<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/NCT04470401</url>
  </required_header>
  <id_info>
    <org_study_id>Eduardo Rocha</org_study_id>
    <nct_id>NCT04470401</nct_id>
  </id_info>
  <brief_title>The Treatment of Shoulder Pain in Hemiplegic Spastic Patients With Botulinum Toxin A</brief_title>
  <acronym>dolomtox</acronym>
  <official_title>The Treatment of Shoulder Pain in Hemiplegic Spastic Patients With Botulinum Toxin A</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Faculdade de Ciências Médicas da Santa Casa de São Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Faculdade de Ciências Médicas da Santa Casa de São Paulo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Stroke is the leading cause of disability in developed countries, and the major cause of&#xD;
      mortality in Brazil.It is associated with low quality of life, disability, decreased muscle&#xD;
      strength and control due to the hypertonia, spasticity. These pathways can develop inadequate&#xD;
      upper and lower limbs functional mechanisms. These changes are linked with disabilities and&#xD;
      painful syndromes.&#xD;
&#xD;
      The shoulder pain relationed after stroke has a variable prevalence from 16 to 84%, from mild&#xD;
      to severe pain and is relationed as a precursor factor of secondary deformities, depression,&#xD;
      longer hospital stay. Its etiology remains controversial with many possibilities as rotator&#xD;
      cuff injuries, glenohumeral dislocation, impact syndrome, bicipital tendinitis, hand shoulder&#xD;
      syndrome, myofascial painful syndrome, presence of spasticity and contractures, adhesive&#xD;
      capsulitis, central pain and others. Its management is controversial and could be done with&#xD;
      physical therapy (kinesiotherapy) intra-articular or local injections (muscles and nerves),&#xD;
      functional electrical stimulation, acupuncture, herbal medicine, tapping, myofascial painful&#xD;
      syndrome treatment, painkillers, anti-inflammatories and antispastic drugs like botulinum&#xD;
      toxin A - tested in few studies, case series, against corticosteroids.&#xD;
&#xD;
      The aim of this study will be to evaluate the effectiveness of the use of 200 units of&#xD;
      abobotulinumtoxin against placebo in both pectoralis major and subscapularis: for reducing&#xD;
      shoulder pain (Visual Analogue Scale, McGill pain scale), active and passive range of&#xD;
      motion(goniometer),upper limb function (Fugl-Meyer test), burden of care questionnaire (apply&#xD;
      to caregivers).&#xD;
&#xD;
      This study is designed as a prospective, double-blind, randomized, controlled study in two&#xD;
      Rehabilitation Centers (Rehabilitation Center from Santa Casa de São Paulo and Hospital de&#xD;
      Clínicas of Universidade de Sao Paulo - Ribeirão Preto).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The principal aim will be the pain evaluation (Visual Analogue Scale and McGill pain scale)&#xD;
      with the use of 200 units of abobotulinumtoxin (Dysport) against placebo in both pectoralis&#xD;
      major and subscapularis, after 01and 04 months of the procedure The secondary objectives will&#xD;
      be analysis the active and passive affected shoulder range of motion (goniometer), the upper&#xD;
      limb function (Fugl-Meyer test), Burden of care questionnaire (apply to caregivers) and the&#xD;
      use of medicine and therapies.&#xD;
&#xD;
      The sample size was calculated to a alpha error (5%), statistical power (80%) and a decrease&#xD;
      of 1.4 points in Visual Analogue Scale, totalizing 10 patients per group, to avoid lack of&#xD;
      statistical power due to possible drop out we will recruit 12 patients per group.&#xD;
&#xD;
      The muscles selected for this study are the pectoralis major and subscapularis muscles, each&#xD;
      receiving 200U of Dysport® distributed in 2 points, guided by electrical stimulation .The&#xD;
      evaluations will be performed in 0, 1 and 4 months after the procedure.&#xD;
&#xD;
      The researchers that will apply and evaluate the patients will be blinded. The patients will&#xD;
      be randomized by 6 blocks of four.&#xD;
&#xD;
      The inclusion criteria will be spasticity in upper limb due to ischemic or hemorrhagic&#xD;
      hemispheric stroke; over 18 years old; diagnosis of hemiplegic painful shoulder syndrome,&#xD;
      regardless of motor dominance; agreement of the patient, family member and / or responsible&#xD;
      caregiver to participate in the study.&#xD;
&#xD;
      The exclusion criteria will be pain before stroke in shoulder affected by hemiplegia;&#xD;
      previous treatment using TXB-A for painful shoulder; cognitive impairment that hinders&#xD;
      assessment and collaboration with treatment; counterindication to the botulinum toxin use;&#xD;
      structured joint deformity in the shoulder affected by pain.&#xD;
&#xD;
      The qualitative variables will be described through percentages of each categories. The&#xD;
      quantitative variables will be analyzed for normality by the Komolgorov-Smirnov. The&#xD;
      comparison of the value average of the pain variable evaluated by VAS will be performed by&#xD;
      the ANOVA test, considering the treatment groups and the moment of evaluation, followed by&#xD;
      post hoc comparisons, if the ANOVA test indicates a significant effect group time.The&#xD;
      dropouts will be evaluated according to the intention to treat. We will use software Stata11&#xD;
      or similar model&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 5, 2019</start_date>
  <completion_date type="Actual">March 5, 2021</completion_date>
  <primary_completion_date type="Actual">September 5, 2020</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>
    <intervention_model_description>Two arms, a placebo group versus a abobotulinumtoxina (400 IU), to be applied in both muscles (200 IU each) subscapularis and pectoral major</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>The patients will receive placebo or botulinum toxin in the same characteristics. Just a assessor of the study will know the groups</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Pain in Visual Analogue Scale</measure>
    <time_frame>1 and 4 months</time_frame>
    <description>Change of 1.4 mm in Visual Analogue Scale (Scale from 0 to 10mm, where 10 is the worst pain sensation and 0 is pain absence</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of pain in McGill scale</measure>
    <time_frame>1 and 4 months</time_frame>
    <description>Change of McGill pain scale in at least 02 categories (in a 20 different categories, and decrease of the total number (maximum of 56 points that represent the worst pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change Upper Limb function in Fugl Meyer scale</measure>
    <time_frame>1 and 4 months</time_frame>
    <description>Change of function in at least 03 points in Full Meyer scale that represents a maximum value of 66 that represents the upper limb higher function</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Shoulder Pain</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Abobotulinumtoxina 400 IU in 2cc of saline solution</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Abobotulinumtoxina - 400IU</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>placebo (2cc of saline solution)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AbobotulinumtoxinA</intervention_name>
    <description>application of 1cc of placebo (saline) or 1cc of abobotulinumtoxinA in both subscapularis and pectoral major muscles</description>
    <arm_group_label>Abobotulinumtoxina - 400IU</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline</intervention_name>
    <description>application of 1cc of placebo (saline) or 1cc of abobotulinumtoxinA in both subscapularis and pectoral major muscles</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Spasticity in upper limb due to ischemic or hemorrhagic hemispheric stroke;&#xD;
&#xD;
          -  Diagnosis of hemiplegic painful shoulder syndrome, regardless of motor dominance;&#xD;
&#xD;
          -  Agreement of the patient, family member and / or responsible caregiver to participate&#xD;
             in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pain before stroke in shoulder affected by hemiplegia;&#xD;
&#xD;
          -  Previous treatment using TXB-A for painful shoulder;&#xD;
&#xD;
          -  Cognitive impairment that hinders assessment and collaboration with treatment;&#xD;
&#xD;
          -  Counter indication to the botulinum toxin use; Structured joint deformity in the&#xD;
             shoulder affected by pain&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Santa Casa SP</name>
      <address>
        <city>São Paulo</city>
        <state>Sao Paulo</state>
        <zip>09040330</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>September 15, 2021</last_update_submitted>
  <last_update_submitted_qc>September 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Shoulder Pain</keyword>
  <keyword>Botulinum toxins</keyword>
  <keyword>Hemiplegia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shoulder Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>abobotulinumtoxinA</mesh_term>
    <mesh_term>Botulinum Toxins, Type A</mesh_term>
  </intervention_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/NCT04470401
org study id: Eduardo Rocha
nct id: NCT04470401
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Stroke is the leading cause of disability in developed countries, and the major cause of
      mortality in Brazil.It is associated with low quality of life, disability, decreased muscle
      strength and control due to the hypertonia, spasticity. These pathways can develop inadequate
      upper and lower limbs functional mechanisms. These changes are linked with disabilities and
      painful syndromes.

      The shoulder pain relationed after stroke has a variable prevalence from 16 to 84%, from mild
      to severe pain and is relationed as a precursor factor of secondary deformities, depression,
      longer hospital stay. Its etiology remains controversial with many possibilities as rotator
      cuff injuries, glenohumeral dislocation, impact syndrome, bicipital tendinitis, hand shoulder
      syndrome, myofascial painful syndrome, presence of spasticity and contractures, adhesive
      capsulitis, central pain and others. Its management is controversial and could be done with
      physical therapy (kinesiotherapy) intra-articular or local injections (muscles and nerves),
      functional electrical stimulation, acupuncture, herbal medicine, tapping, myofascial painful
      syndrome treatment, painkillers, anti-inflammatories and antispastic drugs like botulinum
      toxin A - tested in few studies, case series, against corticosteroids.

      The aim of this study will be to evaluate the effectiveness of the use of 200 units of
      abobotulinumtoxin against placebo in both pectoralis major and subscapularis: for reducing
      shoulder pain (Visual Analogue Scale, McGill pain scale), active and passive range of
      motion(goniometer),upper limb function (Fugl-Meyer test), burden of care questionnaire (apply
      to caregivers).

      This study is designed as a prospective, double-blind, randomized, controlled study in two
      Rehabilitation Centers (Rehabilitation Center from Santa Casa de São Paulo and Hospital de
      Clínicas of Universidade de Sao Paulo - Ribeirão Preto).
The principal aim will be the pain evaluation (Visual Analogue Scale and McGill pain scale)
      with the use of 200 units of abobotulinumtoxin (Dysport) against placebo in both pectoralis
      major and subscapularis, after 01and 04 months of the procedure The secondary objectives will
      be analysis the active and passive affected shoulder range of motion (goniometer), the upper
      limb function (Fugl-Meyer test), Burden of care questionnaire (apply to caregivers) and the
      use of medicine and therapies.

      The sample size was calculated to a alpha error (5%), statistical power (80%) and a decrease
      of 1.4 points in Visual Analogue Scale, totalizing 10 patients per group, to avoid lack of
      statistical power due to possible drop out we will recruit 12 patients per group.

      The muscles selected for this study are the pectoralis major and subscapularis muscles, each
      receiving 200U of Dysport® distributed in 2 points, guided by electrical stimulation .The
      evaluations will be performed in 0, 1 and 4 months after the procedure.

      The researchers that will apply and evaluate the patients will be blinded. The patients will
      be randomized by 6 blocks of four.

      The inclusion criteria will be spasticity in upper limb due to ischemic or hemorrhagic
      hemispheric stroke; over 18 years old; diagnosis of hemiplegic painful shoulder syndrome,
      regardless of motor dominance; agreement of the patient, family member and / or responsible
      caregiver to participate in the study.

      The exclusion criteria will be pain before stroke in shoulder affected by hemiplegia;
      previous treatment using TXB-A for painful shoulder; cognitive impairment that hinders
      assessment and collaboration with treatment; counterindication to the botulinum toxin use;
      structured joint deformity in the shoulder affected by pain.

      The qualitative variables will be described through percentages of each categories. The
      quantitative variables will be analyzed for normality by the Komolgorov-Smirnov. The
      comparison of the value average of the pain variable evaluated by VAS will be performed by
      the ANOVA test, considering the treatment groups and the moment of evaluation, followed by
      post hoc comparisons, if the ANOVA test indicates a significant effect group time.The
      dropouts will be evaluated according to the intention to treat. We will use software Stata11
      or similar model
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Two arms, a placebo group versus a abobotulinumtoxina (400 IU), to be applied in both muscles (200 IU each) subscapularis and pectoral major
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: The patients will receive placebo or botulinum toxin in the same characteristics. Just a assessor of the study will know the groups
measure: Change in Pain in Visual Analogue Scale
time frame: 1 and 4 months
description: Change of 1.4 mm in Visual Analogue Scale (Scale from 0 to 10mm, where 10 is the worst pain sensation and 0 is pain absence
measure: Change of pain in McGill scale
time frame: 1 and 4 months
description: Change of McGill pain scale in at least 02 categories (in a 20 different categories, and decrease of the total number (maximum of 56 points that represent the worst pain.
measure: Change Upper Limb function in Fugl Meyer scale
time frame: 1 and 4 months
description: Change of function in at least 03 points in Full Meyer scale that represents a maximum value of 66 that represents the upper limb higher function
arm group label: Placebo
arm group type: Placebo Comparator
description: Abobotulinumtoxina 400 IU in 2cc of saline solution
arm group label: Abobotulinumtoxina - 400IU
arm group type: Experimental
description: placebo (2cc of saline solution)
intervention type: Drug
intervention name: AbobotulinumtoxinA
description: application of 1cc of placebo (saline) or 1cc of abobotulinumtoxinA in both subscapularis and pectoral major muscles
arm group label: Abobotulinumtoxina - 400IU
intervention type: Drug
intervention name: Saline
description: application of 1cc of placebo (saline) or 1cc of abobotulinumtoxinA in both subscapularis and pectoral major muscles
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Shoulder Pain
mesh term: abobotulinumtoxinA
mesh term: Botulinum Toxins, Type A