<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/NCT04446988</url>
  </required_header>
  <id_info>
    <org_study_id>14102019</org_study_id>
    <nct_id>NCT04446988</nct_id>
  </id_info>
  <brief_title>Ultrasound Versus Fluoroscopic Guided Sacroiliac Joint Injection In Patients With Chronic Sacroiliac Joint Pain</brief_title>
  <official_title>Ultrasound Versus Fluoroscopic Guided Sacroiliac Joint Injection In Patients With Chronic Sacroiliac Joint Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Minia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Minia 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>
      Sacroiliac joint injection in sacroiliitis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Comparison of ultrasound guided and fluoroscopic guided sacroiliac joint injection&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 15, 2019</start_date>
  <completion_date type="Actual">March 15, 2020</completion_date>
  <primary_completion_date type="Actual">February 15, 2020</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>Sacroiliac joint injection with local anesthetic and steroid using ultrasound Versus fluoroscopy in sacroiliitis</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Numeric Rating Scale (NRS) pain scores</measure>
    <time_frame>3 months</time_frame>
    <description>It measures pain intensity (0 no pain - 10 worst pain imaginable)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oswestry disability index score</measure>
    <time_frame>1 month</time_frame>
    <description>It evaluates the physical function (0% minimal disability - 100% bed - bound patient)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Analgesic requirement</measure>
    <time_frame>1 month</time_frame>
    <description>It shows if the patient needs analgesic or not compared to pretreatment (type and dose in mg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction ( global perceived effect on a 7-point scale (GPE) )</measure>
    <time_frame>3 months</time_frame>
    <description>It shows if the patient satisfied with the procedure or not (1= worst ever - 7= best ever)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure time</measure>
    <time_frame>Procedure</time_frame>
    <description>It measures the seconds of procedure in both groups</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Sacro-Iliac Spondylosis</condition>
  <arm_group>
    <arm_group_label>Ultrasound(US)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sacroiliac joint injection using ultrasound</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fluoroscopy(FL)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sacroiliac joint injection using fluoroscopy</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sacroiliac joint injection</intervention_name>
    <description>Injection of sacroiliac joint with local anesthetic and steroid</description>
    <arm_group_label>Fluoroscopy(FL)</arm_group_label>
    <arm_group_label>Ultrasound(US)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of sacroiliitis.&#xD;
&#xD;
          -  At least 3 positive physical examination maneuvers [FABER (flexion, abduction, and&#xD;
             external rotation), POSH (posterior shear), REAB (resisted abduction), Fortin's finger&#xD;
             test],&#xD;
&#xD;
          -  Moderate to severe pain (NRS pain score ≥ 3/10) refractory to oral anti-inflammatory.&#xD;
&#xD;
          -  Age from 18ys to 60ys.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ages less than 18 or more than 85 years.&#xD;
&#xD;
          -  Body Mass Index (BMI) above 35 kg/m2.&#xD;
&#xD;
          -  A diagnosis of severe anxiety or depression and other psychological disorders.&#xD;
&#xD;
          -  Allergy to local anesthetics or steroids and pregnancy.&#xD;
&#xD;
          -  Multiple comorbidities (renal , hepatic, cardiac).&#xD;
&#xD;
          -  Coagulation disorder as bleeding tendency and platelet dysfunction.&#xD;
&#xD;
          -  Contraindication for prone position or radiological exposure.&#xD;
&#xD;
          -  Patient refuse .&#xD;
&#xD;
          -  Pain suggestive of bilateral sacroiliac joint involvement (it would have been&#xD;
             difficult to assess pain and disability secondary to each SIJ).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hany Ka Mickhael, Ass. pr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Minia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ASSIUT University Hospitals</name>
      <address>
        <city>Assiut</city>
        <zip>1225</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <results_reference>
    <citation>Benson DA, Cavanaugh M, Clark K, Karsch-Mizrachi I, Lipman DJ, Ostell J, Sayers EW. GenBank. Nucleic Acids Res. 2013 Jan;41(Database issue):D36-42. doi: 10.1093/nar/gks1195. Epub 2012 Nov 27.</citation>
    <PMID>23193287</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>June 23, 2020</last_update_submitted>
  <last_update_submitted_qc>June 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Minia University</investigator_affiliation>
    <investigator_full_name>DR. Abd El-Raheem Mahmoud</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Sacroiliac</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthralgia</mesh_term>
    <mesh_term>Spondylosis</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/NCT04446988
org study id: 14102019
nct id: NCT04446988
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Sacroiliac joint injection in sacroiliitis
Comparison of ultrasound guided and fluoroscopic guided sacroiliac joint injection
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Sacroiliac joint injection with local anesthetic and steroid using ultrasound Versus fluoroscopy in sacroiliitis
primary purpose: Treatment
masking: None (Open Label)
measure: Numeric Rating Scale (NRS) pain scores
time frame: 3 months
description: It measures pain intensity (0 no pain - 10 worst pain imaginable)
measure: Oswestry disability index score
time frame: 1 month
description: It evaluates the physical function (0% minimal disability - 100% bed - bound patient)
measure: Analgesic requirement
time frame: 1 month
description: It shows if the patient needs analgesic or not compared to pretreatment (type and dose in mg)
measure: Patient satisfaction ( global perceived effect on a 7-point scale (GPE) )
time frame: 3 months
description: It shows if the patient satisfied with the procedure or not (1= worst ever - 7= best ever)
measure: Procedure time
time frame: Procedure
description: It measures the seconds of procedure in both groups
arm group label: Ultrasound(US)
arm group type: Experimental
description: Sacroiliac joint injection using ultrasound
arm group label: Fluoroscopy(FL)
arm group type: Experimental
description: Sacroiliac joint injection using fluoroscopy
intervention type: Device
intervention name: Sacroiliac joint injection
description: Injection of sacroiliac joint with local anesthetic and steroid
arm group label: Fluoroscopy(FL)
arm group label: Ultrasound(US)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Hany Ka Mickhael, Ass. pr.
role: Principal Investigator
affiliation: Minia University
facility: 
country: Egypt
citation: Benson DA, Cavanaugh M, Clark K, Karsch-Mizrachi I, Lipman DJ, Ostell J, Sayers EW. GenBank. Nucleic Acids Res. 2013 Jan;41(Database issue):D36-42. doi: 10.1093/nar/gks1195. Epub 2012 Nov 27.
PMID: 23193287
responsible party type: Principal Investigator
investigator affiliation: Minia University
investigator full name: DR. Abd El-Raheem Mahmoud
investigator title: Clinical Professor
mesh term: Arthralgia
mesh term: Spondylosis
sharing ipd: No