Comparing clinical outcomes using two insole manufacture techniques
Research type
Research Study
Full title
Comparing the effectiveness of computer-aided-design computer-aided-manufacture (CAD/CAM) insoles manufactured from foam-box cast vs direct scan on patient reported outcome measures: A double-blinded, randomised controlled trial.
IRAS ID
317502
Contact name
Graham Chapman
Contact email
Sponsor organisation
NHS Greater Glasgow and Clyde
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Computer aided design (CAD) with computer aided manufacture (CAM) foot orthoses (insoles) represent 14% (n=2739, per annum 2020) of all Orthotic Department provision in NHS Greater Glasgow and Clyde (GGC), representing a significant proportion of Orthotic service users, and financial burden to the National Health Service (NHS). The production of CAD/CAM insoles relies on acquiring a digital model of the patient’s foot from which the final insole can be produced, either by directly scanning the patient’s foot in to the CAD/CAM system to produce a 3D model, or by taking a physical cast of the foot which is then scanned. These two methods of shape-capture are used as standard practice interchangeably throughout NHS Orthotics services, and there is no evidence to specifically support the use of one method over the other. It is clear from the lack of literature and current widespread indiscriminate practices across NHS Orthotic Services, that more research is required to assist with best practice in the manufacture of CAD/CAM insoles.
The main purpose of this study is to find out if insoles produced from a direct 3D scan of the foot are effective in changing foot pain and foot function, compared to insoles produced from a foam-box cast of the foot. In this study, CAD/CAM insoles will be manufactured either from a direct 3D scan of the foot, or from a foam-box cast, and a series of questionnaires will be used to measure any changes in foot pain and foot function. The results from this study will be used to develop an information resource for both patients and Orthotists which will fill gaps in our current knowledge and hopefully guide us further in providing the best possible care for future patients who require insoles.Lay summary of study results:
Background: Foot orthoses produced using computer-aided-design and manufacturer (CAD/CAM) are commonly used to treat musculoskeletal conditions of the foot and ankle, however minimal evidence exists as to the most effective method used to capture the patients foot shape. This trial aimed to determine the effectiveness and cost of insoles manufactured from a direct scan of the foot compared with those manufactured from foam-box casts.
Methods: This double blinded clinical trial randomly assigned participants with lower limb musculoskeletal pathologies into two groups and provided them with custom CAM/CAM foot orthoses manufactured either from a direct scan of the participant’s feet (direct scan group) or from foam-box casts of their feet (foam-box cast group). 114 participants were recruited asked to wear their foot orthoses for 12-weeks. The Foot Health Status Questionnaire (FHSQ) was completed at baseline, 4, 8 and 12-weeks to evaluate the primary outcome measure of pain, as well as secondary outcomes for foot function, foot health and footwear, and the Orthotic and Prosthetic User Survey Client Satisfaction with Device module (OPUS-CSD) which was completed at 12-weeks. Adherence was measured using a daily wear-diary recorded over 12-weeks. The number of manual insole adaptations was also recorded, and staff time, material and transportation costs were evaluated.
Results: 112 participants completed the trial. Despite no significant differences between the groups, both groups reported significant improvements in pain, function and foot health from baseline to 4, 8 and 12-weeks, which all exceeded their respective minimum important differences. The direct scan group reported greater satisfaction at 12-weeks, greater adherence, and required less insole adaptations compared to the foam-box cast group. Overall costs and staff time costs were higher in the foam-box cast group.
Conclusions: CAD/CAM insoles are effective in reducing pain, and improving foot function and health after 4-weeks, and sustained at 12-weeks, however the method of shape capture does not affect these responses. Over 12-weeks participant satisfaction and adherence was greater when using the direct scan approach, which also required fewer manual insole adaptations. There was a greater overall cost associated with foam-box insoles. Clinicians are therefore recommended to use direct foot scanning over foam-box casting when prescribing CAD/CAM insoles for patients with MSK foot and ankle conditions.
Has the registry been updated to include summary results?: Yes
If yes - please enter the URL to summary results: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fclinicaltrials.gov%252Fstudy%252FNCT05444192%253Fterm%253DNCT05444192%2526rank%253D1%2FNBTI%2FqLe8AQ%2FAQ%2Fbe537405-1470-4c2f-9dd5-28d6ab82d200%2F2%2FjtK_CIvfMu&data=05%7C02%7Cstanmore.rec%40hra.nhs.uk%7Cdeabb8d2b2ef41cb504808dd7ceef41c%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638804087921442302%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=hlf%2FJgtnHLOfzWjLFT34NYe1GmYSA13YMqcY76weHwo%3D&reserved=0
If no – why not?:
Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Yes
If yes, describe or provide URLs to disseminated materials: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Flink.springer.com%252Farticle%252F10.1186%252Fs12891-025-08513-2%2FNBTI%2FqLe8AQ%2FAQ%2Fbe537405-1470-4c2f-9dd5-28d6ab82d200%2F3%2F9Rk3C_JYnR&data=05%7C02%7Cstanmore.rec%40hra.nhs.uk%7Cdeabb8d2b2ef41cb504808dd7ceef41c%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638804087921453999%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=I2TBhbNdabGgTJUFIymhnQ%2BDZ4M%2FjE1er2w0kLWDQXg%3D&reserved=0
If pending, date when dissemination is expected:
If no, explain why you didn't follow it:
Have participants been informed of the results of the study?: Yes
If yes, describe and/or provide URLs to materials shared and how they were shared: During enrolment participants were asked if they wished to receive the results of the trial once the trial was completed. Those who requested to see the results were contacted by phone once the trial was complete, and at their request a copy of the published results were either emailed or posted (https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Flink.springer.com%2Farticle%2F10.1186%2Fs12891-025-08513-2&data=05%7C02%7Cstanmore.rec%40hra.nhs.uk%7Cdeabb8d2b2ef41cb504808dd7ceef41c%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638804087921466869%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=ZQAfZ3sR%2FuQ7lWHSUYKV5KqF6zxE8YNgdbFrrAqO8pU%3D&reserved=0), and participants were also given the opportunity to discuss the results with the principle investigator.
If pending, date when feedback is expected:
If no, explain why they haven't:
Have you enabled sharing of study data with others?: Yes
If yes, describe or provide URLs to how it has been shared: In accordance with the data sharing policy associated with the final publication of the trial; study data can be requested from the corresponding author (chief investigator, Dr Chapman) upon reasonable request by email.
If no, explain why sharing hasn't been enabled:
Have you enabled sharing of tissue samples and associated data with others?: No
If yes, describe or provide a URL:
If no, explain why: No tissue samples were collected as part of this trial.REC name
London - Stanmore Research Ethics Committee
REC reference
22/LO/0579
Date of REC Opinion
7 Sep 2022
REC opinion
Favourable Opinion