Abstract
BackgroundFoot 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.MethodsThe 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.DiscussionThis 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.Trial registration numberISRCTN: ISRCTN02824122
Highlights
Foot problems associated with Systemic Sclerosis (SSc)/Scleroderma have been reported to be both common and disabling
Systemic sclerosis (SSc)/Scleroderma is a connective tissue disease characterised by excessive collagen production resulting in microvascular and macrovascular damage, fibrosis of the skin and internal organs [1,2,3]
Foot problems associated with SSc include: Raynaud’s phenomenon, which sometimes can progress to tissue loss/ulceration, subcutaneous calcinosis, skin thickening, callus formation, tendonopathy, foot ulcers, joint space narrowing, bone demineralization, joint subluxation, joint margin erosions and degenerative changes [7,8,9]
Summary
Trial objectives Primary objective To compare foot pain in participants using a commercially available pressure-relieving insole, to those using the sham insole (control), 12 weeks after randomisation. The key staff at site involved with the trial will remain blinded to the intervention allocation during the study This will be achieved by having different teams of therapists responsible for randomising participants to those responsible for administering the assessment questionnaires. Exploratory measures of foot plantar pressures will be carried out at baseline (after randomisation and insole allocation) on consenting participants at the Leeds centre only. The EMED platform will allow analysis of a range of pressure, force, area and temporal variables at high resolution (4 sensors/ cm2) This will enable a detailed model of the interaction of the participants’ foot with the supporting surface to be developed which will inform our characterisation of the baseline effects of the disease. Objective gait analysis All analyses will be according to intention to treat; no interim analyses are planned due to the short follow-up period and the safe nature of the intervention
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