<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/NCT03794505</url>
  </required_header>
  <id_info>
    <org_study_id>F-2018-3401-056</org_study_id>
    <nct_id>NCT03794505</nct_id>
  </id_info>
  <brief_title>Quality of Life and Pain With Infiltration or Suprascapular Nerve Block in Glenohumeral Arthirtis</brief_title>
  <official_title>Health Related Quality of Life and Pain Managment Using Infiltration or Suprascapular Nerve Block Ultrasound Guided in Patients With Glenohumeral Arthirtis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Mexicano del Seguro Social</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto Mexicano del Seguro Social</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>
      Efficacy in pain and health related quality of life of suprascapular nerve block ultrasound&#xD;
      guided and glenohumeral infiltration in glenohumeral arthritis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To describe the efficacy in pain management and health related quality of life of&#xD;
      suprascapular nerve block ultrasound guided and glenohumeral infiltration in patients with&#xD;
      glenohumeral arthritis&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2018</start_date>
  <completion_date type="Actual">August 30, 2018</completion_date>
  <primary_completion_date type="Actual">August 30, 2018</primary_completion_date>
  <phase>Phase 3</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain before</measure>
    <time_frame>VAS before intervention</time_frame>
    <description>visual analogue scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain 2 months after</measure>
    <time_frame>VAS 2 months after</time_frame>
    <description>Visual analogue scale 2 months after procedure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain 6 months after</measure>
    <time_frame>VAS 6 months after</time_frame>
    <description>Visual analogue scale 6 months after procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life before procedure</measure>
    <time_frame>SF12v2 before procedure</time_frame>
    <description>SF12v2 Health related quality of life before procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life 2 months after procedure</measure>
    <time_frame>SF12v2 2 months after</time_frame>
    <description>SF12v2 Health related quality of life 2 months after</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life 6 months after procedure</measure>
    <time_frame>SF12v2 6 months after</time_frame>
    <description>SF12v2 Health related quality of life 6 months after</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Shoulder Arthritis</condition>
  <arm_group>
    <arm_group_label>Shoulder infiltration</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Shoulder infiltration using 2 ml of Lidocaine 2% Injectable Solution and methylprednisolone acetate 40 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Suprascapular nerve block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Suprascapular nerve block ultrasound guided using 25 mg of Ropivacaine HCl Inj 7.5 MG/ML and methylprednisolone acetate 40 mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methylprednisolone Acetate</intervention_name>
    <description>depo-medrol 40 mg</description>
    <arm_group_label>Shoulder infiltration</arm_group_label>
    <arm_group_label>Suprascapular nerve block</arm_group_label>
    <other_name>depo-medrol 40 mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine 2% Injectable Solution</intervention_name>
    <description>2ml of 2% lidocaine</description>
    <arm_group_label>Shoulder infiltration</arm_group_label>
    <other_name>xilocaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ropivacaine HCl Inj 7.5 MG/ML</intervention_name>
    <description>25 mg</description>
    <arm_group_label>Suprascapular nerve block</arm_group_label>
    <other_name>Ropivacaine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  IMSS affiliated&#xD;
&#xD;
          -  Glenohumeral arthritis diagnosed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previusly treatment for the same disease&#xD;
&#xD;
          -  No follow up&#xD;
&#xD;
          -  Dead&#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>Luis Alonso Calderon Cordova, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>IMSS</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Orthopedics, UMAE &quot;Dr. Victorio de la Fuente Narváez&quot; IMSS-UNAM. Ciudad de México, México</name>
      <address>
        <city>Mexico City</city>
        <state>Gustavo A Madero</state>
        <zip>07760</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>January 5, 2019</last_update_submitted>
  <last_update_submitted_qc>January 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Instituto Mexicano del Seguro Social</investigator_affiliation>
    <investigator_full_name>Luis Alonso Calderon Cordova</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methylprednisolone</mesh_term>
    <mesh_term>Methylprednisolone Acetate</mesh_term>
    <mesh_term>Methylprednisolone Hemisuccinate</mesh_term>
    <mesh_term>Prednisolone</mesh_term>
    <mesh_term>Prednisolone acetate</mesh_term>
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Ropivacaine</mesh_term>
    <mesh_term>Prednisolone hemisuccinate</mesh_term>
    <mesh_term>Prednisolone phosphate</mesh_term>
  </intervention_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/NCT03794505
org study id: F-2018-3401-056
nct id: NCT03794505
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Efficacy in pain and health related quality of life of suprascapular nerve block ultrasound
      guided and glenohumeral infiltration in glenohumeral arthritis
To describe the efficacy in pain management and health related quality of life of
      suprascapular nerve block ultrasound guided and glenohumeral infiltration in patients with
      glenohumeral arthritis
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Pain before
time frame: VAS before intervention
description: visual analogue scale
measure: Pain 2 months after
time frame: VAS 2 months after
description: Visual analogue scale 2 months after procedure
measure: Pain 6 months after
time frame: VAS 6 months after
description: Visual analogue scale 6 months after procedure
measure: Quality of life before procedure
time frame: SF12v2 before procedure
description: SF12v2 Health related quality of life before procedure
measure: Quality of life 2 months after procedure
time frame: SF12v2 2 months after
description: SF12v2 Health related quality of life 2 months after
measure: Quality of life 6 months after procedure
time frame: SF12v2 6 months after
description: SF12v2 Health related quality of life 6 months after
arm group label: Shoulder infiltration
arm group type: Active Comparator
description: Shoulder infiltration using 2 ml of Lidocaine 2% Injectable Solution and methylprednisolone acetate 40 mg
arm group label: Suprascapular nerve block
arm group type: Experimental
description: Suprascapular nerve block ultrasound guided using 25 mg of Ropivacaine HCl Inj 7.5 MG/ML and methylprednisolone acetate 40 mg
intervention type: Drug
intervention name: Methylprednisolone Acetate
description: depo-medrol 40 mg
arm group label: Shoulder infiltration
arm group label: Suprascapular nerve block
other name: depo-medrol 40 mg
intervention type: Drug
intervention name: Lidocaine 2% Injectable Solution
description: 2ml of 2% lidocaine
arm group label: Shoulder infiltration
other name: xilocaine
intervention type: Drug
intervention name: Ropivacaine HCl Inj 7.5 MG/ML
description: 25 mg
arm group label: Suprascapular nerve block
other name: Ropivacaine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Luis Alonso Calderon Cordova, MD
role: Principal Investigator
affiliation: IMSS
facility: 
country: Mexico
responsible party type: Principal Investigator
investigator affiliation: Instituto Mexicano del Seguro Social
investigator full name: Luis Alonso Calderon Cordova
investigator title: Principal Investigator
mesh term: Methylprednisolone
mesh term: Methylprednisolone Acetate
mesh term: Methylprednisolone Hemisuccinate
mesh term: Prednisolone
mesh term: Prednisolone acetate
mesh term: Lidocaine
mesh term: Ropivacaine
mesh term: Prednisolone hemisuccinate
mesh term: Prednisolone phosphate
sharing ipd: No