<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/NCT03031054</url>
  </required_header>
  <id_info>
    <org_study_id>HA for CTS</org_study_id>
    <nct_id>NCT03031054</nct_id>
  </id_info>
  <brief_title>The Effect of Hyaluronic Acid for Carpal Tunnel Syndrome</brief_title>
  <official_title>The Effect of Hyaluronic Acid 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>
    <is_us_export>No</is_us_export>
  </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. In addition, the hyaluronic acid was proved&#xD;
      to decrease adhension of soft tissue and nerve during operation. The investigators design a&#xD;
      randomized, double-blind, controlled trial to assess the effect after ultrasound-guided&#xD;
      hydrodissection with hyaluronic acid 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 with hyaluronic acid and control side received one-dose&#xD;
      ultrasound-guided injection with normal saline. No additional treatment after injection&#xD;
      through the study period. The primary outcome is Boston Carpal Tunnel Syndrome Questionnaire&#xD;
      (BCTQ) and secondary outcomes include visual analog scale (VAS), cross-sectional area (CSA)&#xD;
      of the median nerve, sensory nerve conduction velocity of the median nerve, and finger pinch&#xD;
      strength. The evaluation was performed pretreatment as well as on the 2nd week, 1st, 3rd, 6th&#xD;
      month and one year after the treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">October 28, 2019</completion_date>
  <primary_completion_date type="Actual">October 28, 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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 3rd, 6th month and one year after injection</measure>
    <time_frame>Pre-treatment, 2nd week, 1st, 3rd, 6th month and one year</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, 3rd, 6th month and one year after injection</measure>
    <time_frame>Pre-treatment, 2nd week, 1st, 3rd, 6th month and one year</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, 3rd, 6th month and one year after injection</measure>
    <time_frame>Pre-treatment, 2nd week, 1st, 3rd, 6th month and one year</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, 3rd, 6th month and one year after injection</measure>
    <time_frame>Pre-treatment, 2nd week, 1st, 3rd, 6th month and one year</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, 3rd, 6th month and one year after injection</measure>
    <time_frame>Pre-treatment, 2nd week, 1st, 3rd, 6th month and one year</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">35</enrollment>
  <condition>Carpal Tunnel Syndrome</condition>
  <arm_group>
    <arm_group_label>hyaluronic acid hydrodissection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ultrasound-guided hydrodissection with 2.5cc hyaluronic acid between carpal tunnel and median nerve.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal saline hydrodissection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ultrasound-guided hydrodissection with 2.5cc normal saline between carpal tunnel and median nerve.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sono-guided injection with hyaluronic acid</intervention_name>
    <description>Sono-guided injection with hyaluronic acid (ARTZDispo, 25 mg/2.5 ml) between carpal tunnel and median nerve</description>
    <arm_group_label>hyaluronic acid hydrodissection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sono-guided injection with normal saline</intervention_name>
    <description>Sono-guided injection with 2.5cc Normal saline (0.9%) between carpal tunnel and median nerve</description>
    <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>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>Tai Chung Municipality</city>
        <state>Neihu District</state>
        <zip>886</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <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>Ozgenel GY. Effects of hyaluronic acid on peripheral nerve scarring and regeneration in rats. Microsurgery. 2003;23(6):575-81. doi: 10.1002/micr.10209.</citation>
    <PMID>14705074</PMID>
  </results_reference>
  <results_reference>
    <citation>Burns JW, Skinner K, Colt J, Sheidlin A, Bronson R, Yaacobi Y, Goldberg EP. Prevention of tissue injury and postsurgical adhesions by precoating tissues with hyaluronic acid solutions. J Surg Res. 1995 Dec;59(6):644-52. doi: 10.1006/jsre.1995.1218.</citation>
    <PMID>8538160</PMID>
  </results_reference>
  <results_reference>
    <citation>Ozgenel GY, Filiz G. Effects of human amniotic fluid on peripheral nerve scarring and regeneration in rats. J Neurosurg. 2003 Feb;98(2):371-7. doi: 10.3171/jns.2003.98.2.0371.</citation>
    <PMID>12593625</PMID>
  </results_reference>
  <results_reference>
    <citation>Atzei A, Calcagni M, Breda B, Fasolo G, Pajardi G, Cugola L. Clinical evaluation of a hyaluronan-based gel following microsurgical reconstruction of peripheral nerves of the hand. Microsurgery. 2007;27(1):2-7. doi: 10.1002/micr.20299.</citation>
    <PMID>17205576</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>hyaluronic acid</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyaluronic Acid</mesh_term>
  </intervention_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/NCT03031054
org study id: HA for CTS
nct id: NCT03031054
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: 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. In addition, the hyaluronic acid was proved
      to decrease adhension of soft tissue and nerve during operation. The investigators design a
      randomized, double-blind, controlled trial to assess the effect after ultrasound-guided
      hydrodissection with hyaluronic acid 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 with hyaluronic acid and control side received one-dose
      ultrasound-guided injection with normal saline. 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, 3rd, 6th
      month and one year after the treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 3rd, 6th month and one year after injection
time frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month and one year
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, 3rd, 6th month and one year after injection
time frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month and one year
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, 3rd, 6th month and one year after injection
time frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month and one year
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, 3rd, 6th month and one year after injection
time frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month and one year
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, 3rd, 6th month and one year after injection
time frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month and one year
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: hyaluronic acid hydrodissection
arm group type: Experimental
description: Ultrasound-guided hydrodissection with 2.5cc hyaluronic acid between carpal tunnel and median nerve.
arm group label: Normal saline hydrodissection
arm group type: Active Comparator
description: Ultrasound-guided hydrodissection with 2.5cc normal saline between carpal tunnel and median nerve.
intervention type: Procedure
intervention name: Sono-guided injection with hyaluronic acid
description: Sono-guided injection with hyaluronic acid (ARTZDispo, 25 mg/2.5 ml) between carpal tunnel and median nerve
arm group label: hyaluronic acid hydrodissection
intervention type: Procedure
intervention name: Sono-guided injection with normal saline
description: Sono-guided injection with 2.5cc Normal saline (0.9%) between carpal tunnel and median nerve
arm group label: Normal saline 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: 
facility: 
country: Taiwan
citation: Ozgenel GY. Effects of hyaluronic acid on peripheral nerve scarring and regeneration in rats. Microsurgery. 2003;23(6):575-81. doi: 10.1002/micr.10209.
PMID: 14705074
citation: Burns JW, Skinner K, Colt J, Sheidlin A, Bronson R, Yaacobi Y, Goldberg EP. Prevention of tissue injury and postsurgical adhesions by precoating tissues with hyaluronic acid solutions. J Surg Res. 1995 Dec;59(6):644-52. doi: 10.1006/jsre.1995.1218.
PMID: 8538160
citation: Ozgenel GY, Filiz G. Effects of human amniotic fluid on peripheral nerve scarring and regeneration in rats. J Neurosurg. 2003 Feb;98(2):371-7. doi: 10.3171/jns.2003.98.2.0371.
PMID: 12593625
citation: Atzei A, Calcagni M, Breda B, Fasolo G, Pajardi G, Cugola L. Clinical evaluation of a hyaluronan-based gel following microsurgical reconstruction of peripheral nerves of the hand. Microsurgery. 2007;27(1):2-7. doi: 10.1002/micr.20299.
PMID: 17205576
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
mesh term: Hyaluronic Acid
sharing ipd: Yes