<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/NCT01726608</url>
  </required_header>
  <id_info>
    <org_study_id>Reda 7869</org_study_id>
    <nct_id>NCT01726608</nct_id>
  </id_info>
  <brief_title>RFN for SIJ Disease Study</brief_title>
  <official_title>A Sham, Controlled, Randomised Trial to Investigate the Effects of Radiofrequency Neurotomy Using Simplicity III® on Patients With Sacroiliac Joint Pain.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Barts &amp; The London NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Barts &amp; The London NHS Trust</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to investigate if a technique called Simplicity III®&#xD;
      Radiofrequency Neurotomy is effective in improving the management of sacroiliac joint pain.&#xD;
      Currently there are a variety of treatments for managing this pain but there is still some&#xD;
      doubt as to which treatments are the most effective. Simplicity III® is one such treatment&#xD;
      for sacroiliac joint pain and has been used in the NHS for many years. It uses electrical&#xD;
      current to generate heat around the tip of the needle placed close to the nerves that supply&#xD;
      the sacro-iliac joint. This heat ablates the specific nerves supplying the joint and improves&#xD;
      pain.&#xD;
&#xD;
      The traditional method used to treat this type of pain uses multiple injections to target the&#xD;
      nerves supplying the joint. This method is however both time consuming and the results are&#xD;
      variable depending upon the number of injections. Therefore a new electrode, called the&#xD;
      Simplicity III®, was developed to allow the treatment to be undertaken using fewer&#xD;
      injections. Although this treatment has received formal approval, undergone conformity&#xD;
      assessment and is available in certain specialist NHS centres for clinical use, there is&#xD;
      presently limited evidence with regards to its clinical efficacy. We wish to test the&#xD;
      effectiveness of this new device in treating sacroiliac joint pain. The best way to prove the&#xD;
      clinical effectiveness is to compare Simplicity III® against an identical procedure where the&#xD;
      electrode is not switched on and neither the patient nor the doctor is aware whether it was&#xD;
      switched on. Once pain has been assessed at 3 months, those patients not receiving active&#xD;
      treatment and remaining in pain will be offered the active treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <primary_completion_date type="Anticipated">December 2013</primary_completion_date>
  <phase>Phase 4</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Intensity</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Intensity</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of pain</measure>
    <time_frame>3 and 6 months</time_frame>
    <description>Short Form Mcgill Pain Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related Quality of life</measure>
    <time_frame>3 and 6 months</time_frame>
    <description>Short form health survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety and Depression</measure>
    <time_frame>3 and 6 months</time_frame>
    <description>Hospital and Depression Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Disability</measure>
    <time_frame>3 and 6 months</time_frame>
    <description>Oswestry Low Back Pain Disability Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life and quality-adjusted life years</measure>
    <time_frame>3 and 6 months</time_frame>
    <description>Euro Quol EQ-5D scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Portion of patients randomised to sham requiring rescue therapy with RFN</measure>
    <time_frame>3 and 6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Sacro Iliac Joint Pain</condition>
  <arm_group>
    <arm_group_label>Radiofrequency neurotomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Active Radiofrequency Neurotomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Sham radiofrequency neurotomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Comparison of active versus sham radiofrequency neurotomy with Simplicity III</intervention_name>
    <arm_group_label>Radiofrequency neurotomy</arm_group_label>
    <arm_group_label>Sham</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Written, informed consent&#xD;
&#xD;
          2. Age: 18 - 80 years old&#xD;
&#xD;
          3. Low back pain of more than 6 months duration with a minimum pain intensity of greater&#xD;
             than 5 out of 10 on an 11-point numerical rating scale in the 7 days preceding study&#xD;
             entry.&#xD;
&#xD;
          4. Subjects must achieve greater than 80% reduction in pain following each diagnostic,&#xD;
             intra-articular block. Subjects must undergo 2 blocks in total prior to randomisation.&#xD;
&#xD;
          5. Female subjects of potential childbearing age must be using adequate contraception&#xD;
             (i.e. using oral or intramuscular contraception or an IUCD) and must have a negative&#xD;
             urine test.&#xD;
&#xD;
          6. No vulnerable patient groups shall be recruited into this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects who do not fulfill inclusion criteria&#xD;
&#xD;
          2. Subjects who have previously been treated by any sacroiliac joint radiofrequency&#xD;
             neurotomy&#xD;
&#xD;
          3. Subjects who are breastfeeding&#xD;
&#xD;
          4. Contraindications to local anaesthetics and radiofrequency neurotomy as listed in&#xD;
             their respective summary of product characteristics&#xD;
&#xD;
          5. Subjects with documented or suspected alcohol or drug abuse, or who are suspected of&#xD;
             having an addictive personality&#xD;
&#xD;
          6. Subjects to whom any of the following apply: Major trauma to the lumbar spine in the&#xD;
             six months preceding study entry. Infection in the lumbar spine in the six months&#xD;
             preceding study entry&#xD;
&#xD;
          7. Subjects' known to have a condition that, in the investigator's judgment precludes&#xD;
             entry into the study.&#xD;
&#xD;
          8. Subjects with a significant psychiatric disorder (including depression) or subjects&#xD;
             receiving anti-psychotic medication.&#xD;
&#xD;
          9. Subjects who have received an investigational drug or have used an investigational&#xD;
             device in the 30 days preceding study entry.&#xD;
&#xD;
         10. Subjects unable to comply with the study assessments or unable to complete the&#xD;
             questionnaires.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vivek Mehta, MD FRCA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Barts &amp; The London NHS Trust</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sibtain Anwar, MA MB FRCA</last_name>
    <role>Study Director</role>
    <affiliation>Barts &amp; The London NHS Trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Vivek Mehta, MD FRCA</last_name>
    <phone>+442034655361</phone>
    <email>vivek.mehta@bartshealth.nhs.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sibtain Anwar, MA MB FRCA</last_name>
    <phone>+442034655361</phone>
    <email>sibtain.anwar@bartshealth.nhs.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Barts Health NHS Trust</name>
      <address>
        <city>London</city>
        <zip>EC1A 7BE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2013</verification_date>
  <study_first_submitted>November 11, 2012</study_first_submitted>
  <study_first_submitted_qc>November 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 15, 2012</study_first_posted>
  <last_update_submitted>January 28, 2013</last_update_submitted>
  <last_update_submitted_qc>January 28, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 29, 2013</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>Arthralgia</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/NCT01726608
org study id: Reda 7869
nct id: NCT01726608
lead sponsor: 
has dmc: Yes
The purpose of the study is to investigate if a technique called Simplicity III®
      Radiofrequency Neurotomy is effective in improving the management of sacroiliac joint pain.
      Currently there are a variety of treatments for managing this pain but there is still some
      doubt as to which treatments are the most effective. Simplicity III® is one such treatment
      for sacroiliac joint pain and has been used in the NHS for many years. It uses electrical
      current to generate heat around the tip of the needle placed close to the nerves that supply
      the sacro-iliac joint. This heat ablates the specific nerves supplying the joint and improves
      pain.

      The traditional method used to treat this type of pain uses multiple injections to target the
      nerves supplying the joint. This method is however both time consuming and the results are
      variable depending upon the number of injections. Therefore a new electrode, called the
      Simplicity III®, was developed to allow the treatment to be undertaken using fewer
      injections. Although this treatment has received formal approval, undergone conformity
      assessment and is available in certain specialist NHS centres for clinical use, there is
      presently limited evidence with regards to its clinical efficacy. We wish to test the
      effectiveness of this new device in treating sacroiliac joint pain. The best way to prove the
      clinical effectiveness is to compare Simplicity III® against an identical procedure where the
      electrode is not switched on and neither the patient nor the doctor is aware whether it was
      switched on. Once pain has been assessed at 3 months, those patients not receiving active
      treatment and remaining in pain will be offered the active treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Pain Intensity
time frame: 3 months
measure: Pain Intensity
time frame: 6 months
measure: Quality of pain
time frame: 3 and 6 months
description: Short Form Mcgill Pain Questionnaire
measure: Health related Quality of life
time frame: 3 and 6 months
description: Short form health survey
measure: Anxiety and Depression
time frame: 3 and 6 months
description: Hospital and Depression Scale
measure: Functional Disability
time frame: 3 and 6 months
description: Oswestry Low Back Pain Disability Questionnaire
measure: Health related quality of life and quality-adjusted life years
time frame: 3 and 6 months
description: Euro Quol EQ-5D scale
measure: Portion of patients randomised to sham requiring rescue therapy with RFN
time frame: 3 and 6 months
arm group label: Radiofrequency neurotomy
arm group type: Active Comparator
description: Active Radiofrequency Neurotomy
arm group label: Sham
arm group type: Placebo Comparator
description: Sham radiofrequency neurotomy
intervention type: Procedure
intervention name: Comparison of active versus sham radiofrequency neurotomy with Simplicity III
arm group label: Radiofrequency neurotomy
arm group label: Sham
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Vivek Mehta, MD FRCA
role: Principal Investigator
affiliation: Barts & The London NHS Trust
last name: Sibtain Anwar, MA MB FRCA
role: Study Director
affiliation: Barts & The London NHS Trust
last name: Vivek Mehta, MD FRCA
phone: +442034655361
email: vivek.mehta@bartshealth.nhs.uk
last name: Sibtain Anwar, MA MB FRCA
phone: +442034655361
email: sibtain.anwar@bartshealth.nhs.uk
facility: 
status: Recruiting
country: United Kingdom
responsible party type: Sponsor
mesh term: Arthralgia