xml: <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/NCT06034210</url>
    </required_header>
    <id_info>
      <org_study_id>ZolesRCT</org_study_id>
      <nct_id>NCT06034210</nct_id>
    </id_info>
    <brief_title>Effectiveness of Customised 3D-printed Insoles in Reducing Pain Among Frequent Park Runners</brief_title>
    <official_title>The Effectiveness of Customised 3D-printed Insoles on Perceived Pain, Comfort, and Completion Time Among Frequent Park Runners: A Pragmatic Randomised Controlled Trial (The ZOLES Trial)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>St. Mary's University, Twickenham</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Copenhagen University Hospital, Hvidovre</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Aalborg University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Zoles ApS</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>St. Mary's University, Twickenham</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 evaluates the effectiveness of the Zoles customised 3D-printed insoles to mitigate&#xD;
        running-related pain among frequent recreational runners who participate in regular Park Run&#xD;
        activities. All participants will have their feet scanned, after which half of the&#xD;
        participants will be provided with customised 3D-printed insoles, while the other half will&#xD;
        receive no intervention.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The ZOLES trial is a pragmatic, outcome assessor blinded, randomised, controlled, superiority&#xD;
        trial, with a two-group parallel design. Frequent recreational runners who participate in&#xD;
        regular Park Run activities will undergo a foot scanning after which they will be randomised&#xD;
        in a 1:1 allocation ratio to either receive a customised 3D-printed insole (Zoles ApS,&#xD;
        Espergærde, DK-3060, Denmark), or to be in a &quot;do-as-usual&quot; control group. It is expected that&#xD;
        the allocated intervention group participants will have received their customised insoles&#xD;
        around two weeks after baseline during the follow-up period (one week to manufacture, one&#xD;
        week to distribute). The primary endpoint is change in running-related pain 10 weeks after&#xD;
        baseline (∼8 weeks after receiving allocated intervention).&#xD;
  &#xD;
        A full trial protocol, based on the &quot;SPIRIT 2013 explanation and elaboration: guidance for&#xD;
        protocols of clinical trials&quot; and the &quot;PREPARE Trial guide&quot;, will be published and made&#xD;
        publicly available. The trial report will follow the &quot;REPORT guide&quot;, and thus adhere to the&#xD;
        CONSORT guidelines for reporting parallel group randomised trials, using the CONSORT&#xD;
        extension for pragmatic trials, as well as the updated CONSORT-Outcomes 2022 extension. The&#xD;
        TIDieR template is used to describe the intervention to aid future replication.&#xD;
  &#xD;
        The central aim of this study is to establish the effectiveness of the Zoles customised&#xD;
        3D-printed insoles in alleviating running-related pain among frequent recreational runners&#xD;
        participating in regular Park Run activities when compared against a &quot;do-as-usual&quot; control&#xD;
        group. This clinical effectiveness will be reported in the main trial paper, which also&#xD;
        includes the following key secondary outcomes: Global Rating of Change (GRoC) in overall&#xD;
        daily pain and discomfort, Running-related foot/footwear comfort, 5-k (Park Run) completion&#xD;
        time, running-related injury incidence rate, Time-loss from running, running exposure in&#xD;
        miles and time, adherence to the intervention during daily- and running activities, and&#xD;
        adverse events from using the Zoles insoles. Missing values will be imputed using multiple&#xD;
        imputations by chained equations based on the following variables: All previous scores within&#xD;
        the relevant outcome category, Age, Sex, Group Allocation, and enrolment (Park Run) location.&#xD;
  &#xD;
        A total of 200 participants are anticipated to be enrolled, resulting in a minimum of 100&#xD;
        participants in each arm. The enrolment concludes once at least 100 participants have been&#xD;
        allocated to each arm. Being a pragmatic trial, the eligibility criteria are loosely defined&#xD;
        such that participants should simply be regular runners engaged in frequent Park Run&#xD;
        activities, at a minimum 35 years of age. The participants will undergo balanced block&#xD;
        randomization (1:1 allocation ratio), ensuring stratification for sex and enrolment location.&#xD;
        The trial will include prospective weekly data collection using e-mail-distributed surveys&#xD;
        via REDCap (Vanderbilt University, Nashville, TN, USA) throughout the 10-week follow-up&#xD;
        period. After the conclusion of the initial 10-week trial phase, the control group will also&#xD;
        be provided with their customised 3D-printed insoles. This will not be weekly monitored,&#xD;
        however, following an additional 8-week period with the insoles, this group will then&#xD;
        complete the follow-up questionnaire again, to ascertain whether similar benefits or&#xD;
        deterioration from the insoles in a manner consistent with the original experimental group&#xD;
        are experienced. At the conclusion of the trial, and as part of a post-market surveillance&#xD;
        approach, all participants, both from the original experimental and control groups (who by&#xD;
        this point have received the intervention), will be administered a final questionnaire after&#xD;
        a 1-year period to evaluate the long-term effects and durability of the benefits associated&#xD;
        with the customised 3D-printed insoles.&#xD;
  &#xD;
        The primary outcome; change in running-related pain from baseline to follow-up, will be&#xD;
        calculated using negative binomial regression, adjusting for values reported at baseline.&#xD;
        Both the Global Rating of Change (GRoC) in overall daily pain and discomfort, and&#xD;
        Running-related foot/footwear comfort will be calculated similarly. Injury incidence rate&#xD;
        ratios will be estimated per 1000 hours of running exposure using Poisson regression. Mean&#xD;
        time-loss from running will be calculated using negative binomial regression. Adherence to&#xD;
        the intervention will be descriptively analysed and presented, and adverse event due to the&#xD;
        Zoles insoles will be presented in type and frequency. Every analysis in the main trial&#xD;
        report will abide by the intention to treat principle, which means including all participants&#xD;
        in the analyses, regardless of intervention adherence-signifying that participants will be&#xD;
        analyzed based on initial randomization. In the primary trial report, all collected outcomes&#xD;
        will be listed, and it will also be stated that the below-mentioned 'other pre-specified&#xD;
        outcomes' will be reported in a subsequent secondary analysis publication with a clear&#xD;
        reference to the primary trial registration.&#xD;
  &#xD;
        The subsequent secondary analysis publication will hold the label &quot;secondary and long-term&#xD;
        follow-up analysis from a pragmatic randomized controlled trial&quot; in the title. The aims of&#xD;
        this secondary subgroup analysis study are two-fold: First, it is to investigate the&#xD;
        immediate therapeutic effect of Zoles insoles, focusing only on participants with clinically&#xD;
        relevant baseline pain levels (11-NRS ≥ 3). Secondly, this will include our long-term&#xD;
        post-market analysis to evaluate the long-term effects and durability of the benefits&#xD;
        associated with the customised 3D-printed insoles one year post-intervention. In the&#xD;
        secondary subgroup analysis, the following outcomes will be reported: Percentage of&#xD;
        participants achieving a change of at least MCID (11-NRS ≥ 2) in running-related pain, Time&#xD;
        until change in running-related Pain of at least MCID, Change among participants with&#xD;
        clinically relevant running-related pain at baseline, Pre-trial expectations to the&#xD;
        therapeutic effect of using the Zoles insoles, and Post-trial experiences on the therapeutic&#xD;
        effect of using the Zoles insoles. Incorporating the expectations and post-intervention&#xD;
        experiences as covariates, regression models will be constructed to understand the potential&#xD;
        influence of these factors on the efficacy of the Zoles insoles intervention within this&#xD;
        specific subgroup of participants.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 16, 2023</start_date>
    <completion_date type="Anticipated">November 25, 2024</completion_date>
    <primary_completion_date type="Anticipated">November 25, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Running-related Pain</measure>
      <time_frame>10 weeks</time_frame>
      <description>Change in running-related pain from baseline to follow-up during the trial period. Pain is scored on a numeric rating scale from 0 - 10 (0 = No pain at all, 10 = Extremely painful; Salaffi et al., 2004)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Global Rating of Change (GRoC) in overall daily pain and discomfort</measure>
      <time_frame>10 weeks</time_frame>
      <description>Participants' self-perceived change in overall daily pain and discomfort in relation to when they were enrolled in the study. Participants rate their perceived improvement or deterioration on a 7-point scale ranging from -3 = &quot;much worse&quot; to 3 = &quot;much better&quot; (Bobos et al., 2019)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Running-related foot/footwear comfort</measure>
      <time_frame>10 weeks</time_frame>
      <description>Change in running-related foot/footwear comfort from baseline to follow-up during the trial period. Comfort is scored on a numeric rating scale from 0 - 10 (0 = Extremely uncomfortable, 10 = Extremely comfortable; Menz &amp; Bonnano, 2021)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>5k-completion time</measure>
      <time_frame>10 weeks</time_frame>
      <description>Time in minutes taken to complete the weekly 5 km Park Run at their chosen Park Run location</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Running-related injuries</measure>
      <time_frame>10 weeks</time_frame>
      <description>Rate of running-related injuries sustained during the trial period. The incidence rate is defined as the number of injuries per 1000 hours of running exposure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time-loss</measure>
      <time_frame>10 weeks</time_frame>
      <description>Time lost from running in number of days due to running-related pain, discomfort, or injury</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Weekly Milage</measure>
      <time_frame>10 weeks</time_frame>
      <description>Weekly distance covered from running activities during the trial period</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Weekly running exposure</measure>
      <time_frame>10 weeks</time_frame>
      <description>Weekly exposure to running activities in hours and minutes during the trial period</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adherence to intervention, ADL%</measure>
      <time_frame>10 weeks</time_frame>
      <description>Relative use of the Zoles insoles during all sitting/standing/walking/driving activities</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adherence to intervention, RUN%</measure>
      <time_frame>10 weeks</time_frame>
      <description>Relative use of the Zoles insoles during all running activities</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse events from using Zoles insoles</measure>
      <time_frame>52 weeks</time_frame>
      <description>Adverse events will be reported as type and number of events. The included participants will be encouraged to report any adverse events related to the use of Zoles via the trial hotline</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Participants achieving MCID reduction in pain</measure>
      <time_frame>10 weeks</time_frame>
      <description>Percentage of participants achieving a change in running-related pain of at least the size of MCID (NRS ≥ 2, Salaffi et al., 2004) during the trial intervention period</description>
    </other_outcome>
    <other_outcome>
      <measure>Time until MCID reduction in pain</measure>
      <time_frame>10 weeks</time_frame>
      <description>Time until change in running-related Pain of at least MCID. Time in weeks until a change in running-related pain of at least the size of MCID (NRS ≥ 2, Salaffi et al., 2004) during the trial intervention period, for participants with clinically relevant levels of pre-existing pain (NRS ≥ 3, Rathleff et al., 2019) during running-related activities</description>
    </other_outcome>
    <other_outcome>
      <measure>Change among participants with high baseline pain</measure>
      <time_frame>10 weeks</time_frame>
      <description>Change in running-related pain from baseline to follow-up during the trial period for participants with clinically relevant pre-existing pain levels of NRS ≥ 3 (Rathleff et al., 2019) during running activities. Pain is scored on a numeric rating scale from 0 - 10 (0 = No pain at all, 10 = Extremely painful)</description>
    </other_outcome>
    <other_outcome>
      <measure>Pre-trial intervention expectations</measure>
      <time_frame>10 weeks</time_frame>
      <description>Pre-trial expectations to the therapeutic effect of using the Zoles insoles. The participants' expected effects of the insole intervention on running-related pain, 5-k completion time, and foot/footwear comfort are reported at baseline using 5-point Likert scales ranging from &quot;significantly worsen&quot; to &quot;significantly improve&quot;</description>
    </other_outcome>
    <other_outcome>
      <measure>Post-trial intervention experiences</measure>
      <time_frame>10 weeks</time_frame>
      <description>Post-trial experiences on the therapeutic effect of using the Zoles insoles. Post-intervention period, the participants are asked on whether the intervention met, exceeded, or did not meet their expectations using a 5-point Likert scale ranging from &quot;Fell well short of expectations&quot; to &quot;greatly exceeded expectations&quot;</description>
    </other_outcome>
    <other_outcome>
      <measure>Post-market surveillance</measure>
      <time_frame>52 weeks</time_frame>
      <description>Post-market surveillance including the primary outcome and all key secondary outcomes. All participants, both intervention and control groups will be administered a final questionnaire after a 1-year period to evaluate the long-term effects and durability of the benefits associated with the customised 3D-printed insoles</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Pain</condition>
    <arm_group>
      <arm_group_label>ZOLES insoles</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants allocated to the intervention group will receive customised 3D-printed insoles (Zoles ApS, Espergærde, DK-3060, Denmark) to mitigate running-related pain and discomfort. Being a pragmatic trial, all participants are permitted to continue or initiate any usual care of their choice.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Do-as-usual</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participants allocated to the control group are a &quot;do-as-usual&quot; comparator. This implies, that the participants can treat and prevent running-related pain and discomfort in any way they wish, except using the Zoles 3D-printed insoles.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Customised 3D-printed insoles</intervention_name>
      <description>Based on measurements from the 3D scanning procedure, and factoring in individual data such as age, weight, and activity preferences, custom insoles are designed using the ZOLA software. The insoles are then 3D-printed by Zoles ApS in Espergærde (Denmark), using BCN3D printers (Barcelona, Spain) and a TPU (Thermoplastic Polyurethane) filament material from Recreus (Alicante, Spain). The printed insoles are tailored for optimal support, performance, and comfort, with varying densities for areas like the arch and heel. They are finished with an OnSteam® microfiber cover for added durability and comfort. The insoles are intended for regular insertion into participants' shoes to align with their unique biomechanical needs. (Information translated and adapted from: https://www.zoles.eu/da/processen-bag-saalerne/)</description>
      <arm_group_label>ZOLES insoles</arm_group_label>
      <other_name>Zoles insoles</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participant is ≥ 35 years old at commencement of trial&#xD;
  &#xD;
            -  Participant can read, speak and understand English&#xD;
  &#xD;
            -  Participant can receive e-mails and complete online questionnaires&#xD;
  &#xD;
            -  Participant is a frequent runner who participate in regular Park Runs&#xD;
  &#xD;
            -  Participant is capable of running at commencement of trial&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Individuals with severe foot deformities&#xD;
  &#xD;
            -  Individuals with uncontrolled diabetes with foot complications, or other conditions&#xD;
               that might interfere with their ability to safely use the insoles and participate in&#xD;
               running activities&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>35 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Filip Gertz Lysdal, MSc, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Faculty of Sport, Technology and Health Sciences, St Mary's University, United Kingdom</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Suleyman Ibrahim, MEd</last_name>
      <role>Principal Investigator</role>
      <affiliation>Faculty of Sport, Technology and Health Sciences, St Mary's University, United Kingdom</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Chris Djurtoft, PT, MSc</last_name>
      <role>Study Chair</role>
      <affiliation>Department of Clinical Medicine, Aalborg University, Denmark</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Rik Mellor, MSc</last_name>
      <role>Study Chair</role>
      <affiliation>Faculty of Sport, Technology and Health Sciences, St Mary's University, United Kingdom</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Kristian Thorborg, PT, MSc, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Sports Orthopaedic Research Center-Copenhagen (SORC-C), Department of Orthopaedic Surgery, Copenhagen University Hospital, Amager-Hvidovre, Denmark</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Filip Gertz Lysdal, MSc, PhD</last_name>
      <phone>+45 2720 5197</phone>
      <email>filip.lysdal@stmarys.ac.uk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Suleyman Ibrahim, MEd</last_name>
      <phone>+44 7540 374429</phone>
      <email>2213944@live.stmarys.ac.uk</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06034210
  org study id: ZolesRCT
  nct id: NCT06034210
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study evaluates the effectiveness of the Zoles customised 3D-printed insoles to mitigate
        running-related pain among frequent recreational runners who participate in regular Park Run
        activities. All participants will have their feet scanned, after which half of the
        participants will be provided with customised 3D-printed insoles, while the other half will
        receive no intervention.
  The ZOLES trial is a pragmatic, outcome assessor blinded, randomised, controlled, superiority
        trial, with a two-group parallel design. Frequent recreational runners who participate in
        regular Park Run activities will undergo a foot scanning after which they will be randomised
        in a 1:1 allocation ratio to either receive a customised 3D-printed insole (Zoles ApS,
        Espergærde, DK-3060, Denmark), or to be in a "do-as-usual" control group. It is expected that
        the allocated intervention group participants will have received their customised insoles
        around two weeks after baseline during the follow-up period (one week to manufacture, one
        week to distribute). The primary endpoint is change in running-related pain 10 weeks after
        baseline (∼8 weeks after receiving allocated intervention).
  
        A full trial protocol, based on the "SPIRIT 2013 explanation and elaboration: guidance for
        protocols of clinical trials" and the "PREPARE Trial guide", will be published and made
        publicly available. The trial report will follow the "REPORT guide", and thus adhere to the
        CONSORT guidelines for reporting parallel group randomised trials, using the CONSORT
        extension for pragmatic trials, as well as the updated CONSORT-Outcomes 2022 extension. The
        TIDieR template is used to describe the intervention to aid future replication.
  
        The central aim of this study is to establish the effectiveness of the Zoles customised
        3D-printed insoles in alleviating running-related pain among frequent recreational runners
        participating in regular Park Run activities when compared against a "do-as-usual" control
        group. This clinical effectiveness will be reported in the main trial paper, which also
        includes the following key secondary outcomes: Global Rating of Change (GRoC) in overall
        daily pain and discomfort, Running-related foot/footwear comfort, 5-k (Park Run) completion
        time, running-related injury incidence rate, Time-loss from running, running exposure in
        miles and time, adherence to the intervention during daily- and running activities, and
        adverse events from using the Zoles insoles. Missing values will be imputed using multiple
        imputations by chained equations based on the following variables: All previous scores within
        the relevant outcome category, Age, Sex, Group Allocation, and enrolment (Park Run) location.
  
        A total of 200 participants are anticipated to be enrolled, resulting in a minimum of 100
        participants in each arm. The enrolment concludes once at least 100 participants have been
        allocated to each arm. Being a pragmatic trial, the eligibility criteria are loosely defined
        such that participants should simply be regular runners engaged in frequent Park Run
        activities, at a minimum 35 years of age. The participants will undergo balanced block
        randomization (1:1 allocation ratio), ensuring stratification for sex and enrolment location.
        The trial will include prospective weekly data collection using e-mail-distributed surveys
        via REDCap (Vanderbilt University, Nashville, TN, USA) throughout the 10-week follow-up
        period. After the conclusion of the initial 10-week trial phase, the control group will also
        be provided with their customised 3D-printed insoles. This will not be weekly monitored,
        however, following an additional 8-week period with the insoles, this group will then
        complete the follow-up questionnaire again, to ascertain whether similar benefits or
        deterioration from the insoles in a manner consistent with the original experimental group
        are experienced. At the conclusion of the trial, and as part of a post-market surveillance
        approach, all participants, both from the original experimental and control groups (who by
        this point have received the intervention), will be administered a final questionnaire after
        a 1-year period to evaluate the long-term effects and durability of the benefits associated
        with the customised 3D-printed insoles.
  
        The primary outcome; change in running-related pain from baseline to follow-up, will be
        calculated using negative binomial regression, adjusting for values reported at baseline.
        Both the Global Rating of Change (GRoC) in overall daily pain and discomfort, and
        Running-related foot/footwear comfort will be calculated similarly. Injury incidence rate
        ratios will be estimated per 1000 hours of running exposure using Poisson regression. Mean
        time-loss from running will be calculated using negative binomial regression. Adherence to
        the intervention will be descriptively analysed and presented, and adverse event due to the
        Zoles insoles will be presented in type and frequency. Every analysis in the main trial
        report will abide by the intention to treat principle, which means including all participants
        in the analyses, regardless of intervention adherence-signifying that participants will be
        analyzed based on initial randomization. In the primary trial report, all collected outcomes
        will be listed, and it will also be stated that the below-mentioned 'other pre-specified
        outcomes' will be reported in a subsequent secondary analysis publication with a clear
        reference to the primary trial registration.
  
        The subsequent secondary analysis publication will hold the label "secondary and long-term
        follow-up analysis from a pragmatic randomized controlled trial" in the title. The aims of
        this secondary subgroup analysis study are two-fold: First, it is to investigate the
        immediate therapeutic effect of Zoles insoles, focusing only on participants with clinically
        relevant baseline pain levels (11-NRS ≥ 3). Secondly, this will include our long-term
        post-market analysis to evaluate the long-term effects and durability of the benefits
        associated with the customised 3D-printed insoles one year post-intervention. In the
        secondary subgroup analysis, the following outcomes will be reported: Percentage of
        participants achieving a change of at least MCID (11-NRS ≥ 2) in running-related pain, Time
        until change in running-related Pain of at least MCID, Change among participants with
        clinically relevant running-related pain at baseline, Pre-trial expectations to the
        therapeutic effect of using the Zoles insoles, and Post-trial experiences on the therapeutic
        effect of using the Zoles insoles. Incorporating the expectations and post-intervention
        experiences as covariates, regression models will be constructed to understand the potential
        influence of these factors on the efficacy of the Zoles insoles intervention within this
        specific subgroup of participants.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Running-related Pain
  time frame: 10 weeks
  description: Change in running-related pain from baseline to follow-up during the trial period. Pain is scored on a numeric rating scale from 0 - 10 (0 = No pain at all, 10 = Extremely painful; Salaffi et al., 2004)
  measure: Global Rating of Change (GRoC) in overall daily pain and discomfort
  time frame: 10 weeks
  description: Participants' self-perceived change in overall daily pain and discomfort in relation to when they were enrolled in the study. Participants rate their perceived improvement or deterioration on a 7-point scale ranging from -3 = "much worse" to 3 = "much better" (Bobos et al., 2019)
  measure: Running-related foot/footwear comfort
  time frame: 10 weeks
  description: Change in running-related foot/footwear comfort from baseline to follow-up during the trial period. Comfort is scored on a numeric rating scale from 0 - 10 (0 = Extremely uncomfortable, 10 = Extremely comfortable; Menz & Bonnano, 2021)
  measure: 5k-completion time
  time frame: 10 weeks
  description: Time in minutes taken to complete the weekly 5 km Park Run at their chosen Park Run location
  measure: Running-related injuries
  time frame: 10 weeks
  description: Rate of running-related injuries sustained during the trial period. The incidence rate is defined as the number of injuries per 1000 hours of running exposure
  measure: Time-loss
  time frame: 10 weeks
  description: Time lost from running in number of days due to running-related pain, discomfort, or injury
  measure: Weekly Milage
  time frame: 10 weeks
  description: Weekly distance covered from running activities during the trial period
  measure: Weekly running exposure
  time frame: 10 weeks
  description: Weekly exposure to running activities in hours and minutes during the trial period
  measure: Adherence to intervention, ADL%
  time frame: 10 weeks
  description: Relative use of the Zoles insoles during all sitting/standing/walking/driving activities
  measure: Adherence to intervention, RUN%
  time frame: 10 weeks
  description: Relative use of the Zoles insoles during all running activities
  measure: Adverse events from using Zoles insoles
  time frame: 52 weeks
  description: Adverse events will be reported as type and number of events. The included participants will be encouraged to report any adverse events related to the use of Zoles via the trial hotline
  measure: Participants achieving MCID reduction in pain
  time frame: 10 weeks
  description: Percentage of participants achieving a change in running-related pain of at least the size of MCID (NRS ≥ 2, Salaffi et al., 2004) during the trial intervention period
  measure: Time until MCID reduction in pain
  time frame: 10 weeks
  description: Time until change in running-related Pain of at least MCID. Time in weeks until a change in running-related pain of at least the size of MCID (NRS ≥ 2, Salaffi et al., 2004) during the trial intervention period, for participants with clinically relevant levels of pre-existing pain (NRS ≥ 3, Rathleff et al., 2019) during running-related activities
  measure: Change among participants with high baseline pain
  time frame: 10 weeks
  description: Change in running-related pain from baseline to follow-up during the trial period for participants with clinically relevant pre-existing pain levels of NRS ≥ 3 (Rathleff et al., 2019) during running activities. Pain is scored on a numeric rating scale from 0 - 10 (0 = No pain at all, 10 = Extremely painful)
  measure: Pre-trial intervention expectations
  time frame: 10 weeks
  description: Pre-trial expectations to the therapeutic effect of using the Zoles insoles. The participants' expected effects of the insole intervention on running-related pain, 5-k completion time, and foot/footwear comfort are reported at baseline using 5-point Likert scales ranging from "significantly worsen" to "significantly improve"
  measure: Post-trial intervention experiences
  time frame: 10 weeks
  description: Post-trial experiences on the therapeutic effect of using the Zoles insoles. Post-intervention period, the participants are asked on whether the intervention met, exceeded, or did not meet their expectations using a 5-point Likert scale ranging from "Fell well short of expectations" to "greatly exceeded expectations"
  measure: Post-market surveillance
  time frame: 52 weeks
  description: Post-market surveillance including the primary outcome and all key secondary outcomes. All participants, both intervention and control groups will be administered a final questionnaire after a 1-year period to evaluate the long-term effects and durability of the benefits associated with the customised 3D-printed insoles
  arm group label: ZOLES insoles
  arm group type: Experimental
  description: Participants allocated to the intervention group will receive customised 3D-printed insoles (Zoles ApS, Espergærde, DK-3060, Denmark) to mitigate running-related pain and discomfort. Being a pragmatic trial, all participants are permitted to continue or initiate any usual care of their choice.
  arm group label: Do-as-usual
  arm group type: No Intervention
  description: Participants allocated to the control group are a "do-as-usual" comparator. This implies, that the participants can treat and prevent running-related pain and discomfort in any way they wish, except using the Zoles 3D-printed insoles.
  intervention type: Device
  intervention name: Customised 3D-printed insoles
  description: Based on measurements from the 3D scanning procedure, and factoring in individual data such as age, weight, and activity preferences, custom insoles are designed using the ZOLA software. The insoles are then 3D-printed by Zoles ApS in Espergærde (Denmark), using BCN3D printers (Barcelona, Spain) and a TPU (Thermoplastic Polyurethane) filament material from Recreus (Alicante, Spain). The printed insoles are tailored for optimal support, performance, and comfort, with varying densities for areas like the arch and heel. They are finished with an OnSteam® microfiber cover for added durability and comfort. The insoles are intended for regular insertion into participants' shoes to align with their unique biomechanical needs. (Information translated and adapted from: https://www.zoles.eu/da/processen-bag-saalerne/)
  arm group label: ZOLES insoles
  other name: Zoles insoles
  criteria: 
  gender: All
  minimum age: 35 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Filip Gertz Lysdal, MSc, PhD
  role: Study Director
  affiliation: Faculty of Sport, Technology and Health Sciences, St Mary's University, United Kingdom
  last name: Suleyman Ibrahim, MEd
  role: Principal Investigator
  affiliation: Faculty of Sport, Technology and Health Sciences, St Mary's University, United Kingdom
  last name: Chris Djurtoft, PT, MSc
  role: Study Chair
  affiliation: Department of Clinical Medicine, Aalborg University, Denmark
  last name: Rik Mellor, MSc
  role: Study Chair
  affiliation: Faculty of Sport, Technology and Health Sciences, St Mary's University, United Kingdom
  last name: Kristian Thorborg, PT, MSc, PhD
  role: Study Chair
  affiliation: Sports Orthopaedic Research Center-Copenhagen (SORC-C), Department of Orthopaedic Surgery, Copenhagen University Hospital, Amager-Hvidovre, Denmark
  last name: Filip Gertz Lysdal, MSc, PhD
  phone: +45 2720 5197
  email: filip.lysdal@stmarys.ac.uk
  last name: Suleyman Ibrahim, MEd
  phone: +44 7540 374429
  email: 2213944@live.stmarys.ac.uk
  responsible party type: Sponsor
  sharing ipd: No