Orthotic Department, Gartnavel General Hospital, Glasgow, UK.
Allied Health Research unit, University of Central Lancashire, Preston, UK.
BMJ Open. 2024 Apr 2;14(4):e078240. doi: 10.1136/bmjopen-2023-078240.
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.
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 rates, and intervention adherence measured as the daily usage of the insoles over 12 weeks. The change in FHSQ scores for the subdomains and insole usage will be compared between the groups and time points, and between group differences in time in transit, cost-time analysis and environmental impact will be compared.
Ethical approval was obtained from the Health Research Authority, London Stanmore Research Ethics Committee (22/LO/0579). Study findings will be submitted for publication in peer-reviewed journals, conference presentations and webinars.
NCT05444192.
定制鞋垫是治疗许多足部疾病的常规方法，计算机辅助设计和计算机辅助制造（CAD/CAM）在英国的临床实践中得到了广泛应用。用于制作鞋垫的足形捕捉方法在矫形服务中各不相同。本试验旨在研究两种常见的形状捕捉技术对因足部或踝关节疾病需要鞋垫的患者的报告结果的有效性。
这项双盲随机对照试验将涉及从国家卫生服务矫形服务中招募的两个干预组。参与者将被随机分配接受一对定制的 CAD/CAM 鞋垫，这些鞋垫是通过直接数字扫描或他们脚部的泡沫盒铸型制造的，并要求他们佩戴鞋垫 12 周。主要结局测量指标将是足部健康状况问卷（FHSQ）疼痛子量表，在基线（干预后立即）、干预后 4、8 和 12 周记录。次要结局测量指标将包括基线、4、8 和 12 周时 FHSQ 足部功能和足部健康子量表的记录。矫形和假肢用户满意度调查（对设备的满意度）将在 12 周时记录。将测量与每个臂相关的过境时间，即从足形捕捉后每个鞋垫交付的天数。将比较子量表和鞋垫使用的 FHSQ 评分的变化，以及组间和时间点的差异，以及组间的过境时间、成本时间分析和环境影响的差异。
研究结果将提交给同行评议的期刊、会议演讲和网络研讨会发表。
NCT05444192。
