<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/NCT03031041</url>
  </required_header>
  <id_info>
    <org_study_id>Difference PIT for CTS</org_study_id>
    <nct_id>NCT03031041</nct_id>
  </id_info>
  <brief_title>Comparison of Difference Hydrodissection for CTS</brief_title>
  <official_title>Comparison of Difference Hydrodissection Technique in Patients With 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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with&#xD;
      involving compression of the median nerve in the carpal tunnel. Rather than other progressive&#xD;
      disease, CTS is characterized by remission and recurrence. The hydrodissection could decrease&#xD;
      the entrapment of nerve to restore blood supply. Despite the hydrodissection was pervasively&#xD;
      used in clinical practice, current researches contain small participant without control group&#xD;
      or randomized leading to foreseeable selection bias. The investigators design a randomized,&#xD;
      double-blind, controlled trial to assess the effect of different method of ultrasound-guided&#xD;
      hydrodissection in patients with CTS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After obtaining written informed consent, patients with bilateral CTS will been randomized&#xD;
      into intervention and control group. Participants in short-axis group received one-dose&#xD;
      ultrasound-guided hydrodissection with short-axis approach and long-axis group received&#xD;
      one-dose ultrasound-guided injection with long-axis approach. No additional treatment after&#xD;
      injection through the study period. The primary outcome is Boston Carpal Tunnel Syndrome&#xD;
      Questionnaire (BCTQ) and secondary outcomes include visual analog scale (VAS),&#xD;
      cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity of the&#xD;
      median nerve, and finger pinch strength. The evaluation was performed pretreatment as well as&#xD;
      on the 2nd week, 1st, 2nd, 3rd and 6th month after the treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 25, 2017</start_date>
  <completion_date type="Actual">August 30, 2019</completion_date>
  <primary_completion_date type="Actual">August 30, 2019</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 from baseline of severity of symptoms and functional status on 2nd week, 1st, 2nd, 3rd and 6th month after injection</measure>
    <time_frame>Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection</time_frame>
    <description>Boston carpal tunnel syndrome questionnaire (BCTQ) is a frequently used patient-based questionnaire for measurement of CTS which encompasses two components. In total, 11 questions and 8 items were evaluated to rate the symptom severity scale (SSS) and functional status scale (FSS), respectively. Both subscales range from 1 to 5 with a higher score indicating a higher degree of disability. The mean of total SSS and FSS divided with each item score were used for further analysis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline of pain on 2nd week, 1st, 2nd, 3rd and 6th month after injection</measure>
    <time_frame>Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection</time_frame>
    <description>Digital pain severity or paresthesia/dysthesia was evaluated using visual analog scale (VAS). Pain score scale ranged from 0 to 10, with 10 indicating the most severe pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 2nd, 3rd and 6th month after injection</measure>
    <time_frame>Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection</time_frame>
    <description>Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve before treatment and multiple time frame after treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline of conduction velocity, amplitude of median nerve on 2nd week, 1st, 2nd, 3rd and 6th month after injection</measure>
    <time_frame>Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection</time_frame>
    <description>Electrophysiological study of the median nerve before treatment and multiple time frame after treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline of finger pinch on 2nd week, 1st, 2nd, 3rd and 6th month after injection</measure>
    <time_frame>Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection</time_frame>
    <description>The finger pinch strength was measured using 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">47</enrollment>
  <condition>Carpal Tunnel Syndrome</condition>
  <arm_group>
    <arm_group_label>Short-axis hydrodissection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ultrasound-guided short-axis hydrodissection with normal saline between carpal tunnel and median nerve</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Long-axis hydrodissection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ultrasound-guided long-axis hydrodissection with normal saline between carpal tunnel and median nerve</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ultrasound-guided short-axis hydrodissection with 5cc normal saline</intervention_name>
    <description>Ultrasound-guided short-axis hydrodissection with 5cc normal saline between carpal tunnel and median nerve</description>
    <arm_group_label>Short-axis hydrodissection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ultrasound-guided long-axis hydrodissection with 3cc normal saline</intervention_name>
    <description>Ultrasound-guided long-axis hydrodissection with 3cc normal saline between carpal tunnel and median nerve</description>
    <arm_group_label>Long-axis hydrodissection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 20-80 year-old.&#xD;
&#xD;
          -  Diagnosis was confirmed using an electrophysiological study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cancer&#xD;
&#xD;
          -  Coagulopathy&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Inflammation status&#xD;
&#xD;
          -  Cervical radiculopathy&#xD;
&#xD;
          -  Polyneuropathy, brachial plexopathy&#xD;
&#xD;
          -  Thoracic outlet syndrome&#xD;
&#xD;
          -  Previously undergone wrist surgery or steroid injection for CTS&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 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>Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital</name>
      <address>
        <city>Taipei</city>
        <state>Neihu District</state>
        <zip>886</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>DeLea SL, Chavez-Chiang NR, Poole JL, Norton HE, Sibbitt WL Jr, Bankhurst AD. Sonographically guided hydrodissection and corticosteroid injection for scleroderma hand. Clin Rheumatol. 2011 Jun;30(6):805-13. doi: 10.1007/s10067-010-1653-6. Epub 2011 Jan 15.</citation>
    <PMID>21234632</PMID>
  </reference>
  <reference>
    <citation>Mulvaney SW. Ultrasound-guided percutaneous neuroplasty of the lateral femoral cutaneous nerve for the treatment of meralgia paresthetica: a case report and description of a new ultrasound-guided technique. Curr Sports Med Rep. 2011 Mar-Apr;10(2):99-104. doi: 10.1249/JSR.0b013e3182110096.</citation>
    <PMID>21623291</PMID>
  </reference>
  <results_reference>
    <citation>Smith J, Wisniewski SJ, Finnoff JT, Payne JM. Sonographically guided carpal tunnel injections: the ulnar approach. J Ultrasound Med. 2008 Oct;27(10):1485-90. doi: 10.7863/jum.2008.27.10.1485.</citation>
    <PMID>18809959</PMID>
  </results_reference>
  <results_reference>
    <citation>Cass SP. Ultrasound-Guided Nerve Hydrodissection: What is it? A Review of the Literature. Curr Sports Med Rep. 2016 Jan-Feb;15(1):20-2. doi: 10.1249/JSR.0000000000000226.</citation>
    <PMID>26745165</PMID>
  </results_reference>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>January 21, 2017</study_first_submitted>
  <study_first_submitted_qc>January 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>October 29, 2019</last_update_submitted>
  <last_update_submitted_qc>October 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 31, 2019</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 of Department of Physical Medicine and Rehabilitation</investigator_title>
  </responsible_party>
  <keyword>Hydrodissection</keyword>
  <keyword>short-axis</keyword>
  <keyword>long-axis</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>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03031041
org study id: Difference PIT for CTS
nct id: NCT03031041
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with
      involving compression of the median nerve in the carpal tunnel. Rather than other progressive
      disease, CTS is characterized by remission and recurrence. The hydrodissection could decrease
      the entrapment of nerve to restore blood supply. Despite the hydrodissection was pervasively
      used in clinical practice, current researches contain small participant without control group
      or randomized leading to foreseeable selection bias. The investigators design a randomized,
      double-blind, controlled trial to assess the effect of different method of ultrasound-guided
      hydrodissection in patients with CTS.
After obtaining written informed consent, patients with bilateral CTS will been randomized
      into intervention and control group. Participants in short-axis group received one-dose
      ultrasound-guided hydrodissection with short-axis approach and long-axis group received
      one-dose ultrasound-guided injection with long-axis approach. No additional treatment after
      injection through the study period. The primary outcome is Boston Carpal Tunnel Syndrome
      Questionnaire (BCTQ) and secondary outcomes include visual analog scale (VAS),
      cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity of the
      median nerve, and finger pinch strength. The evaluation was performed pretreatment as well as
      on the 2nd week, 1st, 2nd, 3rd and 6th month after the treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 2nd, 3rd and 6th month after injection
time frame: Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection
description: Boston carpal tunnel syndrome questionnaire (BCTQ) is a frequently used patient-based questionnaire for measurement of CTS which encompasses two components. In total, 11 questions and 8 items were evaluated to rate the symptom severity scale (SSS) and functional status scale (FSS), respectively. Both subscales range from 1 to 5 with a higher score indicating a higher degree of disability. The mean of total SSS and FSS divided with each item score were used for further analysis.
measure: Change from baseline of pain on 2nd week, 1st, 2nd, 3rd and 6th month after injection
time frame: Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection
description: Digital pain severity or paresthesia/dysthesia was evaluated using visual analog scale (VAS). Pain score scale ranged from 0 to 10, with 10 indicating the most severe pain.
measure: Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 2nd, 3rd and 6th month after injection
time frame: Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection
description: Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve before treatment and multiple time frame after treatment.
measure: Change from baseline of conduction velocity, amplitude of median nerve on 2nd week, 1st, 2nd, 3rd and 6th month after injection
time frame: Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection
description: Electrophysiological study of the median nerve before treatment and multiple time frame after treatment.
measure: Change from baseline of finger pinch on 2nd week, 1st, 2nd, 3rd and 6th month after injection
time frame: Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection
description: The finger pinch strength was measured using 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: Short-axis hydrodissection
arm group type: Experimental
description: Ultrasound-guided short-axis hydrodissection with normal saline between carpal tunnel and median nerve
arm group label: Long-axis hydrodissection
arm group type: Active Comparator
description: Ultrasound-guided long-axis hydrodissection with normal saline between carpal tunnel and median nerve
intervention type: Procedure
intervention name: Ultrasound-guided short-axis hydrodissection with 5cc normal saline
description: Ultrasound-guided short-axis hydrodissection with 5cc normal saline between carpal tunnel and median nerve
arm group label: Short-axis hydrodissection
intervention type: Procedure
intervention name: Ultrasound-guided long-axis hydrodissection with 3cc normal saline
description: Ultrasound-guided long-axis hydrodissection with 3cc normal saline between carpal tunnel and median nerve
arm group label: Long-axis hydrodissection
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yung-Tsan Wu, MD
role: Principal Investigator
affiliation: Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
facility: 
country: Taiwan
citation: DeLea SL, Chavez-Chiang NR, Poole JL, Norton HE, Sibbitt WL Jr, Bankhurst AD. Sonographically guided hydrodissection and corticosteroid injection for scleroderma hand. Clin Rheumatol. 2011 Jun;30(6):805-13. doi: 10.1007/s10067-010-1653-6. Epub 2011 Jan 15.
PMID: 21234632
citation: Mulvaney SW. Ultrasound-guided percutaneous neuroplasty of the lateral femoral cutaneous nerve for the treatment of meralgia paresthetica: a case report and description of a new ultrasound-guided technique. Curr Sports Med Rep. 2011 Mar-Apr;10(2):99-104. doi: 10.1249/JSR.0b013e3182110096.
PMID: 21623291
citation: Smith J, Wisniewski SJ, Finnoff JT, Payne JM. Sonographically guided carpal tunnel injections: the ulnar approach. J Ultrasound Med. 2008 Oct;27(10):1485-90. doi: 10.7863/jum.2008.27.10.1485.
PMID: 18809959
citation: Cass SP. Ultrasound-Guided Nerve Hydrodissection: What is it? A Review of the Literature. Curr Sports Med Rep. 2016 Jan-Feb;15(1):20-2. doi: 10.1249/JSR.0000000000000226.
PMID: 26745165
responsible party type: Principal Investigator
investigator affiliation: Tri-Service General Hospital
investigator full name: Yung-Tsan Wu
investigator title: Attending Physician of Department of Physical Medicine and Rehabilitation
mesh term: Carpal Tunnel Syndrome
mesh term: Syndrome
sharing ipd: Yes