Advertisement

Clinical Rheumatology

, Volume 32, Issue 5, pp 567–574 | Cite as

Debridement of painful forefoot plantar callosities in rheumatoid arthritis: the CARROT randomised controlled trial

  • Heidi J. Siddle
  • Anthony C. Redmond
  • Robin Waxman
  • Abigail R. Dagg
  • Begonya Alcacer-Pitarch
  • Richard A. Wilkins
  • Philip S. Helliwell
Original Article

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

Keywords

Callus debridement Forefoot pain Metatarsophalangeal joint Plantar callosities Rheumatoid arthritis 

Notes

Acknowledgements

The authors would like to thank Daniel Broadley for assisting with data collection. This paper presents independent research commissioned by the National Institute for Health Research (NIHR) under its Research for Patient Benefit Programme (grant reference number PB-PG-0706-10143). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.

Conflict of interest

HJS, ACR, ARD and PSH have had financial support from the NIHR funding scheme for the submitted work. All authors have no other relationships or activities that could appear to have influenced the submitted work.

References

  1. 1.
    Grondal L, Tengstrand B, Nordmark B, Wretenberg P, Stark A (2008) The foot: still the most important reason for walking incapacity in rheumatoid arthritis: distribution of symptomatic joints in 1,000 RA patients. Acta Orthop 79(2):257–61PubMedCrossRefGoogle Scholar
  2. 2.
    van der Leeden M, Steultjens MP, van Schaardenburg D, Dekker J (2010) Forefoot disease activity in rheumatoid arthritis patients in remission: results of a cohort study. Arthritis Res Ther 12(1):R3PubMedCrossRefGoogle Scholar
  3. 3.
    van der Leeden M, Steultjens M, Dekker JH, Prins AP, Dekker J (2006) Forefoot joint damage, pain and disability in rheumatoid arthritis patients with foot complaints: the role of plantar pressure and gait characteristics. Rheumatology (Oxford) 45(4):465–9CrossRefGoogle Scholar
  4. 4.
    Singh D, Bentley G, Trevino SG (1996) Callosities, corns, and calluses. BMJ 312(7043):1403–6PubMedGoogle Scholar
  5. 5.
    Woodburn J, Helliwell PS (1996) Relation between heel position and the distribution of forefoot plantar pressures and skin callosities in rheumatoid arthritis. Ann Rheum Dis 55(11):806–10PubMedCrossRefGoogle Scholar
  6. 6.
    Redmond A, Allen N, Vernon W (1999) Effect of scalpel debridement on the pain associated with plantar hyperkeratosis. J Am Podiatr Med Assoc 89(10):515–9PubMedGoogle Scholar
  7. 7.
    Balanowski KR, Flynn LM (2005) Effect of painful keratoses debridement on foot pain, balance and function in older adults. Gait Posture 22(4):302–7PubMedCrossRefGoogle Scholar
  8. 8.
    Farndon L, Barnes A, Littlewood K, Harle J, Beecroft C, Burnside J, Wheeler T, Morris S, Walters SJ (2009) Clinical audit of core podiatry treatment in the NHS. J Foot Ankle Res 2:7PubMedCrossRefGoogle Scholar
  9. 9.
    Landorf, KB, Morrow, A, Spink, MJ, Nash, CL, Novak, A, Bird, AR, Potter, J, and Menz, HB (2011). Effectiveness of scalpel debridement for painful plantar calluses in older people: a randomised trial. J Foot Ankle Res 4(Suppl 1): O23. Australasian Podiatry Council Conference, Melbourne, AustraliaGoogle Scholar
  10. 10.
    Young MJ, Cavanagh PR, Thomas G, Johnson MM, Murray H, Boulton AJ (1992) The effect of callus removal on dynamic plantar foot pressures in diabetic patients. Diabet Med 9(1):55–7PubMedCrossRefGoogle Scholar
  11. 11.
    Murray HJ, Young MJ, Hollis S, Boulton AJ (1996) The association between callus formation, high pressures and neuropathy in diabetic foot ulceration. Diabet Med 13(11):979–82PubMedCrossRefGoogle Scholar
  12. 12.
    Woodburn J, Stableford Z, Helliwell PS (2000) Preliminary investigation of debridement of plantar callosities in rheumatoid arthritis. Rheumatology 39(6):652–4PubMedCrossRefGoogle Scholar
  13. 13.
    Davys HJ, Turner DE, Helliwell PS, Conaghan PG, Emery P, Woodburn J (2005) Debridement of plantar callosities in rheumatoid arthritis: a randomized controlled trial. Rheumatology 44(2):207–10PubMedCrossRefGoogle Scholar
  14. 14.
    National Institute for Health and Clinical Excellence (NICE) (2009) Rheumatoid arthritis. The management of rheumatoid arthritis in adults. Royal College of Physicians, London, NICE clinical guideline 79Google Scholar
  15. 15.
    Medical Research Council (MRC). A framework for development and evaluation of RCTs for complex interventions to improve health. 2000, MRC Health Services and Public Health Research Board.Google Scholar
  16. 16.
    Arnett FC, Edworthy SM, Bloch DA, McShane DJ, Fries JF, Cooper NS, Healey LA, Kaplan SR, Liang MH, Luthra HS et al (1988) The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum 31(3):315–24PubMedCrossRefGoogle Scholar
  17. 17.
    Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D (2008) Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ 337:a2390PubMedCrossRefGoogle Scholar
  18. 18.
    Budiman-Mak E, Conrad K, Stuck R, Matters M (2006) Theoretical model and rasch analysis to develop a revised foot function index. Foot Ankle Int 27(7):519–27PubMedGoogle Scholar
  19. 19.
    Kirwan JR, Reeback JS (1986) Stanford health assessment questionnaire modified to assess disability in British patients with rheumatoid arthritis. Br J Rheumatol 25:206–209PubMedCrossRefGoogle Scholar
  20. 20.
    Helliwell P, Reay N, Gilworth G, Redmond A, Slade A, Tennant A, Woodburn J (2005) Development of a foot impact scale for rheumatoid arthritis. Arthritis Rheum 53(3):418–22PubMedCrossRefGoogle Scholar
  21. 21.
    Platto MJ, O'Connell PG, Hicks JE, Gerber LH (1991) The relationship of pain and deformity of the rheumatoid foot to gait and an index of functional ambulation. J Rheumatol 18(1):38–43PubMedGoogle Scholar
  22. 22.
    Cutlip RG, Mancinelli C, Huber F, DiPasquale J (2000) Evaluation of an instrumented walkway for measurement of the kinematic parameters of gait. Gait Posture 12(2):134–8PubMedCrossRefGoogle Scholar
  23. 23.
    McDonough AL, Batavia M, Chen FC, Kwon S, Ziai J (2001) The validity and reliability of the GAITRite system’s measurements: a preliminary evaluation. Arch Phys Med Rehabil 82(3):419–25PubMedCrossRefGoogle Scholar
  24. 24.
    Keenan MA, Peabody TD, Gronley JK, Perry J (1991) Valgus deformities of the feet and characteristics of gait in patients who have rheumatoid arthritis. J Bone Joint Surg Am 73(2):237–47PubMedGoogle Scholar
  25. 25.
    Turner DE, Woodburn J, Helliwell PS, Cornwall MW, Emery P (2003) Pes planovalgus in RA: a descriptive and analytical study of foot function determined by gait analysis. Musculoskeletal Care 1(1):21–33PubMedCrossRefGoogle Scholar
  26. 26.
    Kelly AM (2001) The minimum clinically significant difference in visual analogue scale pain score does not differ with severity of pain. Emerg Med J 18(3):205–7PubMedCrossRefGoogle Scholar
  27. 27.
    Gallagher EJ, Liebman M, Bijur PE (2001) Prospective validation of clinically important changes in pain severity measured on a visual analog scale. Ann Emerg Med 38(6):633–8PubMedCrossRefGoogle Scholar
  28. 28.
    Lee JS, Hobden E, Stiell IG, Wells GA (2003) Clinically important change in the visual analog scale after adequate pain control. Acad Emerg Med 10(10):1128–30PubMedCrossRefGoogle Scholar
  29. 29.
    Dixon WG, Watson K, Lunt M, Hyrich KL, Silman AJ, Symmons DP (2006) Rates of serious infection, including site-specific and bacterial intracellular infection, in rheumatoid arthritis patients receiving anti-tumor necrosis factor therapy: results from the British Society for Rheumatology Biologics Register. Arthritis Rheum 54(8):2368–76PubMedCrossRefGoogle Scholar
  30. 30.
    Tuna H, Birtane M, Tastekin N, Kokino S (2005) Pedobarography and its relation to radiologic erosion scores in rheumatoid arthritis. Rheumatol Int 26(1):42–7PubMedCrossRefGoogle Scholar
  31. 31.
    Redmond AC, Waxman R, Helliwell PS (2006) Provision of foot health services in rheumatology in the UK. Rheumatology 45(5):571–6PubMedCrossRefGoogle Scholar
  32. 32.
    Woodburn J, Barker S, Helliwell PS (2002) A randomized controlled trial of foot orthoses in rheumatoid arthritis. J Rheumatol 29(7):1377–83PubMedGoogle Scholar
  33. 33.
    Firth J, Hale C, Helliwell P, Hill J, Nelson EA (2008) The prevalence of foot ulceration in patients with rheumatoid arthritis. Arthritis Rheum 59(2):200–5PubMedCrossRefGoogle Scholar

Copyright information

© Clinical Rheumatology 2012

Authors and Affiliations

  • Heidi J. Siddle
    • 1
  • Anthony C. Redmond
    • 1
    • 2
  • Robin Waxman
    • 1
  • Abigail R. Dagg
    • 3
  • Begonya Alcacer-Pitarch
    • 1
  • Richard A. Wilkins
    • 1
  • Philip S. Helliwell
    • 1
  1. 1.Division of Rheumatic and Musculoskeletal DiseaseUniversity of LeedsLeedsUK
  2. 2.NIHR Leeds Musculoskeletal Biomedical Research UnitLeeds Teaching Hospitals NHS TrustLeedsUK
  3. 3.Podiatry DepartmentMid Yorkshire Hospitals NHS TrustWest YorkshireUK

Personalised recommendations