<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/NCT02218229</url>
  </required_header>
  <id_info>
    <org_study_id>TSGHIRB: 1-102-05-122</org_study_id>
    <nct_id>NCT02218229</nct_id>
  </id_info>
  <brief_title>The Effect of Extracorporeal Shock Wave Therapy on Carpal Tunnel Syndrome</brief_title>
  <official_title>The Effect of Extracorporeal Shock Wave Therapy on Carpal Tunnel Syndrome</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 shock wave is a new and potential intervention for the reinnervation of peripheral nerve.&#xD;
      The purpose of this study was to assess the effect of extracorporeal shock wave therapy on&#xD;
      carpal tunnel syndrome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recently, many studies show the potential effect of shock wave for the reinnervation for&#xD;
      peripheral neuropathy in the animal mode. Only one study reveal the potential benefit of&#xD;
      shock wave in patients with carpal tunnel syndrome. Althouh its expressive finding, the&#xD;
      number of cases is relatively too small to make a conclusive remark. Large and well-designed&#xD;
      study would expand the new field.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</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 pain on1st, 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 scale before treatment and multiple time frame after treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in severity of symptoms and functional status 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 Boston Carpal Tunnel Syndrome Questionnaire to measure the symptoms and functional status before treatment and multiple time frame after treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in cross-sectional area of the median nerve 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 musculoskeletal sonogram to measure the cross-sectional area of the median nerve.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in conduction velocity, ampliture of median nerve 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>The antidromic sensory nerve conduction velocityof the median nerve was performed on all subjects according to the protocol reported by the American Academy of Neurology with SierraWave, Cadwell (USA). The median nerve was stimulated at the wrist between the palmar longus and flexor carpal radialis tendon at a distance of approximately 14 cm from the active electrode.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in finger pinch 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>The finger pinch strength was measured using Jamar dynamometer (Fabrication Enterprises Inc., USA). The subject was seated with shoulder adducted and neutrally rotated with the elbow flexed at 90°. The forearm and wrist were positioned in a neutral position for the palmar pinch</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Carpal Tunnel Syndrome</condition>
  <arm_group>
    <arm_group_label>Shock waves</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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). Different studies and clinical experiments have demonstrated the efficacy of shock waves in the treatment of musculoskeletal system such as chronic tendinopathies or hypertrophic pseudoarthrosis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Night splint</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The wrist night splint was firmly fixed in a neutral position to immobilize the affected wrist. Patients were ordered to wear the splint while resting at night and at least 8 hours per day during the period of study</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). Different studies and clinical experiments have demonstrated the efficacy of shock waves in the treatment of musculoskeletal system such as chronic tendinopathies or hypertrophic pseudoarthrosis</description>
    <arm_group_label>Shock waves</arm_group_label>
    <other_name>E-SWT, Elettronica Pagani, Italy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Outpatient subjects who had typical symptoms and signs of CTS, such as positive Tinel's&#xD;
        sign or Phalen's test and numbness/tingling in at least two of the first, second, and third&#xD;
        digits and were all confirmed by electrophysiological study, were considered and enrolled.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        The patients who had conditions mimicking CTS, such as cervical radiculopathy,&#xD;
        polyneuropathy, brachial plexopathy, thoracic outlet syndrome or who had previous wrist&#xD;
        surgery or steroid injection for CTS, were all excluded.&#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, School of Medicine, National Defense Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tri-Service General Hospital, School of Medicine, 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>Stevens JC, Sun S, Beard CM, O'Fallon WM, Kurland LT. Carpal tunnel syndrome in Rochester, Minnesota, 1961 to 1980. Neurology. 1988 Jan;38(1):134-8. doi: 10.1212/wnl.38.1.134.</citation>
    <PMID>3336444</PMID>
  </reference>
  <reference>
    <citation>Orhan Z, Alper M, Akman Y, Yavuz O, Yalciner A. An experimental study on the application of extracorporeal shock waves in the treatment of tendon injuries: preliminary report. J Orthop Sci. 2001;6(6):566-70. doi: 10.1007/s007760100013.</citation>
    <PMID>11793180</PMID>
  </reference>
  <reference>
    <citation>Ohtori S, Inoue G, Mannoji C, Saisu T, Takahashi K, Mitsuhashi S, Wada Y, Takahashi K, Yamagata M, Moriya H. Shock wave application to rat skin induces degeneration and reinnervation of sensory nerve fibres. Neurosci Lett. 2001 Nov 23;315(1-2):57-60. doi: 10.1016/s0304-3940(01)02320-5.</citation>
    <PMID>11711214</PMID>
  </reference>
  <reference>
    <citation>Wu YH, Lun JJ, Chen WS, Chong FC. The electrophysiological and functional effect of shock wave on peripheral nerves. Annu Int Conf IEEE Eng Med Biol Soc. 2007;2007:2369-72. doi: 10.1109/IEMBS.2007.4352803.</citation>
    <PMID>18002469</PMID>
  </reference>
  <reference>
    <citation>Romeo P, d'Agostino MC, Lazzerini A, Sansone VC. Extracorporeal shock wave therapy in pillar pain after carpal tunnel release: a preliminary study. Ultrasound Med Biol. 2011 Oct;37(10):1603-8. doi: 10.1016/j.ultrasmedbio.2011.07.002. Epub 2011 Aug 19.</citation>
    <PMID>21856074</PMID>
  </reference>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>August 13, 2014</study_first_submitted>
  <study_first_submitted_qc>August 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>October 10, 2017</last_update_submitted>
  <last_update_submitted_qc>October 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2017</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>carpal tunnel syndrome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carpal Tunnel Syndrome</mesh_term>
    <mesh_term>Syndrome</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/NCT02218229
org study id: TSGHIRB: 1-102-05-122
nct id: NCT02218229
lead sponsor: 
has dmc: Yes
The shock wave is a new and potential intervention for the reinnervation of peripheral nerve.
      The purpose of this study was to assess the effect of extracorporeal shock wave therapy on
      carpal tunnel syndrome.
Recently, many studies show the potential effect of shock wave for the reinnervation for
      peripheral neuropathy in the animal mode. Only one study reveal the potential benefit of
      shock wave in patients with carpal tunnel syndrome. Althouh its expressive finding, the
      number of cases is relatively too small to make a conclusive remark. Large and well-designed
      study would expand the new field.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change from baseline of pain on1st, 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 scale before treatment and multiple time frame after treatment.
measure: Change from baseline in severity of symptoms and functional status 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 Boston Carpal Tunnel Syndrome Questionnaire to measure the symptoms and functional status before treatment and multiple time frame after treatment.
measure: Change from baseline in cross-sectional area of the median nerve 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 musculoskeletal sonogram to measure the cross-sectional area of the median nerve.
measure: Change from baseline in conduction velocity, ampliture of median nerve 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: The antidromic sensory nerve conduction velocityof the median nerve was performed on all subjects according to the protocol reported by the American Academy of Neurology with SierraWave, Cadwell (USA). The median nerve was stimulated at the wrist between the palmar longus and flexor carpal radialis tendon at a distance of approximately 14 cm from the active electrode.
measure: Change from baseline in finger pinch 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: The finger pinch strength was measured using Jamar dynamometer (Fabrication Enterprises Inc., USA). The subject was seated with shoulder adducted and neutrally rotated with the elbow flexed at 90°. The forearm and wrist were positioned in a neutral position for the palmar pinch
arm group label: Shock waves
arm group type: Experimental
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). Different studies and clinical experiments have demonstrated the efficacy of shock waves in the treatment of musculoskeletal system such as chronic tendinopathies or hypertrophic pseudoarthrosis.
arm group label: Night splint
arm group type: No Intervention
description: The wrist night splint was firmly fixed in a neutral position to immobilize the affected wrist. Patients were ordered to wear the splint while resting at night and at least 8 hours per day during the period of study
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). Different studies and clinical experiments have demonstrated the efficacy of shock waves in the treatment of musculoskeletal system such as chronic tendinopathies or hypertrophic pseudoarthrosis
arm group label: Shock waves
other name: E-SWT, Elettronica Pagani, Italy
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, School of Medicine, National Defense Medical Center
facility: 
country: Taiwan
citation: Stevens JC, Sun S, Beard CM, O'Fallon WM, Kurland LT. Carpal tunnel syndrome in Rochester, Minnesota, 1961 to 1980. Neurology. 1988 Jan;38(1):134-8. doi: 10.1212/wnl.38.1.134.
PMID: 3336444
citation: Orhan Z, Alper M, Akman Y, Yavuz O, Yalciner A. An experimental study on the application of extracorporeal shock waves in the treatment of tendon injuries: preliminary report. J Orthop Sci. 2001;6(6):566-70. doi: 10.1007/s007760100013.
PMID: 11793180
citation: Ohtori S, Inoue G, Mannoji C, Saisu T, Takahashi K, Mitsuhashi S, Wada Y, Takahashi K, Yamagata M, Moriya H. Shock wave application to rat skin induces degeneration and reinnervation of sensory nerve fibres. Neurosci Lett. 2001 Nov 23;315(1-2):57-60. doi: 10.1016/s0304-3940(01)02320-5.
PMID: 11711214
citation: Wu YH, Lun JJ, Chen WS, Chong FC. The electrophysiological and functional effect of shock wave on peripheral nerves. Annu Int Conf IEEE Eng Med Biol Soc. 2007;2007:2369-72. doi: 10.1109/IEMBS.2007.4352803.
PMID: 18002469
citation: Romeo P, d'Agostino MC, Lazzerini A, Sansone VC. Extracorporeal shock wave therapy in pillar pain after carpal tunnel release: a preliminary study. Ultrasound Med Biol. 2011 Oct;37(10):1603-8. doi: 10.1016/j.ultrasmedbio.2011.07.002. Epub 2011 Aug 19.
PMID: 21856074
responsible party type: Principal Investigator
investigator affiliation: Tri-Service General Hospital
investigator full name: Yung-Tsan Wu
investigator title: Attending Physician
mesh term: Carpal Tunnel Syndrome
mesh term: Syndrome