3D-printed custom insoles for parkrun runners – DOMEscan/IBV and ZOLES

Running offers tremendous benefits for cardiovascular health, weight management and mental wellbeing, though it can also lead to certain musculoskeletal ailments. This is where the orthopaedic insole market is helping thousands of runners worldwide to enjoy this activity whilst reducing pain and potential health issues. 

This article presents a comprehensive study conducted by orthopaedic and comfort insole manufacturer ZOLES, involving a group of parkrun community runners and the IBV DOMEscan 3D foot scanner as a key tool within their methodology. 

Background and context of the study 

Foot and footwear discomfort increases injury risk, whilst comfort serves as a protective factor against running-related injuries. This enhanced comfort also improves running performance. 

Modern technological advances, particularly 3D printing, have recently refined the manufacturing process of orthopaedic insoles, providing more personalised support and cushioning that can adapt to both foot shape and pressure distribution. 

• Studies on the effects of insoles for runners are limited or incomplete

When testing their results, many studies have an observational or non-randomised design, whilst others compare custom orthopaedic insoles with simulated or generic insoles that may have their own therapeutic properties, potentially diluting the observed benefits of the customised versions.

• There exists only modest compelling evidence linked to very specific injuries

The most convincing evidence for orthotic interventions includes the effect on specific diagnoses such as plantar fasciitis and Achilles tendinopathy, with moderate to low certainty of short-term pain reduction. Moreover, insoles are a complementary element of comprehensive therapeutic treatment. 

In summary, there was a need for a pragmatic trial designed to evaluate both the immediate and long-term prospective efficacy of 3D-printed custom insoles amongst the general population of recreational runners.

 Aims of the study 

For ZOLES, the main question to answer with this study was, does the use of ZOLES 3D customised insoles over 8 weeks improve running-related pain among parkrun recreational runners?

• Primary objective: To determine the efficacy of ZOLES 3D-printed customised insoles in changing running-related pain after 10 weeks. 
• Secondary objectives:

• • Global Rating of Change (GRoC) in pain and general daily discomfort. 
  • Running-related foot/footwear comfort. 
  • Completion time of 5 Km (parkrun).
  • Incidence rate of running-related injuries.
  • Time lost from running.
  • Exposure to running in terms of kilometres and time.
  • Adherence to the intervention during daily and running activities.
  • Adverse events resulting from the use of ZOLES insoles.

Regarding this last point, the variables to consider were:

1. Exploring whether the control group benefits similarly from receiving 3D-printed customised insoles when supplied after the initial 10-week trial phase.
2. Understanding the long-term effects and durability of benefits, assessed one year after the intervention.
3. Investigating the immediate therapeutic effect of ZOLES insoles specifically for participants with clinically relevant baseline pain levels. 
4. Evaluating pre- and post-trial expectations in relation to the therapeutic effects of ZOLES insoles.

Methodology

The ZOLES trial was set up as a pragmatic, randomised, controlled, outcome assessor-blinded trial with a two-group parallel design and a 1:1 allocation ratio. 

Frequent recreational runners underwent foot scanning and were then randomly assigned to either a 3D-printed customised insole or to be part of a “no change” control group. 

The trial protocol was based on the “PREPARE Trial Guide” and adhered to the “SPIRIT 2013 Explanation and Elaboration: Guidance for protocols of clinical trials” and the SPIRIT checklist. The study was developed by St. Mary’s University in collaboration with ZOLES.

• Development of customised insoles

Thanks to the foot scan made using DOMEscan/IBV by Avatar 3D, ideal 3D foot measurements were obtained that allowed for a 100% customised design of the printed insoles for each participant in this study. This level of personalisation enabled the insoles to adapt to the shape of the foot and the biomechanical needs of each runner.

Furthermore, thanks to the use of materials such as TPU (thermoplastic polyurethane), optimal support and comfort were guaranteed, whilst the soles were reinforced by covering them with a microfibre capable of increasing the product’s lifespan. 

Study results 

The clinical study demonstrated that runners who used ZOLES insoles experienced:

• A significant reduction (45%) in running-related pain after 10 weeks.
• Greater comfort both during training and daily activities.
• Faster recovery time and improved performance in 5-Km runs.

“Our collaboration with the IBV 1 spans more than seven years, and we are deeply grateful for the 3D foot scanners they have developed for us. Their technology has been instrumental in advancing our understanding of foot biomechanics. Moreover, the success of the collaboration between the IBV and ZOLES is clearly reflected in the results of this research.”

– Cecilie Lea Lisberg, Co-founder of ZOLES

Thanks to the results of this study, ZOLES has revolutionised the running accessories market. In fact, they incorporated 3D Avatar Feet technology and now offer their customers an alternative that allows them to scan their feet from home and directly order their custom insoles through their website.

This has lowered the barriers to accessing this level of personalisation of the retail experience, allowing the solution to be deployed on a global scale.