title: Debridement of painful forefoot plantar callosities in rheumatoid arthritis: the CARROT randomised controlled trial.
abstract: The objective of this study was to evaluate the long-term benefits of sharp scalpel debridement of painful forefoot plantar callosities in rheumatoid arthritis (RA). The null hypothesis: sharp scalpel debridement would offer no additional long-term advantage in terms of pain and function. Sixty-five people with RA were randomised to receive regular sharp scalpel debridement of painful forefoot plantar callosities in conjunction with a combined therapeutic approach or a combined therapeutic approach alone. The primary outcome measure was change at 18 months in participant-reported forefoot plantar pain measured by a 100-mm visual analogue scale (VAS). Secondary outcome measures were recorded at baseline and study exit and included revised Foot Function Index, Health Assessment Questionnaire, Foot Impact Scale and gait parameters. At 18 months, there were no differences between groups for the primary outcome VAS-measured forefoot plantar pain (left foot (F = 0.23, p = 0.635), right foot (F = 2.14, p = 0.148)). Within-group changes were highly significant (treatment arm, difference = 16.9 (95 % confidence interval (CI) 9.4, 24.4), t = 4.6, p < 0.0001; control arm, difference = 17.5 (95 % CI 9.4, 25.5), t = 4.4, p < 0.0001). There was little change in scores of overall function and foot impact in either group and there were no significant changes in gait parameters noted. The long-term effects of sharp scalpel debridement of painful forefoot plantar callosities in people with RA, when used in conjunction with a combined therapeutic approach, produced no additional benefit over the combined therapeutic approach alone. Trial registration http://www.controlled-trials.com/ISRCTN05190231.
authors.affiliation: Division of Rheumatic and Musculoskeletal Disease, University of Leeds, Chapel Allerton Hospital, Chapeltown Road, Leeds LS7 4SA, UK. h.siddle@leeds.ac.uk
authors.forename: Heidi J
authors.initials: HJ
authors.lastname: Siddle
authors.forename: Anthony C
authors.initials: AC
authors.lastname: Redmond
authors.forename: Robin
authors.initials: R
authors.lastname: Waxman
authors.forename: Abigail R
authors.initials: AR
authors.lastname: Dagg
authors.forename: Begonya
authors.initials: B
authors.lastname: Alcacer-Pitarch
authors.forename: Richard A
authors.initials: RA
authors.lastname: Wilkins
authors.forename: Philip S
authors.initials: PS
authors.lastname: Helliwell
mesh_terms: D001172:Arthritis, Rheumatoid / Q000150:complications*; D002145:Callosities / Q000150:complications* / Q000601:surgery*; D003646:Debridement; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain; D010147:Pain Measurement; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome