<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/NCT02986906</url>
  </required_header>
  <id_info>
    <org_study_id>PIT for ulnar neuropathy</org_study_id>
    <nct_id>NCT02986906</nct_id>
  </id_info>
  <brief_title>Perineural Injection Therapy for Ulnar Neuropathy at Elbow</brief_title>
  <official_title>The Long-term Effect for Perineural Injection Therapy for Ulnar Neuropathy at Elbow</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>
      Ulnar neuropathy at elbow (UNE) is the second common peripheral entrapment neuropathy.&#xD;
      Although many conservative managements of UNE, the effectiveness of these methods are&#xD;
      unsatisfied especial the moderate degree of UNE. Recently, ultrasound-guided perineural&#xD;
      injection therapy (PIT) with 5% dextrose is progressively applicated for clinical treatment&#xD;
      for entrapment neuropathy. However, current studies have not proved the effects of PIT on&#xD;
      peripheral neuropathy because these studies enrolled small number of patients and lacked&#xD;
      controlled design. We design a randomized, double-blind, controlled trail to assess the&#xD;
      effect after ultrasound-guided PIT with 5% dextrose in patients with mild and moderate UNE.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After obtaining written informed consent, 40 patients, clinically diagnosed with mild or&#xD;
      moderate UNE were randomized into intervention or control group. Participants in intervention&#xD;
      group received one-session of ultrasound-guided PIT injection with 5cc. 5% dextrose and&#xD;
      control group received 2cc 0.9% normal saline+3cc Triamcinolone (30mg) (total 5 cc)&#xD;
      ultrasound-guided PIT injection. The primary outcome is Disabilities of the Arm, Shoulder and&#xD;
      Hand (DASH) and secondary outcomes include visual analog scale (VAS), cross-sectional area&#xD;
      (CSA) of the ulnar nerve, motor nerve conduction velocity of the ulnar nerve, and strength of&#xD;
      palmer finger pinch and grasp. The evaluation was performed pretreatment as well as on the&#xD;
      1st, 3rd and 6th month 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 30, 2019</completion_date>
  <primary_completion_date type="Actual">October 30, 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, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from pain on 1st, 3rd, 6th month after injection</measure>
    <time_frame>Pre-treatment, 1st, 3rd, 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>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from severity of symptoms and functional status on 1st, 3rd, 6th month after injection</measure>
    <time_frame>Pre-treatment, 1st, 3rd, 6th month after injection</time_frame>
    <description>Taiwan Disabilities of the Arm, Shoulder and Hand (DASH) contains 11-item disability/symptom scale and each item has five levels of response scoring from 1 to 5. The higher score means more disability or severer symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from nerve conduction velocity on 1st, 3rd, 6th month after injection</measure>
    <time_frame>Pre-treatment, 1st, 3rd, 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>
  <secondary_outcome>
    <measure>Change from cross-sectional area on 1st, 3rd, 6th month after injection</measure>
    <time_frame>Pre-treatment, 1st, 3rd, 6th month after injection</time_frame>
    <description>Using the musculoskeletal sonogram to measure the cross-sectional area of the ulnar nerve before treatment and multiple time frame after treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from palmer finger pinch and grasp on 1st, 3rd, 6th month after injection</measure>
    <time_frame>Pre-treatment, 1st, 3rd, 6th month after injection</time_frame>
    <description>The palmer finger pinch and grasp strength was measured using dynamometer (Fabrication Enterprises Inc., USA) before treatment and multiple time frame after treatment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Ulnar Neuropathy at Elbow</condition>
  <arm_group>
    <arm_group_label>5% dextrose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The perineural injection with 5% dextrose is a new and potential treatment for peripheral entrapment neuropathy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2cc 0.9% normal saline+3cc Triamcinolone (30mg)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Ultrasound-guided injection with 2cc 0.9% normal saline+3cc Triamcinolone (30mg)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>5% dextrose</intervention_name>
    <description>Ultrasound-guided 5cc 5% dextrose injection between medial epicondyle and ulnar nerve</description>
    <arm_group_label>5% dextrose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>2cc 0.9% normal saline+3cc Triamcinolone (30mg)</intervention_name>
    <description>Ultrasound-guided 2cc 0.9% normal saline+3cc Triamcinolone (30mg) injection between medial epicondyle and ulnar nerve</description>
    <arm_group_label>2cc 0.9% normal saline+3cc Triamcinolone (30mg)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ultrasound</intervention_name>
    <description>The ultrasound was used for injection guidance</description>
    <arm_group_label>2cc 0.9% normal saline+3cc Triamcinolone (30mg)</arm_group_label>
    <arm_group_label>5% dextrose</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 ulnar neuropathy&#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>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>
  <results_reference>
    <citation>Campbell WW, Pridgeon RM, Sahni KS. Short segment incremental studies in the evaluation of ulnar neuropathy at the elbow. Muscle Nerve. 1992 Sep;15(9):1050-4. doi: 10.1002/mus.880150910.</citation>
    <PMID>1518514</PMID>
  </results_reference>
  <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>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>November 19, 2019</last_update_submitted>
  <last_update_submitted_qc>November 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 20, 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>ulnar neuropathy at elbow</keyword>
  <keyword>Dextrose</keyword>
  <keyword>perineural injection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Nervous System Diseases</mesh_term>
    <mesh_term>Ulnar Neuropathies</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Triamcinolone</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/NCT02986906
org study id: PIT for ulnar neuropathy
nct id: NCT02986906
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Ulnar neuropathy at elbow (UNE) is the second common peripheral entrapment neuropathy.
      Although many conservative managements of UNE, the effectiveness of these methods are
      unsatisfied especial the moderate degree of UNE. Recently, ultrasound-guided perineural
      injection therapy (PIT) with 5% dextrose is progressively applicated for clinical treatment
      for entrapment neuropathy. However, current studies have not proved the effects of PIT on
      peripheral neuropathy because these studies enrolled small number of patients and lacked
      controlled design. We design a randomized, double-blind, controlled trail to assess the
      effect after ultrasound-guided PIT with 5% dextrose in patients with mild and moderate UNE.
After obtaining written informed consent, 40 patients, clinically diagnosed with mild or
      moderate UNE were randomized into intervention or control group. Participants in intervention
      group received one-session of ultrasound-guided PIT injection with 5cc. 5% dextrose and
      control group received 2cc 0.9% normal saline+3cc Triamcinolone (30mg) (total 5 cc)
      ultrasound-guided PIT injection. The primary outcome is Disabilities of the Arm, Shoulder and
      Hand (DASH) and secondary outcomes include visual analog scale (VAS), cross-sectional area
      (CSA) of the ulnar nerve, motor nerve conduction velocity of the ulnar nerve, and strength of
      palmer finger pinch and grasp. The evaluation was performed pretreatment as well as on the
      1st, 3rd and 6th month after the treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change from pain on 1st, 3rd, 6th month after injection
time frame: Pre-treatment, 1st, 3rd, 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 severity of symptoms and functional status on 1st, 3rd, 6th month after injection
time frame: Pre-treatment, 1st, 3rd, 6th month after injection
description: Taiwan Disabilities of the Arm, Shoulder and Hand (DASH) contains 11-item disability/symptom scale and each item has five levels of response scoring from 1 to 5. The higher score means more disability or severer symptoms.
measure: Change from nerve conduction velocity on 1st, 3rd, 6th month after injection
time frame: Pre-treatment, 1st, 3rd, 6th month after injection
description: Nerve motor conduction velocity of the ulnar nerve before treatment and multiple time frame after treatment.
measure: Change from cross-sectional area on 1st, 3rd, 6th month after injection
time frame: Pre-treatment, 1st, 3rd, 6th month after injection
description: Using the musculoskeletal sonogram to measure the cross-sectional area of the ulnar nerve before treatment and multiple time frame after treatment.
measure: Change from palmer finger pinch and grasp on 1st, 3rd, 6th month after injection
time frame: Pre-treatment, 1st, 3rd, 6th month after injection
description: The palmer finger pinch and grasp strength was measured using dynamometer (Fabrication Enterprises Inc., USA) before treatment and multiple time frame after treatment.
arm group label: 5% dextrose
arm group type: Experimental
description: The perineural injection with 5% dextrose is a new and potential treatment for peripheral entrapment neuropathy
arm group label: 2cc 0.9% normal saline+3cc Triamcinolone (30mg)
arm group type: Active Comparator
description: The Ultrasound-guided injection with 2cc 0.9% normal saline+3cc Triamcinolone (30mg)
intervention type: Drug
intervention name: 5% dextrose
description: Ultrasound-guided 5cc 5% dextrose injection between medial epicondyle and ulnar nerve
arm group label: 5% dextrose
intervention type: Drug
intervention name: 2cc 0.9% normal saline+3cc Triamcinolone (30mg)
description: Ultrasound-guided 2cc 0.9% normal saline+3cc Triamcinolone (30mg) injection between medial epicondyle and ulnar nerve
arm group label: 2cc 0.9% normal saline+3cc Triamcinolone (30mg)
intervention type: Device
intervention name: Ultrasound
description: The ultrasound was used for injection guidance
arm group label: 2cc 0.9% normal saline+3cc Triamcinolone (30mg)
arm group label: 5% dextrose
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: 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
citation: Campbell WW, Pridgeon RM, Sahni KS. Short segment incremental studies in the evaluation of ulnar neuropathy at the elbow. Muscle Nerve. 1992 Sep;15(9):1050-4. doi: 10.1002/mus.880150910.
PMID: 1518514
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
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: Peripheral Nervous System Diseases
mesh term: Ulnar Neuropathies
mesh term: Triamcinolone
sharing ipd: Yes