<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/NCT03804008</url>
  </required_header>
  <id_info>
    <org_study_id>N-20180066</org_study_id>
    <nct_id>NCT03804008</nct_id>
  </id_info>
  <brief_title>Advice vs Advice + Exercise vs Advice + Exercise + Injection for Individuals With Plantar Fasciopathy</brief_title>
  <acronym>FIX-Heel</acronym>
  <official_title>The Efficacy of Fundamental Advice and a Heel Cup Versus Fundamental Advice and a Heel Cup Plus eXercise Versus Fundamental Advice and a Heel Cup Plus Exercise and a Corticosteroid Injection in Individuals With Plantar Fasciopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aalborg University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Center for General Practice at Aalborg University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Aalborg University</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>
      The purpose of this trial is to investigate the efficacy of fundamental patient advice and a&#xD;
      heel cup versus fundamental patient advice and a heel cup plus heavy-slow resistance training&#xD;
      versus fundamental patient advice and a heel cup plus heavy-slow resistance training and an&#xD;
      ultrasound-guided corticosteroid injection in improving the Foot Health Status Questionnaire&#xD;
      pain domain score in individuals with plantar fasciopathy after 12 weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This trial will be designed as a randomised, data analyst-blinded, superiority trial, with a&#xD;
      3-group parallel design to be conducted in Aalborg, Denmark. Reporting of the trial will&#xD;
      follow CONSORT guidelines and TIDieR for intervention description. Reporting of the protocol&#xD;
      will follow the SPIRIT statement. The planning of the trial is done in accordance with the&#xD;
      PREPARE Trial guide.&#xD;
&#xD;
      Participants will be stratified by sex and block randomised in block sizes of 3 to 12 (1:1:1)&#xD;
      into 3 parallel groups of 60 participants using a random number generator on&#xD;
      www.sealedenvelope.com. The block sizes will be random and concealed to the research&#xD;
      assistants responsible of including participants. Group allocation will be coded, and the&#xD;
      data analyst will be blinded to this code until after the analyses have been performed.&#xD;
&#xD;
      The investigators will only conclude superiority of one intervention over the other if the&#xD;
      intention-to-treat analysis leads to mean between-group differences of the Foot Health Status&#xD;
      Questionnaire pain domain ≥14 points (minimally important difference) and P-values &lt;0.05 at&#xD;
      the primary endpoint (12 weeks) after adjustment for the baseline value.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 7, 2019</start_date>
  <completion_date type="Actual">September 23, 2021</completion_date>
  <primary_completion_date type="Actual">September 23, 2021</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>None (Open Label)</masking>
    <masking_description>Analyses will be carried out by a blinded data analyst</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Foot Health Status Questionnaire pain domain</measure>
    <time_frame>During baseline and at follow-ups after 4, 12, 26 and 52 weeks</time_frame>
    <description>The Foot Health Status Questionnaire is a self-report questionnaire ranging from 0 (poor foot health) to 100 (optimum foot health) that assesses multiple dimensions of foot health and function. A validated Danish translation of the original questionnaire will be used.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Foot Health Status Questionnaire function domain</measure>
    <time_frame>During baseline and at follow-ups after 4, 12, 26 and 52 weeks</time_frame>
    <description>Ranging from 0 (poor foot health) to 100 (optimum foot health)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Foot Health Status Questionnaire footwear domain</measure>
    <time_frame>During baseline and at follow-ups after 4, 12, 26 and 52 weeks</time_frame>
    <description>Ranging from 0 (poor foot health) to 100 (optimum foot health)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Foot Health Status Questionnaire general foot health domain</measure>
    <time_frame>During baseline and at follow-ups after 4, 12, 26 and 52 weeks</time_frame>
    <description>Ranging from 0 (poor foot health) to 100 (optimum foot health)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Rating of Change</measure>
    <time_frame>At follow-ups after 12, 26 and 52 weeks</time_frame>
    <description>This will be used to measure the participants' self-reported recovery on a 7-point Likert scale ranging from &quot;much improved&quot; to &quot;much worse&quot;. Participants are categorised as improved if they rate themselves as &quot;much improved&quot; or &quot;improved&quot; (category 6-7) and categorised as not improved if they rate themselves from &quot;slightly improved&quot; to &quot;much worse&quot; (category 1-5)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Patient Acceptable Symptom State</measure>
    <time_frame>From 0 to 52 weeks</time_frame>
    <description>This will be used as a measure of when participants achieve a self-evaluated satisfactory result and feels no further treatment is needed; hence, it is not necessarily a measure of complete recovery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pain Self-Efficacy Questionnaire score</measure>
    <time_frame>During baseline and at follow-ups after 4, 12, 26 and 52 weeks</time_frame>
    <description>The Pain Self-Efficacy Questionnaire ranges from 0 (not at all confident) to 60 (completely confident) with lower scores indicating lower self-efficacy. A Danish translation of the original questionnaire, which has been validated in a Danish chronic pain population, will be used</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in weekly light, moderate and vigorous physical activity level expressed as Metabolic Equivalents</measure>
    <time_frame>Week 1 and Week 13 of the interventions</time_frame>
    <description>Participants will be wearing a wrist-worn accelerometer ((ActiGraph wGT3X-BT (ActiGraph LLC, Pensacola, FL, USA)) during the first three weeks after baseline and again during the first three weeks after the 12-week follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in self-reported health state as measured by the EQ-5D-5L</measure>
    <time_frame>During baseline and at follow-ups after 4, 12, 26 and 52 weeks</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Sick leave</measure>
    <time_frame>During baseline and at follow-ups after 4, 12, 26 and 52 weeks</time_frame>
    <description>Participants are asked how many days of sick leave they have had during the past 4 weeks due to their condition</description>
  </other_outcome>
  <other_outcome>
    <measure>Condition-related expenses</measure>
    <time_frame>During baseline and at follow-ups after 4, 12, 26 and 52 weeks</time_frame>
    <description>Participants are asked which expenses and the size they have had during the past 4 weeks due to their condition</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">180</enrollment>
  <condition>Plantar Fasciopathy</condition>
  <arm_group>
    <arm_group_label>Fundamental advice and a heel cup</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Fundamental advice and a heel cup plus exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Fundamental advice and a heel cup plus exercise and injection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ultrasound-guided corticosteroid injection</intervention_name>
    <description>A 21-gauge, 40 mm needle is connected to a 2.5 cm3 syringe filled with 1 ml Triamcinolonhexacetonid 20mg/ml + 1 ml Lidocain 10 mg7ml. The skin is cleansed with Chlorhexidine alcohol 0.5 %. The needle is inserted with a medial approach under ultrasound-guidance aligned to the long axis of the ultrasound transducer. The injection is placed anterior to the plantar fascia insertion on the calcaneal bone in the region of maximal fascia thickness. Participants are asked to start performing the exercise as soon as they feel ready but not before 24 hours after the injection. Furthermore, they are asked not to progress the method used to achieve 8RM when they start to do the exercise after the injection until Week 3 of the exercise programme. If standing on both feet was sufficient to achieve 8RM at baseline, the participant must not perform the exercise single-legged or to wear a backpack with weights after the injection regardless of any pain reduction afforded by the injection.</description>
    <arm_group_label>Fundamental advice and a heel cup plus exercise and injection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Heavy-slow resistance training</intervention_name>
    <description>Participants will be asked to complete a heel raise standing with the forefoot on a step. The toes are maximally dorsi flexed by placing a towel underneath them. The participant is instructed to perform a heel raise to maximal plantar flexion in the ankle joint and afterwards to lower the heel to maximal dorsiflexion. Supporting oneself for balance by placing the hands on a wall or a rail is allowed. Participants are instructed in performing the exercise with a load as heavy as possible but no higher than 8RM and for as many sets as possible every other day.</description>
    <arm_group_label>Fundamental advice and a heel cup plus exercise</arm_group_label>
    <arm_group_label>Fundamental advice and a heel cup plus exercise and injection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fundamental advice and a silicone heel cup</intervention_name>
    <description>Participants receive brief information about pathology, risk factors and advice on how to decrease activities that lead to symptom flares and slowly increase their activity level based on their symptoms. They also receive a leaflet that includes the same information as the research assistants will deliver orally after inclusion and a silicone heel cup.</description>
    <arm_group_label>Fundamental advice and a heel cup</arm_group_label>
    <arm_group_label>Fundamental advice and a heel cup plus exercise</arm_group_label>
    <arm_group_label>Fundamental advice and a heel cup plus exercise and injection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  history of inferior heel pain for at least three months before enrolment&#xD;
&#xD;
          -  pain on palpation of the medial calcaneal tubercle or the proximal plantar fascia&#xD;
&#xD;
          -  thickness of the plantar fascia of 4.0 mm or greater as measured by ultrasonography&#xD;
&#xD;
          -  mean heel pain of ≥30 mm on a 100 mm VAS during the previous week&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  below 18 years of age&#xD;
&#xD;
          -  diabetes&#xD;
&#xD;
          -  history of inflammatory systemic diseases&#xD;
&#xD;
          -  pregnancy or breastfeeding&#xD;
&#xD;
          -  corticosteroid injection for plantar fasciopathy within the previous six months&#xD;
&#xD;
          -  pain or stiffness in the 1st metatarsophalangeal joint to an extent where the&#xD;
             exercises cannot be performed&#xD;
&#xD;
          -  known hypersensitivity to corticosteroids or local anaesthetics&#xD;
&#xD;
          -  skin or soft tissue infection near the injection site&#xD;
&#xD;
          -  received treatment by a healthcare professional for plantar fasciopathy within the&#xD;
             previous 12 weeks&#xD;
&#xD;
          -  made any substantial changes to usual self-care of the condition in the last 4 weeks&#xD;
             (e.g. started using insoles, started performing stretching, made a substantial&#xD;
             decrease in physical activity level)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael S Rathleff, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Center for General Practice at Aalborg University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of occupational therapy and physiotherapy, Aalborg University Hospital</name>
      <address>
        <city>Hobrovej 18-22</city>
        <zip>9000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>January 7, 2022</last_update_submitted>
  <last_update_submitted_qc>January 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aalborg University</investigator_affiliation>
    <investigator_full_name>Henrik Riel</investigator_full_name>
    <investigator_title>PhD student</investigator_title>
  </responsible_party>
  <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/NCT03804008
org study id: N-20180066
nct id: NCT03804008
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this trial is to investigate the efficacy of fundamental patient advice and a
      heel cup versus fundamental patient advice and a heel cup plus heavy-slow resistance training
      versus fundamental patient advice and a heel cup plus heavy-slow resistance training and an
      ultrasound-guided corticosteroid injection in improving the Foot Health Status Questionnaire
      pain domain score in individuals with plantar fasciopathy after 12 weeks.
This trial will be designed as a randomised, data analyst-blinded, superiority trial, with a
      3-group parallel design to be conducted in Aalborg, Denmark. Reporting of the trial will
      follow CONSORT guidelines and TIDieR for intervention description. Reporting of the protocol
      will follow the SPIRIT statement. The planning of the trial is done in accordance with the
      PREPARE Trial guide.

      Participants will be stratified by sex and block randomised in block sizes of 3 to 12 (1:1:1)
      into 3 parallel groups of 60 participants using a random number generator on
      www.sealedenvelope.com. The block sizes will be random and concealed to the research
      assistants responsible of including participants. Group allocation will be coded, and the
      data analyst will be blinded to this code until after the analyses have been performed.

      The investigators will only conclude superiority of one intervention over the other if the
      intention-to-treat analysis leads to mean between-group differences of the Foot Health Status
      Questionnaire pain domain ≥14 points (minimally important difference) and P-values <0.05 at
      the primary endpoint (12 weeks) after adjustment for the baseline value.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: Analyses will be carried out by a blinded data analyst
measure: Change in Foot Health Status Questionnaire pain domain
time frame: During baseline and at follow-ups after 4, 12, 26 and 52 weeks
description: The Foot Health Status Questionnaire is a self-report questionnaire ranging from 0 (poor foot health) to 100 (optimum foot health) that assesses multiple dimensions of foot health and function. A validated Danish translation of the original questionnaire will be used.
measure: Change in Foot Health Status Questionnaire function domain
time frame: During baseline and at follow-ups after 4, 12, 26 and 52 weeks
description: Ranging from 0 (poor foot health) to 100 (optimum foot health)
measure: Change in Foot Health Status Questionnaire footwear domain
time frame: During baseline and at follow-ups after 4, 12, 26 and 52 weeks
description: Ranging from 0 (poor foot health) to 100 (optimum foot health)
measure: Change in Foot Health Status Questionnaire general foot health domain
time frame: During baseline and at follow-ups after 4, 12, 26 and 52 weeks
description: Ranging from 0 (poor foot health) to 100 (optimum foot health)
measure: Global Rating of Change
time frame: At follow-ups after 12, 26 and 52 weeks
description: This will be used to measure the participants' self-reported recovery on a 7-point Likert scale ranging from "much improved" to "much worse". Participants are categorised as improved if they rate themselves as "much improved" or "improved" (category 6-7) and categorised as not improved if they rate themselves from "slightly improved" to "much worse" (category 1-5)
measure: Time to Patient Acceptable Symptom State
time frame: From 0 to 52 weeks
description: This will be used as a measure of when participants achieve a self-evaluated satisfactory result and feels no further treatment is needed; hence, it is not necessarily a measure of complete recovery
measure: Change in Pain Self-Efficacy Questionnaire score
time frame: During baseline and at follow-ups after 4, 12, 26 and 52 weeks
description: The Pain Self-Efficacy Questionnaire ranges from 0 (not at all confident) to 60 (completely confident) with lower scores indicating lower self-efficacy. A Danish translation of the original questionnaire, which has been validated in a Danish chronic pain population, will be used
measure: Change in weekly light, moderate and vigorous physical activity level expressed as Metabolic Equivalents
time frame: Week 1 and Week 13 of the interventions
description: Participants will be wearing a wrist-worn accelerometer ((ActiGraph wGT3X-BT (ActiGraph LLC, Pensacola, FL, USA)) during the first three weeks after baseline and again during the first three weeks after the 12-week follow-up.
measure: Change in self-reported health state as measured by the EQ-5D-5L
time frame: During baseline and at follow-ups after 4, 12, 26 and 52 weeks
measure: Sick leave
time frame: During baseline and at follow-ups after 4, 12, 26 and 52 weeks
description: Participants are asked how many days of sick leave they have had during the past 4 weeks due to their condition
measure: Condition-related expenses
time frame: During baseline and at follow-ups after 4, 12, 26 and 52 weeks
description: Participants are asked which expenses and the size they have had during the past 4 weeks due to their condition
arm group label: Fundamental advice and a heel cup
arm group type: Active Comparator
arm group label: Fundamental advice and a heel cup plus exercise
arm group type: Active Comparator
arm group label: Fundamental advice and a heel cup plus exercise and injection
arm group type: Active Comparator
intervention type: Drug
intervention name: Ultrasound-guided corticosteroid injection
description: A 21-gauge, 40 mm needle is connected to a 2.5 cm3 syringe filled with 1 ml Triamcinolonhexacetonid 20mg/ml + 1 ml Lidocain 10 mg7ml. The skin is cleansed with Chlorhexidine alcohol 0.5 %. The needle is inserted with a medial approach under ultrasound-guidance aligned to the long axis of the ultrasound transducer. The injection is placed anterior to the plantar fascia insertion on the calcaneal bone in the region of maximal fascia thickness. Participants are asked to start performing the exercise as soon as they feel ready but not before 24 hours after the injection. Furthermore, they are asked not to progress the method used to achieve 8RM when they start to do the exercise after the injection until Week 3 of the exercise programme. If standing on both feet was sufficient to achieve 8RM at baseline, the participant must not perform the exercise single-legged or to wear a backpack with weights after the injection regardless of any pain reduction afforded by the injection.
arm group label: Fundamental advice and a heel cup plus exercise and injection
intervention type: Other
intervention name: Heavy-slow resistance training
description: Participants will be asked to complete a heel raise standing with the forefoot on a step. The toes are maximally dorsi flexed by placing a towel underneath them. The participant is instructed to perform a heel raise to maximal plantar flexion in the ankle joint and afterwards to lower the heel to maximal dorsiflexion. Supporting oneself for balance by placing the hands on a wall or a rail is allowed. Participants are instructed in performing the exercise with a load as heavy as possible but no higher than 8RM and for as many sets as possible every other day.
arm group label: Fundamental advice and a heel cup plus exercise
arm group label: Fundamental advice and a heel cup plus exercise and injection
intervention type: Other
intervention name: Fundamental advice and a silicone heel cup
description: Participants receive brief information about pathology, risk factors and advice on how to decrease activities that lead to symptom flares and slowly increase their activity level based on their symptoms. They also receive a leaflet that includes the same information as the research assistants will deliver orally after inclusion and a silicone heel cup.
arm group label: Fundamental advice and a heel cup
arm group label: Fundamental advice and a heel cup plus exercise
arm group label: Fundamental advice and a heel cup plus exercise and injection
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael S Rathleff, PhD
role: Study Chair
affiliation: Center for General Practice at Aalborg University
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Aalborg University
investigator full name: Henrik Riel
investigator title: PhD student
sharing ipd: Undecided