<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/NCT04461197</url>
  </required_header>
  <id_info>
    <org_study_id>CRESEUE-Foot 2</org_study_id>
    <nct_id>NCT04461197</nct_id>
  </id_info>
  <brief_title>Efficacy of the Treatment of Plantar Orthoses With Extracorporeal Shock Wave Therapy in Plantar Fasciitis</brief_title>
  <official_title>Efficacy of the Therapeutic Effects of Adjunctive Treatment of Plantar Orthoses With Extracorporeal Shock Wave Therapy in Plantar Fasciitis: a Randomized Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Seville</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Seville</source>
  <oversight_info>
    <has_dmc>No</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>
      Plantar fasciitis is inflammation of plantar fascia. It arises from degeneration and chronic&#xD;
      inflammation. Treatment of plantar fasciitis contains conservative methods like rest, body&#xD;
      weight control, stretching exercise, non-steroidal anti-inflammatory drugs and arch supports.&#xD;
      ESWT has commonly been used for the treatment of plantar fasciitis. The shock waves can be&#xD;
      radial or focused. The aim of this study was to evaluate the effectiveness of the adjuvant&#xD;
      use of plantar orthoses in the process of plantar fasciitis when extracorporeal shock waves&#xD;
      are applied. The hypothesis porposed was that the use of extracorporeal shock waves together&#xD;
      with the use of custom foot orthotics improves the symptoms produced by plantar fasciitis.&#xD;
      This study is planned as double-blind, randomized controlled trial. Participants are randomly&#xD;
      allocated to two groups: the ESWT group and the custom foot orthotics and ESWT group. Radial&#xD;
      ESWT will be applied in this study.&#xD;
&#xD;
      The people receiving the therapy and the people assessing the outcomes are blinded . Both&#xD;
      group will recieve ESWT one session per week for three weeks. Each session will last for 2-5&#xD;
      minutes. The primary outcome measure of this study is change in heel pain of affected side&#xD;
      assessed using Visual Analog Scale. The secondary outcome measure is Roles y Maudsley scores.&#xD;
      The primary endpoint of this study is to determine a decrease in pain score according to&#xD;
      Visual Analog Scale.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 20, 2019</start_date>
  <completion_date type="Actual">June 15, 2020</completion_date>
  <primary_completion_date type="Actual">May 15, 2020</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>visual analog scale (VAS)</measure>
    <time_frame>Baseline</time_frame>
    <description>Heel pain intensity was referred to as 0-10, in which 0= no pain at all and 10= the worst pain possible</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Roles-Maudsley (RM) scores</measure>
    <time_frame>Baseline</time_frame>
    <description>This is a self-administered scale of functional valuation which classifies the patients into 4 categories</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">76</enrollment>
  <condition>Fasciitis, Plantar, Chronic</condition>
  <arm_group>
    <arm_group_label>ESWT + orthotic insole</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>(shock waves + orthotic insole +Stretches of the posterior muscle chain)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ESWT + flat insole</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>(shock waves + flat insole + Stretches of the posterior muscle chain)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>customised foot orthoses</intervention_name>
    <description>The foot orthoses for group A were custom made using phenolic foam molds of the feet. Separated molds were made of both feet for all the participants. . The insole was made based on a positive mold of plaster with 45 Shore cork materials with horizontal thrusts just proximal to the metatarsal heads, with the intention of correcting the pathological subtalar pronation, with a 3mm bilateral raising of the heel and a bilateral latex metatarsal bar.</description>
    <arm_group_label>ESWT + orthotic insole</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>orthotic insole</intervention_name>
    <description>For group B, a flat insole of polyester resin was made, fitting it to the foot's size.</description>
    <arm_group_label>ESWT + flat insole</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18 - 65 years&#xD;
&#xD;
          -  able to understand the explanations about the potential benefits and risks of&#xD;
             participating in the study&#xD;
&#xD;
          -  both genders&#xD;
&#xD;
          -  diagnosis of chronic plantar fasciitis&#xD;
&#xD;
          -  duration of symptoms equal or superior to 6 months at the time of enrollment&#xD;
&#xD;
          -  Foot Posture Index ≥ +6 (pronated foot in one or both feet).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  being younger than 18 years of age&#xD;
&#xD;
          -  previous treatments with shock wave devices&#xD;
&#xD;
          -  previous surgery on the painful heel; history of calcaneus fracture&#xD;
&#xD;
          -  any inflammation at the level of the ankle&#xD;
&#xD;
          -  infection in the treated area&#xD;
&#xD;
          -  patients with diabetes mellitus or cardiac or respiratory disease&#xD;
&#xD;
          -  osteomyelitis&#xD;
&#xD;
          -  patients on anticoagulant drugs&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  patients on immunosuppressive therapy&#xD;
&#xD;
          -  rheumatoid arthritis or history of rheumatic disease&#xD;
&#xD;
          -  neurological deficits&#xD;
&#xD;
          -  malignant disease with or without metastases&#xD;
&#xD;
          -  significant liver function abnormalities&#xD;
&#xD;
          -  neurological or vascular insufficiency in the painful heel; fasciotomy or heel spur&#xD;
             surgery&#xD;
&#xD;
          -  discrepancy in the length of the foot &gt; 5 mm; previous back of foot surgery&#xD;
&#xD;
          -  patients treated with rigid plantar supports&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ana J Perez, Dra.</last_name>
    <role>Study Director</role>
    <affiliation>University of Seville</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universidad de Sevilla</name>
      <address>
        <city>Sevilla</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>April 13, 2021</last_update_submitted>
  <last_update_submitted_qc>April 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Seville</investigator_affiliation>
    <investigator_full_name>MANUEL PABON CARRASCO</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Fasciitis, Plantar</keyword>
  <keyword>Foot Orthoses</keyword>
  <keyword>High-Energy Shock Waves</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>
  <patient_data>
    <sharing_ipd>No</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/NCT04461197
org study id: CRESEUE-Foot 2
nct id: NCT04461197
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Plantar fasciitis is inflammation of plantar fascia. It arises from degeneration and chronic
      inflammation. Treatment of plantar fasciitis contains conservative methods like rest, body
      weight control, stretching exercise, non-steroidal anti-inflammatory drugs and arch supports.
      ESWT has commonly been used for the treatment of plantar fasciitis. The shock waves can be
      radial or focused. The aim of this study was to evaluate the effectiveness of the adjuvant
      use of plantar orthoses in the process of plantar fasciitis when extracorporeal shock waves
      are applied. The hypothesis porposed was that the use of extracorporeal shock waves together
      with the use of custom foot orthotics improves the symptoms produced by plantar fasciitis.
      This study is planned as double-blind, randomized controlled trial. Participants are randomly
      allocated to two groups: the ESWT group and the custom foot orthotics and ESWT group. Radial
      ESWT will be applied in this study.

      The people receiving the therapy and the people assessing the outcomes are blinded . Both
      group will recieve ESWT one session per week for three weeks. Each session will last for 2-5
      minutes. The primary outcome measure of this study is change in heel pain of affected side
      assessed using Visual Analog Scale. The secondary outcome measure is Roles y Maudsley scores.
      The primary endpoint of this study is to determine a decrease in pain score according to
      Visual Analog Scale.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: visual analog scale (VAS)
time frame: Baseline
description: Heel pain intensity was referred to as 0-10, in which 0= no pain at all and 10= the worst pain possible
measure: Roles-Maudsley (RM) scores
time frame: Baseline
description: This is a self-administered scale of functional valuation which classifies the patients into 4 categories
arm group label: ESWT + orthotic insole
arm group type: Experimental
description: (shock waves + orthotic insole +Stretches of the posterior muscle chain)
arm group label: ESWT + flat insole
arm group type: Placebo Comparator
description: (shock waves + flat insole + Stretches of the posterior muscle chain)
intervention type: Device
intervention name: customised foot orthoses
description: The foot orthoses for group A were custom made using phenolic foam molds of the feet. Separated molds were made of both feet for all the participants. . The insole was made based on a positive mold of plaster with 45 Shore cork materials with horizontal thrusts just proximal to the metatarsal heads, with the intention of correcting the pathological subtalar pronation, with a 3mm bilateral raising of the heel and a bilateral latex metatarsal bar.
arm group label: ESWT + orthotic insole
intervention type: Device
intervention name: orthotic insole
description: For group B, a flat insole of polyester resin was made, fitting it to the foot's size.
arm group label: ESWT + flat insole
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Ana J Perez, Dra.
role: Study Director
affiliation: University of Seville
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: University of Seville
investigator full name: MANUEL PABON CARRASCO
investigator title: Principal Investigator
mesh term: Fasciitis
mesh term: Fasciitis, Plantar
sharing ipd: No