<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/NCT02242513</url>
  </required_header>
  <id_info>
    <org_study_id>TSGHIRB-2-102-05-95</org_study_id>
    <secondary_id>TSGH-C103-115</secondary_id>
    <nct_id>NCT02242513</nct_id>
  </id_info>
  <brief_title>Ultrasound-guided Pulsed Radiofrequency for Plantar Fasciitis</brief_title>
  <official_title>Ultrasound-guided Pulsed Radiofrequency Stimulation of the Tibial Nerve for Plantar Fasciitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yung-Tsan Wu</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>
      Although there are many conservative method for plantar fasciitis, patients might spend 2&#xD;
      years to achieve resolution. Recent study have shown that pulsed radiofrequency (PRF)&#xD;
      lesioning of peripheral nerve can alleviate kinds of pain condition. However there are no&#xD;
      studies of PRF lesioning of the tibial nerve in patients with plantar fascilitis by using&#xD;
      ultrasound-guided (UG) techniques.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with unilateral plantar Fasciitis will be enrolled and randomized into intervention&#xD;
      and control group. One dose of sono-guided PRF is applied in the intervention group and&#xD;
      xylocaine in control group. Outcome measurements included visual analog scale (VAS)、foot&#xD;
      health status questionnaire and the thickness of plantar fascile measured by musculoskeletal&#xD;
      ultrasonography at different follow-up frame (4th week, 2nd month, 3rd month after&#xD;
      treatment).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</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, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline of pain on 4th, 8th and 12th weeks after treatment.</measure>
    <time_frame>Baseline , 4th, 8th and 12th weeks after treatment.</time_frame>
    <description>Using the Visual analog scale (VAS) and subscore of foot health status questionnaire to measure the pain scale before treatment and multiple time frame after treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline of functional improvement on 4th, 8th and 12th after treatment.</measure>
    <time_frame>Baseline , 4th, 8th and 12th weeks after treatment.</time_frame>
    <description>Using the functional subscore of foot health status questionnaire to measure the functional socre before treatment and multiple time frame after treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline of thickness of plantar fascile on 4th, 8th and 12th weeks after treatment.</measure>
    <time_frame>Baseline , 4th, 8th and 12th weeks after treatment.</time_frame>
    <description>Using the musculoskeletal ultrasonography to measure the thickness before treatment and multiple time frame after treatment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Plantar Fasciitis</condition>
  <arm_group>
    <arm_group_label>pulsed mode radiofrequency</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pulsed radiofrequency (PRF) treatment, a relative novel pain intervention at recent decade, was found to be able to alleviate pain by delivering an electrical field and heat bursts at a temperature less than 42°C to neural tissue in the absence of neural injury. One dose of PRF was given in tibial nerve behine the medial ankle in intervention group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Xylocaine</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>2 c.c xylocaine was given in tibial nerve behind the medial ankle in control group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pulsed radiofrequency (PRF)</intervention_name>
    <description>Pulsed radiofrequency (PRF) treatment, a relative novel pain intervention at recent decade, was found to be able to alleviate pain by delivering an electrical field and heat bursts at a temperature less than 42°C to neural tissue in the absence of neural injury.</description>
    <arm_group_label>pulsed mode radiofrequency</arm_group_label>
    <other_name>Neurotherm NT1000, Neurotherm Inc., USA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Xylocaine</intervention_name>
    <arm_group_label>Xylocaine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Heel pain more than 3 months&#xD;
&#xD;
          -  Age more than 20 year-old&#xD;
&#xD;
          -  The increased thickness of plantar fascile (&gt;4mm) measured by sonography&#xD;
&#xD;
          -  Must be conscious&#xD;
&#xD;
          -  Not receive steroid or other injection in plantar fascile in past 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cancer of any site&#xD;
&#xD;
          -  Coagulopathy&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Inflammation status&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Liang-Cheng Chen, MD, MS</last_name>
    <role>Study Director</role>
    <affiliation>Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, National Defense Medical Center,</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tri-Service General Hospital, School of Medicine, National Defense Medical Center</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>
  <reference>
    <citation>Martin DC, Willis ML, Mullinax LA, Clarke NL, Homburger JA, Berger IH. Pulsed radiofrequency application in the treatment of chronic pain. Pain Pract. 2007 Mar;7(1):31-5. doi: 10.1111/j.1533-2500.2007.00107.x.</citation>
    <PMID>17305676</PMID>
  </reference>
  <reference>
    <citation>Van Zundert J, Patijn J, Kessels A, Lame I, van Suijlekom H, van Kleef M. Pulsed radiofrequency adjacent to the cervical dorsal root ganglion in chronic cervical radicular pain: a double blind sham controlled randomized clinical trial. Pain. 2007 Jan;127(1-2):173-82. doi: 10.1016/j.pain.2006.09.002. Epub 2006 Oct 18.</citation>
    <PMID>17055165</PMID>
  </reference>
  <reference>
    <citation>Rohof OJ. Radiofrequency treatment of peripheral nerves. Pain Pract. 2002 Sep;2(3):257-60. doi: 10.1046/j.1533-2500.2002.02033.x.</citation>
    <PMID>17147740</PMID>
  </reference>
  <results_reference>
    <citation>Thapa D, Ahuja V. Combination of diagnostic medial calcaneal nerve block followed by pulsed radiofrequency for plantar fascitis pain: A new modality. Indian J Anaesth. 2014 Mar;58(2):183-5. doi: 10.4103/0019-5049.130824.</citation>
    <PMID>24963184</PMID>
  </results_reference>
  <results_reference>
    <citation>Erken HY, Ayanoglu S, Akmaz I, Erler K, Kiral A. Prospective study of percutaneous radiofrequency nerve ablation for chronic plantar fasciitis. Foot Ankle Int. 2014 Feb;35(2):95-103. doi: 10.1177/1071100713509803. Epub 2013 Oct 28.</citation>
    <PMID>24165571</PMID>
  </results_reference>
  <results_reference>
    <citation>Sean NY, Singh I, Wai CK. Radiofrequency microtenotomy for the treatment of plantar fasciitis shows good early results. Foot Ankle Surg. 2010 Dec;16(4):174-7. doi: 10.1016/j.fas.2009.10.008. Epub 2009 Nov 25.</citation>
    <PMID>21047605</PMID>
  </results_reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <last_update_submitted>November 30, 2016</last_update_submitted>
  <last_update_submitted_qc>November 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 1, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-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</investigator_title>
  </responsible_party>
  <keyword>Pulsed mode radiofrequency</keyword>
  <keyword>Plantar Fasciitis</keyword>
  <keyword>Ultrasound-guided</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fasciitis</mesh_term>
    <mesh_term>Fasciitis, Plantar</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02242513
org study id: TSGHIRB-2-102-05-95
secondary id: TSGH-C103-115
nct id: NCT02242513
lead sponsor: 
has dmc: Yes
Although there are many conservative method for plantar fasciitis, patients might spend 2
      years to achieve resolution. Recent study have shown that pulsed radiofrequency (PRF)
      lesioning of peripheral nerve can alleviate kinds of pain condition. However there are no
      studies of PRF lesioning of the tibial nerve in patients with plantar fascilitis by using
      ultrasound-guided (UG) techniques.
Patients with unilateral plantar Fasciitis will be enrolled and randomized into intervention
      and control group. One dose of sono-guided PRF is applied in the intervention group and
      xylocaine in control group. Outcome measurements included visual analog scale (VAS)、foot
      health status questionnaire and the thickness of plantar fascile measured by musculoskeletal
      ultrasonography at different follow-up frame (4th week, 2nd month, 3rd month after
      treatment).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Change from baseline of pain on 4th, 8th and 12th weeks after treatment.
time frame: Baseline , 4th, 8th and 12th weeks after treatment.
description: Using the Visual analog scale (VAS) and subscore of foot health status questionnaire to measure the pain scale before treatment and multiple time frame after treatment.
measure: Change from baseline of functional improvement on 4th, 8th and 12th after treatment.
time frame: Baseline , 4th, 8th and 12th weeks after treatment.
description: Using the functional subscore of foot health status questionnaire to measure the functional socre before treatment and multiple time frame after treatment.
measure: Change from baseline of thickness of plantar fascile on 4th, 8th and 12th weeks after treatment.
time frame: Baseline , 4th, 8th and 12th weeks after treatment.
description: Using the musculoskeletal ultrasonography to measure the thickness before treatment and multiple time frame after treatment.
arm group label: pulsed mode radiofrequency
arm group type: Active Comparator
description: Pulsed radiofrequency (PRF) treatment, a relative novel pain intervention at recent decade, was found to be able to alleviate pain by delivering an electrical field and heat bursts at a temperature less than 42°C to neural tissue in the absence of neural injury. One dose of PRF was given in tibial nerve behine the medial ankle in intervention group.
arm group label: Xylocaine
arm group type: Placebo Comparator
description: 2 c.c xylocaine was given in tibial nerve behind the medial ankle in control group.
intervention type: Device
intervention name: Pulsed radiofrequency (PRF)
description: Pulsed radiofrequency (PRF) treatment, a relative novel pain intervention at recent decade, was found to be able to alleviate pain by delivering an electrical field and heat bursts at a temperature less than 42°C to neural tissue in the absence of neural injury.
arm group label: pulsed mode radiofrequency
other name: Neurotherm NT1000, Neurotherm Inc., USA
intervention type: Drug
intervention name: Xylocaine
arm group label: Xylocaine
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Liang-Cheng Chen, MD, MS
role: Study Director
affiliation: Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, National Defense Medical Center,
facility: 
country: Taiwan
citation: Martin DC, Willis ML, Mullinax LA, Clarke NL, Homburger JA, Berger IH. Pulsed radiofrequency application in the treatment of chronic pain. Pain Pract. 2007 Mar;7(1):31-5. doi: 10.1111/j.1533-2500.2007.00107.x.
PMID: 17305676
citation: Van Zundert J, Patijn J, Kessels A, Lame I, van Suijlekom H, van Kleef M. Pulsed radiofrequency adjacent to the cervical dorsal root ganglion in chronic cervical radicular pain: a double blind sham controlled randomized clinical trial. Pain. 2007 Jan;127(1-2):173-82. doi: 10.1016/j.pain.2006.09.002. Epub 2006 Oct 18.
PMID: 17055165
citation: Rohof OJ. Radiofrequency treatment of peripheral nerves. Pain Pract. 2002 Sep;2(3):257-60. doi: 10.1046/j.1533-2500.2002.02033.x.
PMID: 17147740
citation: Thapa D, Ahuja V. Combination of diagnostic medial calcaneal nerve block followed by pulsed radiofrequency for plantar fascitis pain: A new modality. Indian J Anaesth. 2014 Mar;58(2):183-5. doi: 10.4103/0019-5049.130824.
PMID: 24963184
citation: Erken HY, Ayanoglu S, Akmaz I, Erler K, Kiral A. Prospective study of percutaneous radiofrequency nerve ablation for chronic plantar fasciitis. Foot Ankle Int. 2014 Feb;35(2):95-103. doi: 10.1177/1071100713509803. Epub 2013 Oct 28.
PMID: 24165571
citation: Sean NY, Singh I, Wai CK. Radiofrequency microtenotomy for the treatment of plantar fasciitis shows good early results. Foot Ankle Surg. 2010 Dec;16(4):174-7. doi: 10.1016/j.fas.2009.10.008. Epub 2009 Nov 25.
PMID: 21047605
responsible party type: Sponsor-Investigator
investigator affiliation: Tri-Service General Hospital
investigator full name: Yung-Tsan Wu
investigator title: Attending Physician
mesh term: Fasciitis
mesh term: Fasciitis, Plantar
mesh term: Lidocaine