| Pressure and Pain In Systemic Sclerosis/ Scleroderma |
 |
 |
 |
| Saturday, 18 February 2012 11:40 |
|
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 Role of Intravenous Immunoglobulin Preparations in the Treatment of Systemic Sclerosis
Marta Baleva and Krasimir NikolovReceived 12 June 2011; Revised 28 August 2011; Accepted 28 August 2011Scleroderma is progressive autoimmune disease associated with severe disability. The major underlying pathological process in scleroderma is...
» Targeted Therapy for Systemic Sclerosis: How Close are We?
Manuel Ramos-Casals; Vicent Fonollosa-Pla; Pilar Brito-Zerón; Antoni Sisó-AlmirallPosted: 09/14/2010; Nat Rev Rheumatol. 2010;6(5):269-278. © 2010 Nature Publishing GroupDespite recent etiopathogenetic advances, systemic sclerosis continues to be...
» Gene Linked to Autoimmune Diseases
Differences in the sequence of a single gene may be partly responsible for causing around 2% of relatively common autoimmune disorders including diabetes and arthritis.The gene codes for an enzyme called sialic acid acetylesterase (SIAE) that...
» Important Information On Flaxseed And Flaxseed Oil
Flaxseed, called linseed in some countries, is a good source of dietary fiber, , and . Each of these components may contribute to the health effects of eating flaxseed, but flaxseed oil contains no fiber and very little lignan. In addition to its...
» Enhanced Survival Found With Early Detection of Scleroderma-Associated PAH
Early detection of incident systemic sclerosis–associated enhanced survival in a prospective cohort study of 131 patients from the multicenter PHAROS, according to data presented at the annual meeting of the American College of Rheumatology.The...
» When Our Antibodies Turn On Us
More than 32 million Americans harbor potentially toxic proteins that can attack body tissues and lead to autoimmune diseases such as Lupus and , according to a new study. This is the first accurate estimate of the frequency of the proteins, called...