Effectiveness of Customised 3D-printed Insoles in Reducing Pain Among Frequent Park Runners

NCT06034210 | Completed

• 1 other identifier: ZolesRCT
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Running-related Pain

  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)

  10 weeks

Secondary Outcomes (10)

• Global Rating of Change (GRoC) in overall daily pain and discomfort

  10 weeks

• Running-related foot/footwear comfort

  10 weeks

• 5k-completion time

  10 weeks

• Running-related injuries

  10 weeks

• Time-loss

  10 weeks

Other Outcomes (6)

• Participants achieving MCID reduction in pain

  10 weeks

• Time until MCID reduction in pain

  10 weeks

• Change among participants with high baseline pain

  10 weeks

Study Arms (2)

ZOLES insoles

EXPERIMENTAL

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

Do-as-usual

NO INTERVENTION

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.

Interventions

Customised 3D-printed insoles DEVICE

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/)

Also known as: Zoles insoles

ZOLES insoles

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Mary's University, Twickenham: lead
• Copenhagen University Hospital, Hvidovre: collaborator
• Aalborg University: collaborator
• Zoles ApS: collaborator

Study Sites (1)

St Mary's University, Faculty of Sport, Technology and Health Sciences

Twickenham, London, TW1 4SX, United Kingdom

Location

Related Publications (1)

• Ibrahim S, Djurtoft C, Mellor R, Thorborg K, Lysdal FG. The effectiveness of customised 3D-printed insoles on perceived pain, comfort, and completion time among frequent Park Runners: Study protocol for a pragmatic randomised controlled trial (The ZOLES RCT). Foot (Edinb). 2024 Mar;58:102068. doi: 10.1016/j.foot.2024.102068. Epub 2024 Feb 6.

  PMID: 38350194 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Filip Gertz Lysdal, MSc, PhD

  Faculty of Sport, Technology and Health Sciences, St Mary's University, United Kingdom

  STUDY DIRECTOR

• Suleyman Ibrahim, MEd

  Faculty of Sport, Technology and Health Sciences, St Mary's University, United Kingdom

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: September 13, 2023
• Study Start: September 16, 2023
• Primary Completion: January 2, 2024
• Study Completion: November 25, 2024
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)