<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/NCT03770585</url>
  </required_header>
  <id_info>
    <org_study_id>30476/08/15</org_study_id>
    <nct_id>NCT03770585</nct_id>
  </id_info>
  <brief_title>Fluoroscopy Guided Lumbar Facet Joint Injection Versus Ultrasound Guided Injection in Patients With Low Back Pain Due to Facet Syndrome</brief_title>
  <official_title>Comparative Study Between Fluoroscopy Guided Lumbar Facet Joint Injection Versus Ultrasound Guided Injection in Patients With Low Back Pain Due to Facet Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tanta University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to compare the efficacy of fluoroscopy guided lumbar facet joint&#xD;
      injection versus ultrasound guided injection in patients with low back pain due to facet&#xD;
      syndrome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients will be randomly classified into two equal groups (40 patients each) by using&#xD;
      closed envelops, a computer generated random allocation codes.&#xD;
&#xD;
      Group 1(Fluoroscopy guided group) (n =40 patients):&#xD;
&#xD;
      The patient will be placed in the prone position with a pillow under the abdomen to correct&#xD;
      the lumbar lordosis. The joint to be injected is located and marked, the x ray tube is then&#xD;
      slowly rotated till the joint appear in profile as two parallel lines. After cleaning and&#xD;
      drapping and administration of local anesthesia a22-g spinal needle is inserted in line with&#xD;
      x-ray beam till bony contact is felt. All procedures will be performed under sterile&#xD;
      conditions. Each facet joint is infiltrated with a mixture containing 0.5 ml of 0.25 %&#xD;
      bupivacaine and 0.5 ml (20mg) methylprednisolone acetate injected into the joint.&#xD;
&#xD;
      Group2 (Ultrasound guided group) (n=40 patients):&#xD;
&#xD;
      Patients will be placed in a prone position. Posterior paravertebral parasagittal sonograms&#xD;
      will be obtained to identify of the different spinal levels. The spinous process and adjacent&#xD;
      structures (lamina of the vertebral arch, facet joint, accessory process, and mammillary&#xD;
      process) will be delineated by transverse sonograms at the target level, and the midpoint of&#xD;
      the facet joint space will be established. After cleaning and drapping and administration of&#xD;
      local anesthesia. If the joint is clearly or partially visible, a spinal needle is advanced&#xD;
      under US guidance into the joint space of each lumbar facet joint. The needle is inserted 1-2&#xD;
      cm laterally from the midline at the lateral end of the transducer and precisely positioned&#xD;
      in the US plane at an angle of approximately 45owith respect to the axial plane until the&#xD;
      needle tip reached the target and bony contact is felt. This enables visualization of the&#xD;
      needle, which appears as a bright line-shaped echo pattern on the transverse sonogram. If the&#xD;
      needle placement is correct, a mixture containing 0.5 ml of 0.25 % bupivacaine and 0.5&#xD;
      ml(20mg) methylprednisolone acetate is administered intra-articular (until resistance was&#xD;
      encountered) and injected around the posterior facet joint capsule.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 30, 2015</start_date>
  <completion_date type="Actual">July 30, 2018</completion_date>
  <primary_completion_date type="Actual">July 30, 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Success rate of the technique</measure>
    <time_frame>1 day</time_frame>
    <description>Success rate of the technique</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The visual analogue scale (VAS) score</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>The visual analogue scale (VAS) score: before injections and at 1hour,a week, a month, and three months after injections.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oswestry disability index. (ODI)</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>(Pain Intensity, Personal Care, Lifting, Walking, Sitting, Standing, Sleeping, Sex Life, Social Life and Traveling )</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of procedure</measure>
    <time_frame>2 hours</time_frame>
    <description>Duration of procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>1 week</time_frame>
    <description>Allergy, infection</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Facet Syndrome of Lumbar Spine</condition>
  <arm_group>
    <arm_group_label>Group 1(Fluoroscopy guided group)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>IN Fluoroscopy guided group, with x-ray beam, after cleaning and drapping and administration of local anesthesia, a22-g spinal needle is inserted in line till bony contact is felt under sterile conditions. Each facet joint is infiltrated with a mixture containing 0.5 ml of 0.25 % bupivacaine and 0.5 ml (20mg) methylprednisolone acetate injected into the joint.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group2 (Ultrasound guided group)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In Ultrasound guided group, with Ultrasound guidance, , a mixture containing 0.5 ml of 0.25 % bupivacaine and 0.5 ml(20mg) methylprednisolone acetate is administered intra-articular (until resistance was encountered) and injected around the posterior facet joint capsule.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Fluoroscopy guided Facet joint injection</intervention_name>
    <description>Fluoroscopy guided Facet joint injection (The patient will be placed in the prone position with a pillow under the abdomen to correct the lumbar lordosis. The joint to be injected is located and marked, the x ray tube is then slowly rotated till the joint appear in profile as two parallel lines. After cleaning and drapping and administration of local anesthesia a22-g spinal needle is inserted in line with x-ray beam till bony contact is felt. All procedures will be performed under sterile conditions. Each facet joint is infiltrated with a mixture containing 0.5 ml of 0.25 % bupivacaine and 0.5 ml (20mg) methylprednisolone acetate injected into the joint.)</description>
    <arm_group_label>Group 1(Fluoroscopy guided group)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ultrsound guided Facet joint injection</intervention_name>
    <description>Ultrsound guided Facet joint injection (Patients will be placed in a prone position. The needle is inserted 1-2 cm laterally from the midline at the lateral end of the transducer and precisely positioned in the US plane at an angle of approximately 45o with respect to the axial plane)</description>
    <arm_group_label>Group2 (Ultrasound guided group)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients, more than 18 years old, with pain associated with lumbar hyper-extension,&#xD;
             lateral flexion, and tenderness on paravertebral regions corresponding to facet joints&#xD;
             but normal findings on the straight leg raise test and neurologic examination.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusal and lack of consent.&#xD;
&#xD;
          -  Local or systemic infection.&#xD;
&#xD;
          -  allergy to steroids or local anesthetics&#xD;
&#xD;
          -  Patients with coagulopathies.&#xD;
&#xD;
          -  Evidence of nerve root compression at the expected level on MRI.&#xD;
&#xD;
          -  Pregnant patients&#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>Marwa Abogabal, MSc.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Anesthesia, ICU and pain medicine department of Tanta university</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Anesthesia , ICU, and pain medicine department</name>
      <address>
        <city>Tanta</city>
        <zip>43636</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>March 25, 2017</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>December 7, 2018</last_update_submitted>
  <last_update_submitted_qc>December 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</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/NCT03770585
org study id: 30476/08/15
nct id: NCT03770585
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The aim of this study is to compare the efficacy of fluoroscopy guided lumbar facet joint
      injection versus ultrasound guided injection in patients with low back pain due to facet
      syndrome.
All patients will be randomly classified into two equal groups (40 patients each) by using
      closed envelops, a computer generated random allocation codes.

      Group 1(Fluoroscopy guided group) (n =40 patients):

      The patient will be placed in the prone position with a pillow under the abdomen to correct
      the lumbar lordosis. The joint to be injected is located and marked, the x ray tube is then
      slowly rotated till the joint appear in profile as two parallel lines. After cleaning and
      drapping and administration of local anesthesia a22-g spinal needle is inserted in line with
      x-ray beam till bony contact is felt. All procedures will be performed under sterile
      conditions. Each facet joint is infiltrated with a mixture containing 0.5 ml of 0.25 %
      bupivacaine and 0.5 ml (20mg) methylprednisolone acetate injected into the joint.

      Group2 (Ultrasound guided group) (n=40 patients):

      Patients will be placed in a prone position. Posterior paravertebral parasagittal sonograms
      will be obtained to identify of the different spinal levels. The spinous process and adjacent
      structures (lamina of the vertebral arch, facet joint, accessory process, and mammillary
      process) will be delineated by transverse sonograms at the target level, and the midpoint of
      the facet joint space will be established. After cleaning and drapping and administration of
      local anesthesia. If the joint is clearly or partially visible, a spinal needle is advanced
      under US guidance into the joint space of each lumbar facet joint. The needle is inserted 1-2
      cm laterally from the midline at the lateral end of the transducer and precisely positioned
      in the US plane at an angle of approximately 45owith respect to the axial plane until the
      needle tip reached the target and bony contact is felt. This enables visualization of the
      needle, which appears as a bright line-shaped echo pattern on the transverse sonogram. If the
      needle placement is correct, a mixture containing 0.5 ml of 0.25 % bupivacaine and 0.5
      ml(20mg) methylprednisolone acetate is administered intra-articular (until resistance was
      encountered) and injected around the posterior facet joint capsule.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Success rate of the technique
time frame: 1 day
description: Success rate of the technique
measure: The visual analogue scale (VAS) score
time frame: Up to 3 months
description: The visual analogue scale (VAS) score: before injections and at 1hour,a week, a month, and three months after injections.
measure: Oswestry disability index. (ODI)
time frame: Up to 3 months
description: (Pain Intensity, Personal Care, Lifting, Walking, Sitting, Standing, Sleeping, Sex Life, Social Life and Traveling )
measure: Duration of procedure
time frame: 2 hours
description: Duration of procedure
measure: Complications
time frame: 1 week
description: Allergy, infection
arm group label: Group 1(Fluoroscopy guided group)
arm group type: Active Comparator
description: IN Fluoroscopy guided group, with x-ray beam, after cleaning and drapping and administration of local anesthesia, a22-g spinal needle is inserted in line till bony contact is felt under sterile conditions. Each facet joint is infiltrated with a mixture containing 0.5 ml of 0.25 % bupivacaine and 0.5 ml (20mg) methylprednisolone acetate injected into the joint.
arm group label: Group2 (Ultrasound guided group)
arm group type: Active Comparator
description: In Ultrasound guided group, with Ultrasound guidance, , a mixture containing 0.5 ml of 0.25 % bupivacaine and 0.5 ml(20mg) methylprednisolone acetate is administered intra-articular (until resistance was encountered) and injected around the posterior facet joint capsule.
intervention type: Procedure
intervention name: Fluoroscopy guided Facet joint injection
description: Fluoroscopy guided Facet joint injection (The patient will be placed in the prone position with a pillow under the abdomen to correct the lumbar lordosis. The joint to be injected is located and marked, the x ray tube is then slowly rotated till the joint appear in profile as two parallel lines. After cleaning and drapping and administration of local anesthesia a22-g spinal needle is inserted in line with x-ray beam till bony contact is felt. All procedures will be performed under sterile conditions. Each facet joint is infiltrated with a mixture containing 0.5 ml of 0.25 % bupivacaine and 0.5 ml (20mg) methylprednisolone acetate injected into the joint.)
arm group label: Group 1(Fluoroscopy guided group)
intervention type: Procedure
intervention name: Ultrsound guided Facet joint injection
description: Ultrsound guided Facet joint injection (Patients will be placed in a prone position. The needle is inserted 1-2 cm laterally from the midline at the lateral end of the transducer and precisely positioned in the US plane at an angle of approximately 45o with respect to the axial plane)
arm group label: Group2 (Ultrasound guided group)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marwa Abogabal, MSc.
role: Principal Investigator
affiliation: Anesthesia, ICU and pain medicine department of Tanta university
facility: 
country: Egypt
responsible party type: Sponsor
mesh term: Syndrome
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: No