Pressure and Pain In Systemic Sclerosis/ Scleroderma PDF Print E-mail
Saturday, 18 February 2012 12:10
Begonya Alcacer-Pitarch, Maya H Buch, Janine Gray, Christopher P Denton, Ariane Herrick, Nuria Navarro-Coy, Howard Collier, Lorraine Loughrey, Sue Pavitt, Heidi J Siddle, Jonathan Wright, Philip S Helliwell, Paul Emery, Anthony C Redmond
Study protocol, Submitted 14 December 2011, Accepted 6 February 2012, Published 6 February 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 footrelated 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.

Continue reading the full study protocol, by downloading it from the link provided below.

 
More articles :

» The Clinical Relevance of Autoantibodies in Scleroderma

Khanh T Ho and John D ReveillePublished: 12 February 2003Arthritis Res Ther 2003, 5:80-93 (DOI 10.1186/ar628)© 2003 BioMed Central Ltd (Print ISSN 1478-6354; Online ISSN 1478-6362)Scleroderma (systemic sclerosis) is associated with several...

» Autoimmune Disease Symptoms To Look Out For

We have understood for  a long time that the detection and subsequent diagnoses of autoimmune diseases are difficult. However, there are key rheumatic and physical indicators such as joint pain and fatigue, fevers, increasing skin conditions,...

» Leeds Study Could Help Treat Potentially Fatal Condition

A trial of special insoles is being masterminded by Leeds-based researchers to see if they can help sufferers of a potentially fatal tissue disorder. Patients with , a rare but serious connective disorder which leads to the thickening of body...

» B-Cell Depletion Therapy in Systemic Sclerosis: Experimental Rationale and Update on Clinical Evidence

Dimitrios Daoussis, Stamatis-Nick C. Liossis, Georgios Yiannopoulos, and Andrew P. AndonopoulosDivision of Rheumatology, Department of Internal Medicine, Patras University Hospital, University of Patras Medical School, Rion, 26504 Patras,...

» Orphan Drug Status Granted For Revimmune In Treatment of Systemic Sclerosis

, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to RevimmuneTM, the company's proprietary system-of-care based on high-dose administration of Cytoxan(R) (), for the treatment of two...

» arGentis Continues To Expand

But arGentis grew its drug-development pipeline this month with the acquisition of the rights to a rheumatoid arthritis therapy from the - the terms of which, were not disclosed. The treatment was developed at the University of Tennessee Health...