed to more accurately locate the nerve. The patient was asked to lie prone on the table. To locate the nerve, we searched for the occipital artery in the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process. The scalp was cleaned with iodine. After that, the skin was sterilized, and the probe was sheathed in a sterile plastic package GONB was performed by applying the injection to the medial of the artery. A 22-gauge needle was advanced beneath the lateral border of the probe using real-time ultrasound guidance and an in-plane technique. In all patients the occipital nerve was seen medial to the artery. The injected side was determined by the patients' clinical symptoms and according to the painful side reported in their headache diaries. The patients were required to lie down for 30 minutes after the injection to avoid dizziness.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multifidus cervicis plane block with ultrasound guided</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients placed in a lateral position with their affected side upwards. Several gel cushions were placed under their head, neck, and arm to put the neck in a stable and slightly anterior flexion position spinal level was determined by identifying the transverse process of the seventh and sixth cervical vertebrae (C7 and C6). The seventh cervical transverse process (C7) differs from the levels above by having a rudimentary anterior tubercle and a prominent posterior tubercle. After aseptic preparation of the injection area, lidocaine 1% was used to anesthetize the skin. Under continuous ultrasound guidance, the needle (22-G, 0.7 mm × 60 mm, Plexufx, B-BRAUN, Tokyo, Japan) was introduced in-plane through the skin and advanced into the fascial plane between the multifidus cervicis and semispinalis cervicis muscles for the MCP block.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ultrasound-guided nerve block for headache management</intervention_name>
    <description>The study was done to compare the efficacy of two different techniques: multifidus cervicus plan block and greater occipital nerve block in treatment of refractory cervicogenic headache using ultrasound guided.</description>
    <arm_group_label>Greater occipital nerve block with ultrasound</arm_group_label>
    <arm_group_label>Multifidus cervicis plane block with ultrasound guided</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        History of occipital nerve injection, occipital nerve stimulation or history of surgical&#xD;
        procedures in the occipital region,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of allergic reaction to the substance to be applied as local anesthetic.,&#xD;
&#xD;
          -  Pregnancy or lactation,&#xD;
&#xD;
          -  Uncontrolled hypertension,&#xD;
&#xD;
          -  Uncontrolled diabetes mellitus,&#xD;
&#xD;
          -  Uncompensated congestive heart failure,&#xD;
&#xD;
          -  Chronic renal failure,&#xD;
&#xD;
          -  Chronic liver disease,&#xD;
&#xD;
          -  Tumor and/or vascular disease,&#xD;
&#xD;
          -  Inflammatory and/or infectious diseases,&#xD;
&#xD;
          -  Anticoagulant or antiplatelet medication use that may interfere with the injection&#xD;
             process were also excluded.&#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>Zenat Eldadamony Mohamed, PhD MD</last_name>
    <role>Study Chair</role>
    <affiliation>Mansoura University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mansoura University</name>
      <address>
        <city>Mansoura</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Dočekal, P., Keller, O., Marková, J., Opavský, J. (2006) Bolesti hlavy. In: Bolest. Rokyta, R., Kršiak, M., Kozák, J., pp. 2006; 461-477, Tigis, Praha. (in Czech). International Headache Society .The International Classification of Headache Disorders, 2nd edition. Cephalalgia. 2004; 24, 1-160 (Suppl. 1). Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. Fredriksen TA, Antonaci F, Sjaastad O. Cervicogenic headache: too important to be left un-diagnosed. J Headache Pain 2015; 16:6. Chaibi A, Russell MB. Manual therapies for cervicogenic headache: a systematic review. J Headache Pain. 2012; 13:351-359.</citation>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 13, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>June 30, 2020</last_update_submitted>
  <last_update_submitted_qc>June 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cervicogenic Headache</keyword>
  <keyword>Headache</keyword>
  <keyword>Cervicis Plan Block</keyword>
  <keyword>Occipital Nerve Block</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Post-Traumatic Headache</mesh_term>
    <mesh_term>Headache</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/NCT04454541
org study id: UBLOCK
nct id: NCT04454541
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Background: Cervicogenic headache (CH) described as a chronic hemi-cranial pain resulted from
      a disorder of the cervical spine and its anatomic structures innervated by the C1, C2, and C3
      cervical spinal nerves. Traditionally noninvasive and invasive techniques were used for
      treatment. Greater occipital nerve block is the most frequent peripheral nerve block invasive
      technique used for the management of cervicogenic headache Objectives: The study was done to
      compare the efficacy of two different techniques: multifidus cervicus plan block and greater
      occipital nerve block in treatment of refractory cervicogenic headache using ultrasound
      guided.

      Patients and Methods: sixty patients with cervicogenic headache were recruited and diagnosed
      according to ICHD-ш Beta version. Divided into two group, one for greater occipital nerve
      block and the other for multifidus cervicis plane block with ultrasound guided.
This study was done to compare the efficacy of two different techniques: multifidus cervicus
      plane block and greater occipital nerve block in treatment of cervicogenic headache using
      ultrasound guided.

      This prospective study that was approved by Institutional Review Board (IRB), Mansoura
      Faculty of Medicine, Mansoura University, Cairo Egypt (Code Number: R/19.04.483) and all
      participants gave written informed consent. The procedures followed were in accordance with
      our protocol.

      This study included patients with cervicogenic headache disorders that diagnosed according to
      International Classification of Headache Disorder version III (ICHD-III beta version)
      criteria (18)

      Full clinical neurological examination was done for all patients. Blood samples for routine
      laboratory investigations (Complete blood count, creatinine, liver function tests, PT, APTT)
      were taken from all patients, electrocardiography (ECG) were done for all patients. Pain
      intensity was evaluated via visual analog scale (VAS) scores (0 -10). Pain intensity
      evaluation will be done at initial presentation then after 2 and 4 weeks, using the VAS scale
      for affected side of cervicogenic headache. Saturation of pulse oxygen (SpO2), all Procedures
      performed using ultrasound system with a 7 - 13 MHz multi-frequency transducer (LOGIQ P5; GE
      Healthcare).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Arm A-Greater occipital nerve block The ultrasound-guided GONB was performed to more accurately locate the nerve. The patient was asked to lie prone on the table. To locate the nerve, we searched for the occipital artery in the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process.
Arm B- Multifidus cervicus plan block group (MCPB) Patients will receive continuing low-flow non humidified nasal cannula oxygen (2 L/min) and continued intravenous infusion of Ringer's solution while respiratory signs were closely monitored during the procedure.
primary purpose: Treatment
masking: None (Open Label)
measure: Headache free
time frame: 30 minute post intervention
measure: Visual analog scale (VAS)
time frame: 2 Weeks
measure: Visual analog scale (VAS)
time frame: 4 Weeks
arm group label: Greater occipital nerve block with ultrasound
arm group type: Active Comparator
description: A-Greater occipital nerve block The ultrasound-guided GONB was performed to more accurately locate the nerve. The patient was asked to lie prone on the table. To locate the nerve, we searched for the occipital artery in the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process. The scalp was cleaned with iodine. After that, the skin was sterilized, and the probe was sheathed in a sterile plastic package GONB was performed by applying the injection to the medial of the artery. A 22-gauge needle was advanced beneath the lateral border of the probe using real-time ultrasound guidance and an in-plane technique. In all patients the occipital nerve was seen medial to the artery. The injected side was determined by the patients' clinical symptoms and according to the painful side reported in their headache diaries. The patients were required to lie down for 30 minutes after the injection to avoid dizziness.
arm group label: Multifidus cervicis plane block with ultrasound guided
arm group type: Experimental
description: Patients placed in a lateral position with their affected side upwards. Several gel cushions were placed under their head, neck, and arm to put the neck in a stable and slightly anterior flexion position spinal level was determined by identifying the transverse process of the seventh and sixth cervical vertebrae (C7 and C6). The seventh cervical transverse process (C7) differs from the levels above by having a rudimentary anterior tubercle and a prominent posterior tubercle. After aseptic preparation of the injection area, lidocaine 1% was used to anesthetize the skin. Under continuous ultrasound guidance, the needle (22-G, 0.7 mm × 60 mm, Plexufx, B-BRAUN, Tokyo, Japan) was introduced in-plane through the skin and advanced into the fascial plane between the multifidus cervicis and semispinalis cervicis muscles for the MCP block.
intervention type: Procedure
intervention name: Ultrasound-guided nerve block for headache management
description: The study was done to compare the efficacy of two different techniques: multifidus cervicus plan block and greater occipital nerve block in treatment of refractory cervicogenic headache using ultrasound guided.
arm group label: Greater occipital nerve block with ultrasound
arm group label: Multifidus cervicis plane block with ultrasound guided
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Zenat Eldadamony Mohamed, PhD MD
role: Study Chair
affiliation: Mansoura University
facility: 
country: Egypt
citation: Dočekal, P., Keller, O., Marková, J., Opavský, J. (2006) Bolesti hlavy. In: Bolest. Rokyta, R., Kršiak, M., Kozák, J., pp. 2006; 461-477, Tigis, Praha. (in Czech). International Headache Society .The International Classification of Headache Disorders, 2nd edition. Cephalalgia. 2004; 24, 1-160 (Suppl. 1). Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. Fredriksen TA, Antonaci F, Sjaastad O. Cervicogenic headache: too important to be left un-diagnosed. J Headache Pain 2015; 16:6. Chaibi A, Russell MB. Manual therapies for cervicogenic headache: a systematic review. J Headache Pain. 2012; 13:351-359.
responsible party type: Sponsor
mesh term: Post-Traumatic Headache
mesh term: Headache