<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/NCT03834480</url>
  </required_header>
  <id_info>
    <org_study_id>MS17.10.03</org_study_id>
    <nct_id>NCT03834480</nct_id>
  </id_info>
  <brief_title>Intraartecular Platelet Rich Plasma for Sacroiliitis</brief_title>
  <official_title>Ultra Sound Guided Injection of Platelet Rich Plasma Versus Steroid for Sacroiliac Joint Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Comparison between the effect of steroids and platelet-rich plasma on low back pain after&#xD;
      ultrasound-guided sacroiliac injection to determine any is more effective and of long&#xD;
      duration&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective randomized controlled study was conducted at the department of anesthesiology&#xD;
      Mansoura University Hospital during the period from December 2017 to January 2019 on fifty&#xD;
      ASA I-III adult patients, of both sex after approval of IRB (Institutional Review Board) ID&#xD;
      number MS17.10.03 &amp; IRB date 12-11-2017. The patients were randomly allocated into two groups&#xD;
      each of 25 patients according to computer-generated random number codes that were placed in&#xD;
      sealed envelopes, double blinded, with parallel-group comparison.&#xD;
&#xD;
      Steroid Group (S) (n. 25):- Patients were injected by 4 ml of sterile water containing the&#xD;
      methylprednisolone Acetate (Depo-Medrol) per-kg calculated dose (0.5mg/kg up to a lean muscle&#xD;
      body weight of 80kg in the painful sacroiliac joint).&#xD;
&#xD;
      Platelet rich plasma Group (P) (n. 25):-Patients received fixed volume of 4 ml platelet-rich&#xD;
      plasma in the inflamed painful sacroiliac joint.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2017</start_date>
  <completion_date type="Actual">January 1, 2019</completion_date>
  <primary_completion_date type="Actual">December 1, 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>Double (Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>visual analog score</measure>
    <time_frame>Basal and after 6 months</time_frame>
    <description>To evaluate the changes in visual analogue score over a 6-month follow-up period after intra-articular injection and compare these changes among the studied groups.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Sacroiliitis</condition>
  <arm_group>
    <arm_group_label>• Steroid Group (S)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>• Platelet rich plasma Group (PRP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ultrasound guided Sacroiliac intra-articular injection</intervention_name>
    <description>At the level of the sacral hiatus, the sacral cornuae were identified. posterior aspect of the sacroiliac joint, at 4.5 cm depth the SIJ was found. localal anesthetic was injected at the medial edge of the transducer, the spinal needle was advanced in a medial to lateral direction, under direct vision, until the needle was positioned in the SIJ. Local steroid solution or PRP 4ml volume was injected according to the study group and patient enrollment. If the injection is extra-articular, injectate (hyperechoic solution as it contains particulate steroid) can be seen spreading medially over the sacrum. The visual analog score, Oswestry Disability Index (ODI) score and the overall success rate basal, after one week,after one month,after three and six month's follow-up period after the initial block.</description>
    <arm_group_label>• Platelet rich plasma Group (PRP)</arm_group_label>
    <arm_group_label>• Steroid Group (S)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Patients of either sex. 2. ASA I&amp;III. 3. Age between 18 - 70 years. 4. Chronic&#xD;
             lower back pain of sacroiliac origin. 5. Anatomy of the joint can identified by the&#xD;
             ultrasonography. Exclusion criteria&#xD;
&#xD;
               1. Patients with contraindications to sacroiliac injection.&#xD;
&#xD;
               2. Patients known to be allergic to platelet rich plasma or local anesthetics.&#xD;
&#xD;
               3. History of immune suppression or immune compromised diseases&#xD;
&#xD;
               4. Patient below age of 18 as the joint will undergo normal physiological changes.&#xD;
&#xD;
               5. Patient over 70 years.&#xD;
&#xD;
               6. Sacroiliac pain of multiple sources.&#xD;
&#xD;
               7. Preoperative shivering or fever (&gt;38oc).&#xD;
&#xD;
               8. Hepatic, renal and heart failure patients.&#xD;
&#xD;
               9. Patients on; anticoagulants, antiplatelet, and with INR≥1.5.&#xD;
&#xD;
              10. Exclude corticosteroid injection in the sacroiliac joint at the last three&#xD;
                  months.&#xD;
&#xD;
              11. Patient refusal.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Mansoura faculty of Medicine</name>
      <address>
        <city>Mansourah</city>
        <state>Dakahlia</state>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>February 6, 2019</last_update_submitted>
  <last_update_submitted_qc>February 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Platelet reach plasma</keyword>
  <keyword>sacroiliac</keyword>
  <keyword>Ultrasound</keyword>
  <keyword>Steroid</keyword>
  <keyword>Chronic low back Pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sacroiliitis</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/NCT03834480
org study id: MS17.10.03
nct id: NCT03834480
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Comparison between the effect of steroids and platelet-rich plasma on low back pain after
      ultrasound-guided sacroiliac injection to determine any is more effective and of long
      duration
A prospective randomized controlled study was conducted at the department of anesthesiology
      Mansoura University Hospital during the period from December 2017 to January 2019 on fifty
      ASA I-III adult patients, of both sex after approval of IRB (Institutional Review Board) ID
      number MS17.10.03 & IRB date 12-11-2017. The patients were randomly allocated into two groups
      each of 25 patients according to computer-generated random number codes that were placed in
      sealed envelopes, double blinded, with parallel-group comparison.

      Steroid Group (S) (n. 25):- Patients were injected by 4 ml of sterile water containing the
      methylprednisolone Acetate (Depo-Medrol) per-kg calculated dose (0.5mg/kg up to a lean muscle
      body weight of 80kg in the painful sacroiliac joint).

      Platelet rich plasma Group (P) (n. 25):-Patients received fixed volume of 4 ml platelet-rich
      plasma in the inflamed painful sacroiliac joint.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Care Provider, Outcomes Assessor)
measure: visual analog score
time frame: Basal and after 6 months
description: To evaluate the changes in visual analogue score over a 6-month follow-up period after intra-articular injection and compare these changes among the studied groups.
arm group label: • Steroid Group (S)
arm group type: Experimental
arm group label: • Platelet rich plasma Group (PRP)
arm group type: Experimental
intervention type: Other
intervention name: Ultrasound guided Sacroiliac intra-articular injection
description: At the level of the sacral hiatus, the sacral cornuae were identified. posterior aspect of the sacroiliac joint, at 4.5 cm depth the SIJ was found. localal anesthetic was injected at the medial edge of the transducer, the spinal needle was advanced in a medial to lateral direction, under direct vision, until the needle was positioned in the SIJ. Local steroid solution or PRP 4ml volume was injected according to the study group and patient enrollment. If the injection is extra-articular, injectate (hyperechoic solution as it contains particulate steroid) can be seen spreading medially over the sacrum. The visual analog score, Oswestry Disability Index (ODI) score and the overall success rate basal, after one week,after one month,after three and six month's follow-up period after the initial block.
arm group label: • Platelet rich plasma Group (PRP)
arm group label: • Steroid Group (S)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Sponsor
mesh term: Sacroiliitis