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Logo of bmcmudisBioMed Centralsearchsubmit a manuscriptregisterthis articleBMC Musculoskeletal Disorders
BMC Musculoskelet Disord. 2012; 13: 11.
Published online Feb 6, 2012. doi:  10.1186/1471-2474-13-11
PMCID: PMC3395828
Pressure and pain In Systemic sclerosis/Scleroderma - an evaluation of a simple intervention (PISCES): randomised controlled trial protocol
Begonya Alcacer-Pitarch,corresponding author#1 Maya H Buch,#1 Janine Gray,#2 Christopher P Denton,#3 Ariane Herrick,#4 Nuria Navarro-Coy,#2 Howard Collier,#2 Lorraine Loughrey,#1 Sue Pavitt,#5 Heidi J Siddle,#1 Jonathan Wright,#2 Philip S Helliwell,#1 Paul Emery,#1,6 and Anthony C Redmond#1,6
1Division of Musculoskeletal Disease, Leeds Institute of Molecular Medicine, University of Leeds, Leeds, UK
2Clinical Trials Research Unit, Leeds Institute of Molecular Medicine, University of Leeds, Leeds, UK
3Centre for Rheumatology, Hampstead Campus University College London, London, UK
4University of Manchester Rheumatic Diseases Centre, Salford Royal Hospitals NHS Trust, Salford, UK
5Leeds Institute of Health Sciences, University of Leeds, Leeds, UK
6Leeds NIHR Musculoskeletal Biomedical Research Unit, Leeds, UK
corresponding authorCorresponding author.
#Contributed equally.
Begonya Alcacer-Pitarch: B.Alcacer-Pitarch/at/; Maya H Buch: M.Buch/at/; Janine Gray: J.C.Gray/at/; Christopher P Denton: cdenton/at/; Ariane Herrick: Ariane.herrick/at/; Nuria Navarro-Coy: N.Navarro-Coy/at/; Howard Collier: H.A.Collier/at/; Lorraine Loughrey: L.R.Loughrey/at/; Sue Pavitt: S.Pavitt/at/; Heidi J Siddle: H.Siddle/at/; Jonathan Wright: J.Wright/at/; Philip S Helliwell: P.Helliwell/at/; Paul Emery: P.Emery/at/; Anthony C Redmond: A.Redmond/at/
Received December 14, 2011; Accepted February 6, 2012.
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.
Trial registration number
Keywords: Foot pain, Plantar pressures, Scleroderma, Systemic sclerosis, Insoles
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