<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/NCT02986828</url>
  </required_header>
  <id_info>
    <org_study_id>PRP and hydrodissection</org_study_id>
    <nct_id>NCT02986828</nct_id>
  </id_info>
  <brief_title>Platelet Rich Plasma and Hydrodissection for Carpal Tunnel Syndrome</brief_title>
  <official_title>The Long-term Effect of Platelet Rich Plasma and Hydrodissection for 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. The platelet rich plasma (PRP) is a new and potential treatment for patients&#xD;
      with kinds of musculoskeletal disorders and recent reports showed being beneficial for&#xD;
      peripheral neuropathy in animal studies. Since 2014, three small clinical trials showed the&#xD;
      positive effect of PRP in peripheral neuropathy included CTSin a pilot research. However,&#xD;
      these studies have not entirely proved the effects of PRP on peripheral neuropathy because&#xD;
      these studies enrolled small number of patients and lacked controlled design. The&#xD;
      investigators design a randomized, double-blind, controlled trail to assess the effect after&#xD;
      ultrasound-guided PRP injection 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 side. Participants in intervention group received one-dose&#xD;
      ultrasound-guided PRP injection and control side received one-dose ultrasound-guided normal&#xD;
      saline injection. No additional treatment after injection through the study period. The&#xD;
      primary outcome is Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and secondary outcomes&#xD;
      include visual analog scale (VAS), cross-sectional area (CSA) of the median nerve, sensory&#xD;
      nerve conduction velocity of the median nerve, and finger pinch strength. The evaluation was&#xD;
      performed pretreatment as well as on the 2nd week, 1st, 3rd, 6th month and one year after the&#xD;
      treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2016</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 baseline of pain on 2nd week, 1st, 3rd, 6th month and 1 year after injection</measure>
    <time_frame>Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year 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, 3rd, 6th month and 1 year after injection</measure>
    <time_frame>Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection</time_frame>
    <description>Using the Boston Carpal Tunnel Syndrome Questionnaire to measure the severity of 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, 3rd, 6th month and 1 year after injection</measure>
    <time_frame>Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 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 conduction velocity, amplitude of median nerve on 2nd week, 1st, 3rd, 6th month and 1 year after injection</measure>
    <time_frame>Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 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>
  <secondary_outcome>
    <measure>Change from finger pinch on 2nd week, 1st, 3rd, 6th month and 1 year after injection</measure>
    <time_frame>Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection</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">26</enrollment>
  <condition>Carpal Tunnel Syndrome</condition>
  <arm_group>
    <arm_group_label>platelet rich plasma injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The platelet rich plasma (PRP) is a new and potential treatment for peripheral neuropathy in many animal studies.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal saline</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Normal saline for ultrasound-guided hydrodissection</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>platelet rich plasma</intervention_name>
    <description>Ultrasound-guided 3cc PRP injection between proximal carpal tunnel and median nerve.</description>
    <arm_group_label>platelet rich plasma injection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline</intervention_name>
    <description>Ultrasound-guided 3cc normal saline injection between proximal carpal tunnel and median nerve.</description>
    <arm_group_label>Normal saline</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ultrasound</intervention_name>
    <arm_group_label>Normal saline</arm_group_label>
    <arm_group_label>platelet rich plasma injection</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>Anjayani S, Wirohadidjojo YW, Adam AM, Suwandi D, Seweng A, Amiruddin MD. Sensory improvement of leprosy peripheral neuropathy in patients treated with perineural injection of platelet-rich plasma. Int J Dermatol. 2014 Jan;53(1):109-13. doi: 10.1111/ijd.12162. Epub 2013 Oct 29.</citation>
    <PMID>24168291</PMID>
  </results_reference>
  <results_reference>
    <citation>Sanchez M, Yoshioka T, Ortega M, Delgado D, Anitua E. Ultrasound-guided platelet-rich plasma injections for the treatment of common peroneal nerve palsy associated with multiple ligament injuries of the knee. Knee Surg Sports Traumatol Arthrosc. 2014 May;22(5):1084-9. doi: 10.1007/s00167-013-2479-y. Epub 2013 Mar 22.</citation>
    <PMID>23519544</PMID>
  </results_reference>
  <results_reference>
    <citation>Scala M, Mereu P, Spagnolo F, Massa M, Barla A, Mosci S, Forno G, Ingenito A, Strada P. The use of platelet-rich plasma gel in patients with mixed tumour undergoing superficial parotidectomy: a randomized study. In Vivo. 2014 Jan-Feb;28(1):121-4.</citation>
    <PMID>24425846</PMID>
  </results_reference>
  <results_reference>
    <citation>Malahias MA, Johnson EO, Babis GC, Nikolaou VS. Single injection of platelet-rich plasma as a novel treatment of carpal tunnel syndrome. Neural Regen Res. 2015 Nov;10(11):1856-9. doi: 10.4103/1673-5374.165322.</citation>
    <PMID>26807124</PMID>
  </results_reference>
  <verification_date>October 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>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>platelet rich plasma</keyword>
  <keyword>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/NCT02986828
org study id: PRP and hydrodissection
nct id: NCT02986828
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. The platelet rich plasma (PRP) is a new and potential treatment for patients
      with kinds of musculoskeletal disorders and recent reports showed being beneficial for
      peripheral neuropathy in animal studies. Since 2014, three small clinical trials showed the
      positive effect of PRP in peripheral neuropathy included CTSin a pilot research. However,
      these studies have not entirely proved the effects of PRP on peripheral neuropathy because
      these studies enrolled small number of patients and lacked controlled design. The
      investigators design a randomized, double-blind, controlled trail to assess the effect after
      ultrasound-guided PRP injection in patients with CTS.
After obtaining written informed consent, patients with bilateral CTS will been randomized
      into intervention and control side. Participants in intervention group received one-dose
      ultrasound-guided PRP injection and control side received one-dose ultrasound-guided normal
      saline injection. 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, Investigator)
measure: Change from baseline of pain on 2nd week, 1st, 3rd, 6th month and 1 year after injection
time frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year 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, 3rd, 6th month and 1 year after injection
time frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection
description: Using the Boston Carpal Tunnel Syndrome Questionnaire to measure the severity of 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, 3rd, 6th month and 1 year after injection
time frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 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 conduction velocity, amplitude of median nerve on 2nd week, 1st, 3rd, 6th month and 1 year after injection
time frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection
description: antidromic sensory nerve conduction velocity of the median nerve before treatment and multiple time frame after treatment.
measure: Change from finger pinch on 2nd week, 1st, 3rd, 6th month and 1 year after injection
time frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection
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: platelet rich plasma injection
arm group type: Experimental
description: The platelet rich plasma (PRP) is a new and potential treatment for peripheral neuropathy in many animal studies.
arm group label: Normal saline
arm group type: Active Comparator
description: Normal saline for ultrasound-guided hydrodissection
intervention type: Drug
intervention name: platelet rich plasma
description: Ultrasound-guided 3cc PRP injection between proximal carpal tunnel and median nerve.
arm group label: platelet rich plasma injection
intervention type: Drug
intervention name: Normal saline
description: Ultrasound-guided 3cc normal saline injection between proximal carpal tunnel and median nerve.
arm group label: Normal saline
intervention type: Device
intervention name: Ultrasound
arm group label: Normal saline
arm group label: platelet rich plasma injection
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: Anjayani S, Wirohadidjojo YW, Adam AM, Suwandi D, Seweng A, Amiruddin MD. Sensory improvement of leprosy peripheral neuropathy in patients treated with perineural injection of platelet-rich plasma. Int J Dermatol. 2014 Jan;53(1):109-13. doi: 10.1111/ijd.12162. Epub 2013 Oct 29.
PMID: 24168291
citation: Sanchez M, Yoshioka T, Ortega M, Delgado D, Anitua E. Ultrasound-guided platelet-rich plasma injections for the treatment of common peroneal nerve palsy associated with multiple ligament injuries of the knee. Knee Surg Sports Traumatol Arthrosc. 2014 May;22(5):1084-9. doi: 10.1007/s00167-013-2479-y. Epub 2013 Mar 22.
PMID: 23519544
citation: Scala M, Mereu P, Spagnolo F, Massa M, Barla A, Mosci S, Forno G, Ingenito A, Strada P. The use of platelet-rich plasma gel in patients with mixed tumour undergoing superficial parotidectomy: a randomized study. In Vivo. 2014 Jan-Feb;28(1):121-4.
PMID: 24425846
citation: Malahias MA, Johnson EO, Babis GC, Nikolaou VS. Single injection of platelet-rich plasma as a novel treatment of carpal tunnel syndrome. Neural Regen Res. 2015 Nov;10(11):1856-9. doi: 10.4103/1673-5374.165322.
PMID: 26807124
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