<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/NCT02253771</url>
  </required_header>
  <id_info>
    <org_study_id>Orth-001</org_study_id>
    <nct_id>NCT02253771</nct_id>
  </id_info>
  <brief_title>Shockwave Therapy for Acute Low Back Pain</brief_title>
  <official_title>Shockwave Therapy for Acute Low Back Pain: a Randomized Placebo-controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Muenster</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Muenster</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>
      The purpose of this study is to determine whether shockwave therapy is more effective in the&#xD;
      treatment of unspecific acute low back pain than sham therapy.&#xD;
&#xD;
      60 patients with acute low back pain will be recruited to a single-blinded, randomized,&#xD;
      placebo-controlled trial. They are randomized to receive either shockwave therapy or sham&#xD;
      treatment by a identically looking device for 4 weeks, twice a week. Additionally patients&#xD;
      receive physiotherapy twice a week and are allowed to take an anti-inflammatory drug, if&#xD;
      necessary for even 4 weeks. The primary outcome variable will be measured at day 0, every&#xD;
      week during treatment (day 7; 14; 21 and 28) and up to 4 weeks after the last treatment. The&#xD;
      clinical outcome will be primarily measured by pain intensity using a visual analogue scale.&#xD;
      Secondary outcome measures are Oswestry Disability Index, Beck's Pain Depression Scale,&#xD;
      Roland Morris Disability Questionnaire and the EQ-5D. Data will be analysed for the&#xD;
      difference in change of scores between groups using one-way t-test.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 8, 2017</start_date>
  <completion_date type="Actual">January 15, 2019</completion_date>
  <primary_completion_date type="Actual">September 13, 2018</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in pain, using visual analogue scale (VAS)</measure>
    <time_frame>Day 0; 7; 14; 21; 28, after 6 and 8 weeks.</time_frame>
    <description>Change in pain, using visual analogue scale (VAS 1-10)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in other clinical questionnaires (Oswestry disability Index)</measure>
    <time_frame>day 0; 7; 14; 21, after 6 and 8 weeks.</time_frame>
    <description>Oswestry disability Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in other clinical questionnaires (Beck's depression scale)</measure>
    <time_frame>day 0; 7; 14; 21, after 6 and 8 weeks.</time_frame>
    <description>Beck's depression scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in other clinical questionnaires (EQ-5D)</measure>
    <time_frame>day 0; 7; 14; 21, after 6 and 8 weeks.</time_frame>
    <description>EQ-5D</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in other clinical questionnaires (Roland-Morris-Score)</measure>
    <time_frame>day 0; 7; 14; 21, after 6 and 8 weeks.</time_frame>
    <description>Roland-Morris-Score</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>Acute Low Back Pain (Low Back Pain for Less Than 3 Months)</condition>
  <arm_group>
    <arm_group_label>shockwave therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>shockwave therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo treatment</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>sham shockwave therapy by an identically looking device without any function</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>shockwave therapy</intervention_name>
    <description>Shockwave therapy with 2000 impulses/treatment at 12 Hz; 8 treatment over 4 weeks, twice a week</description>
    <arm_group_label>shockwave therapy</arm_group_label>
    <other_name>EMS Swiss Dolorclast® Classic (EMS Electro Medical Systems S.a.)</other_name>
    <other_name>CE Certificate: 0124</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>placebo shockwave therapy</intervention_name>
    <description>sham shockwave therapy by an identically looking device without any function</description>
    <arm_group_label>Placebo treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        low back pain for less than 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with relevant leg pain&#xD;
&#xD;
          -  Patients with spine operations in the past&#xD;
&#xD;
          -  neurologic symptoms&#xD;
&#xD;
          -  scoliosis with Cobb angle &gt; 10°&#xD;
&#xD;
          -  Patients experienced in shock wave therapy&#xD;
&#xD;
          -  Patientes with ongoing therapy with blood diluting drugs such as phenprocumon&#xD;
&#xD;
          -  Patients with osteoporosis&#xD;
&#xD;
          -  Patients with back pain after trauma&#xD;
&#xD;
          -  Patients with infective diseases or tumor diseases&#xD;
&#xD;
          -  Patients with relevant psychological diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Niklas Deventer, Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitätsklinikum Münster, Klinik für Allgemeine Orthopädie und Tumororthopädie</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tobias Schulte, Prof. Dr. med.</last_name>
    <role>Study Director</role>
    <affiliation>Department of Orthopaedics and Trauma Surgery, University Hospital, Ruhr University Bochum</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tobias Lange, Dr. med., MBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Orthopaedics and Trauma Surgery, University Hospital, Ruhr University Bochum</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universitätsklinikum Münster, Klinik für Allgemeine Orthopädie und Tumororthopädie</name>
      <address>
        <city>Münster</city>
        <state>NRW</state>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Barker KL, Elliott CJ, Sackley CM, Fairbank JC. Treatment of chronic back pain by sensory discrimination training. A Phase I RCT of a novel device (FairMed) vs. TENS. BMC Musculoskelet Disord. 2008 Jun 28;9:97. doi: 10.1186/1471-2474-9-97.</citation>
    <PMID>18588702</PMID>
  </reference>
  <reference>
    <citation>Seco J, Kovacs FM, Urrutia G. The efficacy, safety, effectiveness, and cost-effectiveness of ultrasound and shock wave therapies for low back pain: a systematic review. Spine J. 2011 Oct;11(10):966-77. doi: 10.1016/j.spinee.2011.02.002. Epub 2011 Apr 9.</citation>
    <PMID>21482199</PMID>
  </reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>August 31, 2014</study_first_submitted>
  <study_first_submitted_qc>September 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>January 28, 2021</last_update_submitted>
  <last_update_submitted_qc>January 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital Muenster</investigator_affiliation>
    <investigator_full_name>Niklas Deventer</investigator_full_name>
    <investigator_title>Dr. med. Niklas Deventer</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</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/NCT02253771
org study id: Orth-001
nct id: NCT02253771
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine whether shockwave therapy is more effective in the
      treatment of unspecific acute low back pain than sham therapy.

      60 patients with acute low back pain will be recruited to a single-blinded, randomized,
      placebo-controlled trial. They are randomized to receive either shockwave therapy or sham
      treatment by a identically looking device for 4 weeks, twice a week. Additionally patients
      receive physiotherapy twice a week and are allowed to take an anti-inflammatory drug, if
      necessary for even 4 weeks. The primary outcome variable will be measured at day 0, every
      week during treatment (day 7; 14; 21 and 28) and up to 4 weeks after the last treatment. The
      clinical outcome will be primarily measured by pain intensity using a visual analogue scale.
      Secondary outcome measures are Oswestry Disability Index, Beck's Pain Depression Scale,
      Roland Morris Disability Questionnaire and the EQ-5D. Data will be analysed for the
      difference in change of scores between groups using one-way t-test.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change in pain, using visual analogue scale (VAS)
time frame: Day 0; 7; 14; 21; 28, after 6 and 8 weeks.
description: Change in pain, using visual analogue scale (VAS 1-10)
measure: Change in other clinical questionnaires (Oswestry disability Index)
time frame: day 0; 7; 14; 21, after 6 and 8 weeks.
description: Oswestry disability Index
measure: Change in other clinical questionnaires (Beck's depression scale)
time frame: day 0; 7; 14; 21, after 6 and 8 weeks.
description: Beck's depression scale
measure: Change in other clinical questionnaires (EQ-5D)
time frame: day 0; 7; 14; 21, after 6 and 8 weeks.
description: EQ-5D
measure: Change in other clinical questionnaires (Roland-Morris-Score)
time frame: day 0; 7; 14; 21, after 6 and 8 weeks.
description: Roland-Morris-Score
arm group label: shockwave therapy
arm group type: Experimental
description: shockwave therapy
arm group label: Placebo treatment
arm group type: Placebo Comparator
description: sham shockwave therapy by an identically looking device without any function
intervention type: Device
intervention name: shockwave therapy
description: Shockwave therapy with 2000 impulses/treatment at 12 Hz; 8 treatment over 4 weeks, twice a week
arm group label: shockwave therapy
other name: EMS Swiss Dolorclast® Classic (EMS Electro Medical Systems S.a.)
other name: CE Certificate: 0124
intervention type: Device
intervention name: placebo shockwave therapy
description: sham shockwave therapy by an identically looking device without any function
arm group label: Placebo treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Niklas Deventer, Dr. med.
role: Principal Investigator
affiliation: Universitätsklinikum Münster, Klinik für Allgemeine Orthopädie und Tumororthopädie
last name: Tobias Schulte, Prof. Dr. med.
role: Study Director
affiliation: Department of Orthopaedics and Trauma Surgery, University Hospital, Ruhr University Bochum
last name: Tobias Lange, Dr. med., MBA
role: Principal Investigator
affiliation: Department of Orthopaedics and Trauma Surgery, University Hospital, Ruhr University Bochum
facility: 
country: Germany
citation: Barker KL, Elliott CJ, Sackley CM, Fairbank JC. Treatment of chronic back pain by sensory discrimination training. A Phase I RCT of a novel device (FairMed) vs. TENS. BMC Musculoskelet Disord. 2008 Jun 28;9:97. doi: 10.1186/1471-2474-9-97.
PMID: 18588702
citation: Seco J, Kovacs FM, Urrutia G. The efficacy, safety, effectiveness, and cost-effectiveness of ultrasound and shock wave therapies for low back pain: a systematic review. Spine J. 2011 Oct;11(10):966-77. doi: 10.1016/j.spinee.2011.02.002. Epub 2011 Apr 9.
PMID: 21482199
responsible party type: Principal Investigator
investigator affiliation: University Hospital Muenster
investigator full name: Niklas Deventer
investigator title: Dr. med. Niklas Deventer
mesh term: Back Pain
mesh term: Low Back Pain