Effectiveness of custom-made foot orthoses in patients with systemic lupus erythaematosus: protocol for a randomised controlled trial

María Reina-Bueno, María Del Carmen Vázquez-Bautista, Inmaculada C Palomo-Toucedo, Gabriel Domínguez-Maldonado, José Manuel Castillo-López, Javier Ramos-Ortega, Pedro V Munuera-Martínez, María Reina-Bueno, María Del Carmen Vázquez-Bautista, Inmaculada C Palomo-Toucedo, Gabriel Domínguez-Maldonado, José Manuel Castillo-López, Javier Ramos-Ortega, Pedro V Munuera-Martínez

Abstract

Introduction: Systemic lupus erythaematosus (SLE) is a chronic autoimmune disease of heterogeneous involvement. The disease may affect feet with a high prevalence of symptoms such as, for example, pain, forefoot and rearfoot deformities, and biomechanics dysfunctions. Custom-made foot orthoses (CMFO) have been previously reported to be effective in patients with other rheumatic diseases. However, as far as the authors know, there exist no studies about their effectiveness in SLE. This study aims at determining the effect of CMFO versus placebo flat cushioning insoles on pain, foot functionality, fatigue and quality of life in patients with SLE.

Methods and analysis: A randomised controlled trial would compare the effects of (1) CMFO and group B, which received a placebo, flat cushioning insoles, for 3 months. The main outcome measures are foot pain, foot functionality and foot-related disability. The secondary outcome measures are fatigue and quality of life.

Ethics and dissemination: The study has been approved by the Portal de Ética de la Investigación Biomédica de Andalucía ethical committee 1494-N-19. The results will be disseminated regardless of the magnitude or direction of effect.

Trial registartion number: Clinicaltrials.gov identifier NCT04098055.

Keywords: foot & ankle; musculoskeletal disorders; pain management; rheumatology.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Consolidated Standards of Reporting Trials flow diagram outlining the flow of participants through the trial.
Figure 2
Figure 2
Clinical measurements emplacement: primary outcomes measures. FFI, Foot Function Index; MFPDI, Manchester Foot Pain and Disability Index.
Figure 3
Figure 3
Clinical measurements emplacement: secondary outcomes measures. FFS, Fatigue Severity Scale.

References

    1. Sociedad Española de Reumatología . Manual de Enfermedades reumáticas Ser, 2014. Available:
    1. López-longo FJ, Calvo-Alén J. Registro nacional de pacientes Con lupus eritematoso sistémico de la Sociedad Española. Reum Clin 2014;10:17–24.
    1. Pipili C, Sfritzeri A, Cholongitas E. Deforming arthropathy in systemic lupus erythematosus. Eur J Intern Med 2008;19:482–7.10.1016/j.ejim.2008.01.017
    1. Morales-Lozano R, Martínez-Barrio J, González-Fernández ML, et al. . The feet in systemic lupus erythematosus; are we underestimating their involvement and functional impact? Clin Exp Rheumatol 2016;34:609–17.
    1. Alves EM, Macieira JC, Borba E, et al. . Spontaneous tendon rupture in systemic lupus erythematosus: association with Jaccoud's arthropathy. Lupus 2010;19:247–54.10.1177/0961203309351729
    1. López Longo FJ. Artropatía de Jaccoud: Algo más que lupus. Semin la Fund Esp Reumatol 2011;12:36–41.
    1. Cherry L, Alcacer-Pitarch B, Hopkinson N, et al. . The prevalence of self-reported lower limb and foot health problems experienced by participants with systemic lupus erythematosus: results of a UK national survey. Lupus 2017;26:410–6.10.1177/0961203316670730
    1. Otter SJ, Kumar S, Gow P, et al. . Patterns of foot complaints in systemic lupus erythematosus: a cross sectional survey. J Foot Ankle Res 2016;9:4–11.10.1186/s13047-016-0143-8
    1. Mukherjee S, Cherry L, Zarroug J, et al. . A pilot investigation of the prevalence of US-detectable forefoot joint pathology and reported foot-related disability in participants with systemic lupus erythematosus. J Foot Ankle Res 2016;9:1–6.10.1186/s13047-016-0158-1
    1. Reina-Bueno M, Vázquez-Bautista MDC, Pérez-García S, et al. . Effectiveness of custom-made foot orthoses in patients with rheumatoid arthritis: a randomized controlled trial. Clin Rehabil 2019;33:661–9.10.1177/0269215518819118
    1. Rome K, Clark H, Gray J, et al. . Clinical effectiveness and cost-effectiveness of foot orthoses for people with established rheumatoid arthritis: an exploratory clinical trial. Scand J Rheumatol 2017;46:187–93.10.1080/03009742.2016.1196500
    1. Castro-Méndez A, Munuera PV, Albornoz-Cabello M. The short-term effect of custom-made foot orthoses in subjects with excessive foot pronation and lower back pain: a randomized, double-blinded, clinical trial. Prosthet Orthot Int 2013;37:384–90.10.1177/0309364612471370
    1. Helliwell P, Woodburn J, Redmond A. The foot and ankle in rheumatoid arthritis. Edinburgh: Elsevier Ltd, 2007.
    1. Davys HJ, Turner DE, Helliwell PS, et al. . Debridement of plantar callosities in rheumatoid arthritis: a randomized controlled trial. Rheumatology 2005;44:207–10.10.1093/rheumatology/keh435
    1. Gibson KS, Woodburn J, Porter D, et al. . Functionally optimized orthoses for early rheumatoid arthritis foot disease: a study of mechanisms and patient experience. Arthritis Care Res 2014;66:1456–64.10.1002/acr.22060
    1. Gijon-Nogueron G, Ramos-Petersen L, Ortega-Avila AB, et al. . Effectiveness of foot orthoses in patients with rheumatoid arthritis related to disability and pain: a systematic review and meta-analysis. Qual Life Res 2018;27:3059–69.10.1007/s11136-018-1913-5
    1. Hennessy K, Burns J, Penkala S. Reducing plantar pressure in rheumatoid arthritis: a comparison of running versus off-the-shelf orthopaedic footwear. Clin Biomech 2007;22:917–23.10.1016/j.clinbiomech.2007.04.011
    1. Hennessy K, Woodburn J, Steultjens MPM. Custom foot orthoses for rheumatoid arthritis: a systematic review. Arthritis Care Res 2012;64:311–20.10.1002/acr.21559
    1. Mejjad O, Vittecoq O, Pouplin S, et al. . Foot orthotics decrease pain but do not improve gait in rheumatoid arthritis patients. Joint Bone Spine 2004;71:542–5.10.1016/j.jbspin.2003.09.007
    1. Moreira E, Jones A, Oliveira HA, et al. . Effectiveness of insole use in rheumatoid feet: a randomized controlled trial. Scand J Rheumatol 2016;45:363–70.10.3109/03009742.2015.1110198
    1. Najafi B, Barnica E, Wrobel JS, et al. . Dynamic plantar loading index: understanding the benefit of custom foot orthoses for painful pes cavus. J Biomech 2012;45:1705–11.10.1016/j.jbiomech.2012.03.006
    1. Novak P, Burger H, Tomsic M, et al. . Influence of foot orthoses on plantar pressures, foot pain and walking ability of rheumatoid arthritis patients--a randomised controlled study. Disabil Rehabil 2009;31:638–45.10.1080/09638280802239441
    1. Budiman-Mak E, Conrad KJ, Roach KE, et al. . Can foot orthoses prevent hallux valgus deformity in rheumatoid arthritis? A randomized clinical trial. J Clin Rheumatol 1995;1:313–22.10.1097/00124743-199512000-00001
    1. Cameron-Fiddes V, Santos D. The use of ‘off-the-shelf’ foot orthoses in the reduction of foot symptoms in patients with early rheumatoid arthritis. Foot 2013;23:123–9.10.1016/j.foot.2013.09.001
    1. Chalmers AC, Busby C, Goyert J, et al. . Metatarsalgia and rheumatoid arthritis--a randomized, single blind, sequential trial comparing 2 types of foot orthoses and supportive shoes. J Rheumatol 2000;27:1643–7.
    1. Cho NS, Hwang JH, Chang HJ, et al. . Randomized controlled trial for clinical effects of varying types of insoles combined with specialized shoes in patients with rheumatoid arthritis of the foot. Clin Rehabil 2009;23:512–21.10.1177/0269215508101737
    1. Conceição CSda, Gomes Neto M, Mendes SMD, et al. . Systematic review and meta-analysis of effects of foot orthoses on pain and disability in rheumatoid arthritis patients. Disabil Rehabil 2015;37:1209–13.10.3109/09638288.2014.961654
    1. Conrad KJ, Budiman-Mak E, Roach KE, et al. . Impacts of foot orthoses on pain and disability in rheumatoid arthritics. J Clin Epidemiol 1996;49:1–7.10.1016/0895-4356(96)00534-3
    1. Cuesta Calleja R, Polo García A, González Fernández ML. Evidencia científica del tratamiento ortopodológico en pie afectado POR artritis reumatoide. Rev Int Cienc Podol 2018;12:15–26.10.5209/RICP.57986
    1. Egan M, Brosseau L, Farmer M, et al. . Splints and orthosis for treating rheumatoid arthritis. Cochrane Database Syst Rev;34.10.1002/14651858.CD004018
    1. Argimón-Pallás JM, Jiménez-Villa J. Métodos de investigación clínica y epidemiológica. Elsevier: Barcelona:, 2013.
    1. Fanouriakis A, Kostopoulou M, Alunno A. Update of the EULAR recommendations for the management of systemic lupus erythematosus. Ann Rheum Dis 2019;2019:736–45.
    1. Farrar JT, Young JP, LaMoreaux L, et al. . Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain 2001;94:149–58.10.1016/S0304-3959(01)00349-9
    1. Paez-Moguer J, Budiman-Mak E, Cuesta-Vargas AI. Cross-cultural adaptation and validation of the foot function index to Spanish. Foot Ankle Surg 2014;20:34–9.10.1016/j.fas.2013.09.005
    1. Gijon-Nogueron G, Ndosi M, Luque-Suarez A, et al. . Cross-cultural adaptation and validation of the Manchester foot pain and disability index into Spanish. Qual Life Res 2014;23:571–9.10.1007/s11136-013-0507-5
    1. Krupp LB, LaRocca NG, Muir-Nash J, et al. . The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol 1989;46:1121–3 10.1001/archneur.1989.00520460115022
    1. Monteagudo Piqueras O, Hernando Arizaleta L, Palomar Rodríguez JA. Normas poblacionales de referencia de la versión española del SF-12V2 para La Región de Murcia. Gaceta Sanitaria 2011;25:50–61.10.1016/j.gaceta.2010.09.001
    1. Cohen J. Statistical power analysis for the behavioral sciences. Stat Power Anal Behav Sci 1988;2:567.
    1. Rosenthal R, Rubin DB, simple A. A simple, general purpose display of magnitude of experimental effect. J Educ Psychol 1982;74:166–9.10.1037/0022-0663.74.2.166

Source: PubMed

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

3
Abonnieren