Effectiveness of Customised 3D-printed Insoles in Reducing Pain Among Frequent Park Runners
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT06034210 |
Recruitment Status :
Active, not recruiting
First Posted : September 13, 2023
Last Update Posted : March 18, 2024
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pain | Device: Customised 3D-printed insoles | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 210 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
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) |
Actual Study Start Date : | September 16, 2023 |
Actual Primary Completion Date : | January 2, 2024 |
Estimated Study Completion Date : | November 25, 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: ZOLES insoles
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.
|
Device: Customised 3D-printed insoles
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/)
Other Name: Zoles insoles |
No Intervention: Do-as-usual
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.
|
- Running-related Pain [ Time Frame: 10 weeks ]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)
- Global Rating of Change (GRoC) in overall daily pain and discomfort [ Time Frame: 10 weeks ]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)
- Running-related foot/footwear comfort [ Time Frame: 10 weeks ]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)
- 5k-completion time [ Time Frame: 10 weeks ]Time in minutes taken to complete the weekly 5 km Park Run at their chosen Park Run location
- Running-related injuries [ Time Frame: 10 weeks ]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
- Time-loss [ Time Frame: 10 weeks ]Time lost from running in number of days due to running-related pain, discomfort, or injury
- Weekly Milage [ Time Frame: 10 weeks ]Weekly distance covered from running activities during the trial period
- Weekly running exposure [ Time Frame: 10 weeks ]Weekly exposure to running activities in hours and minutes during the trial period
- Adherence to intervention, ADL% [ Time Frame: 10 weeks ]Relative use of the Zoles insoles during all sitting/standing/walking/driving activities
- Adherence to intervention, RUN% [ Time Frame: 10 weeks ]Relative use of the Zoles insoles during all running activities
- Adverse events from using Zoles insoles [ Time Frame: 52 weeks ]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
- Participants achieving MCID reduction in pain [ Time Frame: 10 weeks ]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
- Time until MCID reduction in pain [ Time Frame: 10 weeks ]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
- Change among participants with high baseline pain [ Time Frame: 10 weeks ]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)
- Pre-trial intervention expectations [ Time Frame: 10 weeks ]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"
- Post-trial intervention experiences [ Time Frame: 10 weeks ]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"
- Post-market surveillance [ Time Frame: 52 weeks ]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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 35 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Participant is ≥ 35 years old at commencement of trial
- Participant can read, speak and understand English
- Participant can receive e-mails and complete online questionnaires
- Participant is a frequent runner who participate in regular Park Runs
- Participant is capable of running at commencement of trial
Exclusion Criteria:
- Individuals with severe foot deformities
- Individuals with uncontrolled diabetes with foot complications, or other conditions that might interfere with their ability to safely use the insoles and participate in running activities
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06034210
United Kingdom | |
St Mary's University, Faculty of Sport, Technology and Health Sciences | |
Twickenham, London, United Kingdom, TW1 4SX |
Study Director: | Filip Gertz Lysdal, MSc, PhD | Faculty of Sport, Technology and Health Sciences, St Mary's University, United Kingdom | |
Principal Investigator: | Suleyman Ibrahim, MEd | Faculty of Sport, Technology and Health Sciences, St Mary's University, United Kingdom | |
Study Chair: | Chris Djurtoft, PT, MSc | Department of Clinical Medicine, Aalborg University, Denmark | |
Study Chair: | Rik Mellor, MSc | Faculty of Sport, Technology and Health Sciences, St Mary's University, United Kingdom | |
Study Chair: | Kristian Thorborg, PT, MSc, PhD | Sports Orthopaedic Research Center-Copenhagen (SORC-C), Department of Orthopaedic Surgery, Copenhagen University Hospital, Amager-Hvidovre, Denmark |
Documents provided by St. Mary's University, Twickenham:
Responsible Party: | St. Mary's University, Twickenham |
ClinicalTrials.gov Identifier: | NCT06034210 |
Other Study ID Numbers: |
ZolesRCT |
First Posted: | September 13, 2023 Key Record Dates |
Last Update Posted: | March 18, 2024 |
Last Verified: | March 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |