<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/NCT03020693</url>
  </required_header>
  <id_info>
    <org_study_id>PI-2015-12</org_study_id>
    <nct_id>NCT03020693</nct_id>
  </id_info>
  <brief_title>Effectiveness of Invasive Electrostimulation Combined With an Exercise Program in Plantar Fasciitis</brief_title>
  <official_title>Effectiveness of Invasive Electrostimulation Combined With an Exercise Program in Plantar. A Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal</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>
      This study evaluates the effectiveness of an electrostimulation treatment with TENS using a&#xD;
      needle and a surface electrode combined with an exercise program to fasciitis plantar. Half&#xD;
      participants will receive invasive electrostimulation (TENS using a needle) and exercises&#xD;
      while the other half will receive electrostimulation placebo and exercises.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There are a lot of treatments to fasciitis plantar. Exercises are the treatments more&#xD;
      recommended to fasciitis plantar but not all patients improve only with exercises. Dry&#xD;
      needling is recommended to relieve the pain in the heel. TENS is used to decrease the pain in&#xD;
      the fasciitis plantar. Investigators will apply to half participants a treatment that&#xD;
      combines TENS + Dry needling (invasive electrostimulation ) with exercises while the other&#xD;
      half receive electrostimulation placebo (TENS using surface electrodes with non-therapeutic&#xD;
      intensity) + exercises.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 27, 2017</start_date>
  <completion_date type="Actual">March 13, 2018</completion_date>
  <primary_completion_date type="Actual">March 13, 2018</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in pain scores on the visual analogue scale at 6 weeks in patients with plantar fasciitis.</measure>
    <time_frame>6 weeks</time_frame>
    <description>It will evaluate the pain with Visual Analogue Scale in the first step in the first and tenth session. At 6 weeks, a new measurement will be made.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in strength scores at 6 weeks from first session in patients with plantar fasciitis.</measure>
    <time_frame>6 weeks</time_frame>
    <description>It will evaluate the strength using dynamometer in the first and tenth session. At 6 weeks, a new measurement will be made.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the pain in the Trigger points at 6 weeks from first session in patients with plantar fasciitis.</measure>
    <time_frame>6 weeks</time_frame>
    <description>It will evaluate the pain with algometer in the first and tenth session in the plantar muscle. It will measure the change of pain in the Trigger points in the plantar muscle. At 6 weeks, a new measurement will be made .Three measurements will be made and the average data will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the functionality of foot and ankle at 6 weeks from first session in patients with plantar fasciitis.</measure>
    <time_frame>6 weeks</time_frame>
    <description>It will evaluate the functionality using Foot and Ankle Ability Measure questionnaire (FAAM) in the first and tenth session. At 6 weeks, a new measurement will be made.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the functionality and quality of life of foot and ankle at 6 weeks from first session in patients with plantar fasciitis.</measure>
    <time_frame>6 weeks</time_frame>
    <description>It will evaluate the functionality and quality of life using Foot Health Status Questionnaire (FHSQ) in the first and tenth session. At 6 weeks, a new measurement will be made.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Fasciitis, Plantar</condition>
  <arm_group>
    <arm_group_label>Invasive electrostimulation combined with exercises.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dry needling + TENS ( 4 Hz 200 microseconds during 30 minutes to therapeutic intensity) combined with exercises program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo electrostimulation and exercises.</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sham dry needling + TENS ( 4 Hz 200 microseconds during 30 minutes to non-therapeutic intensity) with surface electrodes combined with exercises program.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Invasive electrostimulation combined with exercises</intervention_name>
    <description>Procedure for producing analgesia by introducing the TENS current through a needle combined with a exercises program.</description>
    <arm_group_label>Invasive electrostimulation combined with exercises.</arm_group_label>
    <other_name>dry needling with TENS</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Placebo electrostimulation and exercises</intervention_name>
    <description>First: Sham dry needling. After: electrostimulation using surfaces electrodes. Finally a exercises program.</description>
    <arm_group_label>Placebo electrostimulation and exercises.</arm_group_label>
    <other_name>Non-invasive electrostimulation combined with exercises</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Medical diagnosis of plantar fasciitis&#xD;
&#xD;
          -  Age equal or superior to 18 years old.&#xD;
&#xD;
          -  VAS minimum of 2 points int the first steps after a prolonged decreasing period.&#xD;
&#xD;
          -  Having an evolution of a month or more of pain.&#xD;
&#xD;
          -  Not having received acupuncture or dry needling as treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Peripheral Neuropathies.&#xD;
&#xD;
          -  Tarsus tunnel syndrome.&#xD;
&#xD;
          -  Rheumatic diseases.&#xD;
&#xD;
          -  Contraindication to dry needling: nickel allergy, fear of needles, sky with erosions.&#xD;
&#xD;
          -  Clotting disorders such as thrombosis or thrombophlebitis.&#xD;
&#xD;
          -  Fractures, infections and/ or tumor processes.&#xD;
&#xD;
          -  Have been treated for plantar fasciitis in the las 4 weeks.&#xD;
&#xD;
          -  Previous surgery in the foot&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Communication Disorders.&#xD;
&#xD;
          -  Holders of pacemakers or electrostimulators.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fundacion Hospital Ramón y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>28834</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Thiagarajah AG. How effective is acupuncture for reducing pain due to plantar fasciitis? Singapore Med J. 2017 Feb;58(2):92-97. doi: 10.11622/smedj.2016143. Epub 2016 Aug 16.</citation>
    <PMID>27526703</PMID>
  </reference>
  <results_reference>
    <citation>Eftekharsadat B, Babaei-Ghazani A, Zeinolabedinzadeh V. Dry needling in patients with chronic heel pain due to plantar fasciitis: A single-blinded randomized clinical trial. Med J Islam Repub Iran. 2016 Jul 23;30:401. eCollection 2016.</citation>
    <PMID>27683642</PMID>
  </results_reference>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>December 28, 2016</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>February 11, 2019</last_update_submitted>
  <last_update_submitted_qc>February 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>electrostimulation</keyword>
  <keyword>exercise program</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>
  <!-- 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/NCT03020693
org study id: PI-2015-12
nct id: NCT03020693
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study evaluates the effectiveness of an electrostimulation treatment with TENS using a
      needle and a surface electrode combined with an exercise program to fasciitis plantar. Half
      participants will receive invasive electrostimulation (TENS using a needle) and exercises
      while the other half will receive electrostimulation placebo and exercises.
There are a lot of treatments to fasciitis plantar. Exercises are the treatments more
      recommended to fasciitis plantar but not all patients improve only with exercises. Dry
      needling is recommended to relieve the pain in the heel. TENS is used to decrease the pain in
      the fasciitis plantar. Investigators will apply to half participants a treatment that
      combines TENS + Dry needling (invasive electrostimulation ) with exercises while the other
      half receive electrostimulation placebo (TENS using surface electrodes with non-therapeutic
      intensity) + exercises.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Change from baseline in pain scores on the visual analogue scale at 6 weeks in patients with plantar fasciitis.
time frame: 6 weeks
description: It will evaluate the pain with Visual Analogue Scale in the first step in the first and tenth session. At 6 weeks, a new measurement will be made.
measure: Change in strength scores at 6 weeks from first session in patients with plantar fasciitis.
time frame: 6 weeks
description: It will evaluate the strength using dynamometer in the first and tenth session. At 6 weeks, a new measurement will be made.
measure: Change in the pain in the Trigger points at 6 weeks from first session in patients with plantar fasciitis.
time frame: 6 weeks
description: It will evaluate the pain with algometer in the first and tenth session in the plantar muscle. It will measure the change of pain in the Trigger points in the plantar muscle. At 6 weeks, a new measurement will be made .Three measurements will be made and the average data will be recorded.
measure: Change in the functionality of foot and ankle at 6 weeks from first session in patients with plantar fasciitis.
time frame: 6 weeks
description: It will evaluate the functionality using Foot and Ankle Ability Measure questionnaire (FAAM) in the first and tenth session. At 6 weeks, a new measurement will be made.
measure: Change in the functionality and quality of life of foot and ankle at 6 weeks from first session in patients with plantar fasciitis.
time frame: 6 weeks
description: It will evaluate the functionality and quality of life using Foot Health Status Questionnaire (FHSQ) in the first and tenth session. At 6 weeks, a new measurement will be made.
arm group label: Invasive electrostimulation combined with exercises.
arm group type: Experimental
description: Dry needling + TENS ( 4 Hz 200 microseconds during 30 minutes to therapeutic intensity) combined with exercises program.
arm group label: Placebo electrostimulation and exercises.
arm group type: Active Comparator
description: Sham dry needling + TENS ( 4 Hz 200 microseconds during 30 minutes to non-therapeutic intensity) with surface electrodes combined with exercises program.
intervention type: Procedure
intervention name: Invasive electrostimulation combined with exercises
description: Procedure for producing analgesia by introducing the TENS current through a needle combined with a exercises program.
arm group label: Invasive electrostimulation combined with exercises.
other name: dry needling with TENS
intervention type: Procedure
intervention name: Placebo electrostimulation and exercises
description: First: Sham dry needling. After: electrostimulation using surfaces electrodes. Finally a exercises program.
arm group label: Placebo electrostimulation and exercises.
other name: Non-invasive electrostimulation combined with exercises
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Spain
citation: Thiagarajah AG. How effective is acupuncture for reducing pain due to plantar fasciitis? Singapore Med J. 2017 Feb;58(2):92-97. doi: 10.11622/smedj.2016143. Epub 2016 Aug 16.
PMID: 27526703
citation: Eftekharsadat B, Babaei-Ghazani A, Zeinolabedinzadeh V. Dry needling in patients with chronic heel pain due to plantar fasciitis: A single-blinded randomized clinical trial. Med J Islam Repub Iran. 2016 Jul 23;30:401. eCollection 2016.
PMID: 27683642
responsible party type: Sponsor
mesh term: Fasciitis
mesh term: Fasciitis, Plantar