<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/NCT04474106</url>
  </required_header>
  <id_info>
    <org_study_id>NEUROwave</org_study_id>
    <nct_id>NCT04474106</nct_id>
  </id_info>
  <brief_title>NEUROwave - Extracorporeal Shock Wave Therapy (ESWT) in Acute Traumatic Complete (AIS A) and Incomplete (AIS B-D) Cross-sectional Lesions on Motor and Sensory Function Within Six Months After Injury</brief_title>
  <official_title>The Effect of Extracorporeal Shock Wave Therapy (ESWT) in Acute Traumatic Complete (AIS A) and Incomplete (AIS B-D) Cross-sectional Lesions on Motor and Sensory Function Within Six Months After Injury: A Two-arm Three-stage Adaptive, Prospective, Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AUVA</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AUVA</source>
  <oversight_info>
    <has_dmc>Yes</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>
      It has been hypothesized that there are two mechanisms of acute traumatic spinal cord injury&#xD;
      (SCI): the primary mechanical damage and the secondary injury due to additional pathological&#xD;
      processes initiated by the primary injury. Neurological damage due to laceration, contusion,&#xD;
      distraction or compression of the spinal cord is called ''primary injury''. This mechanical&#xD;
      injury leads to a cascade of biochemical and pathological changes, described as ''secondary&#xD;
      injury'', which occurs minutes to weeks after the initial trauma and causes further&#xD;
      neurological deterioration. This secondary cascade involves vascular changes, an inflammatory&#xD;
      response, neurotoxicity, apoptosis and glial scarring, and further compromises neurological&#xD;
      impairment after traumatic spinal cord injury. Edema, ischemia and loss of autoregulation&#xD;
      continue to spread bi-directionally from the initial lesion along the spinal cord for up to&#xD;
      72 hours after the trauma.&#xD;
&#xD;
      It has been postulated that the damage caused by the primary injury mechanism is irreversible&#xD;
      and therapeutic approaches in recent years have focused on modulating the secondary injury&#xD;
      cascade.&#xD;
&#xD;
      Researchers found significantly greater numbers of myelinated fibers in peripheral nerves&#xD;
      after a single ESWT application in an experimental model on rats after a homotopic nerve&#xD;
      autograft into the sciatic nerve.&#xD;
&#xD;
      In another study a spinal cord ischemia model in mice was performed. ESWT was applied&#xD;
      immediately after surgery and the treated animals showed a significantly better motor&#xD;
      function and decreased neuronal degeneration compared to the control group within the first 7&#xD;
      days after surgery.&#xD;
&#xD;
      Researchers investigated the effect of low-energy ESWT for the duration of three weeks on a&#xD;
      thoracic spinal cord contusion injury model in rats. Animals in the ESWT group demonstrated&#xD;
      significantly better locomotor improvement and reduced neuronal loss compared to the control&#xD;
      animals at 7, 35, and 42 days after contusion.&#xD;
&#xD;
      It has been postulated previously, that ESWT improves the metabolic activity of various cell&#xD;
      types and induces an improved rate of axonal regeneration.&#xD;
&#xD;
      ESWT might be a promising therapeutic strategy in the treatment of traumatic SCI.&#xD;
&#xD;
      The underlying study aims to investigate the effect of ESWT after acute traumatic spinal cord&#xD;
      injury in humans within 48 hours of trauma in order to intervene in the secondary injury&#xD;
      phase with the objective to reduce the extent of neuronal damage.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 2, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>
    <intervention_model_description>Two-arm three-stage adaptive, prospective, multi-center, randomized, double-blind, placebo-controlled clinical trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Stratified block randomization with a block size of four and a 1:1 allocation will be used to assign participants to one of two groups (treatment vs. placebo). Three neurological levels of injury will be used for stratification.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>changes in total motor scores (TMSC) = TMSC after 6 month minus TMSC at baseline</measure>
    <time_frame>day 0 to 6 month</time_frame>
    <description>greater improvement in motor and sensory function (the AIS grade) can be achieved in patients after spinal trauma (AIS A-D) by applying a single extracorporeal shockwave therapy compared to the control group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>American Spinal Injury Association (ASIA) Impaiment Scale (AIS) grade</measure>
    <time_frame>day 0 to 6 month</time_frame>
    <description>the AIS grade ranges from AIS A to AIS D, whereby AIS A are complete lesions and AIS B-D represent incomplete lesions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>degree of spasticity</measure>
    <time_frame>day 0 to 6 month</time_frame>
    <description>self-rated degree of spasticity according to Penn Spasm Frequency Scale (PSFS); the scale ranges from 0 to 4, whereby 0 refers to no spasticity and 4 refers to more than 10 spasms per hour</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Walking ability (yes/no)</measure>
    <time_frame>day 0 to 6 month</time_frame>
    <description>walking ability is being assessed using different walking tests as part of standard clinical routine: Walking Index for Spinal Cord Injury (WISCI) II, Timed up and go test (TUG), 10 Meter-Timed-Walk, 6 Minute-Walk-Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urological function</measure>
    <time_frame>day 0 to 6 month</time_frame>
    <description>Urological function will be assessed by several questions which should be answered with yes or no:&#xD;
Permanent catheter: yes/no&#xD;
Sensation of urinary bladder filling: yes/no&#xD;
Documentation of the first attempt of bladder emptying: pos/neg, date&#xD;
Self-catheterization: yes/no&#xD;
Do you feel sensory innervation of the external genitalia (penis / labia)?&#xD;
Do you feel the change of the catheter or manipulations on the catheter?&#xD;
Do you feel the urge to defecate?&#xD;
Do you feel stool evacuation?&#xD;
Male patients: Have you had an erection since your injury?&#xD;
Female patients: Have you felt sexually aroused since your injury?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plantar reflex (left/right: yes/no)</measure>
    <time_frame>day 0 to 6 month</time_frame>
    <description>The plantar reflex (also called Babinski Test) will be performed separately on each foot to assess if pathological reflexes are present.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Independence in everyday life</measure>
    <time_frame>day 0 to 6 month</time_frame>
    <description>of patients is assessed with the Spinal Cord Independence Measure (SCIM II)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adverse events (AEs)</measure>
    <time_frame>day 0 to 21 days</time_frame>
    <description>The number of study related adverse events (AEs) are measured according to NCI CTCAE, version 5.0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nine-Hole Peg Test (NHPT) (if feasible)</measure>
    <time_frame>day 0 to 6 month</time_frame>
    <description>An evaluation of hand motor function is assessed in those patients who have their lesions above the level T5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Grasp and Release Test (GRT)</measure>
    <time_frame>day 0 to 6 month</time_frame>
    <description>An evaluation of hand motor function is assessed in those patients who have their lesions above the level T5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pinch grip: yes/no</measure>
    <time_frame>day 0 to 6 month</time_frame>
    <description>An evaluation of hand motor function is assessed in those patients who have their lesions above the level T5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clenched grip: yes/no</measure>
    <time_frame>day 0 to 6 month</time_frame>
    <description>An evaluation of hand motor function is assessed in those patients who have their lesions above the level T5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pencil grip: yes/no</measure>
    <time_frame>day 0 to 6 month</time_frame>
    <description>An evaluation of hand motor function is assessed in those patients who have their lesions above the level T5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lumbrical grip: yes/no</measure>
    <time_frame>day 0 to 6 month</time_frame>
    <description>An evaluation of hand motor function is assessed in those patients who have their lesions above the level T5</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">246</enrollment>
  <condition>Acute Traumatic Spinal Cord Injury</condition>
  <arm_group>
    <arm_group_label>ESWT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The extracorporeal shockwave therapy is applied once at the level of lesion and 5 segments above and below; or below the occiput (in lesions higher than C6) and above the sacrum (in lesions lower than T12). In addition, the ESWT is applied to the soles of both feet on the medial side of the plantar surface. The ESWT is applied as soon as possible within 48 hours post-injury.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>In the control group, the same procedure is performed, but without the device emitting extracorporeal shock waves using a dummy head.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Shock waves</intervention_name>
    <description>The shockwave generator orthogold 100® generates high-energy acoustic waves that behave much like other sound waves except that they have much greater pressure and energy. As with sound waves, Spark Waves® can easily travel great distance as long as the acoustic impedance stays the same.</description>
    <arm_group_label>ESWT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>dummy head</intervention_name>
    <description>The shockwave generator orthogold 100® will be used in combination with a dummy head, to Refrain shock waves</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with acute traumatic spinal injuries who are awake, responsive, and oriented&#xD;
             at admission&#xD;
&#xD;
          -  Patients from the age of 18 years&#xD;
&#xD;
          -  Admission to hospital within 24 hours after injury&#xD;
&#xD;
          -  Written consent to participate in the study&#xD;
&#xD;
          -  Participation in the Austrian Spinal Cord Injury Study (ASCIS)-Registry (only for the&#xD;
             Austrian hospitals)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who cannot cooperate or are not capable to give consent to participate&#xD;
&#xD;
          -  Serious traumatic brain injuries that prevent accurate participation in study&#xD;
             procedures and/or adequacy of informed consent Participation in other interventional&#xD;
             clinical trials&#xD;
&#xD;
          -  Serious concomitant injuries that prevent the neurological initial assessment&#xD;
&#xD;
          -  Preexisting neurological conditions that affect the primary endpoint of the study and&#xD;
             potentially mask or reduce the therapeutic effect of the ESWT application&#xD;
&#xD;
          -  High dose administration of corticosteroids&#xD;
&#xD;
          -  Complete spinal cord transection&#xD;
&#xD;
          -  Patients with pacemakers or implantable defibrillators&#xD;
&#xD;
          -  Patients who are using devices which are sensitive to electromagnetic radiation&#xD;
&#xD;
          -  (potential) Pregnancy&#xD;
&#xD;
          -  Patients with tumors&#xD;
&#xD;
          -  Patients with severe coagulation disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wolfgang Schaden, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>AUVA</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Wolfgang Schaden, Dr</last_name>
    <phone>0043 5 9393 20170</phone>
    <email>wolfgang.schaden@auva.at</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Iris Leister, MSc</last_name>
    <email>iris.leister@pmu.ac.at</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Medical University Innsbruck</name>
      <address>
        <city>Innsbruck</city>
        <state>Tirol</state>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Richard Lindtner, Dr</last_name>
    </contact>
    <contact_backup>
      <last_name>Rene Schmid, Dr.</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Rehazentrum Bad Häring</name>
      <address>
        <city>Bad Häring</city>
        <zip>6323</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Landeskarnkenhaus Feldkirch</name>
      <address>
        <city>Feldkirch</city>
        <zip>6807</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rene El-Attal, Prim</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Unfallkrankenhaus Graz</name>
      <address>
        <city>Graz</city>
        <zip>8020</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Plecko, Prim</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Rehazentrum Tobelbad</name>
      <address>
        <city>Graz</city>
        <zip>8144</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Rehazentrum Weißer Hof</name>
      <address>
        <city>Klosterneuburg</city>
        <zip>3400</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Unfallkrankenhaus Linz</name>
      <address>
        <city>Linz</city>
        <zip>4010</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Klaus Katzensteiner, Prim.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinik Linz, Neurochirurgie Traumatologie</name>
      <address>
        <city>Linz</city>
        <zip>4020</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Andreas Gruber, Prof. Dr.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Unfallkrankenhaus Salzburg</name>
      <address>
        <city>Salzburg</city>
        <zip>5010</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alexander Schmelz, Prim.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinik für Orthopädie und Traumatologie</name>
      <address>
        <city>Salzburg</city>
        <zip>5020</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Thomas Freude, Prof. Dr.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Unfallkrankenhaus St. Pölten</name>
      <address>
        <city>St. Pölten</city>
        <zip>3100</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Hermann Schnell, Dr.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinik Wien, AKH</name>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stefan Hajdu, Prof.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Unfallkrankenhaus Meidling</name>
      <address>
        <city>Wien</city>
        <zip>1120</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christian Fialka, Prim.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Unfallkrankenhaus Lorenz Böhler</name>
      <address>
        <city>Wien</city>
        <zip>1200</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thomas Hausner, Prim</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>SMZ Ost, Donauspital Abteilung für Unfallchirurgie</name>
      <address>
        <city>Wien</city>
        <zip>1220</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Medhi Mousavi, Prim</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Unfallkrankenhaus Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>12683</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Andreas Niedeggen, Dr.</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>August 23, 2023</last_update_submitted>
  <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>AUVA</investigator_affiliation>
    <investigator_full_name>Wolfgang Schaden</investigator_full_name>
    <investigator_title>Deputy Medical Director of Austrian Workers´ Compensation Board (AUVA)</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04474106
org study id: NEUROwave
nct id: NCT04474106
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
It has been hypothesized that there are two mechanisms of acute traumatic spinal cord injury
      (SCI): the primary mechanical damage and the secondary injury due to additional pathological
      processes initiated by the primary injury. Neurological damage due to laceration, contusion,
      distraction or compression of the spinal cord is called ''primary injury''. This mechanical
      injury leads to a cascade of biochemical and pathological changes, described as ''secondary
      injury'', which occurs minutes to weeks after the initial trauma and causes further
      neurological deterioration. This secondary cascade involves vascular changes, an inflammatory
      response, neurotoxicity, apoptosis and glial scarring, and further compromises neurological
      impairment after traumatic spinal cord injury. Edema, ischemia and loss of autoregulation
      continue to spread bi-directionally from the initial lesion along the spinal cord for up to
      72 hours after the trauma.

      It has been postulated that the damage caused by the primary injury mechanism is irreversible
      and therapeutic approaches in recent years have focused on modulating the secondary injury
      cascade.

      Researchers found significantly greater numbers of myelinated fibers in peripheral nerves
      after a single ESWT application in an experimental model on rats after a homotopic nerve
      autograft into the sciatic nerve.

      In another study a spinal cord ischemia model in mice was performed. ESWT was applied
      immediately after surgery and the treated animals showed a significantly better motor
      function and decreased neuronal degeneration compared to the control group within the first 7
      days after surgery.

      Researchers investigated the effect of low-energy ESWT for the duration of three weeks on a
      thoracic spinal cord contusion injury model in rats. Animals in the ESWT group demonstrated
      significantly better locomotor improvement and reduced neuronal loss compared to the control
      animals at 7, 35, and 42 days after contusion.

      It has been postulated previously, that ESWT improves the metabolic activity of various cell
      types and induces an improved rate of axonal regeneration.

      ESWT might be a promising therapeutic strategy in the treatment of traumatic SCI.

      The underlying study aims to investigate the effect of ESWT after acute traumatic spinal cord
      injury in humans within 48 hours of trauma in order to intervene in the secondary injury
      phase with the objective to reduce the extent of neuronal damage.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Two-arm three-stage adaptive, prospective, multi-center, randomized, double-blind, placebo-controlled clinical trial
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Stratified block randomization with a block size of four and a 1:1 allocation will be used to assign participants to one of two groups (treatment vs. placebo). Three neurological levels of injury will be used for stratification.
measure: changes in total motor scores (TMSC) = TMSC after 6 month minus TMSC at baseline
time frame: day 0 to 6 month
description: greater improvement in motor and sensory function (the AIS grade) can be achieved in patients after spinal trauma (AIS A-D) by applying a single extracorporeal shockwave therapy compared to the control group.
measure: American Spinal Injury Association (ASIA) Impaiment Scale (AIS) grade
time frame: day 0 to 6 month
description: the AIS grade ranges from AIS A to AIS D, whereby AIS A are complete lesions and AIS B-D represent incomplete lesions
measure: degree of spasticity
time frame: day 0 to 6 month
description: self-rated degree of spasticity according to Penn Spasm Frequency Scale (PSFS); the scale ranges from 0 to 4, whereby 0 refers to no spasticity and 4 refers to more than 10 spasms per hour
measure: Walking ability (yes/no)
time frame: day 0 to 6 month
description: walking ability is being assessed using different walking tests as part of standard clinical routine: Walking Index for Spinal Cord Injury (WISCI) II, Timed up and go test (TUG), 10 Meter-Timed-Walk, 6 Minute-Walk-Test
measure: Urological function
time frame: day 0 to 6 month
description: Urological function will be assessed by several questions which should be answered with yes or no:
Permanent catheter: yes/no
Sensation of urinary bladder filling: yes/no
Documentation of the first attempt of bladder emptying: pos/neg, date
Self-catheterization: yes/no
Do you feel sensory innervation of the external genitalia (penis / labia)?
Do you feel the change of the catheter or manipulations on the catheter?
Do you feel the urge to defecate?
Do you feel stool evacuation?
Male patients: Have you had an erection since your injury?
Female patients: Have you felt sexually aroused since your injury?
measure: Plantar reflex (left/right: yes/no)
time frame: day 0 to 6 month
description: The plantar reflex (also called Babinski Test) will be performed separately on each foot to assess if pathological reflexes are present.
measure: Independence in everyday life
time frame: day 0 to 6 month
description: of patients is assessed with the Spinal Cord Independence Measure (SCIM II)
measure: adverse events (AEs)
time frame: day 0 to 21 days
description: The number of study related adverse events (AEs) are measured according to NCI CTCAE, version 5.0.
measure: Nine-Hole Peg Test (NHPT) (if feasible)
time frame: day 0 to 6 month
description: An evaluation of hand motor function is assessed in those patients who have their lesions above the level T5
measure: Grasp and Release Test (GRT)
time frame: day 0 to 6 month
description: An evaluation of hand motor function is assessed in those patients who have their lesions above the level T5
measure: Pinch grip: yes/no
time frame: day 0 to 6 month
description: An evaluation of hand motor function is assessed in those patients who have their lesions above the level T5
measure: Clenched grip: yes/no
time frame: day 0 to 6 month
description: An evaluation of hand motor function is assessed in those patients who have their lesions above the level T5
measure: Pencil grip: yes/no
time frame: day 0 to 6 month
description: An evaluation of hand motor function is assessed in those patients who have their lesions above the level T5
measure: Lumbrical grip: yes/no
time frame: day 0 to 6 month
description: An evaluation of hand motor function is assessed in those patients who have their lesions above the level T5
arm group label: ESWT
arm group type: Experimental
description: The extracorporeal shockwave therapy is applied once at the level of lesion and 5 segments above and below; or below the occiput (in lesions higher than C6) and above the sacrum (in lesions lower than T12). In addition, the ESWT is applied to the soles of both feet on the medial side of the plantar surface. The ESWT is applied as soon as possible within 48 hours post-injury.
arm group label: Control
arm group type: Sham Comparator
description: In the control group, the same procedure is performed, but without the device emitting extracorporeal shock waves using a dummy head.
intervention type: Device
intervention name: Shock waves
description: The shockwave generator orthogold 100® generates high-energy acoustic waves that behave much like other sound waves except that they have much greater pressure and energy. As with sound waves, Spark Waves® can easily travel great distance as long as the acoustic impedance stays the same.
arm group label: ESWT
intervention type: Device
intervention name: dummy head
description: The shockwave generator orthogold 100® will be used in combination with a dummy head, to Refrain shock waves
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Wolfgang Schaden, Dr.
role: Principal Investigator
affiliation: AUVA
last name: Wolfgang Schaden, Dr
phone: 0043 5 9393 20170
email: wolfgang.schaden@auva.at
last name: Iris Leister, MSc
email: iris.leister@pmu.ac.at
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
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status: Recruiting
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status: Active, not recruiting
facility: 
status: Active, not recruiting
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status: Recruiting
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status: Not yet recruiting
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status: Recruiting
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status: Not yet recruiting
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status: Not yet recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Not yet recruiting
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status: Not yet recruiting
contact: 
country: Austria
country: Germany
responsible party type: Principal Investigator
investigator affiliation: AUVA
investigator full name: Wolfgang Schaden
investigator title: Deputy Medical Director of Austrian Workers´ Compensation Board (AUVA)
mesh term: Spinal Cord Injuries
mesh term: Wounds and Injuries
sharing ipd: Undecided