Comparing the effectiveness of computer-aided design/computer-aided manufacturing (CAD/CAM) of insoles manufactured from foam box cast versus direct scans on patient-reported outcome measures: a protocol for a double-blinded, randomised controlled trial

Introduction Custom insoles are a routine treatment for many foot pathologies, and the use of computer-aided design and computer-aided manufacturing (CAD/CAM) is well established within clinical practice in the UK. The method of foot shape capture used to produce insoles varies throughout orthotic services. This trial aims to investigate the effectiveness of two common shape-capture techniques on patient-reported outcomes in people who require insoles for a foot or ankle pathology. Methods and analysis This double-blinded randomised controlled trial will involve two intervention groups recruited from a National Health Service orthotic service. Participants will be randomly assigned to receive a pair of custom CAD/CAM insoles, manufactured either from a direct digital scan or a foam box cast of their feet and asked to wear the insoles for 12 weeks. The primary outcome measure will be the Foot Health Status Questionnaire (FHSQ) pain subdomain, recorded at baseline (immediately after receiving the intervention), 4, 8 and 12 weeks post intervention. Secondary outcome measures will include FHSQ foot function and foot health subdomains recorded at baseline, 4, 8 and 12 weeks. The Orthotic and Prosthetic User Survey Satisfaction with Device will be recorded at 12 weeks. The transit times associated with each arm will be measured as the number of days for each insole to be delivered after foot shape capture. Tertiary outcome measures will include participant recruitment and dropout ...
Source: BMJ Open - Category: General Medicine Authors: Tags: Open access, Evidence based practice Source Type: research