<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/NCT03247842</url>
  </required_header>
  <id_info>
    <org_study_id>3024/01/15</org_study_id>
    <nct_id>NCT03247842</nct_id>
  </id_info>
  <brief_title>The Analgesic Efficacy Supra-scapular Nerve RF After Breast Surgery</brief_title>
  <official_title>The Analgesic and Rehabilitative Value of Supra-scapular Nerve Radiofrequency in Patients With Chronic Shoulder Pain After Breast Surgery.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tanta University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tanta 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>
      Eighty patients with chronic shoulder pain after breast surgery were allocated randomly into&#xD;
      2 groups; forty patients received fluoroscopically guided supra-scapular nerve pulsed&#xD;
      radiofrequency (PRF) followed by injection of 0.25% bupivacaine solution containing 40 mg of&#xD;
      methylprednisolone (group1) and forty patients received fluoroscopically guided&#xD;
      supra-scapular nerve injection of of 0.25% bupivacaine solution containing 40 mg of&#xD;
      methylprednisolone (group 2) without active pulsed radiofrequency only demo mode was applied.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eighty patients with chronic shoulder pain after breast surgery were allocated randomly into&#xD;
      2 groups ; forty patients received fluoroscopically guided supra-scapular nerve pulsed&#xD;
      radiofrequency (PRF) followed by injection through the radiofrequency needle of 0.25%&#xD;
      bupivacaine solution containing 40 mg of methylprednisolone (group1) and forty patients&#xD;
      received fluoroscopically guided supra-scapular nerve injection of 0.25% bupivacaine solution&#xD;
      containing 40 mg of methylprednisolone (group 2) without active pulsed radiofrequency only&#xD;
      demo mode was applied.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 25, 2017</start_date>
  <completion_date type="Actual">June 30, 2019</completion_date>
  <primary_completion_date type="Actual">September 30, 2017</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>postoperative pain</measure>
    <time_frame>immedite postopertive</time_frame>
    <description>assessment using visual analogue scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>shoulder movement</measure>
    <time_frame>6 months after surgery</time_frame>
    <description>shoulder mobility using long arm geniometry</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Chronic Pain Syndrome</condition>
  <arm_group>
    <arm_group_label>suprascapular nerve RF</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Eighty patients with chronic shoulder pain after breast surgery were allocated randomly into 2 groups (Figure1); forty patients received fluoroscopically guided supra-scapular nerve pulsed radiofrequency (PRF) followed by injection through the radiofrequency needle of mL of 0.25% bupivacaine solution containing 40 mg of methylprednisolone (group1)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>suprascapular nerve block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>and forty patients received fluoroscopically guided supra-scapular nerve injection of mL of 0.25% bupivacaine solution containing 40 mg of methylprednisolone (group 2) without active pulsed radiofrequency only demo mode was applied.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>suprascapular nerve block</intervention_name>
    <description>Sixty patients with shoulder dystocia after breast surgery will receive stellate ganglion neurolysis with supra-scapular nerve radiofrequency,</description>
    <arm_group_label>suprascapular nerve RF</arm_group_label>
    <arm_group_label>suprascapular nerve block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with post-mastectomy pain&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria are patients with any medical contraindications to neurolysis,&#xD;
             patients with other bone metastases.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>patients with cancer breast</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Tanta university hospital</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>April 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>June 12, 2020</last_update_submitted>
  <last_update_submitted_qc>June 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tanta University</investigator_affiliation>
    <investigator_full_name>Ayman Abd Al-maksoud Yousef</investigator_full_name>
    <investigator_title>assistant professor</investigator_title>
  </responsible_party>
  <keyword>post mastectomy pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03247842
org study id: 3024/01/15
nct id: NCT03247842
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Eighty patients with chronic shoulder pain after breast surgery were allocated randomly into
      2 groups; forty patients received fluoroscopically guided supra-scapular nerve pulsed
      radiofrequency (PRF) followed by injection of 0.25% bupivacaine solution containing 40 mg of
      methylprednisolone (group1) and forty patients received fluoroscopically guided
      supra-scapular nerve injection of of 0.25% bupivacaine solution containing 40 mg of
      methylprednisolone (group 2) without active pulsed radiofrequency only demo mode was applied.
Eighty patients with chronic shoulder pain after breast surgery were allocated randomly into
      2 groups ; forty patients received fluoroscopically guided supra-scapular nerve pulsed
      radiofrequency (PRF) followed by injection through the radiofrequency needle of 0.25%
      bupivacaine solution containing 40 mg of methylprednisolone (group1) and forty patients
      received fluoroscopically guided supra-scapular nerve injection of 0.25% bupivacaine solution
      containing 40 mg of methylprednisolone (group 2) without active pulsed radiofrequency only
      demo mode was applied.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: postoperative pain
time frame: immedite postopertive
description: assessment using visual analogue scale
measure: shoulder movement
time frame: 6 months after surgery
description: shoulder mobility using long arm geniometry
arm group label: suprascapular nerve RF
arm group type: Active Comparator
description: Eighty patients with chronic shoulder pain after breast surgery were allocated randomly into 2 groups (Figure1); forty patients received fluoroscopically guided supra-scapular nerve pulsed radiofrequency (PRF) followed by injection through the radiofrequency needle of mL of 0.25% bupivacaine solution containing 40 mg of methylprednisolone (group1)
arm group label: suprascapular nerve block
arm group type: Active Comparator
description: and forty patients received fluoroscopically guided supra-scapular nerve injection of mL of 0.25% bupivacaine solution containing 40 mg of methylprednisolone (group 2) without active pulsed radiofrequency only demo mode was applied.
intervention type: Procedure
intervention name: suprascapular nerve block
description: Sixty patients with shoulder dystocia after breast surgery will receive stellate ganglion neurolysis with supra-scapular nerve radiofrequency,
arm group label: suprascapular nerve RF
arm group label: suprascapular nerve block
criteria: 
gender: Female
gender based: Yes
gender description: patients with cancer breast
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Tanta University
investigator full name: Ayman Abd Al-maksoud Yousef
investigator title: assistant professor
mesh term: Chronic Pain
sharing ipd: Undecided