<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/NCT01719081</url>
  </required_header>
  <id_info>
    <org_study_id>11-0880-AE</org_study_id>
    <nct_id>NCT01719081</nct_id>
  </id_info>
  <brief_title>Sacroiliac Joint Injection: Comparison of Xray Versus Ultrasound</brief_title>
  <official_title>Ultrasound for Sacroiliac Joint Injection: Evaluation of the Efficacy of Two Image-Guided Techniques for Sacroiliac Joint Injection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Health Network, Toronto</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project involves the assessment of the efficacy of two different image guided techniques&#xD;
      in patients with low back pain due to arthritis of the sacroiliac joint (SIJ).&#xD;
      Intra-articular injection of local anesthetics and steroids is performed to relieve pain&#xD;
      originating from the SIJ. Fluoroscopy has been used traditionally for image guidance for this&#xD;
      procedure but there is a growing interest in use of ultrasound (US) for this procedure. US&#xD;
      avoids radiation exposure to the patient and the health care team (HCT) and is less&#xD;
      expensive. We aim to compare procedural efficacy related outcomes for SIJ injections&#xD;
      performed using these image-guided modalities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a prospective, randomized trial. Patients with low back pain which is diagnosed&#xD;
      secondary to SIJ disease will be identified beforehand in clinic and offered a therapeutic&#xD;
      joint injection. Informed consent will be obtained. Patients will be randomized for SIJ block&#xD;
      with 3 mL of 0.25% bupivacaine with 1:200,000 epinephrine and 40 mg depomedrol using guidance&#xD;
      with ultrasound or fluoroscopy. In both groups, confirmation of needle placement will be&#xD;
      obtained using contrast injection imaging before the injection is performed. Record will be&#xD;
      made of the number of times the needle is correctly placed into the articular space, as well&#xD;
      as the number of attempts to do so. The final position of the needle will be recorded. Pain&#xD;
      scores will be assessed before the procedure, as well as post-procedure at 24 and 72 hours,&#xD;
      as well as 1 week, 1 month, and 3 months. Patients will keep a pain diary and will be&#xD;
      followed up at 3 months time in clinic.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of needle placement into SIJ</measure>
    <time_frame>Assessed at time of injection</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain - Numeric Rating Scale Score at 1 month</measure>
    <time_frame>One month from time of injection</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement of functional ability at 1 month</measure>
    <time_frame>1 month from time of injection</time_frame>
    <description>Oswestry Disability Index completed at 1 month to determine level of disability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>1 month from time of injection</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average daily consumption of opioids at 1 month</measure>
    <time_frame>1 month from injection</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient discomfort with procedure</measure>
    <time_frame>Measured at time of procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of needle readjustments</measure>
    <time_frame>Measured at time of procedure</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Assessment of complications</measure>
    <time_frame>Until 3 months after procedure</time_frame>
    <description>Complications assessed at any point until 3 months after procedure</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Sacroiliac Joint Arthritis Causing Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Ultrasound Guided SIJ Injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Needle placement will be performed under US guidance. Fluoroscopy will be used to confirm needle placement prior to medication injection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Xray Guided SIJ Injection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Needle placement will be performed under fluoroscopy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sacroiliac Joint Injection</intervention_name>
    <description>Medication injected into the sacroiliac joint: Bupivicaine 3ml 0.25% with epinephrine 1/200,000 and Depo-Medrol 40mg.</description>
    <arm_group_label>Ultrasound Guided SIJ Injection</arm_group_label>
    <arm_group_label>Xray Guided SIJ Injection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Suspicion of SIJ disease on history: pain below the lumbo-sacral junction; pain with&#xD;
             full weight-bearing on one leg; pain worse going down hills or inclines; very low back&#xD;
             pain associated with groin pain and absence of lumbar symptoms&#xD;
&#xD;
          -  Two positive responses to the following maneuver: FABER (flexion abduction and&#xD;
             external rotation of hip), POSH (posterior shear test), REAB (resisted abduction)&#xD;
&#xD;
          -  Baseline NRS pain score &gt; or = to 4&#xD;
&#xD;
          -  Refractory to oral analgesic therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ongoing litigation issues related to the patient's pain&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  allergy to steroids or local anesthetics&#xD;
&#xD;
          -  multiple comorbidities&#xD;
&#xD;
          -  BMI &gt; 35&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anuj Bhatia, MD, FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Health Network, Toronto</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Toronto Western Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5T 2S8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>December 2013</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>December 21, 2016</last_update_submitted>
  <last_update_submitted_qc>December 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sacroiliac Joint</keyword>
  <keyword>Ultrasound</keyword>
  <keyword>Fluoroscopy</keyword>
  <keyword>Chronic Pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sacroiliitis</mesh_term>
    <mesh_term>Low Back Pain</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/NCT01719081
org study id: 11-0880-AE
nct id: NCT01719081
lead sponsor: 
has dmc: Yes
This project involves the assessment of the efficacy of two different image guided techniques
      in patients with low back pain due to arthritis of the sacroiliac joint (SIJ).
      Intra-articular injection of local anesthetics and steroids is performed to relieve pain
      originating from the SIJ. Fluoroscopy has been used traditionally for image guidance for this
      procedure but there is a growing interest in use of ultrasound (US) for this procedure. US
      avoids radiation exposure to the patient and the health care team (HCT) and is less
      expensive. We aim to compare procedural efficacy related outcomes for SIJ injections
      performed using these image-guided modalities.
The study is a prospective, randomized trial. Patients with low back pain which is diagnosed
      secondary to SIJ disease will be identified beforehand in clinic and offered a therapeutic
      joint injection. Informed consent will be obtained. Patients will be randomized for SIJ block
      with 3 mL of 0.25% bupivacaine with 1:200,000 epinephrine and 40 mg depomedrol using guidance
      with ultrasound or fluoroscopy. In both groups, confirmation of needle placement will be
      obtained using contrast injection imaging before the injection is performed. Record will be
      made of the number of times the needle is correctly placed into the articular space, as well
      as the number of attempts to do so. The final position of the needle will be recorded. Pain
      scores will be assessed before the procedure, as well as post-procedure at 24 and 72 hours,
      as well as 1 week, 1 month, and 3 months. Patients will keep a pain diary and will be
      followed up at 3 months time in clinic.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Incidence of needle placement into SIJ
time frame: Assessed at time of injection
measure: Pain - Numeric Rating Scale Score at 1 month
time frame: One month from time of injection
measure: Improvement of functional ability at 1 month
time frame: 1 month from time of injection
description: Oswestry Disability Index completed at 1 month to determine level of disability
measure: Patient Satisfaction
time frame: 1 month from time of injection
measure: Average daily consumption of opioids at 1 month
time frame: 1 month from injection
measure: Patient discomfort with procedure
time frame: Measured at time of procedure
measure: Number of needle readjustments
time frame: Measured at time of procedure
measure: Assessment of complications
time frame: Until 3 months after procedure
description: Complications assessed at any point until 3 months after procedure
arm group label: Ultrasound Guided SIJ Injection
arm group type: Experimental
description: Needle placement will be performed under US guidance. Fluoroscopy will be used to confirm needle placement prior to medication injection.
arm group label: Xray Guided SIJ Injection
arm group type: Active Comparator
description: Needle placement will be performed under fluoroscopy.
intervention type: Procedure
intervention name: Sacroiliac Joint Injection
description: Medication injected into the sacroiliac joint: Bupivicaine 3ml 0.25% with epinephrine 1/200,000 and Depo-Medrol 40mg.
arm group label: Ultrasound Guided SIJ Injection
arm group label: Xray Guided SIJ Injection
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Anuj Bhatia, MD, FRCPC
role: Principal Investigator
affiliation: University Health Network, Toronto
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Sacroiliitis
mesh term: Low Back Pain