Pressure and pain In Systemic sclerosis/Scleroderma - an evaluation of a simple intervention (PISCES): randomised controlled trial protocol

BMC Musculoskeletal Disorders

Anthony C Redmond³  Paul Emery³  Philip S Helliwell²  Jonathan Wright¹  Heidi J Siddle²  Sue Pavitt⁴  Lorraine Loughrey²  Howard Collier¹  Nuria Navarro-Coy¹  Ariane Herrick⁶  Christopher P Denton⁵  Janine Gray¹  Maya H Buch²  Begonya Alcacer-Pitarch² 

[1] Clinical Trials Research Unit, Leeds Institute of Molecular Medicine, University of Leeds, Leeds, UK;Division of Musculoskeletal Disease, Leeds Institute of Molecular Medicine, University of Leeds, Leeds, UK;Leeds NIHR Musculoskeletal Biomedical Research Unit, Leeds, UK;Leeds Institute of Health Sciences, University of Leeds, Leeds, UK;Centre for Rheumatology, Hampstead Campus University College London, London, UK;University of Manchester Rheumatic Diseases Centre, Salford Royal Hospitals NHS Trust, Salford, UK

关键词: Insoles;    Systemic sclerosis;    Scleroderma;    Plantar pressures;    Foot pain;   

Others  :  1150717
DOI  :  10.1186/1471-2474-13-11

 received in 2011-12-14, accepted in 2012-02-06,  发布年份 2012

【 摘 要 】

Background

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.

Methods

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.

Discussion

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.

Trial registration number

ISRCTN: ISRCTN02824122

【 授权许可】

   
2012 Alcacer-Pitarch et al; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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