<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/NCT04434105</url>
  </required_header>
  <id_info>
    <org_study_id>001</org_study_id>
    <nct_id>NCT04434105</nct_id>
  </id_info>
  <brief_title>Ultrasound-guided PRP Versus Steroid Injections in Management of Carpal Tunnel Syndrome</brief_title>
  <official_title>Ultrasound-guided PRP Versus Steroid Injections in Management of Carpal Tunnel Syndrome; a Comparative Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tanta University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tanta University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients will be randomly divided into 3 equal groups: Group I received ultrasound guided&#xD;
      injection of 2 mL PRP into the affected carpal tunnel. Group II received ultrasound guided&#xD;
      injection of 2 mL steroids (40 mg triamcinolone acetonide). Group III received ultrasound&#xD;
      guided injection of 2 mL saline as placebo control.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be randomly divided into 3 equal groups: Group I received ultrasound guided&#xD;
      injection of 2 mL PRP into the affected carpal tunnel. Group II received ultrasound guided&#xD;
      injection of 2 mL steroids (40 mg triamcinolone acetonide). Group III received ultrasound&#xD;
      guided injection of 2 mL saline as placebo control.&#xD;
&#xD;
      Each group will be injected twice with 2 weeks intervals. All procedures were done after&#xD;
      informed consent. Evaluation of the patients at baseline, 3 and 6 months after last injection&#xD;
      was done clinically by measuring visual analogue scale (VAS), electrophysiologically (by&#xD;
      measuring motor and sensory nerve conduction studies of median nerve using a standardized&#xD;
      technique) and ultrasonographic study by measuring cross sectional area (CSA) of median nerve&#xD;
      at the level of pisiform.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">February 1, 2020</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">November 2020</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>visual analogue scale</measure>
    <time_frame>Change from 3 months after last injection and 6 months after last injection</time_frame>
    <description>Scale for assessement the degree of pain along 0-10 scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>measuring motor and sensory nerve conduction studies of median nerve using a standardized technique</measure>
    <time_frame>Change from 3 months after last injection and 6 months after last injection</time_frame>
    <description>electrophysiologically by measuring motor and sensory nerve conduction studies of median nerve using a standardized technique</description>
  </primary_outcome>
  <primary_outcome>
    <measure>cross-sectional area (CSA) of the median nerve at the level of the pisiform.</measure>
    <time_frame>Change from 3 months after last injection and 6 months after last injection</time_frame>
    <description>ultrasonographic study by measuring cross-sectional area (CSA) of the median nerve at the level of the pisiform.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Carpal Tunnel Syndrome</condition>
  <arm_group>
    <arm_group_label>PRP group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients received ultrasound-guided injection of 2 mL PRP into the affected carpal tunnel.patients will be injected twice with 2 weeks intervals</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Steroid group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients received ultrasound-guided injection of 2 mL steroids (40 mg triamcinolone acetonide). into the affected carpal tunnel. patients will be injected twice with 2 weeks intervals</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>patients received ultrasound-guided injection of 2 mL saline patients will be injected twice with 2 weeks intervals</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>platlet rich plasma (PRP)</intervention_name>
    <description>Platelet-rich plasma (PRP) promotes angiogenesis, neurogenesis, and nerve regeneration, also it could reduce swelling and inflammation of the flexor tenosynovitis.</description>
    <arm_group_label>PRP group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Triamcinolone Acetonide</intervention_name>
    <description>40 mg triamcinolone acetonide</description>
    <arm_group_label>Steroid group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline</intervention_name>
    <description>Saline</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  mild or moderate idiopathic CTS (diagnosed clinically, ultrasonography &amp;&#xD;
             electrophysiologically and classified according to the American Association of&#xD;
             neuromuscular diagnostic medicine monograph).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with severe or secondary type of CTS&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Tanta University Hospital</name>
      <address>
        <city>Tanta</city>
        <zip>31527</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4705801/</url>
    <description>effect of PRP on CTS</description>
  </link>
  <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>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 14, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 15, 2020</last_update_submitted>
  <last_update_submitted_qc>June 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tanta University</investigator_affiliation>
    <investigator_full_name>Mohammed Hassan Abu-Zaid</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <keyword>PRP injection</keyword>
  <keyword>Local injection</keyword>
  <keyword>CTS</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>Triamcinolone Acetonide</mesh_term>
    <mesh_term>Triamcinolone hexacetonide</mesh_term>
    <mesh_term>Triamcinolone diacetate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04434105
org study id: 001
nct id: NCT04434105
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Patients will be randomly divided into 3 equal groups: Group I received ultrasound guided
      injection of 2 mL PRP into the affected carpal tunnel. Group II received ultrasound guided
      injection of 2 mL steroids (40 mg triamcinolone acetonide). Group III received ultrasound
      guided injection of 2 mL saline as placebo control.
Patients will be randomly divided into 3 equal groups: Group I received ultrasound guided
      injection of 2 mL PRP into the affected carpal tunnel. Group II received ultrasound guided
      injection of 2 mL steroids (40 mg triamcinolone acetonide). Group III received ultrasound
      guided injection of 2 mL saline as placebo control.

      Each group will be injected twice with 2 weeks intervals. All procedures were done after
      informed consent. Evaluation of the patients at baseline, 3 and 6 months after last injection
      was done clinically by measuring visual analogue scale (VAS), electrophysiologically (by
      measuring motor and sensory nerve conduction studies of median nerve using a standardized
      technique) and ultrasonographic study by measuring cross sectional area (CSA) of median nerve
      at the level of pisiform.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: visual analogue scale
time frame: Change from 3 months after last injection and 6 months after last injection
description: Scale for assessement the degree of pain along 0-10 scale
measure: measuring motor and sensory nerve conduction studies of median nerve using a standardized technique
time frame: Change from 3 months after last injection and 6 months after last injection
description: electrophysiologically by measuring motor and sensory nerve conduction studies of median nerve using a standardized technique
measure: cross-sectional area (CSA) of the median nerve at the level of the pisiform.
time frame: Change from 3 months after last injection and 6 months after last injection
description: ultrasonographic study by measuring cross-sectional area (CSA) of the median nerve at the level of the pisiform.
arm group label: PRP group
arm group type: Experimental
description: patients received ultrasound-guided injection of 2 mL PRP into the affected carpal tunnel.patients will be injected twice with 2 weeks intervals
arm group label: Steroid group
arm group type: Active Comparator
description: patients received ultrasound-guided injection of 2 mL steroids (40 mg triamcinolone acetonide). into the affected carpal tunnel. patients will be injected twice with 2 weeks intervals
arm group label: Control group
arm group type: Placebo Comparator
description: patients received ultrasound-guided injection of 2 mL saline patients will be injected twice with 2 weeks intervals
intervention type: Drug
intervention name: platlet rich plasma (PRP)
description: Platelet-rich plasma (PRP) promotes angiogenesis, neurogenesis, and nerve regeneration, also it could reduce swelling and inflammation of the flexor tenosynovitis.
arm group label: PRP group
intervention type: Drug
intervention name: Triamcinolone Acetonide
description: 40 mg triamcinolone acetonide
arm group label: Steroid group
intervention type: Drug
intervention name: Saline
description: Saline
arm group label: Control group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
country: Egypt
url: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4705801/
description: effect of PRP on CTS
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: Tanta University
investigator full name: Mohammed Hassan Abu-Zaid
investigator title: principal investigator
mesh term: Carpal Tunnel Syndrome
mesh term: Syndrome
mesh term: Triamcinolone
mesh term: Triamcinolone Acetonide
mesh term: Triamcinolone hexacetonide
mesh term: Triamcinolone diacetate
sharing ipd: Undecided