<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/NCT02221011</url>
  </required_header>
  <id_info>
    <org_study_id>TSGHIRB: 2-102-05-018</org_study_id>
    <nct_id>NCT02221011</nct_id>
  </id_info>
  <brief_title>The Effect of Extracorporeal Shock Wave Therapy on Spasticity</brief_title>
  <official_title>The Effect of Extracorporeal Shock Wave Therapy on Spasticity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tri-Service General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tri-Service General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The effect of traditional treatment for spasticity is barely satisfactory. The shock wave has&#xD;
      been used to treat the spasticity with expressively response and the effect could persist for&#xD;
      1-3 months in different studies. However most sutdies lack the sham or control group. The&#xD;
      purpose of this study was to assess the effect of shock wave for spasticity in wrist and&#xD;
      hand.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The patients with spasticity for at least 6 months were randomized for 3 groups. Group I:&#xD;
      patients receive one session of shock wave per week for 3 weeks; Group II: patients receive&#xD;
      only one session of shock wave; Group III: patients receive the sham shock wave per week for&#xD;
      3 weeks. The outcome measurements include Modified Asthow scale, passive range of motion,&#xD;
      Disability Assessment Scale and Fugl-Meyer Assessment Scale (hand function and wrist&#xD;
      control).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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 (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline of spasticity on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.</measure>
    <time_frame>Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.</time_frame>
    <description>Using the modyfied Ashworth Scale to measure the spasticity before treatment and multiple time frame after treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline of range of motion on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.</measure>
    <time_frame>Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.</time_frame>
    <description>Using the digital goniometer to measure the passive range of motion before treatment and multiple time frame after treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline of pain on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.</measure>
    <time_frame>Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.</time_frame>
    <description>Using the Visual analog scale (VAS) to measure the pain from spasticity scale before treatment and multiple time frame after treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline of disability on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.</measure>
    <time_frame>Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.</time_frame>
    <description>Using the Disability Assessment Scale to measure the disabilty scale before treatment and multiple time frame after treatment.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Spasticity</condition>
  <arm_group>
    <arm_group_label>shock wave (three times)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>E-SWT, Elettronica Pagani, Italy 3.5 bars 1500 beats in FCU, FCR 3 bars 4000 beats diffuse in intrinsic muscle Once a week for 3 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham shock wave</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>E-SWT, Elettronica Pagani, Italy Sham without energy, 1500 beats in FCU, FCR and 4000 beats diffuse in intrinsic muscle</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Shock wave (one time)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>E-SWT, Elettronica Pagani, Italy 3.5 bars 1500 beats in FCU, FCR 3 bars 4000 beats diffuse in intrinsic muscle Only one dose</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Shock wave</intervention_name>
    <description>Shock waves are defined a sequence of acoustic pulse characterized by a high peak pressure (100 MPa), fast pressure rise (&lt; 10 ns) and short duration (10 μs) is conveyed by an appropriate generator to a specific target area with an energy density in the range of 0.003-0.890 mJ/mm2.&#xD;
Different studies and clinical experiments have demonstrated the efficacy of shock waves in the treatment of musculoskeletal system such as chronic tendinopathies, calcific tendinitis of the shoulder, lateral epicondylitis, plantar fasciitis, and several tendon diseases.</description>
    <arm_group_label>Sham shock wave</arm_group_label>
    <arm_group_label>Shock wave (one time)</arm_group_label>
    <arm_group_label>shock wave (three times)</arm_group_label>
    <other_name>E-SWT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Age between 20-80 year-old Spasticity measured as Modified Asthow Scale more than 1+ point&#xD;
        and persist at least 6 months Clear consciousness No receive Phenol injection or Botulinum&#xD;
        toxin in past 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Cancer Joint contracture Coagulopathy Pregnancy Pacemaker Inflammation status&#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>Yung-Tsan Wu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tri-Service General Hospital National Defense Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tri-Service General Hospital National Defense Medical Center</name>
      <address>
        <city>Taipei</city>
        <state>Neihu</state>
        <zip>886</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>Rompe JD, Hope C, Kullmer K, Heine J, Burger R. Analgesic effect of extracorporeal shock-wave therapy on chronic tennis elbow. J Bone Joint Surg Br. 1996 Mar;78(2):233-7.</citation>
    <PMID>8666632</PMID>
  </reference>
  <reference>
    <citation>Loew M, Daecke W, Kusnierczak D, Rahmanzadeh M, Ewerbeck V. Shock-wave therapy is effective for chronic calcifying tendinitis of the shoulder. J Bone Joint Surg Br. 1999 Sep;81(5):863-7. doi: 10.1302/0301-620x.81b5.9374.</citation>
    <PMID>10530851</PMID>
  </reference>
  <reference>
    <citation>Manganotti P, Amelio E. Long-term effect of shock wave therapy on upper limb hypertonia in patients affected by stroke. Stroke. 2005 Sep;36(9):1967-71. doi: 10.1161/01.STR.0000177880.06663.5c. Epub 2005 Aug 18.</citation>
    <PMID>16109905</PMID>
  </reference>
  <reference>
    <citation>Vidal X, Morral A, Costa L, Tur M. Radial extracorporeal shock wave therapy (rESWT) in the treatment of spasticity in cerebral palsy: a randomized, placebo-controlled clinical trial. NeuroRehabilitation. 2011;29(4):413-9. doi: 10.3233/NRE-2011-0720.</citation>
    <PMID>22207070</PMID>
  </reference>
  <reference>
    <citation>Sohn MK, Cho KH, Kim YJ, Hwang SL. Spasticity and electrophysiologic changes after extracorporeal shock wave therapy on gastrocnemius. Ann Rehabil Med. 2011 Oct;35(5):599-604. doi: 10.5535/arm.2011.35.5.599. Epub 2011 Oct 31.</citation>
    <PMID>22506181</PMID>
  </reference>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>April 12, 2016</last_update_submitted>
  <last_update_submitted_qc>April 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tri-Service General Hospital</investigator_affiliation>
    <investigator_full_name>Yung-Tsan Wu</investigator_full_name>
    <investigator_title>Attending Physician</investigator_title>
  </responsible_party>
  <keyword>Shock wave</keyword>
  <keyword>Spasticity</keyword>
  <keyword>Effect</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Spasticity</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/NCT02221011
org study id: TSGHIRB: 2-102-05-018
nct id: NCT02221011
lead sponsor: 
has dmc: Yes
The effect of traditional treatment for spasticity is barely satisfactory. The shock wave has
      been used to treat the spasticity with expressively response and the effect could persist for
      1-3 months in different studies. However most sutdies lack the sham or control group. The
      purpose of this study was to assess the effect of shock wave for spasticity in wrist and
      hand.
The patients with spasticity for at least 6 months were randomized for 3 groups. Group I:
      patients receive one session of shock wave per week for 3 weeks; Group II: patients receive
      only one session of shock wave; Group III: patients receive the sham shock wave per week for
      3 weeks. The outcome measurements include Modified Asthow scale, passive range of motion,
      Disability Assessment Scale and Fugl-Meyer Assessment Scale (hand function and wrist
      control).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change from baseline of spasticity on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.
time frame: Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.
description: Using the modyfied Ashworth Scale to measure the spasticity before treatment and multiple time frame after treatment.
measure: Change from baseline of range of motion on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.
time frame: Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.
description: Using the digital goniometer to measure the passive range of motion before treatment and multiple time frame after treatment.
measure: Change from baseline of pain on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.
time frame: Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.
description: Using the Visual analog scale (VAS) to measure the pain from spasticity scale before treatment and multiple time frame after treatment.
measure: Change from baseline of disability on 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.
time frame: Pre-treatment, 1st, 2nd, 4th, 8th, 12th and 16th weeks after treatment.
description: Using the Disability Assessment Scale to measure the disabilty scale before treatment and multiple time frame after treatment.
arm group label: shock wave (three times)
arm group type: Experimental
description: E-SWT, Elettronica Pagani, Italy 3.5 bars 1500 beats in FCU, FCR 3 bars 4000 beats diffuse in intrinsic muscle Once a week for 3 weeks
arm group label: Sham shock wave
arm group type: Sham Comparator
description: E-SWT, Elettronica Pagani, Italy Sham without energy, 1500 beats in FCU, FCR and 4000 beats diffuse in intrinsic muscle
arm group label: Shock wave (one time)
arm group type: Experimental
description: E-SWT, Elettronica Pagani, Italy 3.5 bars 1500 beats in FCU, FCR 3 bars 4000 beats diffuse in intrinsic muscle Only one dose
intervention type: Device
intervention name: Shock wave
description: Shock waves are defined a sequence of acoustic pulse characterized by a high peak pressure (100 MPa), fast pressure rise (< 10 ns) and short duration (10 μs) is conveyed by an appropriate generator to a specific target area with an energy density in the range of 0.003-0.890 mJ/mm2.
Different studies and clinical experiments have demonstrated the efficacy of shock waves in the treatment of musculoskeletal system such as chronic tendinopathies, calcific tendinitis of the shoulder, lateral epicondylitis, plantar fasciitis, and several tendon diseases.
arm group label: Sham shock wave
arm group label: Shock wave (one time)
arm group label: shock wave (three times)
other name: E-SWT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yung-Tsan Wu, MD
role: Principal Investigator
affiliation: Tri-Service General Hospital National Defense Medical Center
facility: 
country: Taiwan
citation: Rompe JD, Hope C, Kullmer K, Heine J, Burger R. Analgesic effect of extracorporeal shock-wave therapy on chronic tennis elbow. J Bone Joint Surg Br. 1996 Mar;78(2):233-7.
PMID: 8666632
citation: Loew M, Daecke W, Kusnierczak D, Rahmanzadeh M, Ewerbeck V. Shock-wave therapy is effective for chronic calcifying tendinitis of the shoulder. J Bone Joint Surg Br. 1999 Sep;81(5):863-7. doi: 10.1302/0301-620x.81b5.9374.
PMID: 10530851
citation: Manganotti P, Amelio E. Long-term effect of shock wave therapy on upper limb hypertonia in patients affected by stroke. Stroke. 2005 Sep;36(9):1967-71. doi: 10.1161/01.STR.0000177880.06663.5c. Epub 2005 Aug 18.
PMID: 16109905
citation: Vidal X, Morral A, Costa L, Tur M. Radial extracorporeal shock wave therapy (rESWT) in the treatment of spasticity in cerebral palsy: a randomized, placebo-controlled clinical trial. NeuroRehabilitation. 2011;29(4):413-9. doi: 10.3233/NRE-2011-0720.
PMID: 22207070
citation: Sohn MK, Cho KH, Kim YJ, Hwang SL. Spasticity and electrophysiologic changes after extracorporeal shock wave therapy on gastrocnemius. Ann Rehabil Med. 2011 Oct;35(5):599-604. doi: 10.5535/arm.2011.35.5.599. Epub 2011 Oct 31.
PMID: 22506181
responsible party type: Principal Investigator
investigator affiliation: Tri-Service General Hospital
investigator full name: Yung-Tsan Wu
investigator title: Attending Physician
mesh term: Muscle Spasticity