<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/NCT02254876</url>
  </required_header>
  <id_info>
    <org_study_id>4496/2013</org_study_id>
    <nct_id>NCT02254876</nct_id>
  </id_info>
  <brief_title>Effectiveness of NeuroMuscular Taping on Painful Hemiplegic Shoulder</brief_title>
  <official_title>Effectiveness of NeuroMuscular Taping in a Population of Post Stroke Hemiplegic Patients Suffering From Painful Shoulder Syndrome - Randomized Controlled Trial (RCT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Bologna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Bologna</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Painful Shoulder Syndrome is a frequent complication after stroke occurring in between 5% and&#xD;
      84% of patients, often having a strong impact on their well-being and resulting in delays&#xD;
      achieving rehabilitative objectives.&#xD;
&#xD;
      The aim of the study is to demonstrate the effectiveness of Neuromuscular Taping in a&#xD;
      population of post-stroke hemiplegic patients suffering from painful shoulder syndrome with&#xD;
      respect to pain, spasticity and range of motion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will use two groups according to the methodology of Randomized Controlled Trials.&#xD;
      Both components of the two groups were treated by four rehabilitation sessions defined as&#xD;
      &quot;standard&quot;. This involves joint health and passive mobility for the glenohumeral and&#xD;
      scapulothoracic joints for a period of about 45 minutes each.&#xD;
&#xD;
      The patients of the sample group underwent the application of the NeuroMuscular Taping (NMT)&#xD;
      before each rehabilitative session. The control group was addressed exclusively to the&#xD;
      &quot;standard&quot; treatment. The sessions were spaced apart about five days to ensure the optimum&#xD;
      adhesion of NMT.&#xD;
&#xD;
      The results were evaluated by administering rating scales for pain (VAS) and spasticity&#xD;
      (Modified Ashworth Scale). The ROM was evaluated using the manual goniometer. The outcomes&#xD;
      (Pain, Spasticity, ROM) were assessed at base line, before and after each treatment session&#xD;
      and at 1 month follow up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2013</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain</measure>
    <time_frame>Before and after each treatment session and at 1 month follow up</time_frame>
    <description>The investigators assessed this outcome with a Visual Analogue Scale (VAS).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Spasticity</measure>
    <time_frame>Before and after each treatment session and at 1 month follow up</time_frame>
    <description>The investigators assessed this outcome with the Modified Ashworth Scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ROM</measure>
    <time_frame>Before and after each treatment session and at one month follow up.</time_frame>
    <description>The investigators assessed this outcome using manual goniometer.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Hemiplegia</condition>
  <arm_group>
    <arm_group_label>Standard physical therapy program</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard physical therapy program is delivered for four rehabilitation sessions for a period of about 45 minutes each.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NeuroMuscular Taping (NMT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NeuroMuscular Taping is delivered in addiction to the &quot;Standard Treatment&quot; for four rehabilitation sessions. The sessions were spaced apart about five days to ensure the optimum adhesion of the NMT.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard physical therapy program</intervention_name>
    <description>Standard physical therapy program in this study involves joint health and passive mobility at the level of the shoulder girdle and upper limb affected by Painful Shoulder Syndrome associated with the modulation of hypertonic muscle groups.</description>
    <arm_group_label>NeuroMuscular Taping (NMT)</arm_group_label>
    <arm_group_label>Standard physical therapy program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>NeuroMuscular Taping (NMT)</intervention_name>
    <description>The NeuroMuscular Taping (NMT) consists of the application on the skin of an adhesive tape with a particular structure to elastic waves and with characteristics comparable to those cutaneous. Because of these characterises it allows activation of endogenous analgesic, structural and muscular support, vascular and lymphatic activation.&#xD;
In this study the NMT is applied with decompressive mode on Pectoralis Major, Deltoids, Supraspinatus.</description>
    <arm_group_label>NeuroMuscular Taping (NMT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Right or left hemiplegia resulting from an ischemic or hemorrhagic stroke&#xD;
&#xD;
          -  Painful Shoulder Syndrome, with pain at rest and during functional movement of the&#xD;
             shoulder girdle&#xD;
&#xD;
          -  Spasticity with an Ashworth score greater than or equal to 1.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Flaccidity&#xD;
&#xD;
          -  Thermoalgesic sensitivity deficits&#xD;
&#xD;
          -  Previous surgery to the shoulder&#xD;
&#xD;
          -  Cognitive impairment&#xD;
&#xD;
          -  Taking anti-inflammatory drugs and/or muscle relaxants during the course of the trial&#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>Paolo Pillastrini</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Bologna</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Policlinico S.Orsola-Malpighi</name>
      <address>
        <city>Bologna</city>
        <state>Emilia Romagna</state>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Camerota F, Galli M, Cimolin V, Celletti C, Ancillao A, Blow D, Albertini G. Neuromuscular taping for the upper limb in Cerebral Palsy: A case study in a patient with hemiplegia. Dev Neurorehabil. 2014 Dec;17(6):384-7. doi: 10.3109/17518423.2013.830152. Epub 2013 Oct 2.</citation>
    <PMID>24087981</PMID>
  </reference>
  <reference>
    <citation>Murie-Fernandez M, Carmona Iragui M, Gnanakumar V, Meyer M, Foley N, Teasell R. [Painful hemiplegic shoulder in stroke patients: causes and management]. Neurologia. 2012 May;27(4):234-44. doi: 10.1016/j.nrl.2011.02.010. Epub 2011 Apr 22. Spanish.</citation>
    <PMID>21514698</PMID>
  </reference>
  <reference>
    <citation>Smith M. Management of hemiplegic shoulder pain following stroke. Nurs Stand. 2012 Jul 4-10;26(44):35-44. doi: 10.7748/ns2012.07.26.44.35.c9191.</citation>
    <PMID>22876427</PMID>
  </reference>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>October 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>May 28, 2015</last_update_submitted>
  <last_update_submitted_qc>May 28, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 29, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Bologna</investigator_affiliation>
    <investigator_full_name>paolo pillastrini</investigator_full_name>
    <investigator_title>Associate Professor and President of Baccaluareate Course in Physiotherapy</investigator_title>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>Hemiplegia</keyword>
  <keyword>Painful shoulder Syndrome</keyword>
  <keyword>NeuroMuscolar Taping</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemiplegia</mesh_term>
  </condition_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/NCT02254876
org study id: 4496/2013
nct id: NCT02254876
lead sponsor: 
has dmc: No
Painful Shoulder Syndrome is a frequent complication after stroke occurring in between 5% and
      84% of patients, often having a strong impact on their well-being and resulting in delays
      achieving rehabilitative objectives.

      The aim of the study is to demonstrate the effectiveness of Neuromuscular Taping in a
      population of post-stroke hemiplegic patients suffering from painful shoulder syndrome with
      respect to pain, spasticity and range of motion.
The study will use two groups according to the methodology of Randomized Controlled Trials.
      Both components of the two groups were treated by four rehabilitation sessions defined as
      "standard". This involves joint health and passive mobility for the glenohumeral and
      scapulothoracic joints for a period of about 45 minutes each.

      The patients of the sample group underwent the application of the NeuroMuscular Taping (NMT)
      before each rehabilitative session. The control group was addressed exclusively to the
      "standard" treatment. The sessions were spaced apart about five days to ensure the optimum
      adhesion of NMT.

      The results were evaluated by administering rating scales for pain (VAS) and spasticity
      (Modified Ashworth Scale). The ROM was evaluated using the manual goniometer. The outcomes
      (Pain, Spasticity, ROM) were assessed at base line, before and after each treatment session
      and at 1 month follow up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Pain
time frame: Before and after each treatment session and at 1 month follow up
description: The investigators assessed this outcome with a Visual Analogue Scale (VAS).
measure: Spasticity
time frame: Before and after each treatment session and at 1 month follow up
description: The investigators assessed this outcome with the Modified Ashworth Scale.
measure: ROM
time frame: Before and after each treatment session and at one month follow up.
description: The investigators assessed this outcome using manual goniometer.
arm group label: Standard physical therapy program
arm group type: Active Comparator
description: Standard physical therapy program is delivered for four rehabilitation sessions for a period of about 45 minutes each.
arm group label: NeuroMuscular Taping (NMT)
arm group type: Experimental
description: NeuroMuscular Taping is delivered in addiction to the "Standard Treatment" for four rehabilitation sessions. The sessions were spaced apart about five days to ensure the optimum adhesion of the NMT.
intervention type: Other
intervention name: Standard physical therapy program
description: Standard physical therapy program in this study involves joint health and passive mobility at the level of the shoulder girdle and upper limb affected by Painful Shoulder Syndrome associated with the modulation of hypertonic muscle groups.
arm group label: NeuroMuscular Taping (NMT)
arm group label: Standard physical therapy program
intervention type: Other
intervention name: NeuroMuscular Taping (NMT)
description: The NeuroMuscular Taping (NMT) consists of the application on the skin of an adhesive tape with a particular structure to elastic waves and with characteristics comparable to those cutaneous. Because of these characterises it allows activation of endogenous analgesic, structural and muscular support, vascular and lymphatic activation.
In this study the NMT is applied with decompressive mode on Pectoralis Major, Deltoids, Supraspinatus.
arm group label: NeuroMuscular Taping (NMT)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Paolo Pillastrini
role: Principal Investigator
affiliation: University of Bologna
facility: 
country: Italy
citation: Camerota F, Galli M, Cimolin V, Celletti C, Ancillao A, Blow D, Albertini G. Neuromuscular taping for the upper limb in Cerebral Palsy: A case study in a patient with hemiplegia. Dev Neurorehabil. 2014 Dec;17(6):384-7. doi: 10.3109/17518423.2013.830152. Epub 2013 Oct 2.
PMID: 24087981
citation: Murie-Fernandez M, Carmona Iragui M, Gnanakumar V, Meyer M, Foley N, Teasell R. [Painful hemiplegic shoulder in stroke patients: causes and management]. Neurologia. 2012 May;27(4):234-44. doi: 10.1016/j.nrl.2011.02.010. Epub 2011 Apr 22. Spanish.
PMID: 21514698
citation: Smith M. Management of hemiplegic shoulder pain following stroke. Nurs Stand. 2012 Jul 4-10;26(44):35-44. doi: 10.7748/ns2012.07.26.44.35.c9191.
PMID: 22876427
responsible party type: Principal Investigator
investigator affiliation: University of Bologna
investigator full name: paolo pillastrini
investigator title: Associate Professor and President of Baccaluareate Course in Physiotherapy
mesh term: Hemiplegia