<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/NCT03802435</url>
  </required_header>
  <id_info>
    <org_study_id>Different PIT for CTS</org_study_id>
    <nct_id>NCT03802435</nct_id>
  </id_info>
  <brief_title>Different Sessions of Perineural Injection With Dextrose for Carpal Tunnel Syndrome</brief_title>
  <official_title>Comparison of Long-term Effect in Different Sessions of Perineural Injection With Dextrose for 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. The technique of perineural&#xD;
      injection therapy (PIT) by using 5% dextrose (D5W) is now commonly used for peeling the nerve&#xD;
      from surrounding soft tissue (called nerve hydrodissection), which may help antineurogenic&#xD;
      inflammation, allow the impulse to pass, and rescue the nerve with ischemic damage. However,&#xD;
      the evidence and reference of PIT and nerve hydrodissection are very seldom until our series&#xD;
      researches since 2017. Moreover, our research revealed PIT with D5W is more beneficial than&#xD;
      that of corticosteroid in patients with mild-to-moderate CTS at 4 to 6 months postinjection.&#xD;
      However, the accumulative effect and long-term effect (more than 6 months) of PIT is still&#xD;
      unknown. Hence, we design a randomized, double- blind, controlled trail to assess the&#xD;
      long-term effect of ultrasound-guided PIT in patients with CTS. The aim one is to survey the&#xD;
      possible accumulative effect of different sessions of PIT (6 months follow-up) and aim two is&#xD;
      to evaluate the long-term effect and safety of PIT (one year follow-up).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After obtaining written informed consent, patients clinically diagnosed with mild-to-moderate&#xD;
      CTS were includes and randomized into three groups. Group A, patients received two-sessions&#xD;
      of ultrasound-guided PIT with 10cc D5W (3 months interval); Group B, patients received&#xD;
      one-session of ultrasound-guided PIT with 10cc D5W and 5cc normal saline separately (3 months&#xD;
      interval); Group C (control group), patients received two-sessions of ultrasound-guided PIT&#xD;
      with nerve hydrodissection with 10cc normal saline. The primary outcome is Boston Carpal&#xD;
      Tunnel Syndrome Questionnaire (BCTQ) and secondary outcomes include visual analog scale&#xD;
      (VAS), cross-sectional area (CSA) of the median nerve, nerve conduction velocity of the&#xD;
      median nerve, and Global assessment of treatment. The evaluations were performed pretreatment&#xD;
      as well as on the 1st, 3rd, 6th, 9th month and one year after first injection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 1, 2019</start_date>
  <completion_date type="Anticipated">October 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2022</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 1st, 3rd, 6th, 9th month and one year after injection</measure>
    <time_frame>Pre-treatment, 1st, 3rd, 6th, 9th month and one year 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 1st, 3rd, 6th, 9th month and one year after injection</measure>
    <time_frame>Pre-treatment, 1st, 3rd, 6th, 9th month and one year 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 1st, 3rd, 6th, 9th month and one year after injection</measure>
    <time_frame>Pre-treatment, 1st, 3rd, 6th, 9th month and one year 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 electrophysiological measurement on 1st, 3rd, 6th, 9th month and one year after injection</measure>
    <time_frame>Pre-treatment, 1st, 3rd, 6th, 9th month and one year 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>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">75</enrollment>
  <condition>Carpal Tunnel Syndrome</condition>
  <arm_group>
    <arm_group_label>Two-sessions of ultrasound-guided PIT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>two-sessions of ultrasound-guided PIT with 10cc 5% dextrose (3 months interval)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>One-session of ultrasound-guided PIT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>one-session of ultrasound-guided PIT with 10cc 5% dextrose and 10cc normal saline separately (3 months interval)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Two-session of ultrasound-guided nerve hydrodissection</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>two-sessions of ultrasound-guided PIT with nerve hydrodissection with 10cc normal saline (3 months interval).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>two-sessions of ultrasound-guided PIT</intervention_name>
    <description>two-sessions of ultrasound-guided PIT with 10cc D5W (3 months interval)</description>
    <arm_group_label>Two-sessions of ultrasound-guided PIT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>One-sessions of ultrasound-guided PIT</intervention_name>
    <description>One-session of ultrasound-guided PIT with 10cc D5W and 10cc normal saline separately (3 months interval)</description>
    <arm_group_label>One-session of ultrasound-guided PIT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Placebo ultrasound-guided injection with nerve hydrodissection</intervention_name>
    <description>Two-sessions of ultrasound-guided PIT with nerve hydrodissection with 10cc normal saline (3 months interval).</description>
    <arm_group_label>Two-session of ultrasound-guided nerve 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>
  <overall_contact>
    <last_name>Yung-Tsan Wu, MD</last_name>
    <phone>+886287923311</phone>
    <phone_ext>17068</phone_ext>
    <email>crwu98@gmail.com</email>
  </overall_contact>
  <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>
    <status>Recruiting</status>
    <contact>
      <last_name>Yung-Tsan Wu, MD</last_name>
      <phone>287923311</phone>
      <phone_ext>17068</phone_ext>
      <email>crwu98@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <results_reference>
    <citation>Wu YT, Chen SR, Li TY, Ho TY, Shen YP, Tsai CK, Chen LC. Nerve hydrodissection for carpal tunnel syndrome: A prospective, randomized, double-blind, controlled trial. Muscle Nerve. 2019 Feb;59(2):174-180. doi: 10.1002/mus.26358. Epub 2018 Dec 4.</citation>
    <PMID>30339737</PMID>
  </results_reference>
  <results_reference>
    <citation>Wu YT, Ho TY, Chou YC, Ke MJ, Li TY, Tsai CK, Chen LC. Six-month Efficacy of Perineural Dextrose for Carpal Tunnel Syndrome: A Prospective, Randomized, Double-Blind, Controlled Trial. Mayo Clin Proc. 2017 Aug;92(8):1179-1189. doi: 10.1016/j.mayocp.2017.05.025.</citation>
    <PMID>28778254</PMID>
  </results_reference>
  <results_reference>
    <citation>Wu YT, Ke MJ, Ho TY, Li TY, Shen YP, Chen LC. Randomized double-blinded clinical trial of 5% dextrose versus triamcinolone injection for carpal tunnel syndrome patients. Ann Neurol. 2018 Oct;84(4):601-610. doi: 10.1002/ana.25332. Epub 2018 Oct 4.</citation>
    <PMID>30187524</PMID>
  </results_reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>April 25, 2022</last_update_submitted>
  <last_update_submitted_qc>April 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2022</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>perineural injection therapy</keyword>
  <keyword>nerve 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/NCT03802435
org study id: Different PIT for CTS
nct id: NCT03802435
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. The technique of perineural
      injection therapy (PIT) by using 5% dextrose (D5W) is now commonly used for peeling the nerve
      from surrounding soft tissue (called nerve hydrodissection), which may help antineurogenic
      inflammation, allow the impulse to pass, and rescue the nerve with ischemic damage. However,
      the evidence and reference of PIT and nerve hydrodissection are very seldom until our series
      researches since 2017. Moreover, our research revealed PIT with D5W is more beneficial than
      that of corticosteroid in patients with mild-to-moderate CTS at 4 to 6 months postinjection.
      However, the accumulative effect and long-term effect (more than 6 months) of PIT is still
      unknown. Hence, we design a randomized, double- blind, controlled trail to assess the
      long-term effect of ultrasound-guided PIT in patients with CTS. The aim one is to survey the
      possible accumulative effect of different sessions of PIT (6 months follow-up) and aim two is
      to evaluate the long-term effect and safety of PIT (one year follow-up).
After obtaining written informed consent, patients clinically diagnosed with mild-to-moderate
      CTS were includes and randomized into three groups. Group A, patients received two-sessions
      of ultrasound-guided PIT with 10cc D5W (3 months interval); Group B, patients received
      one-session of ultrasound-guided PIT with 10cc D5W and 5cc normal saline separately (3 months
      interval); Group C (control group), patients received two-sessions of ultrasound-guided PIT
      with nerve hydrodissection with 10cc normal saline. 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, nerve conduction velocity of the
      median nerve, and Global assessment of treatment. The evaluations were performed pretreatment
      as well as on the 1st, 3rd, 6th, 9th month and one year after first injection.
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 1st, 3rd, 6th, 9th month and one year after injection
time frame: Pre-treatment, 1st, 3rd, 6th, 9th month and one year 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 1st, 3rd, 6th, 9th month and one year after injection
time frame: Pre-treatment, 1st, 3rd, 6th, 9th month and one year 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 1st, 3rd, 6th, 9th month and one year after injection
time frame: Pre-treatment, 1st, 3rd, 6th, 9th month and one year 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 electrophysiological measurement on 1st, 3rd, 6th, 9th month and one year after injection
time frame: Pre-treatment, 1st, 3rd, 6th, 9th month and one year after injection
description: Antidromic sensory nerve conduction velocity of the median nerve before treatment and multiple time frame after treatment.
arm group label: Two-sessions of ultrasound-guided PIT
arm group type: Experimental
description: two-sessions of ultrasound-guided PIT with 10cc 5% dextrose (3 months interval)
arm group label: One-session of ultrasound-guided PIT
arm group type: Active Comparator
description: one-session of ultrasound-guided PIT with 10cc 5% dextrose and 10cc normal saline separately (3 months interval)
arm group label: Two-session of ultrasound-guided nerve hydrodissection
arm group type: Placebo Comparator
description: two-sessions of ultrasound-guided PIT with nerve hydrodissection with 10cc normal saline (3 months interval).
intervention type: Procedure
intervention name: two-sessions of ultrasound-guided PIT
description: two-sessions of ultrasound-guided PIT with 10cc D5W (3 months interval)
arm group label: Two-sessions of ultrasound-guided PIT
intervention type: Procedure
intervention name: One-sessions of ultrasound-guided PIT
description: One-session of ultrasound-guided PIT with 10cc D5W and 10cc normal saline separately (3 months interval)
arm group label: One-session of ultrasound-guided PIT
intervention type: Procedure
intervention name: Placebo ultrasound-guided injection with nerve hydrodissection
description: Two-sessions of ultrasound-guided PIT with nerve hydrodissection with 10cc normal saline (3 months interval).
arm group label: Two-session of ultrasound-guided nerve 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
last name: Yung-Tsan Wu, MD
phone: +886287923311
phone ext: 17068
email: crwu98@gmail.com
facility: 
status: Recruiting
contact: 
country: Taiwan
citation: Wu YT, Chen SR, Li TY, Ho TY, Shen YP, Tsai CK, Chen LC. Nerve hydrodissection for carpal tunnel syndrome: A prospective, randomized, double-blind, controlled trial. Muscle Nerve. 2019 Feb;59(2):174-180. doi: 10.1002/mus.26358. Epub 2018 Dec 4.
PMID: 30339737
citation: Wu YT, Ho TY, Chou YC, Ke MJ, Li TY, Tsai CK, Chen LC. Six-month Efficacy of Perineural Dextrose for Carpal Tunnel Syndrome: A Prospective, Randomized, Double-Blind, Controlled Trial. Mayo Clin Proc. 2017 Aug;92(8):1179-1189. doi: 10.1016/j.mayocp.2017.05.025.
PMID: 28778254
citation: Wu YT, Ke MJ, Ho TY, Li TY, Shen YP, Chen LC. Randomized double-blinded clinical trial of 5% dextrose versus triamcinolone injection for carpal tunnel syndrome patients. Ann Neurol. 2018 Oct;84(4):601-610. doi: 10.1002/ana.25332. Epub 2018 Oct 4.
PMID: 30187524
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