<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/NCT03040557</url>
  </required_header>
  <id_info>
    <org_study_id>APRibeiro</org_study_id>
    <nct_id>NCT03040557</nct_id>
  </id_info>
  <brief_title>Flexible Footwear and Insole in Heel Pain</brief_title>
  <official_title>Therapeutic Effect of Minimalist Flexible Footwear and Insoles on Clinical, Functional and Biomechanical Aspects of the Individuals With Plantar Fasciitis and Calcaneus Spur</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The plantar fasciitis (PF), most frequent injury of the musculoskeletal system, is the main&#xD;
      cause of heel pain and functional disability. The mechanical stress, stretching of plantar&#xD;
      fascia consequently the overload on the feet, is a major intrinsic causes the onset of FP,&#xD;
      especially when exposed to repetitive activities, such as walking. Another extrinsic&#xD;
      etiologic factor of great influence is inadequate shoes that can lead to a deterioration and&#xD;
      progression of the disease. One of the great difficulties of their conservative treatment is&#xD;
      long rehabilitation period, lasting on average 10 to 18 months. Among them, the insoles stand&#xD;
      out as one of the effective mechanical treatments to improve the immediate pain symptoms, in&#xD;
      the short term. Other literary evidence, not specific to FP, has shown the benefits, the&#xD;
      short and long term, a flexible footwear promotes more flexible feet and overload reduction.&#xD;
      Objective: Verify therapeutic effect in the long term, a flexible footwear and low cost and&#xD;
      orthopedic insole on the clinical aspect, functional and biomechanics of the gait of women&#xD;
      with acute FP and chronic with presence of heel spur. It will be conducted a randomized&#xD;
      controlled trial with blinded evaluator, in which 79 women with plantar fasciitis will be&#xD;
      randomized and allocated to the intervention group with minimalist flexible footwear (MFG,&#xD;
      acute n=12 and chronic=15) or the intervention group with orthopedic insole (COIG, acute n=14&#xD;
      and chronic n=14) or control group (CG, n=24). The intervention will have duration six&#xD;
      months, six hours a day, seven days a week (42 hours/week). For all groups will be allowed to&#xD;
      use pain medication support (paracetamol 500 mg) with a maximum dose of two grams daily. The&#xD;
      primary outcome will be the symptom of pain verified by visual analogue scale (VAS), the&#xD;
      inability to areas of the feet by the total score of the FFI (Foot Function Index), health&#xD;
      feet by FHSQ-Br questionnaire (Foot Health Questionnaire Status) and the distance traveled by&#xD;
      the six-minute walk test (6MWT). The secondary: plantar pressure and ground reaction force&#xD;
      during gait, paracetamol consumption and the joint angles of the lower limbs. The effects of&#xD;
      time (Start, 3 and 6 months), group (GIC and GIP CG) and interaction (time and group) are&#xD;
      calculated by means of ANOVA case-wise two factors. A 5% alpha to significant differences and&#xD;
      Cohen coefficient for describing the size effect of the intervention is assumed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective controlled study with random allocation. The independent variable (group) has&#xD;
      three levels: intervention with flexible footwear, intervention with custom orthopedic&#xD;
      insoles and control without intervention, only with medical conservative treatment. This&#xD;
      independent variable is related to the set of dependent variables stemmed from clinical,&#xD;
      functional and biomechanical data. All groups, both will use the intervention minimalist&#xD;
      flexible footwear (MFG), as the intervention group insole (COIG) and the group that did not&#xD;
      receive intervention (GC) shall consist of patients with PF (plantar fasciitis) in different&#xD;
      stages of the disease.These will be required to fit in all the pre-established criteria for&#xD;
      diagnosis of the disease confirmed by physical examination, X-ray and ultrasound. Patients in&#xD;
      the group with chronic fasciitis plantar associated with heel spur should necessarily present&#xD;
      themselves diagnosed radiographically by the doctor that came in the Rheumatology Clinic of&#xD;
      the University. All participants will be informed of the procedures in this research through&#xD;
      a free and informed consent form, prepared in accordance with Resolution 466/12 of the&#xD;
      National Health Board. The eligibility criteria for this study will be: female volunteers&#xD;
      aged between 30 and 50 years, body mass index (BMI) less than 35 kg / m2, no history of any&#xD;
      surgical procedure on knees, ankles and hips or muscle injury in the last 6 months and no&#xD;
      neurological and rheumatologic disease diagnosed. Furthermore, they may not show difference&#xD;
      in length of the lower limbs greater than 1 cm and rigid hallux and performing some kind of&#xD;
      conservative treatment for PF, except drug. Patients should be able to walk independently for&#xD;
      at least 6 hours a day without the aid of orthotics / canes to perform their activities of&#xD;
      daily living. There may also have prostheses and / or orthoses in the lower limbs. Patients&#xD;
      may not have received corticosteroid injection in the heel in previous periods of three and&#xD;
      six months, respectively. In addition to these criteria, patients may not present: joint&#xD;
      instability ankle (positive test results of the medial ligament and lateral), dementia or&#xD;
      inability to provide information consistent.It will be conducted a randomized controlled&#xD;
      trial with blinded evaluator, in which 75 women with plantar fasciitis will be randomized and&#xD;
      allocated to the intervention group with flexible footwear (MFG, acute n=15 and chronic=15)&#xD;
      or the intervention group with orthopedic insole (COIG, acute n=15 and chronic n=15) or&#xD;
      control group (CG, n=15). The intervention will have duration six months, six hours a day,&#xD;
      seven days a week (42 hours/week). For all groups will be allowed to use pain medication&#xD;
      support (paracetamol 500 mg) with a maximum dose of two grams daily. The primary outcome will&#xD;
      be the symptom of pain verified by visual analogue scale (VAS), the inability to areas of the&#xD;
      feet by the total score of the FFI (Foot Function Index), health feet by FHSQ-Br&#xD;
      questionnaire (Foot Health Questionnaire Status) and the distance traveled by the six-minute&#xD;
      walk test (6MWT). The secondary: plantar pressure and ground reaction force during gait,&#xD;
      paracetamol consumption and the joint angles of the lower limbs. The effects of time (Start,&#xD;
      3 and 6 months), group (GIC and GIP CG) and interaction (time and group) are calculated by&#xD;
      means of ANOVA case-wise two factors. A 5% alpha to significant differences and Cohen&#xD;
      coefficient for describing the size effect of the intervention is assumed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">December 1, 2019</completion_date>
  <primary_completion_date type="Actual">December 1, 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>
    <intervention_model_description>A randomized, parallel and controlled clinical trial with blind assessor was conducted in which 79 women were randomized and allocated to the intervention groups</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>The intervention groups were: minimalist flexible footwear group-MFG (n=12 women with PF; n=15 women with CS), Orthopedic insole on minimalist footwear group-COIG (n=14 women with PF; n=14 women with CS) and control-GC group (n=24). Both groups were followed for six months and were assessed at baseline condition and after three and six months (end of intervention).</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Symptom pain on foot</measure>
    <time_frame>Change from Symptom pain on foot at 3 and 6 months</time_frame>
    <description>The primary outcome will be the symptom of pain verified by visual analogue scale (VAS/cm)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Foot Function Index (FFI)</measure>
    <time_frame>Change from domains of the FFI at 6 months</time_frame>
    <description>The domains of disability feet by the all score of the FFI (Foot Function Index in score)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Foot Health Status Questionnaire (FHSQ-Br)</measure>
    <time_frame>Change from FHSQ-Br at 6 months</time_frame>
    <description>Health feet by FHSQ-Br questionnaire (Foot Health Status Questionnaire in units)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Six-minute walk test (6MWT)</measure>
    <time_frame>Change from 6MWT at 3 and 6 months</time_frame>
    <description>The distance traveled by the six-minute walk test (6MWT in kilometers)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plantar pressure</measure>
    <time_frame>Change from plantar pressure at 3 and 6 months</time_frame>
    <description>The peak pressure (kPa), contact area (cm) and contact time (ms) by platform pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ground reaction force</measure>
    <time_frame>Change from maximum force at 3 and 6 months</time_frame>
    <description>Maximum Force (Newton/N) during gait</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For all groups will be allowed to use pain medication support for foot pain</measure>
    <time_frame>The groups will be allowed to use pain medication support for foot pain at 3 and 6 months</time_frame>
    <description>For all groups will be allowed to use pain medication support (paracetamol 500 mg) with a maximum dose of two grams daily.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">65</enrollment>
  <condition>Plantar Fasciitis of Right Foot (Disorder)</condition>
  <condition>Heel Spur</condition>
  <arm_group>
    <arm_group_label>Flexible footwear</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The intervention with flexible footwear in women with plantar fasciitis (MFG), acute n=12 and chronic=15) will have a duration will be six months, for six hours a day, seven days a week (42 hours / week).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Orthopedic insole</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The intervention with orthopedic insole in women with plantar fasciitis (COIG, acute n=14 and chronic=14) will have a duration will be six months, for six hours a day, seven days a week (42 hours / week).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Flexible footwear</intervention_name>
    <description>- Arm Flexible footwear: The intervention will be with flexible shoes in women with plantar fasciitis (acute and chronic) and will have a duration will be six months, for six hours a day, seven days a week (42 hours / week).</description>
    <arm_group_label>Flexible footwear</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Orthopedic insole</intervention_name>
    <description>- Arm Orthopedic insole: The intervention will be with orthopedic insole in women with plantar fasciitis (acute and chronic) and will have a duration will be six months, for six hours a day, seven days a week (42 hours / week).</description>
    <arm_group_label>Orthopedic insole</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Women volunteers aged between 30 and 50 years&#xD;
&#xD;
          -  Diagnosis of plantar fasciitis (PF) or heel spur&#xD;
&#xD;
          -  Healthy women&#xD;
&#xD;
          -  Body mass index (BMI) less than 35 kg/m2&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Difference in length of the lower limbs greater than 1 cm&#xD;
&#xD;
          -  Surgical procedure on the knees, ankles and hips or muscle injury in the last 6 months&#xD;
&#xD;
          -  Diagnosed neurological and rheumatic disease&#xD;
&#xD;
          -  Rigid hallux&#xD;
&#xD;
          -  Conservative treatment for PF, except drug&#xD;
&#xD;
          -  Walk dependent with prostheses and / or orthoses in the lower limbs&#xD;
&#xD;
          -  Corticosteroid injection in the heel in previous periods of three and six months,&#xD;
             respectively&#xD;
&#xD;
          -  Joint instability ankle&#xD;
&#xD;
          -  Dementia or inability to provide information consistent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ana Paula Ribeiro, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of the São Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>School of Medicine, University of São Paulo</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <zip>056360160</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>October 1, 2016</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>April 29, 2020</last_update_submitted>
  <last_update_submitted_qc>April 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Ana Paula Ribeiro</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>plantar fasciitis</keyword>
  <keyword>shoes</keyword>
  <keyword>insoles</keyword>
  <keyword>pain</keyword>
  <keyword>foot</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>
    <mesh_term>Heel Spur</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/NCT03040557
org study id: APRibeiro
nct id: NCT03040557
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The plantar fasciitis (PF), most frequent injury of the musculoskeletal system, is the main
      cause of heel pain and functional disability. The mechanical stress, stretching of plantar
      fascia consequently the overload on the feet, is a major intrinsic causes the onset of FP,
      especially when exposed to repetitive activities, such as walking. Another extrinsic
      etiologic factor of great influence is inadequate shoes that can lead to a deterioration and
      progression of the disease. One of the great difficulties of their conservative treatment is
      long rehabilitation period, lasting on average 10 to 18 months. Among them, the insoles stand
      out as one of the effective mechanical treatments to improve the immediate pain symptoms, in
      the short term. Other literary evidence, not specific to FP, has shown the benefits, the
      short and long term, a flexible footwear promotes more flexible feet and overload reduction.
      Objective: Verify therapeutic effect in the long term, a flexible footwear and low cost and
      orthopedic insole on the clinical aspect, functional and biomechanics of the gait of women
      with acute FP and chronic with presence of heel spur. It will be conducted a randomized
      controlled trial with blinded evaluator, in which 79 women with plantar fasciitis will be
      randomized and allocated to the intervention group with minimalist flexible footwear (MFG,
      acute n=12 and chronic=15) or the intervention group with orthopedic insole (COIG, acute n=14
      and chronic n=14) or control group (CG, n=24). The intervention will have duration six
      months, six hours a day, seven days a week (42 hours/week). For all groups will be allowed to
      use pain medication support (paracetamol 500 mg) with a maximum dose of two grams daily. The
      primary outcome will be the symptom of pain verified by visual analogue scale (VAS), the
      inability to areas of the feet by the total score of the FFI (Foot Function Index), health
      feet by FHSQ-Br questionnaire (Foot Health Questionnaire Status) and the distance traveled by
      the six-minute walk test (6MWT). The secondary: plantar pressure and ground reaction force
      during gait, paracetamol consumption and the joint angles of the lower limbs. The effects of
      time (Start, 3 and 6 months), group (GIC and GIP CG) and interaction (time and group) are
      calculated by means of ANOVA case-wise two factors. A 5% alpha to significant differences and
      Cohen coefficient for describing the size effect of the intervention is assumed.
A prospective controlled study with random allocation. The independent variable (group) has
      three levels: intervention with flexible footwear, intervention with custom orthopedic
      insoles and control without intervention, only with medical conservative treatment. This
      independent variable is related to the set of dependent variables stemmed from clinical,
      functional and biomechanical data. All groups, both will use the intervention minimalist
      flexible footwear (MFG), as the intervention group insole (COIG) and the group that did not
      receive intervention (GC) shall consist of patients with PF (plantar fasciitis) in different
      stages of the disease.These will be required to fit in all the pre-established criteria for
      diagnosis of the disease confirmed by physical examination, X-ray and ultrasound. Patients in
      the group with chronic fasciitis plantar associated with heel spur should necessarily present
      themselves diagnosed radiographically by the doctor that came in the Rheumatology Clinic of
      the University. All participants will be informed of the procedures in this research through
      a free and informed consent form, prepared in accordance with Resolution 466/12 of the
      National Health Board. The eligibility criteria for this study will be: female volunteers
      aged between 30 and 50 years, body mass index (BMI) less than 35 kg / m2, no history of any
      surgical procedure on knees, ankles and hips or muscle injury in the last 6 months and no
      neurological and rheumatologic disease diagnosed. Furthermore, they may not show difference
      in length of the lower limbs greater than 1 cm and rigid hallux and performing some kind of
      conservative treatment for PF, except drug. Patients should be able to walk independently for
      at least 6 hours a day without the aid of orthotics / canes to perform their activities of
      daily living. There may also have prostheses and / or orthoses in the lower limbs. Patients
      may not have received corticosteroid injection in the heel in previous periods of three and
      six months, respectively. In addition to these criteria, patients may not present: joint
      instability ankle (positive test results of the medial ligament and lateral), dementia or
      inability to provide information consistent.It will be conducted a randomized controlled
      trial with blinded evaluator, in which 75 women with plantar fasciitis will be randomized and
      allocated to the intervention group with flexible footwear (MFG, acute n=15 and chronic=15)
      or the intervention group with orthopedic insole (COIG, acute n=15 and chronic n=15) or
      control group (CG, n=15). The intervention will have duration six months, six hours a day,
      seven days a week (42 hours/week). For all groups will be allowed to use pain medication
      support (paracetamol 500 mg) with a maximum dose of two grams daily. The primary outcome will
      be the symptom of pain verified by visual analogue scale (VAS), the inability to areas of the
      feet by the total score of the FFI (Foot Function Index), health feet by FHSQ-Br
      questionnaire (Foot Health Questionnaire Status) and the distance traveled by the six-minute
      walk test (6MWT). The secondary: plantar pressure and ground reaction force during gait,
      paracetamol consumption and the joint angles of the lower limbs. The effects of time (Start,
      3 and 6 months), group (GIC and GIP CG) and interaction (time and group) are calculated by
      means of ANOVA case-wise two factors. A 5% alpha to significant differences and Cohen
      coefficient for describing the size effect of the intervention is assumed.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A randomized, parallel and controlled clinical trial with blind assessor was conducted in which 79 women were randomized and allocated to the intervention groups
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
masking description: The intervention groups were: minimalist flexible footwear group-MFG (n=12 women with PF; n=15 women with CS), Orthopedic insole on minimalist footwear group-COIG (n=14 women with PF; n=14 women with CS) and control-GC group (n=24). Both groups were followed for six months and were assessed at baseline condition and after three and six months (end of intervention).
measure: Symptom pain on foot
time frame: Change from Symptom pain on foot at 3 and 6 months
description: The primary outcome will be the symptom of pain verified by visual analogue scale (VAS/cm)
measure: Foot Function Index (FFI)
time frame: Change from domains of the FFI at 6 months
description: The domains of disability feet by the all score of the FFI (Foot Function Index in score)
measure: Foot Health Status Questionnaire (FHSQ-Br)
time frame: Change from FHSQ-Br at 6 months
description: Health feet by FHSQ-Br questionnaire (Foot Health Status Questionnaire in units)
measure: Six-minute walk test (6MWT)
time frame: Change from 6MWT at 3 and 6 months
description: The distance traveled by the six-minute walk test (6MWT in kilometers)
measure: Plantar pressure
time frame: Change from plantar pressure at 3 and 6 months
description: The peak pressure (kPa), contact area (cm) and contact time (ms) by platform pressure
measure: Ground reaction force
time frame: Change from maximum force at 3 and 6 months
description: Maximum Force (Newton/N) during gait
measure: For all groups will be allowed to use pain medication support for foot pain
time frame: The groups will be allowed to use pain medication support for foot pain at 3 and 6 months
description: For all groups will be allowed to use pain medication support (paracetamol 500 mg) with a maximum dose of two grams daily.
arm group label: Flexible footwear
arm group type: Active Comparator
description: The intervention with flexible footwear in women with plantar fasciitis (MFG), acute n=12 and chronic=15) will have a duration will be six months, for six hours a day, seven days a week (42 hours / week).
arm group label: Orthopedic insole
arm group type: Active Comparator
description: The intervention with orthopedic insole in women with plantar fasciitis (COIG, acute n=14 and chronic=14) will have a duration will be six months, for six hours a day, seven days a week (42 hours / week).
intervention type: Device
intervention name: Flexible footwear
description: - Arm Flexible footwear: The intervention will be with flexible shoes in women with plantar fasciitis (acute and chronic) and will have a duration will be six months, for six hours a day, seven days a week (42 hours / week).
arm group label: Flexible footwear
intervention type: Device
intervention name: Orthopedic insole
description: - Arm Orthopedic insole: The intervention will be with orthopedic insole in women with plantar fasciitis (acute and chronic) and will have a duration will be six months, for six hours a day, seven days a week (42 hours / week).
arm group label: Orthopedic insole
criteria: 
gender: Female
minimum age: 30 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ana Paula Ribeiro, Ph.D.
role: Principal Investigator
affiliation: University of the São Paulo
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Ana Paula Ribeiro
investigator title: Principal Investigator
mesh term: Fasciitis
mesh term: Fasciitis, Plantar
mesh term: Heel Spur
sharing ipd: No