<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/NCT02212444</url>
  </required_header>
  <id_info>
    <org_study_id>14/P/051</org_study_id>
    <secondary_id>14/SW/0116</secondary_id>
    <nct_id>NCT02212444</nct_id>
  </id_info>
  <brief_title>Comparing the Effects of Two Foot and Ankle Splints for Foot Pain</brief_title>
  <official_title>The Effectiveness of a Dynamic Elastomeric Fabric Orthoses (DEFO) in the Management of Plantar Fasciitis: A Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Plymouth NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Plymouth NHS Trust</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Plantar fasciitis (severe pain in the heel) is a common problem that has a significant impact&#xD;
      on quality of life. There is some evidence to support the use of orthoses and stretches in&#xD;
      the conservative management of plantar fasciitis but current orthotic management may not be&#xD;
      optimal. More prolonged stretching with night splints may achieve better results but such&#xD;
      splints are clinically not well tolerated. Therefore, there is a potential need to apply&#xD;
      prolonged stretching during the day and during dynamic tasks such as walking. This has led to&#xD;
      the development of other rigid and semi-rigid splints that have shown promising results in&#xD;
      small scale clinical trials. There are disadvantages however with the more rigid bracing and&#xD;
      orthoses seen in these types of splints. For example, they are often difficult to accommodate&#xD;
      with a person's available shoes; this can be particularly difficult for women and thus limits&#xD;
      their compliance with the intervention. Further, more rigid bracing can be uncomfortable&#xD;
      during fast walking and running and so limits participation in such activities.&#xD;
&#xD;
      Recently a novel orthotic, a customised dynamic elastomeric fabric orthoses (DEFO), has been&#xD;
      developed. Being made from lycra® based materials the sock-like splint is lightweight and&#xD;
      discrete, allowing it to be accommodated easily into most shoe types and potentially better&#xD;
      tolerated when worn at night compared to currently available splints. Its design further&#xD;
      allows it to be used comfortably during dynamic tasks such as walking and running as&#xD;
      supported by initial anecdotal evidence in athletes. To date there has been no evaluation&#xD;
      into the effectiveness of the DEFO in the general population with plantar fasciitis.&#xD;
&#xD;
      This study will look at the feasibility of conducting a randomised controlled trial into the&#xD;
      use of a DEFO compared to an off-the-shelf orthoses as an adjunct to usual care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Plantar fasciitis is the most common foot and ankle pathology that affects the general&#xD;
      population. It affects over 1 million people in the USA equating to ~0.2 million in the UK.&#xD;
      It is characterized by severe pain felt on the plantar aspect of the heel around the plantar&#xD;
      fascia origin which is significantly thicker than normal.&#xD;
&#xD;
      Usually conservative treatment comprises a referral to physiotherapy and provision of&#xD;
      orthotics. Physiotherapy consists of teaching a home program of calf and plantar fascia&#xD;
      stretches in addition to weight management and footwear advice.&#xD;
&#xD;
      Orthotic management includes the provision of off-the-shelf orthotics or customised&#xD;
      orthotics. Some studies of customised orthoses demonstrate significant improvements in foot&#xD;
      pain related function at 3 and 12 months in people with plantar fasciitis compared to a sham&#xD;
      intervention. However, a systematic review of the randomised controlled trials found no&#xD;
      evidence to support their use on short or long term foot pain, pain related function or&#xD;
      disability.&#xD;
&#xD;
      Dynamic elastomeric fabric orthoses (DEFOs) have been successfully used in a variety of&#xD;
      patient groups. The plantar fasciitis DEFOs is a custom-made close-fitting sock of&#xD;
      elastomeric construction. It is worn next to the skin where the sock can exert an external&#xD;
      torsional, compressive, and supportive effect, thus positively influencing the biomechanics&#xD;
      of the heal.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</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>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Foot and Ankle Ability Measure (FAAM)</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>This is a patient reported questionnaire asking about the impact of the foot and ankle on 21 activities of daily living and 8-sport related activities. It has demonstrated validity for this client group (correlating with physical function subscales of the SF-36) and shows good test-retest reliability</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue scales</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>Visual analogue / Numerical rating scales are commonly used to measure pain in clinical trials, having demonstrated good validity, reliability and responsiveness. Patients will indicate (a) their current heel pain and (b) their worst pain over the last 48 hrs using a numerical rating scale. 0 will indicate no pain at all and 10 will indicate their worst imaginable pain and numbers from 0-10 will be shown.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ankle Range of Motion</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>The extensibility of the ankle plantarflexors will be determined by measuring the angle of the tibia to the vertical using an inclinometer during a &quot;lunge stretch&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plantar Fascia thickness</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>The thickness of the plantar fascia enthesis will be measured using ultrasound.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (QoL)</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>This will be measured using both the Foot Health Status Questionnaire and the EQ-5D. The Foot Health Status Questionnaire measures foot health related quality of life and has demonstrated validity and reliability whilst the EQ-5D is recommended for health economic evaluations (and hence piloting of its use in this feasibility study is of value).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Satisfaction</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>A questionnaire, developed for the purposes of this study, will ascertain people's satisfaction with the DEFO/orthoses and their adherence over the previous week. This will be assessed 12 and 24 weeks (via post) after issuing the orthotic.</description>
  </other_outcome>
  <other_outcome>
    <measure>Participant characteristics</measure>
    <time_frame>week 1</time_frame>
    <description>The following patient characteristics and risk factors for the development of plantar fasciitis will be taken at baseline:&#xD;
Age, gender&#xD;
Duration of plantar fasciitis&#xD;
Body mass index&#xD;
Occupation and average hours standing per day&#xD;
Physical activity (International Physical Activity Questionnaire&#xD;
The number and type of hip / trunk exercises prescribed after the initial assessment by the treating therapist.</description>
  </other_outcome>
  <other_outcome>
    <measure>Recruitment and drop-out rates</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>Data on recruitment and attrition rates will be entered into a database. Where possible, reasons for dropping out will be ascertained&#xD;
Percentage of completed measures at each time-point:&#xD;
The percentage of completed measures at each time-point for each participant will be entered onto a database</description>
  </other_outcome>
  <other_outcome>
    <measure>Feasibility</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>At the end of the study participants and PHNT staff will complete a questionnaire on the feasibility of the study and provide suggestions that may aid the running of future trials</description>
  </other_outcome>
  <other_outcome>
    <measure>Effectiveness of blinding</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>Following each measurement time point the assessor (RM) will be asked to indicate which group they think the participant was allocated to.</description>
  </other_outcome>
  <other_outcome>
    <measure>Cost</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>Unit cost of each orthotic intervention (off-the-shelf orthotic Vs DEFO) will be gathered to help inform future economic evaluations. This will include an estimate of the time required to take the different measures required for fitting and ordering each orthosis.</description>
  </other_outcome>
  <other_outcome>
    <measure>Adherence</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>A questionnaire, developed for the purposes of this study, will ascertain people's satisfaction with the DEFO/orthoses and their adherence to treatment over the previous week. This will be assessed 12 and 24 weeks (via post) after issuing the orthotic.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Plantar Fasciitis</condition>
  <arm_group>
    <arm_group_label>Dynamic elastomeric fabric orthoses (DEFO)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The DEFO will be provided after taking the baseline measures and orthoses measurements at the baseline session ~ 3 weeks later. The orthoses will be supplied via post and used for a period of 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Off-the-self orthotics</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Off-the-shelf-Orthotics: Patients in the usual care group will be referred for off -the-shelf triplanar orthoses as indicated by a biomechanical assessment of foot posture while standing / walking on visit 1. The off the shelf orthotic will be provided after taking the baseline measures and orthoses measurements at the baseline session ~ 3 weeks later. The orthoses will be supplied via post and used for a period of 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dynamic elastomeric fabric orthoses (DEFO)</intervention_name>
    <description>A patient customised dynamic elastomeric fabric orthoses (DEFO)</description>
    <arm_group_label>Dynamic elastomeric fabric orthoses (DEFO)</arm_group_label>
    <other_name>DEFO</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Off -the-shelf triplanar orthoses</intervention_name>
    <arm_group_label>Off-the-self orthotics</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over 18 years old&#xD;
&#xD;
          -  Plantar heel pain for greater than 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Calcaneal fracture&#xD;
&#xD;
          -  Additional neurological or orthopaedic / rheumatological impairments&#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>Jonathan J Marsden, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Plumouth University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Richard McKee, B.Sc.(Hons)</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Plymouth NHS Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Plymouth Hospitals NHS Trust</name>
      <address>
        <city>Plymouth</city>
        <state>Devon</state>
        <zip>PL6 8DH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <last_update_submitted>June 2, 2016</last_update_submitted>
  <last_update_submitted_qc>June 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 3, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>plantar fasciitis</keyword>
  <keyword>dynamic elastomeric fabric orthoses (DEFO)</keyword>
  <keyword>feasibility</keyword>
  <keyword>Physiotherapy</keyword>
  <keyword>Musculoskeletal</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/NCT02212444
org study id: 14/P/051
secondary id: 14/SW/0116
nct id: NCT02212444
lead sponsor: 
has dmc: Yes
Plantar fasciitis (severe pain in the heel) is a common problem that has a significant impact
      on quality of life. There is some evidence to support the use of orthoses and stretches in
      the conservative management of plantar fasciitis but current orthotic management may not be
      optimal. More prolonged stretching with night splints may achieve better results but such
      splints are clinically not well tolerated. Therefore, there is a potential need to apply
      prolonged stretching during the day and during dynamic tasks such as walking. This has led to
      the development of other rigid and semi-rigid splints that have shown promising results in
      small scale clinical trials. There are disadvantages however with the more rigid bracing and
      orthoses seen in these types of splints. For example, they are often difficult to accommodate
      with a person's available shoes; this can be particularly difficult for women and thus limits
      their compliance with the intervention. Further, more rigid bracing can be uncomfortable
      during fast walking and running and so limits participation in such activities.

      Recently a novel orthotic, a customised dynamic elastomeric fabric orthoses (DEFO), has been
      developed. Being made from lycra® based materials the sock-like splint is lightweight and
      discrete, allowing it to be accommodated easily into most shoe types and potentially better
      tolerated when worn at night compared to currently available splints. Its design further
      allows it to be used comfortably during dynamic tasks such as walking and running as
      supported by initial anecdotal evidence in athletes. To date there has been no evaluation
      into the effectiveness of the DEFO in the general population with plantar fasciitis.

      This study will look at the feasibility of conducting a randomised controlled trial into the
      use of a DEFO compared to an off-the-shelf orthoses as an adjunct to usual care.
Plantar fasciitis is the most common foot and ankle pathology that affects the general
      population. It affects over 1 million people in the USA equating to ~0.2 million in the UK.
      It is characterized by severe pain felt on the plantar aspect of the heel around the plantar
      fascia origin which is significantly thicker than normal.

      Usually conservative treatment comprises a referral to physiotherapy and provision of
      orthotics. Physiotherapy consists of teaching a home program of calf and plantar fascia
      stretches in addition to weight management and footwear advice.

      Orthotic management includes the provision of off-the-shelf orthotics or customised
      orthotics. Some studies of customised orthoses demonstrate significant improvements in foot
      pain related function at 3 and 12 months in people with plantar fasciitis compared to a sham
      intervention. However, a systematic review of the randomised controlled trials found no
      evidence to support their use on short or long term foot pain, pain related function or
      disability.

      Dynamic elastomeric fabric orthoses (DEFOs) have been successfully used in a variety of
      patient groups. The plantar fasciitis DEFOs is a custom-made close-fitting sock of
      elastomeric construction. It is worn next to the skin where the sock can exert an external
      torsional, compressive, and supportive effect, thus positively influencing the biomechanics
      of the heal.
allocation: Randomized
intervention model: Parallel Assignment
masking: Single (Outcomes Assessor)
measure: Foot and Ankle Ability Measure (FAAM)
time frame: Up to 12 weeks
description: This is a patient reported questionnaire asking about the impact of the foot and ankle on 21 activities of daily living and 8-sport related activities. It has demonstrated validity for this client group (correlating with physical function subscales of the SF-36) and shows good test-retest reliability
measure: Visual Analogue scales
time frame: Up to 12 weeks
description: Visual analogue / Numerical rating scales are commonly used to measure pain in clinical trials, having demonstrated good validity, reliability and responsiveness. Patients will indicate (a) their current heel pain and (b) their worst pain over the last 48 hrs using a numerical rating scale. 0 will indicate no pain at all and 10 will indicate their worst imaginable pain and numbers from 0-10 will be shown.
measure: Ankle Range of Motion
time frame: Up to 12 weeks
description: The extensibility of the ankle plantarflexors will be determined by measuring the angle of the tibia to the vertical using an inclinometer during a "lunge stretch".
measure: Plantar Fascia thickness
time frame: Up to 12 weeks
description: The thickness of the plantar fascia enthesis will be measured using ultrasound.
measure: Quality of Life (QoL)
time frame: Up to 12 weeks
description: This will be measured using both the Foot Health Status Questionnaire and the EQ-5D. The Foot Health Status Questionnaire measures foot health related quality of life and has demonstrated validity and reliability whilst the EQ-5D is recommended for health economic evaluations (and hence piloting of its use in this feasibility study is of value).
measure: Satisfaction
time frame: Up to 24 weeks
description: A questionnaire, developed for the purposes of this study, will ascertain people's satisfaction with the DEFO/orthoses and their adherence over the previous week. This will be assessed 12 and 24 weeks (via post) after issuing the orthotic.
measure: Participant characteristics
time frame: week 1
description: The following patient characteristics and risk factors for the development of plantar fasciitis will be taken at baseline:
Age, gender
Duration of plantar fasciitis
Body mass index
Occupation and average hours standing per day
Physical activity (International Physical Activity Questionnaire
The number and type of hip / trunk exercises prescribed after the initial assessment by the treating therapist.
measure: Recruitment and drop-out rates
time frame: Up to 24 weeks
description: Data on recruitment and attrition rates will be entered into a database. Where possible, reasons for dropping out will be ascertained
Percentage of completed measures at each time-point:
The percentage of completed measures at each time-point for each participant will be entered onto a database
measure: Feasibility
time frame: Up to 24 weeks
description: At the end of the study participants and PHNT staff will complete a questionnaire on the feasibility of the study and provide suggestions that may aid the running of future trials
measure: Effectiveness of blinding
time frame: Up to 12 weeks
description: Following each measurement time point the assessor (RM) will be asked to indicate which group they think the participant was allocated to.
measure: Cost
time frame: Up to 24 weeks
description: Unit cost of each orthotic intervention (off-the-shelf orthotic Vs DEFO) will be gathered to help inform future economic evaluations. This will include an estimate of the time required to take the different measures required for fitting and ordering each orthosis.
measure: Adherence
time frame: Up to 24 weeks
description: A questionnaire, developed for the purposes of this study, will ascertain people's satisfaction with the DEFO/orthoses and their adherence to treatment over the previous week. This will be assessed 12 and 24 weeks (via post) after issuing the orthotic.
arm group label: Dynamic elastomeric fabric orthoses (DEFO)
arm group type: Experimental
description: The DEFO will be provided after taking the baseline measures and orthoses measurements at the baseline session ~ 3 weeks later. The orthoses will be supplied via post and used for a period of 12 weeks.
arm group label: Off-the-self orthotics
arm group type: Active Comparator
description: Off-the-shelf-Orthotics: Patients in the usual care group will be referred for off -the-shelf triplanar orthoses as indicated by a biomechanical assessment of foot posture while standing / walking on visit 1. The off the shelf orthotic will be provided after taking the baseline measures and orthoses measurements at the baseline session ~ 3 weeks later. The orthoses will be supplied via post and used for a period of 12 weeks.
intervention type: Device
intervention name: Dynamic elastomeric fabric orthoses (DEFO)
description: A patient customised dynamic elastomeric fabric orthoses (DEFO)
arm group label: Dynamic elastomeric fabric orthoses (DEFO)
other name: DEFO
intervention type: Device
intervention name: Off -the-shelf triplanar orthoses
arm group label: Off-the-self orthotics
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jonathan J Marsden, PhD
role: Study Chair
affiliation: Plumouth University
last name: Richard McKee, B.Sc.(Hons)
role: Principal Investigator
affiliation: University Hospital Plymouth NHS Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Fasciitis
mesh term: Fasciitis, Plantar