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

IntroductionSystemic 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)...

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Bibliographic Details
Published in:BMJ open 2021-03, Vol.11 (3), p.e042627
Main Authors: Reina-Bueno, María, Vázquez-Bautista, María del Carmen, Palomo-Toucedo, Inmaculada C, Domínguez-Maldonado, Gabriel, Castillo-López, José Manuel, Ramos-Ortega, Javier, Munuera-Martínez, Pedro V
Format: Article
Language:English
Subjects:
Ankle
Associations
Biomechanics
foot & ankle
Foot diseases
Foot Orthoses
Humans
Lupus
Lupus Erythematosus, Systemic - complications
Lupus Erythematosus, Systemic - therapy
musculoskeletal disorders
Pain
Pain - etiology
pain management
Pain Measurement
Patients
Posture
Quality of Life
Randomized Controlled Trials as Topic
Rheumatoid arthritis
Rheumatology
Treatment Outcome
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Summary:IntroductionSystemic 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 analysisA 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 disseminationThe 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 numberClinicaltrials.gov identifier NCT04098055.
ISSN:2044-6055
2044-6055
DOI:10.1136/bmjopen-2020-042627