Division of Musculoskeletal Disease, Leeds Institute of Molecular Medicine, University of Leeds, Leeds, UK.
BMC Musculoskelet Disord. 2012 Feb 6;13:11. doi: 10.1186/1471-2474-13-11.
Foot problems associated with Systemic Sclerosis (SSc)/Scleroderma have been reported to be both common and disabling. There are only limited data describing specifically, the mechanical changes occurring in the foot in SSc. A pilot project conducted in preparation for this trial confirmed the previous reports of foot related impairment and reduced foot function in people with SSc and demonstrated a link to mechanical etiologies. To-date there have been no formal studies of interventions directed at the foot problems experienced by people with Systemic Sclerosis. The primary aim of this trial is to evaluate whether foot pain and foot-related health status in people with Systemic Sclerosis can be improved through the provision of a simple pressure-relieving insole.
The proposed trial is a pragmatic, multicenter, randomised controlled clinical trial following a completed pilot study. In four participating centres, 140 consenting patients with SSc and plantar foot pain will be randomised to receive either a commercially available pressure relieving and thermally insulating insole, or a sham insole with no cushioning or thermal properties. The primary end point is a reduction in pain measured using the Foot Function Index Pain subscale, 12 weeks after the start of intervention. Participants will complete the primary outcome measure (Foot Function Index pain sub-scale) prior to randomisation and at 12 weeks post randomisation. Secondary outcomes include participant reported pain and disability as derived from the Manchester Foot Pain and Disability Questionnaire and plantar pressures with and without the insoles in situ.
This trial protocol proposes a rigorous and potentially significant evaluation of a simple and readily provided therapeutic approach which, if effective, could be of a great benefit for this group of patients.
ISRCTN: ISRCTN02824122.
已有报道称，系统性硬化症（SSc）/硬皮病相关的足部问题既常见又致残。目前仅有有限的数据专门描述 SSc 患者足部发生的机械变化。在开展本试验之前进行的一项试点项目证实了先前关于 SSc 患者足部相关损伤和足部功能下降的报告，并证明了这些损伤与机械病因之间存在关联。迄今为止，尚无针对系统性硬化症患者所经历的足部问题的干预措施进行的正式研究。本试验的主要目的是评估通过提供简单的减压鞋垫是否可以改善系统性硬化症患者的足部疼痛和足部相关健康状况。
本拟议试验是一项实用性、多中心、随机对照临床试验，其基于一项已完成的试点研究。在四个参与中心，将 140 名同意参与的 SSc 合并足底疼痛患者随机分配接受市售减压和隔热鞋垫或无缓冲或热性能的假鞋垫。主要终点是在干预开始后 12 周，使用足部功能指数疼痛子量表评估疼痛减轻程度。参与者将在随机分组前和随机分组后 12 周完成主要结局测量（足部功能指数疼痛子量表）。次要结局包括源自曼彻斯特足部疼痛和残疾问卷的患者报告的疼痛和残疾，以及有无鞋垫时的足底压力。
本试验方案提出了对一种简单且易于提供的治疗方法的严格且潜在重要的评估，如果有效，这种方法可能会使这组患者极大受益。
ISRCTN: ISRCTN02824122。
