<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/NCT04467450</url>
  </required_header>
  <id_info>
    <org_study_id>RC6-5-2020</org_study_id>
    <nct_id>NCT04467450</nct_id>
  </id_info>
  <brief_title>Ultrasound Guided Botulinum Toxin Type A Injection of Subacromial-Subdeltoid Bursa in Hemiplegic Shoulder Pain</brief_title>
  <official_title>Ultrasound Guided Botulinum Toxin Type A Injection of Subacromial-Subdeltoid Bursa in Hemiplegic Shoulder Pain: Comparative Study Versus Corticosteroid Injection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Benha University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Benha University</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Good shoulder function is a prerequisite for effective hand function, as well as for&#xD;
      performing multiple tasks involving mobility, ambulation, and activities of daily living&#xD;
      (ADL). A common sequela of stroke is hemiplegic shoulder pain, which can hamper functional&#xD;
      recovery and subsequently lead to disability. Hemiplegic shoulder pain can begin as early as&#xD;
      2 weeks post stroke but typically occurs within 2-3 months post stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subject and methods: Patients with clinical diagnosis of hemiparesis on the criteria of the&#xD;
      World Health Organization (WHO, 2001) will be recruited from Benha university hospitals'&#xD;
      outpatients and inpatients units of Rheumatology ,Rehabilitation and Physical medicine&#xD;
      department The diagnosis of stroke was confirmed by the findings of either brain CT or MRI.&#xD;
&#xD;
      All patients should have localized severe shoulder pain of the paretic upper limb with or&#xD;
      without limitation of shoulder range of motion (ROM) with the following inclusion criteria:&#xD;
&#xD;
      Hemiplegic shoulder pain (HSP) duration at least 3 months, pain score &gt;3 on a pain visual&#xD;
      analog scale (VAS) of 0 to 10 cm (0 no pain, 10 worst possible pain) at rest, and/or pain at&#xD;
      movement score &gt;5 on VAS during passive shoulder abduction, pain was not relieved by&#xD;
      conventional treatment (common analgesics, such as paracetamol and non-steroidal&#xD;
      anti-inflammatory drugs; slings; physical modalities such as transcutaneous electrical nerve&#xD;
      stimulation of shoulder muscles or manual therapy). No significant spasticity in the upper&#xD;
      shoulder joint, defined as Modified Ashworth Scale (MAS) score ≤2 , ultrasonographically&#xD;
      diagnosed subacromial subdeltoid (SASD ) bursitis. previous shoulder steroid or botulinum&#xD;
      toxin A injection in the affected side or known allergy for botulinum toxin.&#xD;
&#xD;
      Complete history will be addressed from all subjects emphasizing the age, sex, type of stroke&#xD;
      (hemorrhagic, thrombotic) ,duration of the stroke, side of hemiplegia , duration of shoulder&#xD;
      pain .Complete neurological and musculoskeletal examination .All patients will be examined by&#xD;
      a single independent physiatrist.&#xD;
&#xD;
      Patients will be classified based on the type of the injected material into 2 categories: 18&#xD;
      patients will be injected by 20 IU botulinum Toxin A, ( BoNT/A) group and 18 patients will be&#xD;
      injected by 40 mg methyl prednisolone (steroid group) The assessment of therapeutic effects&#xD;
      will be performed at the start of the study, and in the 3rd and 10th weeks. Shoulder pain&#xD;
      will quantified by VAS score at rest (night pain ) and during the day ( movement pain ) .&#xD;
&#xD;
      The physiatrist who will carry out the initial assessment and will perform the&#xD;
      intra-articular injection will not participate in follow-up assessments.&#xD;
&#xD;
      Upper limb motor function was assessed sensorimotor function assessment for the upper&#xD;
      extremity domain of the Fugl-Meyer Assessment (FMA-UE) .&#xD;
&#xD;
      Spasticity around the shoulder will be assessed by MAS. Physical disability and behavior&#xD;
      related to activities of daily living will be assessed by Modified Barthel ADL index for&#xD;
      stroke patients .&#xD;
&#xD;
      Subacromial subdeltoid bursitis(SASD) will be assessed in the paretic shoulder by high&#xD;
      frequency probe SASD bursitis if there is thickness ≥ 2mm and / or effusion or both&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">December 15, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 20, 2020</primary_completion_date>
  <phase>Early Phase 1</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>visual analog scale (VAS) for pain</measure>
    <time_frame>One hour before the injection.</time_frame>
    <description>The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum &quot;no pain&quot; on the left end (0 cm) of the scale and the &quot;worst pain&quot; on the right end of the scale (10 cm).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>visual analog scale (VAS) for pain</measure>
    <time_frame>In the 1st follow up visit 2 weeks after the injection</time_frame>
    <description>The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum &quot;no pain&quot; on the left end (0 cm) of the scale and the &quot;worst pain&quot; on the right end of the scale (10 cm).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>visual analog scale (VAS) for pain</measure>
    <time_frame>In the 2nd follow up visit 10 weeks after the injection .</time_frame>
    <description>The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum &quot;no pain&quot; on the left end (0 cm) of the scale and the &quot;worst pain&quot; on the right end of the scale (10 cm).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Modified Ashworth scale (MAS)</measure>
    <time_frame>One hour before the injection</time_frame>
    <description>measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity.[1] Scoring (taken from Bohannon and Smith, 1987):&#xD;
0: No increase in muscle tone&#xD;
1: Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension&#xD;
1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM&#xD;
2: More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved&#xD;
3: Considerable increase in muscle tone, passive movement difficult&#xD;
4: Affected part(s) rigid in flexion or extension</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Modified Ashworth scale (MAS)</measure>
    <time_frame>In the 1st follow up visit 2 weeks after the injection</time_frame>
    <description>measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity.[1] Scoring (taken from Bohannon and Smith, 1987):&#xD;
0: No increase in muscle tone&#xD;
1: Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension&#xD;
1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM&#xD;
2: More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved&#xD;
3: Considerable increase in muscle tone, passive movement difficult&#xD;
4: Affected part(s) rigid in flexion or extension</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Modified Ashworth scale (MAS)</measure>
    <time_frame>In the 2nd follow up visit 10 weeks after the injection</time_frame>
    <description>measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity.[1] Scoring (taken from Bohannon and Smith, 1987):&#xD;
0: No increase in muscle tone&#xD;
1: Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension&#xD;
1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM&#xD;
2: More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved&#xD;
3: Considerable increase in muscle tone, passive movement difficult&#xD;
4: Affected part(s) rigid in flexion or extension</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fugl-Meyer Assessment (FMA-UE)</measure>
    <time_frame>One hour before the injection.</time_frame>
    <description>The FM scale is a 226-point multi-item Likert-type scale developed as an evaluative measure of recovery from hemiplegic stroke. It is divided into 5 domains: motor function, sensory function, balance, joint range of motion, and joint pain. Each domain contains multiple items, each scored on a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully).&#xD;
In our study we will assess only motor function domain of the upper limb excluding coordination testing and the total possible scale score for (FMA-UE) is 60.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fugl-Meyer Assessment (FMA-UE)</measure>
    <time_frame>In the 1st follow up visit 2 weeks after the injection</time_frame>
    <description>The FM scale is a 226-point multi-item Likert-type scale developed as an evaluative measure of recovery from hemiplegic stroke. It is divided into 5 domains: motor function, sensory function, balance, joint range of motion, and joint pain. Each domain contains multiple items, each scored on a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully).&#xD;
In our study we will assess only motor function domain of the upper limb excluding coordination testing and the total possible scale score for (FMA-UE) is 60.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fugl-Meyer Assessment (FMA-UE)</measure>
    <time_frame>In the 2nd follow up visit 10 weeks after the injection</time_frame>
    <description>The FM scale is a 226-point multi-item Likert-type scale developed as an evaluative measure of recovery from hemiplegic stroke. It is divided into 5 domains: motor function, sensory function, balance, joint range of motion, and joint pain. Each domain contains multiple items, each scored on a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully).&#xD;
In our study we will assess only motor function domain of the upper limb excluding coordination testing and the total possible scale score for (FMA-UE) is 60.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Modified Barthel ADL index*</measure>
    <time_frame>One hour before the injection.</time_frame>
    <description>Measure of physical disability used widely to assess behaviour relating to activities of daily living for stroke patients or patients with other disabling conditions. It measures what patients do in practice. Assessment is made by anyone who knows the patient well.&#xD;
Total score of 20 Score &lt;15 - usually represents moderate disability &lt;10- usually represents severe disability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Modified Barthel ADL index*</measure>
    <time_frame>In the 1st follow up visit 2 weeks after the injection</time_frame>
    <description>Measure of physical disability used widely to assess behaviour relating to activities of daily living for stroke patients or patients with other disabling conditions. It measures what patients do in practice. Assessment is made by anyone who knows the patient well.&#xD;
Total score of 20 Score &lt;15 - usually represents moderate disability &lt;10- usually represents severe disability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Modified Barthel ADL index*</measure>
    <time_frame>In the 2nd follow up visit 10 weeks after the injection</time_frame>
    <description>Measure of physical disability used widely to assess behaviour relating to activities of daily living for stroke patients or patients with other disabling conditions. It measures what patients do in practice. Assessment is made by anyone who knows the patient well.&#xD;
Total score of 20 Score &lt;15 - usually represents moderate disability &lt;10- usually represents severe disability.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">36</enrollment>
  <condition>Subacromial Bursitis</condition>
  <condition>Subdeltoid Bursitis</condition>
  <arm_group>
    <arm_group_label>Botox injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>half of the hemiplegic patients will be injected by botulinum toxin A in the inflamed subacromial-subdeltoid bursa guided by musculoskeletal ultrasound</description>
  </arm_group>
  <arm_group>
    <arm_group_label>methyl prednisolonate injection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>the other half of the hemiplegic patients will be injected by methylprednisolonate in the inflamed subacromial-subdeltoid bursa guided by musculoskeletal ultrasound</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>botulinum toxin type A</intervention_name>
    <description>ultrasound guided injection of the botulinum toxin type A in the inflamed subacromial subdeltoid bursa</description>
    <arm_group_label>Botox injection</arm_group_label>
    <other_name>botox 100 IU</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methyl Prednisolonate</intervention_name>
    <description>ultrasound guided injection of Methyl Prednisolonate in the inflamed subacromial subdeltoid bursa</description>
    <arm_group_label>methyl prednisolonate injection</arm_group_label>
    <other_name>Depomedrol 40mg /2ml</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Clinical diagnosis of hemiparesis caused by stroke diagnosed according to World Health&#xD;
             Organization (WHO, 2001),&#xD;
&#xD;
          2. Shoulder pain for more than 3 months.&#xD;
&#xD;
          3. pain score &gt;3 on a pain visual analog scale at rest.&#xD;
&#xD;
          4. pain score &gt;5 on a pain visual analog scale during activity.&#xD;
&#xD;
          5. pain was not relieved by conventional treatment (common analgesics, and non-steroidal&#xD;
             anti-inflammatory drugs, slings or physical modalities).&#xD;
&#xD;
          6. No significant spasticity in the upper shoulder joint, defined as Modified Ashworth&#xD;
             Scale (MAS) score ≤2&#xD;
&#xD;
          7. Ultrasonographically diagnosed subacromial subdeltoid (SASD ) bursitis.&#xD;
&#xD;
        Exclusion Criteria :&#xD;
&#xD;
          1. history of shoulder pain or limited ROM before stroke.&#xD;
&#xD;
          2. previous trauma history affecting shoulder&#xD;
&#xD;
          3. shoulder subluxation&#xD;
&#xD;
          4. shoulder diseases ( osteoarthritis , rheumatoid arthritis , others )&#xD;
&#xD;
          5. other neurologic diseases&#xD;
&#xD;
          6. resistance greater than a MAS score 2&#xD;
&#xD;
          7. previous shoulder botulinum toxin or steroid injection in the affected side or known&#xD;
             allergy for botulinum toxin.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eman Baraka, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assisstant Profesoor</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Eman Baraka, MD</last_name>
    <phone>00210032080424</phone>
    <email>dremanbaraka@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Eman</name>
      <address>
        <city>Banhā</city>
        <state>Qalyubia</state>
        <zip>13512</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eman Baraka, MD</last_name>
      <phone>00201032080424</phone>
      <email>dremanbaraka@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <results_reference>
    <citation>Lee JH, Lee SH, Song SH. Clinical effectiveness of botulinum toxin type B in the treatment of subacromial bursitis or shoulder impingement syndrome. Clin J Pain. 2011 Jul-Aug;27(6):523-8. doi: 10.1097/AJP.0b013e31820e1310.</citation>
    <PMID>21368663</PMID>
  </results_reference>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>July 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>October 6, 2020</last_update_submitted>
  <last_update_submitted_qc>October 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Benha University</investigator_affiliation>
    <investigator_full_name>Eman Baraka</investigator_full_name>
    <investigator_title>Assisstant professor</investigator_title>
  </responsible_party>
  <keyword>stroke</keyword>
  <keyword>hemiplegia</keyword>
  <keyword>botulinum toxin</keyword>
  <keyword>musculoskeletal ultrasound</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shoulder Pain</mesh_term>
    <mesh_term>Bursitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methylprednisolone Acetate</mesh_term>
    <mesh_term>Botulinum Toxins</mesh_term>
    <mesh_term>Botulinum Toxins, Type A</mesh_term>
    <mesh_term>abobotulinumtoxinA</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/NCT04467450
org study id: RC6-5-2020
nct id: NCT04467450
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Good shoulder function is a prerequisite for effective hand function, as well as for
      performing multiple tasks involving mobility, ambulation, and activities of daily living
      (ADL). A common sequela of stroke is hemiplegic shoulder pain, which can hamper functional
      recovery and subsequently lead to disability. Hemiplegic shoulder pain can begin as early as
      2 weeks post stroke but typically occurs within 2-3 months post stroke.
Subject and methods: Patients with clinical diagnosis of hemiparesis on the criteria of the
      World Health Organization (WHO, 2001) will be recruited from Benha university hospitals'
      outpatients and inpatients units of Rheumatology ,Rehabilitation and Physical medicine
      department The diagnosis of stroke was confirmed by the findings of either brain CT or MRI.

      All patients should have localized severe shoulder pain of the paretic upper limb with or
      without limitation of shoulder range of motion (ROM) with the following inclusion criteria:

      Hemiplegic shoulder pain (HSP) duration at least 3 months, pain score >3 on a pain visual
      analog scale (VAS) of 0 to 10 cm (0 no pain, 10 worst possible pain) at rest, and/or pain at
      movement score >5 on VAS during passive shoulder abduction, pain was not relieved by
      conventional treatment (common analgesics, such as paracetamol and non-steroidal
      anti-inflammatory drugs; slings; physical modalities such as transcutaneous electrical nerve
      stimulation of shoulder muscles or manual therapy). No significant spasticity in the upper
      shoulder joint, defined as Modified Ashworth Scale (MAS) score ≤2 , ultrasonographically
      diagnosed subacromial subdeltoid (SASD ) bursitis. previous shoulder steroid or botulinum
      toxin A injection in the affected side or known allergy for botulinum toxin.

      Complete history will be addressed from all subjects emphasizing the age, sex, type of stroke
      (hemorrhagic, thrombotic) ,duration of the stroke, side of hemiplegia , duration of shoulder
      pain .Complete neurological and musculoskeletal examination .All patients will be examined by
      a single independent physiatrist.

      Patients will be classified based on the type of the injected material into 2 categories: 18
      patients will be injected by 20 IU botulinum Toxin A, ( BoNT/A) group and 18 patients will be
      injected by 40 mg methyl prednisolone (steroid group) The assessment of therapeutic effects
      will be performed at the start of the study, and in the 3rd and 10th weeks. Shoulder pain
      will quantified by VAS score at rest (night pain ) and during the day ( movement pain ) .

      The physiatrist who will carry out the initial assessment and will perform the
      intra-articular injection will not participate in follow-up assessments.

      Upper limb motor function was assessed sensorimotor function assessment for the upper
      extremity domain of the Fugl-Meyer Assessment (FMA-UE) .

      Spasticity around the shoulder will be assessed by MAS. Physical disability and behavior
      related to activities of daily living will be assessed by Modified Barthel ADL index for
      stroke patients .

      Subacromial subdeltoid bursitis(SASD) will be assessed in the paretic shoulder by high
      frequency probe SASD bursitis if there is thickness ≥ 2mm and / or effusion or both
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: visual analog scale (VAS) for pain
time frame: One hour before the injection.
description: The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).
measure: visual analog scale (VAS) for pain
time frame: In the 1st follow up visit 2 weeks after the injection
description: The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).
measure: visual analog scale (VAS) for pain
time frame: In the 2nd follow up visit 10 weeks after the injection .
description: The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).
measure: The Modified Ashworth scale (MAS)
time frame: One hour before the injection
description: measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity.[1] Scoring (taken from Bohannon and Smith, 1987):
0: No increase in muscle tone
1: Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension
1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM
2: More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
3: Considerable increase in muscle tone, passive movement difficult
4: Affected part(s) rigid in flexion or extension
measure: The Modified Ashworth scale (MAS)
time frame: In the 1st follow up visit 2 weeks after the injection
description: measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity.[1] Scoring (taken from Bohannon and Smith, 1987):
0: No increase in muscle tone
1: Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension
1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM
2: More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
3: Considerable increase in muscle tone, passive movement difficult
4: Affected part(s) rigid in flexion or extension
measure: The Modified Ashworth scale (MAS)
time frame: In the 2nd follow up visit 10 weeks after the injection
description: measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity.[1] Scoring (taken from Bohannon and Smith, 1987):
0: No increase in muscle tone
1: Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension
1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM
2: More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
3: Considerable increase in muscle tone, passive movement difficult
4: Affected part(s) rigid in flexion or extension
measure: Fugl-Meyer Assessment (FMA-UE)
time frame: One hour before the injection.
description: The FM scale is a 226-point multi-item Likert-type scale developed as an evaluative measure of recovery from hemiplegic stroke. It is divided into 5 domains: motor function, sensory function, balance, joint range of motion, and joint pain. Each domain contains multiple items, each scored on a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully).
In our study we will assess only motor function domain of the upper limb excluding coordination testing and the total possible scale score for (FMA-UE) is 60.
measure: Fugl-Meyer Assessment (FMA-UE)
time frame: In the 1st follow up visit 2 weeks after the injection
description: The FM scale is a 226-point multi-item Likert-type scale developed as an evaluative measure of recovery from hemiplegic stroke. It is divided into 5 domains: motor function, sensory function, balance, joint range of motion, and joint pain. Each domain contains multiple items, each scored on a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully).
In our study we will assess only motor function domain of the upper limb excluding coordination testing and the total possible scale score for (FMA-UE) is 60.
measure: Fugl-Meyer Assessment (FMA-UE)
time frame: In the 2nd follow up visit 10 weeks after the injection
description: The FM scale is a 226-point multi-item Likert-type scale developed as an evaluative measure of recovery from hemiplegic stroke. It is divided into 5 domains: motor function, sensory function, balance, joint range of motion, and joint pain. Each domain contains multiple items, each scored on a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully).
In our study we will assess only motor function domain of the upper limb excluding coordination testing and the total possible scale score for (FMA-UE) is 60.
measure: Modified Barthel ADL index*
time frame: One hour before the injection.
description: Measure of physical disability used widely to assess behaviour relating to activities of daily living for stroke patients or patients with other disabling conditions. It measures what patients do in practice. Assessment is made by anyone who knows the patient well.
Total score of 20 Score <15 - usually represents moderate disability <10- usually represents severe disability.
measure: Modified Barthel ADL index*
time frame: In the 1st follow up visit 2 weeks after the injection
description: Measure of physical disability used widely to assess behaviour relating to activities of daily living for stroke patients or patients with other disabling conditions. It measures what patients do in practice. Assessment is made by anyone who knows the patient well.
Total score of 20 Score <15 - usually represents moderate disability <10- usually represents severe disability.
measure: Modified Barthel ADL index*
time frame: In the 2nd follow up visit 10 weeks after the injection
description: Measure of physical disability used widely to assess behaviour relating to activities of daily living for stroke patients or patients with other disabling conditions. It measures what patients do in practice. Assessment is made by anyone who knows the patient well.
Total score of 20 Score <15 - usually represents moderate disability <10- usually represents severe disability.
arm group label: Botox injection
arm group type: Experimental
description: half of the hemiplegic patients will be injected by botulinum toxin A in the inflamed subacromial-subdeltoid bursa guided by musculoskeletal ultrasound
arm group label: methyl prednisolonate injection
arm group type: Active Comparator
description: the other half of the hemiplegic patients will be injected by methylprednisolonate in the inflamed subacromial-subdeltoid bursa guided by musculoskeletal ultrasound
intervention type: Drug
intervention name: botulinum toxin type A
description: ultrasound guided injection of the botulinum toxin type A in the inflamed subacromial subdeltoid bursa
arm group label: Botox injection
other name: botox 100 IU
intervention type: Drug
intervention name: Methyl Prednisolonate
description: ultrasound guided injection of Methyl Prednisolonate in the inflamed subacromial subdeltoid bursa
arm group label: methyl prednisolonate injection
other name: Depomedrol 40mg /2ml
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eman Baraka, MD
role: Principal Investigator
affiliation: Assisstant Profesoor
last name: Eman Baraka, MD
phone: 00210032080424
email: dremanbaraka@yahoo.com
facility: 
status: Recruiting
contact: 
country: Egypt
citation: Lee JH, Lee SH, Song SH. Clinical effectiveness of botulinum toxin type B in the treatment of subacromial bursitis or shoulder impingement syndrome. Clin J Pain. 2011 Jul-Aug;27(6):523-8. doi: 10.1097/AJP.0b013e31820e1310.
PMID: 21368663
responsible party type: Principal Investigator
investigator affiliation: Benha University
investigator full name: Eman Baraka
investigator title: Assisstant professor
mesh term: Shoulder Pain
mesh term: Bursitis
mesh term: Methylprednisolone Acetate
mesh term: Botulinum Toxins
mesh term: Botulinum Toxins, Type A
mesh term: abobotulinumtoxinA
sharing ipd: No