<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/NCT03802422</url>
  </required_header>
  <id_info>
    <org_study_id>Vitamin for CTS</org_study_id>
    <nct_id>NCT03802422</nct_id>
  </id_info>
  <brief_title>Vitamin B12 for Carpal Tunnel Syndrome</brief_title>
  <official_title>Perineural Injection Therapy With Vitamin B12 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. 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 Vitamin B12 was considered&#xD;
      to be beneficial for peripheral neuropathy and pain relief. The investigators design a&#xD;
      randomized, double-blind, controlled trail to assess the effect after ultrasound-guided&#xD;
      hydrodissection with Vitamin B12 in patients with CTS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After obtaining written informed consent, patients with mild to moderate CTS will been&#xD;
      randomized into intervention and control group. Participants in intervention group received&#xD;
      one-dose ultrasound-guided hydrodissection with 3cc Vitamin B12 and control side received&#xD;
      one-dose ultrasound-guided injection 3cc normal saline. 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. The evaluation was performed pretreatment as well as on the 2nd week, 1st, 2nd,&#xD;
      3rd and 6th month after the treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    It is hard to enroll patients due to Covid-19 pandemic.&#xD;
  </why_stopped>
  <start_date type="Actual">April 20, 2019</start_date>
  <completion_date type="Actual">April 8, 2020</completion_date>
  <primary_completion_date type="Actual">April 8, 2020</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, 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 electrophysiological measurement 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>Antidromic sensory nerve conduction velocity of the median nerve before treatment and multiple time frame after treatment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Carpal Tunnel Syndrome</condition>
  <arm_group>
    <arm_group_label>Vitamin B12 hydrodissection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ultrasound-guided hydrodissection with Vitamin B12 between carpal tunnel and median nerve.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal saline hydrodissection</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Ultrasound-guided hydrodissection with normal saline between carpal tunnel and median nerve.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vitamin B12</intervention_name>
    <description>Ultrasound-guided hydrodissection with 3cc Vitamin B12 (methycobal, 500μg/ml) between carpal tunnel and median nerve.</description>
    <arm_group_label>Vitamin B12 hydrodissection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline</intervention_name>
    <description>Ultrasound-guided hydrodissection with 3cc 0.9% normal saline 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>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>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, 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>
  <results_reference>
    <citation>Xu G, Lv ZW, Feng Y, Tang WZ, Xu GX. A single-center randomized controlled trial of local methylcobalamin injection for subacute herpetic neuralgia. Pain Med. 2013 Jun;14(6):884-94. doi: 10.1111/pme.12081. Epub 2013 Apr 8.</citation>
    <PMID>23566267</PMID>
  </results_reference>
  <verification_date>October 2020</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>October 6, 2020</last_update_submitted>
  <last_update_submitted_qc>October 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2020</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>Vitamin B12</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>Vitamin B 12</mesh_term>
    <mesh_term>Hydroxocobalamin</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/NCT03802422
org study id: Vitamin for CTS
nct id: NCT03802422
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. In addition, the Vitamin B12 was considered
      to be beneficial for peripheral neuropathy and pain relief. The investigators design a
      randomized, double-blind, controlled trail to assess the effect after ultrasound-guided
      hydrodissection with Vitamin B12 in patients with CTS.
After obtaining written informed consent, patients with mild to moderate CTS will been
      randomized into intervention and control group. Participants in intervention group received
      one-dose ultrasound-guided hydrodissection with 3cc Vitamin B12 and control side received
      one-dose ultrasound-guided injection 3cc 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. 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: 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, 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 electrophysiological measurement 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: Antidromic sensory nerve conduction velocity of the median nerve before treatment and multiple time frame after treatment.
arm group label: Vitamin B12 hydrodissection
arm group type: Experimental
description: Ultrasound-guided hydrodissection with Vitamin B12 between carpal tunnel and median nerve.
arm group label: Normal saline hydrodissection
arm group type: Placebo Comparator
description: Ultrasound-guided hydrodissection with normal saline between carpal tunnel and median nerve.
intervention type: Drug
intervention name: Vitamin B12
description: Ultrasound-guided hydrodissection with 3cc Vitamin B12 (methycobal, 500μg/ml) between carpal tunnel and median nerve.
arm group label: Vitamin B12 hydrodissection
intervention type: Drug
intervention name: Normal saline
description: Ultrasound-guided hydrodissection with 3cc 0.9% normal saline 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: 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: 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, 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
citation: Xu G, Lv ZW, Feng Y, Tang WZ, Xu GX. A single-center randomized controlled trial of local methylcobalamin injection for subacute herpetic neuralgia. Pain Med. 2013 Jun;14(6):884-94. doi: 10.1111/pme.12081. Epub 2013 Apr 8.
PMID: 23566267
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: Vitamin B 12
mesh term: Hydroxocobalamin
sharing ipd: Yes