<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/NCT04433377</url>
  </required_header>
  <id_info>
    <org_study_id>2020-118</org_study_id>
    <nct_id>NCT04433377</nct_id>
  </id_info>
  <brief_title>Comparison Suprascapular Nerve Block and Subacromial Injection in Hemiplegic Shoulder Pain</brief_title>
  <official_title>Comparison of the Effects of Ultrasound-guided Suprascapular Nerve Block and Subacromial Injection in Hemiplegic Shoulder Pain: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul Physical Medicine Rehabilitation Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul Physical Medicine Rehabilitation Training and Research Hospital</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>
      Hemiplegic shoulder pain is the most common poststroke painful condition. Hemiplegic shoulder&#xD;
      pain reduces range of motion (ROM) and hand function, resulting in limited daily life&#xD;
      activity and decreased quality of life.&#xD;
&#xD;
      In the literature, the effectiveness of suprascapular nerve block and subacromial injection&#xD;
      in hemiplegia patients with shoulder pain has been previously evaluated, but these injection&#xD;
      treatments have not been compared.&#xD;
&#xD;
      Therefore, the aim of this study is to compare the effectiveness of suprascapular nerve block&#xD;
      and subacromial injection on pain, shoulder (ROM), function and quality of life in hemiplegia&#xD;
      patients with shoulder pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be randomly assigned Subacromial injection group or Suprascapular nerve block&#xD;
      group&#xD;
&#xD;
      In the suprascapular nerve block group, suprascapular nerve block will be performed with a&#xD;
      MyLab60 model a high resolution 7-12-MHz linear probe ultrasonography device. After the&#xD;
      suprascapular fossa will be observed by ultrasonography, a betamethasone dipropionate plus&#xD;
      betamethasone sodium phosphate solution (6.43 mg / mL + 2.63 mg / mL; 1 mL), 0.5 %&#xD;
      bupivacaine (2 mL) and physiological serum (2 mL) will be injected with an in-plane technique&#xD;
      using a 22 gauge 90-mm injector.&#xD;
&#xD;
      In the subacromial injection group, subacromial injection will be performed with a MyLab60&#xD;
      model a high resolution 7-12-MHz linear probe ultrasonography device. After the subacromial&#xD;
      bursa will be observed by ultrasonography, a betamethasone dipropionate plus betamethasone&#xD;
      sodium phosphate solution (6.43 mg/mL + 2.63 mg/mL; 1 mL), 2% lidocaine (2 mL) and&#xD;
      physiological serum (2 mL) will be injected with an in-plane technique using a 21 gauge 38-mm&#xD;
      injector.&#xD;
&#xD;
      A home exercise program will be given both groups. The exercise program consisted of passive&#xD;
      and active-assistive ROM exercises (3 sets daily, 20 times in each set).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 28, 2020</start_date>
  <completion_date type="Actual">October 1, 2020</completion_date>
  <primary_completion_date type="Actual">August 1, 2020</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline in Visual Analog Scale (VAS) score</measure>
    <time_frame>baseline, month 1 and month 3</time_frame>
    <description>Self-reported neck pain intensity will be evaluated with the Visual Analog Scale (VAS). Patients will be asked about the average pain intensity that they had felt in the past week (&quot;0&quot; defines &quot;no pain&quot; and &quot;10&quot; defines &quot;unbearable pain'').</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Shoulder ROM</measure>
    <time_frame>baseline, month 1 and month 3</time_frame>
    <description>The shoulder ROM (flexion, abduction, internal rotation, external rotation) will be passively assessed by goniometry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Independence Measure (FIM)</measure>
    <time_frame>baseline, month 1 and month 3</time_frame>
    <description>Functional independence measure (FIM) will be used to evaluate independence for the activities of daily living. It was developed to measure the results of the rehabilitation on the patient. The higher scores in FIM are interpreted as better functional independence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EuroQol 5D-3L questionnaire (EQ-5D-3L)</measure>
    <time_frame>baseline, month 1 and month 3</time_frame>
    <description>The EQ-5D-3L scale, which scores five health conditions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) through evaluation at 3 levels (no problems, some problems, or extreme problems), will be used to evaluate the quality of life</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Hemiplegia</condition>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Suprascapular nerve block group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Suprascapular nerve block will be performed with a MyLab60 model a high resolution 7-12-MHz linear probe ultrasonography device. After the suprascapular fossa will be observed by ultrasonography, a betamethasone dipropionate plus betamethasone sodium phosphate solution (6.43 mg / mL + 2.63 mg / mL; 1 mL), 0.5 % bupivacaine (2 mL) and physiological serum (2 mL) will be injected with an in-plane technique using a 22 gauge 90-mm injector.&#xD;
Home exercise: The exercise program consists of passive and active-assistive ROM exercises (3 sets daily, 20 times in each set).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subacromial injection group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subacromial injection will be performed with a MyLab60 model a high resolution 7-12-MHz linear probe ultrasonography device. After the subacromial bursa will be observed by ultrasonography, a betamethasone dipropionate plus betamethasone sodium phosphate solution (6.43 mg/mL + 2.63 mg/mL; 1 mL), 2% lidocaine (2 mL) and physiological serum (2 mL) will be injected with an in-plane technique using a 21 gauge 38-mm injector.&#xD;
Home exercise: The exercise program consists of passive and active-assistive ROM exercises (3 sets daily, 20 times in each set).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Suprascapular nerve block</intervention_name>
    <description>A betamethasone dipropionate plus betamethasone sodium phosphate solution (6.43 mg / mL + 2.63 mg / mL; 1 mL), 0.5 % bupivacaine (2 mL) and physiological serum (2 mL) are injected with an in-plane technique using a 22 gauge 90-mm injector</description>
    <arm_group_label>Suprascapular nerve block group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Subacromial injection</intervention_name>
    <description>A betamethasone dipropionate plus betamethasone sodium phosphate solution (6.43 mg/mL + 2.63 mg/mL; 1 mL), 2% lidocaine (2 mL) and physiological serum (2 mL) are injected with an in-plane technique using a 21 gauge 38-mm injector.</description>
    <arm_group_label>Subacromial injection group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Brunstrom stage 2 to 5&#xD;
&#xD;
          -  spasticity &lt;4 according to the modified Ashworth scale&#xD;
&#xD;
          -  having hemiplegia less than 12 months&#xD;
&#xD;
          -  Presence of shoulder pain lasting more than 3 months&#xD;
&#xD;
          -  Conservative treatment for painful shoulder before injection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients over 75 years old, under 30 years old&#xD;
&#xD;
          -  Anti-coagulant or antiaggregant use&#xD;
&#xD;
          -  Presence of diabetes mellitus&#xD;
&#xD;
          -  Patients who could not be cooperated and Mini-mental Test (MMSE) score &lt;24&#xD;
&#xD;
          -  Having previously had suprascapular block or subacromial injection&#xD;
&#xD;
          -  Presence of complex regional pain syndrome (type I),&#xD;
&#xD;
          -  The presence of neglect syndrome&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mustafa Corum, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Istanbul Physical Medicine Rehabilitation Training &amp; Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Istanbul Physical Medicine and Rehabilitation Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <state>Bahcelievler</state>
        <zip>34180</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>October 13, 2020</last_update_submitted>
  <last_update_submitted_qc>October 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul Physical Medicine Rehabilitation Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Mustafa Corum</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shoulder Pain</mesh_term>
    <mesh_term>Hemiplegia</mesh_term>
  </condition_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/NCT04433377
org study id: 2020-118
nct id: NCT04433377
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Hemiplegic shoulder pain is the most common poststroke painful condition. Hemiplegic shoulder
      pain reduces range of motion (ROM) and hand function, resulting in limited daily life
      activity and decreased quality of life.

      In the literature, the effectiveness of suprascapular nerve block and subacromial injection
      in hemiplegia patients with shoulder pain has been previously evaluated, but these injection
      treatments have not been compared.

      Therefore, the aim of this study is to compare the effectiveness of suprascapular nerve block
      and subacromial injection on pain, shoulder (ROM), function and quality of life in hemiplegia
      patients with shoulder pain.
Patients will be randomly assigned Subacromial injection group or Suprascapular nerve block
      group

      In the suprascapular nerve block group, suprascapular nerve block will be performed with a
      MyLab60 model a high resolution 7-12-MHz linear probe ultrasonography device. After the
      suprascapular fossa will be observed by ultrasonography, a betamethasone dipropionate plus
      betamethasone sodium phosphate solution (6.43 mg / mL + 2.63 mg / mL; 1 mL), 0.5 %
      bupivacaine (2 mL) and physiological serum (2 mL) will be injected with an in-plane technique
      using a 22 gauge 90-mm injector.

      In the subacromial injection group, subacromial injection will be performed with a MyLab60
      model a high resolution 7-12-MHz linear probe ultrasonography device. After the subacromial
      bursa will be observed by ultrasonography, a betamethasone dipropionate plus betamethasone
      sodium phosphate solution (6.43 mg/mL + 2.63 mg/mL; 1 mL), 2% lidocaine (2 mL) and
      physiological serum (2 mL) will be injected with an in-plane technique using a 21 gauge 38-mm
      injector.

      A home exercise program will be given both groups. The exercise program consisted of passive
      and active-assistive ROM exercises (3 sets daily, 20 times in each set).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Change from Baseline in Visual Analog Scale (VAS) score
time frame: baseline, month 1 and month 3
description: Self-reported neck pain intensity will be evaluated with the Visual Analog Scale (VAS). Patients will be asked about the average pain intensity that they had felt in the past week ("0" defines "no pain" and "10" defines "unbearable pain'').
measure: Shoulder ROM
time frame: baseline, month 1 and month 3
description: The shoulder ROM (flexion, abduction, internal rotation, external rotation) will be passively assessed by goniometry.
measure: Functional Independence Measure (FIM)
time frame: baseline, month 1 and month 3
description: Functional independence measure (FIM) will be used to evaluate independence for the activities of daily living. It was developed to measure the results of the rehabilitation on the patient. The higher scores in FIM are interpreted as better functional independence
measure: EuroQol 5D-3L questionnaire (EQ-5D-3L)
time frame: baseline, month 1 and month 3
description: The EQ-5D-3L scale, which scores five health conditions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) through evaluation at 3 levels (no problems, some problems, or extreme problems), will be used to evaluate the quality of life
arm group label: Suprascapular nerve block group
arm group type: Experimental
description: Suprascapular nerve block will be performed with a MyLab60 model a high resolution 7-12-MHz linear probe ultrasonography device. After the suprascapular fossa will be observed by ultrasonography, a betamethasone dipropionate plus betamethasone sodium phosphate solution (6.43 mg / mL + 2.63 mg / mL; 1 mL), 0.5 % bupivacaine (2 mL) and physiological serum (2 mL) will be injected with an in-plane technique using a 22 gauge 90-mm injector.
Home exercise: The exercise program consists of passive and active-assistive ROM exercises (3 sets daily, 20 times in each set).
arm group label: Subacromial injection group
arm group type: Experimental
description: Subacromial injection will be performed with a MyLab60 model a high resolution 7-12-MHz linear probe ultrasonography device. After the subacromial bursa will be observed by ultrasonography, a betamethasone dipropionate plus betamethasone sodium phosphate solution (6.43 mg/mL + 2.63 mg/mL; 1 mL), 2% lidocaine (2 mL) and physiological serum (2 mL) will be injected with an in-plane technique using a 21 gauge 38-mm injector.
Home exercise: The exercise program consists of passive and active-assistive ROM exercises (3 sets daily, 20 times in each set).
intervention type: Procedure
intervention name: Suprascapular nerve block
description: A betamethasone dipropionate plus betamethasone sodium phosphate solution (6.43 mg / mL + 2.63 mg / mL; 1 mL), 0.5 % bupivacaine (2 mL) and physiological serum (2 mL) are injected with an in-plane technique using a 22 gauge 90-mm injector
arm group label: Suprascapular nerve block group
intervention type: Procedure
intervention name: Subacromial injection
description: A betamethasone dipropionate plus betamethasone sodium phosphate solution (6.43 mg/mL + 2.63 mg/mL; 1 mL), 2% lidocaine (2 mL) and physiological serum (2 mL) are injected with an in-plane technique using a 21 gauge 38-mm injector.
arm group label: Subacromial injection group
criteria: 
gender: All
minimum age: 30 Years
maximum age: 75 Years
healthy volunteers: No
last name: Mustafa Corum, MD
role: Principal Investigator
affiliation: Istanbul Physical Medicine Rehabilitation Training & Research Hospital
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
investigator full name: Mustafa Corum
investigator title: Principal Investigator
mesh term: Shoulder Pain
mesh term: Hemiplegia
sharing ipd: No