<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/NCT02990962</url>
  </required_header>
  <id_info>
    <org_study_id>PIT for CTS</org_study_id>
    <nct_id>NCT02990962</nct_id>
  </id_info>
  <brief_title>The Effect of Perineural Injection Therapy Versus Steroid in Patients With Carpal Tunnel Syndrome</brief_title>
  <official_title>The Long-term Effect of Perineural Injection Therapy Versus Steroid 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>
  </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. Although many conservative&#xD;
      managements of CTS, the effectiveness of these methods is insignificant or only persist for a&#xD;
      short duration including steroid injection. Recently, the ultrasound-guided perineural&#xD;
      injection with 5% dextrose was widely used for entrapment neuropathy with positive benefit.&#xD;
      The investigators design a randomized, double-blind, controlled trail to assess the effect of&#xD;
      ultrasound-guided perineural injection with 5% dextrose in patients with CTS and compared&#xD;
      with steroid injection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After obtaining written informed consent, patients of clinically diagnosed with CTS were&#xD;
      randomized into intervention and control group. Participants in intervention group received&#xD;
      one-session ultrasound-guided perineural injection with 5% dextrose and control group&#xD;
      received one-session ultrasound-guided perineural injection with steroid. No additional&#xD;
      treatment after injection through the study period. The primary outcome is visual analog&#xD;
      scale (VAS) and secondary outcomes include Boston Carpal Tunnel Syndrome Questionnaire&#xD;
      (BCTQ), cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity of&#xD;
      the median nerve, and finger pinch strength. The evaluation was performed pretreatment as&#xD;
      well as on the 2nd week, 1st, 2nd, 3rd and 6 month after the treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">April 1, 2018</completion_date>
  <primary_completion_date type="Actual">April 1, 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 pain on 2nd week, 1st, 2nd, 3rd and 6 month after the treatment.</measure>
    <time_frame>Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection</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 of severity of symptoms and functional status on 2nd week, 1st, 2nd, 3rd and 6 month after the treatment.</measure>
    <time_frame>Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection</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 of cross-sectional area of the median nerve on 2nd week, 1st, 2nd, 3rd and 6 month after the treatment.</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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline of nerve conduction velicity on 2nd week, 1st, 2nd, 3rd and 6 month after the treatment.</measure>
    <time_frame>Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection</time_frame>
    <description>Nerve motor conduction velocity of the ulnar nerve before treatment and multiple time frame after treatment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Carpal Tunnel Syndrome</condition>
  <arm_group>
    <arm_group_label>Perineural injection with 5% dextrose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ultrasound-guided perineural injection with 5% Dextrose (5cc) between carpal tunnel and median nerve.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Perineural injection with steroid</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ultrasound-guided perineural injection with 1cc 2% Xylocaine+4cc Triamcinolone (40mg) between carpal tunnel and median nerve.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>5% dextrose</intervention_name>
    <description>Ultrasound-guided perineural injection with 5% dextrose (5cc) between carpal tunnel and surrounding median nerve with hydrodissection.</description>
    <arm_group_label>Perineural injection with 5% dextrose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>1cc 2% Xylocaine+4cc Triamcinolone (40mg)</intervention_name>
    <description>Ultrasound-guided perineural injection with1cc 2% Xylocaine+4cc Triamcinolone (40mg) between carpal tunnel and surrounding median nerve with hydrodissection.</description>
    <arm_group_label>Perineural injection with steroid</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 20-85 year-old.&#xD;
&#xD;
          -  Diagnosis was confirmed using an electrophysiological study and ultrasonography&#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>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>
  </results_reference>
  <results_reference>
    <citation>Tsui BC, Wagner A, Finucane B. Electrophysiologic effect of injectates on peripheral nerve stimulation. Reg Anesth Pain Med. 2004 May-Jun;29(3):189-93. doi: 10.1016/j.rapm.2004.02.002.</citation>
    <PMID>15138901</PMID>
  </results_reference>
  <results_reference>
    <citation>Tsui BCH, Kropelin B. The electrophysiological effect of dextrose 5% in water on single-shot peripheral nerve stimulation. Anesth Analg. 2005 Jun;100(6):1837-1839. doi: 10.1213/01.ANE.0000153020.84780.A5.</citation>
    <PMID>15920223</PMID>
  </results_reference>
  <results_reference>
    <citation>Girlanda P, Dattola R, Venuto C, Mangiapane R, Nicolosi C, Messina C. Local steroid treatment in idiopathic carpal tunnel syndrome: short- and long-term efficacy. J Neurol. 1993;240(3):187-90. doi: 10.1007/BF00857526.</citation>
    <PMID>8482993</PMID>
  </results_reference>
  <results_reference>
    <citation>Armstrong T, Devor W, Borschel L, Contreras R. Intracarpal steroid injection is safe and effective for short-term management of carpal tunnel syndrome. Muscle Nerve. 2004 Jan;29(1):82-8. doi: 10.1002/mus.10512.</citation>
    <PMID>14694502</PMID>
  </results_reference>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>December 9, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>April 23, 2018</last_update_submitted>
  <last_update_submitted_qc>April 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 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 physical medicine and rehabilitation</investigator_title>
  </responsible_party>
  <keyword>perineural injection</keyword>
  <keyword>ultrasound-guided</keyword>
  <keyword>dextrose</keyword>
  <keyword>steroid</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>Triamcinolone</mesh_term>
    <mesh_term>Lidocaine</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/NCT02990962
org study id: PIT for CTS
nct id: NCT02990962
lead sponsor: 
has dmc: Yes
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. Although many conservative
      managements of CTS, the effectiveness of these methods is insignificant or only persist for a
      short duration including steroid injection. Recently, the ultrasound-guided perineural
      injection with 5% dextrose was widely used for entrapment neuropathy with positive benefit.
      The investigators design a randomized, double-blind, controlled trail to assess the effect of
      ultrasound-guided perineural injection with 5% dextrose in patients with CTS and compared
      with steroid injection.
After obtaining written informed consent, patients of clinically diagnosed with CTS were
      randomized into intervention and control group. Participants in intervention group received
      one-session ultrasound-guided perineural injection with 5% dextrose and control group
      received one-session ultrasound-guided perineural injection with steroid. 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, 3rd and 6 month after the treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change from baseline of pain on 2nd week, 1st, 2nd, 3rd and 6 month after the treatment.
time frame: Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection
description: Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment.
measure: Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 2nd, 3rd and 6 month after the treatment.
time frame: Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection
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 of cross-sectional area of the median nerve on 2nd week, 1st, 2nd, 3rd and 6 month after the treatment.
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.
measure: Change from baseline of nerve conduction velicity on 2nd week, 1st, 2nd, 3rd and 6 month after the treatment.
time frame: Pre-treatment, 2nd week, 1st, 2nd, 3rd and 6th month after injection
description: Nerve motor conduction velocity of the ulnar nerve before treatment and multiple time frame after treatment.
arm group label: Perineural injection with 5% dextrose
arm group type: Experimental
description: Ultrasound-guided perineural injection with 5% Dextrose (5cc) between carpal tunnel and median nerve.
arm group label: Perineural injection with steroid
arm group type: Active Comparator
description: Ultrasound-guided perineural injection with 1cc 2% Xylocaine+4cc Triamcinolone (40mg) between carpal tunnel and median nerve.
intervention type: Drug
intervention name: 5% dextrose
description: Ultrasound-guided perineural injection with 5% dextrose (5cc) between carpal tunnel and surrounding median nerve with hydrodissection.
arm group label: Perineural injection with 5% dextrose
intervention type: Drug
intervention name: 1cc 2% Xylocaine+4cc Triamcinolone (40mg)
description: Ultrasound-guided perineural injection with1cc 2% Xylocaine+4cc Triamcinolone (40mg) between carpal tunnel and surrounding median nerve with hydrodissection.
arm group label: Perineural injection with steroid
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: 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: Tsui BC, Wagner A, Finucane B. Electrophysiologic effect of injectates on peripheral nerve stimulation. Reg Anesth Pain Med. 2004 May-Jun;29(3):189-93. doi: 10.1016/j.rapm.2004.02.002.
PMID: 15138901
citation: Tsui BCH, Kropelin B. The electrophysiological effect of dextrose 5% in water on single-shot peripheral nerve stimulation. Anesth Analg. 2005 Jun;100(6):1837-1839. doi: 10.1213/01.ANE.0000153020.84780.A5.
PMID: 15920223
citation: Girlanda P, Dattola R, Venuto C, Mangiapane R, Nicolosi C, Messina C. Local steroid treatment in idiopathic carpal tunnel syndrome: short- and long-term efficacy. J Neurol. 1993;240(3):187-90. doi: 10.1007/BF00857526.
PMID: 8482993
citation: Armstrong T, Devor W, Borschel L, Contreras R. Intracarpal steroid injection is safe and effective for short-term management of carpal tunnel syndrome. Muscle Nerve. 2004 Jan;29(1):82-8. doi: 10.1002/mus.10512.
PMID: 14694502
responsible party type: Principal Investigator
investigator affiliation: Tri-Service General Hospital
investigator full name: Yung-Tsan Wu
investigator title: Attending physician of physical medicine and rehabilitation
mesh term: Carpal Tunnel Syndrome
mesh term: Syndrome
mesh term: Triamcinolone
mesh term: Lidocaine
sharing ipd: Yes