FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W2333078312> ?p ?o ?g. }

• W2333078312 endingPage "A505" @default.
• W2333078312 startingPage "A505.1" @default.
• W2333078312 abstract "<h3>Background</h3> Foot problems associated with systemic sclerosis (SSc; scleroderma) are common and disabling. To-date there have been no formal studies of interventions directed at the foot problems experienced in people with SSc. <h3>Objectives</h3> The main objective of this randomized controlled trial was to evaluate whether foot pain in SSc can be improved through the routine provision of a simple pressure-relieving and insulating insole. <h3>Methods</h3> A multicentre RCT conducted in four UK participating centres. A total of 141 consenting patients with confirmed SSc (ARA/ACR 1980 criteria) and plantar foot pain were randomised to receive either a commercially available pressure-relieving thermally insulating insole (Prothotic™ Duoform, RRP £8.55) or a sham insole identical in appearance to the active intervention but with minimal cushioning or thermal properties. Randomisation on a 1:1 basis was performed centrally using a 24-hour, automated randomisation system at a UKCRC registered clinical trials research unit. The primary end point was a reduction in pain measured using the 100mm pain subscale of the Foot Function Index, after 12 weeks of intervention. Sample size was determined <i>a priori</i> on a requirement to detect a 15mm difference (SD 25.7, alpha =0.05 and power =90%). In a subset of 49 patients at the lead centre (Leeds), plantar pressure measures (maximum mean pressure at heel and forefoot, with and without insoles in situ) were also obtained for entry into an exploratory analysis. <h3>Results</h3> Analysis of baseline characteristics indicated excellent comparability between the active intervention and sham group for centre, gender, age, SSc subset and Rodnan skin score. One hundred and thirty patients provided valid data for the primary endpoint. In both groups there was a systematic improvement in FFI pain subscale scores from baseline to 12 weeks (Active group -13.1mm, 95%CI -18.66 to-7.55 ; Sham group -10.7, 95%CI -16.17 to -5.28). An ANCOVA model adjusting for centre, gender and baseline FFI score confirmed no difference in effect between the intervention and sham groups (difference=-2.4, 95%CI -7.70 to 2.94, p=0.3778). Compared to a shoe-only baseline measure, pressure was lowered in the heel region by use of the active insole (median difference (range) -24kPa (-75,22)) compared to the sham -4.6kPa ((-23,10), (p<0.01)), but in the forefoot the difference between insole types was not significant; pressure change -17.2 kPa (-61,19) for active insoles and -10.8kPa (-39,0) for sham insoles (p=0.31). <h3>Conclusions</h3> The study compared a simple therapeutic insole with a sham device and found that over 12 weeks both produced a clinically worthwhile improvement in patient reported foot pain but with no difference between intervention arms. The active device produced a significantly greater reduction in pressure than the sham at the heel although not at the forefoot. This exploratory analysis suggests therefore, that despite careful selection the sham device introduced some unintended physical effect. The difficulty with employing a true sham as a control in physical intervention trials such as this may suggest the need for a zero intervention arm for similar studies in future. <h3>Acknowledgements</h3> Funding: Arthritis Research UK Clinical Studies Group for Autoimmune Rheumatic Diseases (award number 18826). Trial regn. ISRCTN 02824122 Our thanks to all TSC and TMG contributors and to the clinical staff at each site. <b>Disclosure of Interest</b>: None Declared" @default.
• W2333078312 created "2016-06-24" @default.
• W2333078312 creator A5008098676 @default.
• W2333078312 creator A5018678002 @default.
• W2333078312 creator A5022272906 @default.
• W2333078312 creator A5030655955 @default.
• W2333078312 creator A5034935738 @default.
• W2333078312 creator A5049574404 @default.
• W2333078312 creator A5051239558 @default.
• W2333078312 creator A5056447660 @default.
• W2333078312 creator A5062129045 @default.
• W2333078312 creator A5063415724 @default.
• W2333078312 creator A5067582147 @default.
• W2333078312 creator A5069451301 @default.
• W2333078312 creator A5078264006 @default.
• W2333078312 creator A5080866168 @default.
• W2333078312 date "2013-06-01" @default.
• W2333078312 modified "2023-09-23" @default.
• W2333078312 title "FRI0390 Effects of pressure relieving insoles for foot problems in people with ssc: the pisces randomized controlled trial" @default.
• W2333078312 doi "https://doi.org/10.1136/annrheumdis-2013-eular.1517" @default.
• W2333078312 hasPublicationYear "2013" @default.
• W2333078312 type Work @default.
• W2333078312 sameAs 2333078312 @default.
• W2333078312 citedByCount "1" @default.
• W2333078312 countsByYear W23330783122020 @default.
• W2333078312 crossrefType "journal-article" @default.
• W2333078312 hasAuthorship W2333078312A5008098676 @default.
• W2333078312 hasAuthorship W2333078312A5018678002 @default.
• W2333078312 hasAuthorship W2333078312A5022272906 @default.
• W2333078312 hasAuthorship W2333078312A5030655955 @default.
• W2333078312 hasAuthorship W2333078312A5034935738 @default.
• W2333078312 hasAuthorship W2333078312A5049574404 @default.
• W2333078312 hasAuthorship W2333078312A5051239558 @default.
• W2333078312 hasAuthorship W2333078312A5056447660 @default.
• W2333078312 hasAuthorship W2333078312A5062129045 @default.
• W2333078312 hasAuthorship W2333078312A5063415724 @default.
• W2333078312 hasAuthorship W2333078312A5067582147 @default.
• W2333078312 hasAuthorship W2333078312A5069451301 @default.
• W2333078312 hasAuthorship W2333078312A5078264006 @default.
• W2333078312 hasAuthorship W2333078312A5080866168 @default.
• W2333078312 hasConcept C105702510 @default.
• W2333078312 hasConcept C115076146 @default.
• W2333078312 hasConcept C138885662 @default.
• W2333078312 hasConcept C141071460 @default.
• W2333078312 hasConcept C168563851 @default.
• W2333078312 hasConcept C1862650 @default.
• W2333078312 hasConcept C2776577363 @default.
• W2333078312 hasConcept C2777248721 @default.
• W2333078312 hasConcept C2908657372 @default.
• W2333078312 hasConcept C41895202 @default.
• W2333078312 hasConcept C71924100 @default.
• W2333078312 hasConcept C81182388 @default.
• W2333078312 hasConcept C99508421 @default.
• W2333078312 hasConceptScore W2333078312C105702510 @default.
• W2333078312 hasConceptScore W2333078312C115076146 @default.
• W2333078312 hasConceptScore W2333078312C138885662 @default.
• W2333078312 hasConceptScore W2333078312C141071460 @default.
• W2333078312 hasConceptScore W2333078312C168563851 @default.
• W2333078312 hasConceptScore W2333078312C1862650 @default.
• W2333078312 hasConceptScore W2333078312C2776577363 @default.
• W2333078312 hasConceptScore W2333078312C2777248721 @default.
• W2333078312 hasConceptScore W2333078312C2908657372 @default.
• W2333078312 hasConceptScore W2333078312C41895202 @default.
• W2333078312 hasConceptScore W2333078312C71924100 @default.
• W2333078312 hasConceptScore W2333078312C81182388 @default.
• W2333078312 hasConceptScore W2333078312C99508421 @default.
• W2333078312 hasIssue "Suppl 3" @default.
• W2333078312 hasLocation W23330783121 @default.
• W2333078312 hasOpenAccess W2333078312 @default.
• W2333078312 hasPrimaryLocation W23330783121 @default.
• W2333078312 hasRelatedWork W1975870596 @default.
• W2333078312 hasRelatedWork W2017672556 @default.
• W2333078312 hasRelatedWork W2100846818 @default.
• W2333078312 hasRelatedWork W2121487937 @default.
• W2333078312 hasRelatedWork W2149526519 @default.
• W2333078312 hasRelatedWork W2318460547 @default.
• W2333078312 hasRelatedWork W2325603378 @default.
• W2333078312 hasRelatedWork W2328161899 @default.
• W2333078312 hasRelatedWork W2333078312 @default.
• W2333078312 hasRelatedWork W3217252303 @default.
• W2333078312 hasVolume "72" @default.
• W2333078312 isParatext "false" @default.
• W2333078312 isRetracted "false" @default.
• W2333078312 magId "2333078312" @default.
• W2333078312 workType "article" @default.