Effectiveness of a long-term use of a minimalist footwear versus habitual shoe on pain, function and mechanical loads in knee osteoarthritis: a randomized controlled trial

Autor(es)

Trombini-Souza, Francis ^[1] ; Fuller, Ricardo ^[2] ; Matias, Alessandra ^[1] ; Yokota, Mariane ^[1] ; Butugan, Marco ^[1] ; Goldenstein-Schainberg, Claudia ^[2] ; Sacco, Isabel C. N. ^[1]

Afiliação do(s) autor(es)

^[1] Univ Sao Paulo, Sch Med, Dept Phys Therapy Speech & Occupat Therapy, BR-05360160 Sao Paulo - Brazil

^[2] Univ Sao Paulo, Sch Med, Div Rheumatol, BR-05360160 Sao Paulo - Brazil

• Tipo de documento: Artigo Científico
• Fonte: BMC MUSCULOSKELETAL DISORDERS; v. 13, JUL 12 2012.
• Citações Web of Science: 7

Resumo

Background: Recent studies have shown an important reduction of joint overload during locomotion in elderly women with knee osteoarthritis (OA) after short- term use of minimalist shoes. Our aim is to investigate the chronic effect of inexpensive and minimalist footwear on the clinical and functional aspects of OA and gait biomechanics of elderly women with knee OA. Methods/Design: Fifty-six elderly women with knee OA grade 2 or 3 (Kellgren and Lawrence) are randomized into blocks and allocated to either the intervention group, which will use flexible, non-heeled shoes-Moleca (R)-for six months for at least six hours daily, or the control group, which could not use these shoes. Neither group is undergoing physical therapy treatment throughout the intervention period. Moleca (R) is a women's double canvas, flexible, flat walking shoe without heels, with a 5-mm anti-slip rubber sole and a 3-mm internal wedge of ethylene vinyl acetate. Both groups will be followed for six months and will be assessed at baseline condition, after three months, and after six months (end of intervention). All the assessments will be performed by a physiotherapist that is blind to the group allocation. The primary outcome is the pain Western Ontario and McMaster Universities Osteoarthritis (WOMAC) score. The secondary outcomes are global WOMAC score; joint stiffness and disability WOMAC scores; knee pain with a visual analogue scale; walking distance in the six-minute walk test; Lequesne score; amount and frequency (number of days) of paracetamol (500 mg) intake over six months; knee adduction moment during gait; global medical assessment score; and global patient auto-assessment score. At baseline, all patients receive a diary to record the hours of daily use of the footwear intervention; every two weeks, the same physiotherapist makes phone calls to all patients in order to verify adherence to treatment. The statistical analysis will be based on intention to treat analysis, as well as general linear models of analysis of variance for repeated measure to detect treatment-time interactions (alpha = 5%). Discussion: This is the first randomized, clinical trial protocol to assess the chronic effect of minimalist footwear on the clinical and functional aspects and gait biomechanics of elderly women with knee osteoarthritis. We expect that the use of Moleca (R) shoes for six months will provide pain relief, reduction of the knee adduction moment when walking, and improve joint function in elderly women with knee OA, and that the treatment, thus, can be considered another inexpensive and easy-to-use option for conservative OA treatment. (AU)

• Processo FAPESP: 11/03300-0 - Influência terapêutica de um calçado flexível, sem salto e de baixo custo sobre os aspectos clínicos e cinemáticos da marcha de idosas com osteoartrite de joelho
• Beneficiário: Alessandra Bento Matias
• Modalidade de apoio: Bolsas no Brasil - Iniciação Científica
• Processo FAPESP: 11/01640-8 - Efeito terapêutico de um calçado flexível e sem salto sobre os aspectos clínicos, funcionais e biomecânicos da marcha de idosas com osteoartrite de joelho: um ensaio clínico randomizado
• Beneficiário: Francis Trombini de Souza
• Modalidade de apoio: Bolsas no Brasil - Doutorado
• Processo FAPESP: 11/03069-6 - Efeito crônico da utilização de um calçado flexível e sem salto sobre os aspectos clínicos e cinéticos da marcha de idosas com osteoartrite de joelho
• Beneficiário: Mariane Yokota
• Modalidade de apoio: Bolsas no Brasil - Iniciação Científica