<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/NCT02203994</url>
  </required_header>
  <id_info>
    <org_study_id>2014-07</org_study_id>
    <nct_id>NCT02203994</nct_id>
  </id_info>
  <brief_title>Extracorporeal Shock Wave Therapy (ESWT) for the Treatment of Spasticity in Persons With Spinal Cord Injury</brief_title>
  <acronym>ESWT</acronym>
  <official_title>The Effect of Extracorporeal Shock Wave Therapy (ESWT) on Lower Limb Spasticity in Persons With an Incomplete Spinal Cord Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Swiss Paraplegic Centre Nottwil</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Swiss Paraplegic Centre Nottwil</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Spasticity is the most problematic self-reported secondary medical problem in patients with&#xD;
      spinal cord injury. It has the potential to negatively influence quality of life through&#xD;
      restricting activities of daily living. Problematic spasticity can cause pain and fatigue,&#xD;
      disturb sleep, contribute to the developement of contractures and pressure ulcers, and has a&#xD;
      negative effect on patients morbidity. For this reason there is enormous interest in&#xD;
      therapeutic interventions addressing to decrease spasticity in persons with spinal cord&#xD;
      injury. Recently, studies reported positive effects of extracorporeal shock wave therapy on&#xD;
      spasticity in patients with stroke, focal limb dystonia and cerebral palsy. To date, no&#xD;
      studies are published, assessing the effect of extracorporeal shock wave therapy on focal&#xD;
      spasticity in patients with spinal cord injury.&#xD;
&#xD;
      The purpose of this study is to investigate the effect of a one-time ESWT on lower limb&#xD;
      spasticity in patients with an incomplete spinal cord injury.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2014</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>severity of spasticity</measure>
    <time_frame>time 0, time 2h</time_frame>
    <description>Ashworth Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>personal goal attainment</measure>
    <time_frame>at day 0, 1, 3 and 5</time_frame>
    <description>Goal Attainment Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>walking speed</measure>
    <time_frame>difference between pre- and post-intervention</time_frame>
    <description>10 Meters Walking Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>walking distance</measure>
    <time_frame>difference between pre- and post-intervention</time_frame>
    <description>6 Minutes Walking Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>thickness of the treated muscle</measure>
    <time_frame>difference between pre- and post-intervention</time_frame>
    <description>thickness measurement of the treated muscle using ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>severity of spasticity</measure>
    <time_frame>time 0, time 2h</time_frame>
    <description>Adductor Tone Rating Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>severity of spasticity</measure>
    <time_frame>time 0, time 2h</time_frame>
    <description>Penn Spasm Frequency Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>severity of spasticity</measure>
    <time_frame>time 0, time 2h</time_frame>
    <description>Clonus Scale</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Spinal Cord Injury</condition>
  <condition>Spasticity</condition>
  <arm_group>
    <arm_group_label>extracorporeal shock wave therapy (ESWT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>one-time treatment of the spastic muscle/ spastic muscles (adductor muscles and/ or M. triceps surae) with extracorporeal shock wave therapy (device: Duolith® SD 1 &quot;T-Top&quot; (Storz Medical AG, Tägerwilen, Switzerland))</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Duolith® SD 1 &quot;T-Top&quot; (Storz Medical AG, Switzerland)</intervention_name>
    <description>2000 pulses per muscle, energy level: 0.030 mJ/mm2, frequency: 4 Hz</description>
    <arm_group_label>extracorporeal shock wave therapy (ESWT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Traumatic or non traumatic spinal cord injury&#xD;
&#xD;
          -  Minimum age: 18 years&#xD;
&#xD;
          -  Minimum time since spinal cord injury: two years&#xD;
&#xD;
          -  Lesion: C3-Th10&#xD;
&#xD;
          -  American Association of Spinal Cord Injury Impairment Score C and D&#xD;
&#xD;
          -  Focal spasticity in the adductor muscles and/ or triceps surae&#xD;
&#xD;
          -  Ability to walk 14 meters&#xD;
&#xD;
          -  Spasticity/clonus/spasms disturbing the activities of daily living or participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Changes in spasticity medication during the last 3 months&#xD;
&#xD;
          -  Treatment with botulinum toxin during the last 6 months&#xD;
&#xD;
          -  Anticoagulant medication&#xD;
&#xD;
          -  Thrombosis&#xD;
&#xD;
          -  Malignant tumors&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Inflammations or skin lesions in the treated area&#xD;
&#xD;
          -  Acute urinary tract infection&#xD;
&#xD;
          -  Intended change in spasticity medication within 5 days after intervention&#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>Michael Baumberger, Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Swiss Paraplegic Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Swiss Paraplegic Centre</name>
      <address>
        <city>Nottwil</city>
        <state>LU</state>
        <zip>6207</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>January 25, 2017</last_update_submitted>
  <last_update_submitted_qc>January 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>extracorporal shock wave therapy (ESWT)</keyword>
  <keyword>spasticity</keyword>
  <keyword>spinal cord injury</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Spasticity</mesh_term>
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Wounds and Injuries</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/NCT02203994
org study id: 2014-07
nct id: NCT02203994
lead sponsor: 
has dmc: Yes
Spasticity is the most problematic self-reported secondary medical problem in patients with
      spinal cord injury. It has the potential to negatively influence quality of life through
      restricting activities of daily living. Problematic spasticity can cause pain and fatigue,
      disturb sleep, contribute to the developement of contractures and pressure ulcers, and has a
      negative effect on patients morbidity. For this reason there is enormous interest in
      therapeutic interventions addressing to decrease spasticity in persons with spinal cord
      injury. Recently, studies reported positive effects of extracorporeal shock wave therapy on
      spasticity in patients with stroke, focal limb dystonia and cerebral palsy. To date, no
      studies are published, assessing the effect of extracorporeal shock wave therapy on focal
      spasticity in patients with spinal cord injury.

      The purpose of this study is to investigate the effect of a one-time ESWT on lower limb
      spasticity in patients with an incomplete spinal cord injury.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: severity of spasticity
time frame: time 0, time 2h
description: Ashworth Scale
measure: personal goal attainment
time frame: at day 0, 1, 3 and 5
description: Goal Attainment Scale
measure: walking speed
time frame: difference between pre- and post-intervention
description: 10 Meters Walking Test
measure: walking distance
time frame: difference between pre- and post-intervention
description: 6 Minutes Walking Test
measure: thickness of the treated muscle
time frame: difference between pre- and post-intervention
description: thickness measurement of the treated muscle using ultrasound
measure: severity of spasticity
time frame: time 0, time 2h
description: Adductor Tone Rating Scale
measure: severity of spasticity
time frame: time 0, time 2h
description: Penn Spasm Frequency Scale
measure: severity of spasticity
time frame: time 0, time 2h
description: Clonus Scale
arm group label: extracorporeal shock wave therapy (ESWT)
arm group type: Experimental
description: one-time treatment of the spastic muscle/ spastic muscles (adductor muscles and/ or M. triceps surae) with extracorporeal shock wave therapy (device: Duolith® SD 1 "T-Top" (Storz Medical AG, Tägerwilen, Switzerland))
intervention type: Device
intervention name: Duolith® SD 1 "T-Top" (Storz Medical AG, Switzerland)
description: 2000 pulses per muscle, energy level: 0.030 mJ/mm2, frequency: 4 Hz
arm group label: extracorporeal shock wave therapy (ESWT)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Michael Baumberger, Dr. med.
role: Principal Investigator
affiliation: Swiss Paraplegic Centre
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Muscle Spasticity
mesh term: Spinal Cord Injuries
mesh term: Wounds and Injuries