<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/NCT02991001</url>
  </required_header>
  <id_info>
    <org_study_id>Hydrodissection for CTS</org_study_id>
    <nct_id>NCT02991001</nct_id>
  </id_info>
  <brief_title>The Effect of Hydrodissection for Carpal Tunnel Syndrome</brief_title>
  <official_title>The Effect of Hydrodissection for 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 trail to assess the effect after ultrasound-guided hydrodissection&#xD;
      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 intervention group received one-dose&#xD;
      ultrasound-guided hydrodissection and control side received one-dose ultrasound-guided&#xD;
      injection at subcutaneous layer beyond carpal tunnel. No additional treatment after injection&#xD;
      through the study period. The primary outcome is visual analog scale (VAS) and secondary&#xD;
      outcomes include Boston Carpal Tunnel Syndrome Questionnaire (BCTQ), cross-sectional area&#xD;
      (CSA) of the median nerve, sensory nerve conduction velocity of the median nerve, and finger&#xD;
      pinch strength. The evaluation was performed pretreatment as well as on the 2nd week, 1st,&#xD;
      2nd and 3rd month after the treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">April 15, 2018</completion_date>
  <primary_completion_date type="Actual">April 15, 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>Double (Participant, Investigator)</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 and 3rd 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 and 3rd 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 and 3rd 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 and 3rd month after injection</measure>
    <time_frame>Pre-treatment, 2nd week, 1st, 2nd , 3rd and 6th month after injection</time_frame>
    <description>Antidromic sensory nerve conduction velocity 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 and 3rd 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">34</enrollment>
  <condition>Carpal Tunnel Syndrome</condition>
  <arm_group>
    <arm_group_label>Normal saline hydrodissection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ultrasound-guided hydrodissection with normal saline between carpal tunnel and median nerve.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Ultrasound-guided injection with normal saline at subcutaneous layer beyond the carpal tunnel region</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ultrasound-guided hydrodissection</intervention_name>
    <description>Ultrasound-guided hydrodissection with 5cc normal saline between carpal tunnel and median nerve.</description>
    <arm_group_label>Normal saline hydrodissection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Placebo ultrasound-guided injection</intervention_name>
    <description>Ultrasound-guided injection with 5cc normal saline at subcutaneous layer beyond carpal tunnel</description>
    <arm_group_label>Normal saline</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ultrasound</intervention_name>
    <arm_group_label>Normal saline</arm_group_label>
    <arm_group_label>Normal saline hydrodissection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal Saline</intervention_name>
    <arm_group_label>Normal saline</arm_group_label>
    <arm_group_label>Normal saline 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>Accepts Healthy Volunteers</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>
  <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>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>
  </results_reference>
  <results_reference>
    <citation>Choi CK, Lee HS, Kwon JY, Lee WJ. Clinical implications of real-time visualized ultrasound-guided injection for the treatment of ulnar neuropathy at the elbow: a pilot study. Ann Rehabil Med. 2015 Apr;39(2):176-82. doi: 10.5535/arm.2015.39.2.176. Epub 2015 Apr 24.</citation>
    <PMID>25932413</PMID>
  </results_reference>
  <results_reference>
    <citation>Chang KV, Hung CY, Ozcakar L. Snapping Thumb and Superficial Radial Nerve Entrapment in De Quervain Disease: Ultrasound Imaging/Guidance Revisited. Pain Med. 2015 Nov;16(11):2214-5. doi: 10.1111/pme.12867. Epub 2015 Jul 27. No abstract available.</citation>
    <PMID>26218266</PMID>
  </results_reference>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>December 9, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>July 31, 2018</last_update_submitted>
  <last_update_submitted_qc>July 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2018</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>
  <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/NCT02991001
org study id: Hydrodissection for CTS
nct id: NCT02991001
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 trail to assess the effect after 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 intervention group received one-dose
      ultrasound-guided hydrodissection and control side received one-dose ultrasound-guided
      injection at subcutaneous layer beyond carpal tunnel. No additional treatment after injection
      through the study period. The primary outcome is visual analog scale (VAS) and secondary
      outcomes include Boston Carpal Tunnel Syndrome Questionnaire (BCTQ), 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 and 3rd month after the treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
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 and 3rd 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 and 3rd 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 and 3rd 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 and 3rd month after injection
time frame: Pre-treatment, 2nd week, 1st, 2nd , 3rd and 6th month after injection
description: Antidromic sensory nerve conduction velocity of the median nerve before treatment and multiple time frame after treatment.
measure: Change from baseline of finger pinch on 2nd week, 1st, 2nd and 3rd 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: Normal saline hydrodissection
arm group type: Experimental
description: Ultrasound-guided hydrodissection with normal saline between carpal tunnel and median nerve.
arm group label: Normal saline
arm group type: Placebo Comparator
description: Ultrasound-guided injection with normal saline at subcutaneous layer beyond the carpal tunnel region
intervention type: Procedure
intervention name: Ultrasound-guided hydrodissection
description: Ultrasound-guided hydrodissection with 5cc normal saline between carpal tunnel and median nerve.
arm group label: Normal saline hydrodissection
intervention type: Procedure
intervention name: Placebo ultrasound-guided injection
description: Ultrasound-guided injection with 5cc normal saline at subcutaneous layer beyond carpal tunnel
arm group label: Normal saline
intervention type: Device
intervention name: Ultrasound
arm group label: Normal saline
arm group label: Normal saline hydrodissection
intervention type: Drug
intervention name: Normal Saline
arm group label: Normal saline
arm group label: Normal saline hydrodissection
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yung-Tsan Wu, MD
role: Principal Investigator
affiliation: Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
facility: 
country: Taiwan
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: 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: Choi CK, Lee HS, Kwon JY, Lee WJ. Clinical implications of real-time visualized ultrasound-guided injection for the treatment of ulnar neuropathy at the elbow: a pilot study. Ann Rehabil Med. 2015 Apr;39(2):176-82. doi: 10.5535/arm.2015.39.2.176. Epub 2015 Apr 24.
PMID: 25932413
citation: Chang KV, Hung CY, Ozcakar L. Snapping Thumb and Superficial Radial Nerve Entrapment in De Quervain Disease: Ultrasound Imaging/Guidance Revisited. Pain Med. 2015 Nov;16(11):2214-5. doi: 10.1111/pme.12867. Epub 2015 Jul 27. No abstract available.
PMID: 26218266
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