<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/NCT03264729</url>
  </required_header>
  <id_info>
    <org_study_id>N-20170021</org_study_id>
    <nct_id>NCT03264729</nct_id>
  </id_info>
  <brief_title>The Acute Effect of Isotonic Versus Isometric Exercise Versus Walking on Pain in Individuals With Plantar Fasciopathy</brief_title>
  <official_title>The Acute Effect of Isotonic Versus Isometric Exercise Versus Walking on Pain in Individuals With Plantar Fasciopathy: a Randomised, Participant-blinded, Cross-over Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aalborg University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>
      This study investigates the acute effect of isotonic versus isometric exercise versus walking&#xD;
      on pain in individuals with plantar heel pain and an ultrasound-diagnosed plantar&#xD;
      fasciopathy. The hypothesis is that isometric exercise will induce greater participant rated&#xD;
      pain relief than isotonic exercise and walking during aggravating activity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be required to attend three sessions (isometric, isotonic, or walking)&#xD;
      within a maximum of two weeks. The order in which the participant completes the sessions will&#xD;
      be randomised.There will be a minimum of 48 hours between sessions. To account for potential&#xD;
      time of day differences in terms of pain, all sessions will be performed within ±1 hour (e.g.&#xD;
      if the first session is performed at 10 AM the remaining two sessions will be performed&#xD;
      between 9 and 11 AM). After diagnosis, randomisation of the order of which the sessions will&#xD;
      be performed, and have their pain during an aggravating activity examined (aggravating&#xD;
      activities will be static stance, half squat or heel raise). Subsequently the participants&#xD;
      will be instructed in performing either isotonic or isometric heel raise or walking,&#xD;
      (determined according to the randomisation) by a physiotherapist.&#xD;
&#xD;
      All statistical analyses will be performed according to a pre-established analysis plan using&#xD;
      STATA ver. 14. The assumption of negligible carryover effects is investigated with a&#xD;
      preliminary test. The primary analysis will test the presence of a difference in EIH between&#xD;
      isotonic and isometric exercise and walking and a 3 X 2 repeated measures ANOVA will be&#xD;
      performed. Independent factors will be exercise type (isometric vs. isotonic vs. walking) and&#xD;
      time (pre vs. post). If an interaction is found, post-hoc paired t-tests will be performed.&#xD;
      The standardised mean difference (effect size) and its confidence intervals will be&#xD;
      calculated and presented in a forest plot. Apriori it has been determined that no conclusions&#xD;
      will be made favouring either of the exercises nor walking if pain is reduced less than the&#xD;
      clinically important difference of 19 mm VAS. In addition, the proportion of clinically&#xD;
      relevant pain reductions (i.e. a pain reduction of at least 19 mm VAS) will be calculated.&#xD;
      EIH by pain experienced during the aggravating activity before the exercises and walking will&#xD;
      also be presented in a plot.&#xD;
&#xD;
      Secondary analyses using a 3 X 2 repeated measures ANOVAs will test if there is a difference&#xD;
      in the thickness of the plantar fascia and a difference in PPTs from before to after either&#xD;
      of the exercises or walking and a difference in pain experienced during the exercises or&#xD;
      walking. If interactions are found post-hoc paired t-tests will be performed. A paired t-test&#xD;
      will be performed to investigate potential differences in plantar fascia thickness from&#xD;
      before to after the initial PPT and pain aggravating activity are performed. Effect sizes&#xD;
      will be calculated for the difference in pressure pain threshold and plantar fascia&#xD;
      thickness. The association between thickness of the plantar fascia and the difference in pain&#xD;
      from before to after the exercise activities will be investigated using Pearson's correlation&#xD;
      coefficient.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 24, 2017</start_date>
  <completion_date type="Actual">October 3, 2017</completion_date>
  <primary_completion_date type="Actual">October 3, 2017</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in pain</measure>
    <time_frame>Immediately before and after each exercise/walking</time_frame>
    <description>This is measured during an aggravating task on a 100 mm VAS, where 0 mm is no pain and 100 mm is worst pain imaginable and is also referred to as exercise-induced hypoalgesia (EIH)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in pressure pain threshold</measure>
    <time_frame>Immediately before and after each exercise/walking</time_frame>
    <description>Measured on the tenderest spot under the heel by an algometer in kPa</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in thickness of the plantar fascia</measure>
    <time_frame>Immediately before and after each exercise/walking</time_frame>
    <description>Measured by ultrasonography in mm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain</measure>
    <time_frame>During each exercise/walking</time_frame>
    <description>Measured on a 100 mm VAS, where 0 mm is no pain and 100 mm is worst pain imaginable.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Plantar Fasciopathy</condition>
  <arm_group>
    <arm_group_label>Isometric exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Isotonic exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Walking</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Isometric exercise</intervention_name>
    <description>The isometric exercise is performed standing with the forefoot on a step. The participant is instructed to stand still with the ankle joint in neutral and hold this position. Supporting oneself for balance by placing the hands on a wall or a rail is allowed. The participant performs 5 sets of 45-second isometric holds. The load used is the heaviest possible load that the participant is able to withstand for 1 minute. As with the isotonic exercise, if the participant's body weight is inadequate the participant is fitted with a backpack with books and/or weights.</description>
    <arm_group_label>Isometric exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Isotonic exercise</intervention_name>
    <description>The isotonic exercise is performed 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 a maximal plantar flexion in the ankle joint, and afterwards to lower the heel to maximal dorsi flexion. Supporting oneself for balance by placing the hands on a wall or a rail is allowed. The participant performs 4 sets of 8 repetitions with a load of 8RM. The contraction time is 3s concentric, 2s isometric and 3s eccentric and will be guided by a metronome.&#xD;
If the participant's body weight is inadequate to reach sufficient loading during the exercises the participant is fitted with a backpack with books and/or weights.</description>
    <arm_group_label>Isotonic exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Walking</intervention_name>
    <description>The walking will be performed barefoot and the participant will be instructed in walking at a pace similar to the pace they would use when walking around in their home. The duration of the walking session will be four minutes to match the duration during the exercises.</description>
    <arm_group_label>Walking</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&#xD;
&#xD;
          -  Pain during at least one of three pain aggravating activities (static stance, half&#xD;
             squat and heel raise)&#xD;
&#xD;
          -  Mean heel pain of ≥ 20 mm on a 100 mm VAS [0mm = no pain, 100mm = worst pain&#xD;
             imaginable] during the past week&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Below 18 years of age&#xD;
&#xD;
          -  History of inflammatory systemic diseases&#xD;
&#xD;
          -  Pain or stiffness in the 1st metatarsophalangeal joint to an extent where the&#xD;
             exercises cannot be performed&#xD;
&#xD;
          -  Prior heel surgery&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Pain medication&#xD;
&#xD;
          -  Corticosteroid injection for plantar fasciopathy within the past six months&#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>Henrik Riel, M.Sc.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Research Unit for General Practice in Aalborg, Department of Clinical Medicine, Aalborg University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Unit for General Practice</name>
      <address>
        <city>Aalborg East</city>
        <zip>9220</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>October 4, 2017</last_update_submitted>
  <last_update_submitted_qc>October 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2017</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>
  <keyword>plantar heel pain</keyword>
  <!-- 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/NCT03264729
org study id: N-20170021
nct id: NCT03264729
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study investigates the acute effect of isotonic versus isometric exercise versus walking
      on pain in individuals with plantar heel pain and an ultrasound-diagnosed plantar
      fasciopathy. The hypothesis is that isometric exercise will induce greater participant rated
      pain relief than isotonic exercise and walking during aggravating activity.
Participants will be required to attend three sessions (isometric, isotonic, or walking)
      within a maximum of two weeks. The order in which the participant completes the sessions will
      be randomised.There will be a minimum of 48 hours between sessions. To account for potential
      time of day differences in terms of pain, all sessions will be performed within ±1 hour (e.g.
      if the first session is performed at 10 AM the remaining two sessions will be performed
      between 9 and 11 AM). After diagnosis, randomisation of the order of which the sessions will
      be performed, and have their pain during an aggravating activity examined (aggravating
      activities will be static stance, half squat or heel raise). Subsequently the participants
      will be instructed in performing either isotonic or isometric heel raise or walking,
      (determined according to the randomisation) by a physiotherapist.

      All statistical analyses will be performed according to a pre-established analysis plan using
      STATA ver. 14. The assumption of negligible carryover effects is investigated with a
      preliminary test. The primary analysis will test the presence of a difference in EIH between
      isotonic and isometric exercise and walking and a 3 X 2 repeated measures ANOVA will be
      performed. Independent factors will be exercise type (isometric vs. isotonic vs. walking) and
      time (pre vs. post). If an interaction is found, post-hoc paired t-tests will be performed.
      The standardised mean difference (effect size) and its confidence intervals will be
      calculated and presented in a forest plot. Apriori it has been determined that no conclusions
      will be made favouring either of the exercises nor walking if pain is reduced less than the
      clinically important difference of 19 mm VAS. In addition, the proportion of clinically
      relevant pain reductions (i.e. a pain reduction of at least 19 mm VAS) will be calculated.
      EIH by pain experienced during the aggravating activity before the exercises and walking will
      also be presented in a plot.

      Secondary analyses using a 3 X 2 repeated measures ANOVAs will test if there is a difference
      in the thickness of the plantar fascia and a difference in PPTs from before to after either
      of the exercises or walking and a difference in pain experienced during the exercises or
      walking. If interactions are found post-hoc paired t-tests will be performed. A paired t-test
      will be performed to investigate potential differences in plantar fascia thickness from
      before to after the initial PPT and pain aggravating activity are performed. Effect sizes
      will be calculated for the difference in pressure pain threshold and plantar fascia
      thickness. The association between thickness of the plantar fascia and the difference in pain
      from before to after the exercise activities will be investigated using Pearson's correlation
      coefficient.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change in pain
time frame: Immediately before and after each exercise/walking
description: This is measured during an aggravating task on a 100 mm VAS, where 0 mm is no pain and 100 mm is worst pain imaginable and is also referred to as exercise-induced hypoalgesia (EIH)
measure: Change in pressure pain threshold
time frame: Immediately before and after each exercise/walking
description: Measured on the tenderest spot under the heel by an algometer in kPa
measure: Change in thickness of the plantar fascia
time frame: Immediately before and after each exercise/walking
description: Measured by ultrasonography in mm
measure: Pain
time frame: During each exercise/walking
description: Measured on a 100 mm VAS, where 0 mm is no pain and 100 mm is worst pain imaginable.
arm group label: Isometric exercise
arm group type: Experimental
arm group label: Isotonic exercise
arm group type: Active Comparator
arm group label: Walking
arm group type: Active Comparator
intervention type: Other
intervention name: Isometric exercise
description: The isometric exercise is performed standing with the forefoot on a step. The participant is instructed to stand still with the ankle joint in neutral and hold this position. Supporting oneself for balance by placing the hands on a wall or a rail is allowed. The participant performs 5 sets of 45-second isometric holds. The load used is the heaviest possible load that the participant is able to withstand for 1 minute. As with the isotonic exercise, if the participant's body weight is inadequate the participant is fitted with a backpack with books and/or weights.
arm group label: Isometric exercise
intervention type: Other
intervention name: Isotonic exercise
description: The isotonic exercise is performed 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 a maximal plantar flexion in the ankle joint, and afterwards to lower the heel to maximal dorsi flexion. Supporting oneself for balance by placing the hands on a wall or a rail is allowed. The participant performs 4 sets of 8 repetitions with a load of 8RM. The contraction time is 3s concentric, 2s isometric and 3s eccentric and will be guided by a metronome.
If the participant's body weight is inadequate to reach sufficient loading during the exercises the participant is fitted with a backpack with books and/or weights.
arm group label: Isotonic exercise
intervention type: Other
intervention name: Walking
description: The walking will be performed barefoot and the participant will be instructed in walking at a pace similar to the pace they would use when walking around in their home. The duration of the walking session will be four minutes to match the duration during the exercises.
arm group label: Walking
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Henrik Riel, M.Sc.
role: Principal Investigator
affiliation: Research Unit for General Practice in Aalborg, Department of Clinical Medicine, Aalborg University
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Aalborg University
investigator full name: Henrik Riel
investigator title: PhD Student