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Therapeutic effect of a flexible and non-heeled footwear on the clinical, functional feature and gait biomechanics in elderly women with knee osteoarthritis: a randomized clinical trial

Grant number: 11/01640-8
Support type:Scholarships in Brazil - Doctorate
Effective date (Start): June 01, 2011
Effective date (End): December 31, 2013
Field of knowledge:Health Sciences - Physiotherapy and Occupational Therapy
Principal researcher:Isabel de Camargo Neves Sacco
Grantee:Francis Trombini de Souza
Home Institution: Faculdade de Medicina (FM). Universidade de São Paulo (USP). São Paulo , SP, Brazil


Osteoarthritis (OA), classified as a chronic degenerative rheumatic disease is, undoubtedly, the most common disorder of the musculoskeletal system, which contributes to an incapacity to work of about 15% of adults worldwide. This disease has the mechanical stress as a major cause of onset and progression of disease, especially in joints with constant movement and overloading as the knee. Given this, one of the main treatment aims at reducing intra-articular load. Recent studies have demonstrated an acute, that the use of footwear that mimic gait barefoot can minimize joint overload, however, not yet aware of any study that evaluated the effect of using this type of footwear for in patients with chronic knee OA. Then, the objective of this study is to evaluate the chronic therapeutic effect of an inexpensive and flexible footwear without heels on the clinical, functional and gait biomechanical of elderly women with knee OA. The disease clinical and functional aspects will be evaluated using a visual analogue scale (VAS) for pain, WOMAC and Lequesne questionnaires of quality of life in patients with OA and six-minute walk test (6MWT). Biomechanical analysis of the gait will be performed by infra-red cameras and a force platform. From the data of kinematics and kinetics, will be calculated moments of the knee joint by inverse dynamics solutions. Participants will be 56 elderly women with knee OA grades 2 and 3 (Kellgren and Lawrence). Participants will be randomized (in blocks) and placed in the group that will use a flexible and shoes without heels, called the intervention group (IG) or in a group will not use these shoes (CG). Both groups will be followed for 6 months. The process will be divided as follows: Step 1, where there will be screening and initial assessment of prospective participants, step 2, where they will be evaluated through VAS pain, function and quality of life by means of questionnaires, WOMAC and Lequesne and the 6MWT, and by evaluating the biomechanics of gait. In step three (3 month follow-up), the OAG will be evaluated again by the VAS and WOMAC questionnaires and Lequene. In step 4, after 6 months of starting the monitoring process, both groups will be reevaluated through the VAS, WOMAC, Lequesne, 6MWT and biomechanical analysis of the gait. This step is the final evaluation, characterizing the end of intervention. Comparisons between groups will be conducted by independent t tests and cross-moments by testing analysis of variance (ANOVA) for repeated measures followed by post hoc Newman-Keuls. This procedure will be performed for each variable. Comparisons of the variables of WOMAC and Lequesne be compared using the Mann-Whitney.

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Scientific publications
(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)
SACCO, I. C. N.; TROMBINI-SOUZA, F.; BUTUGAN, M. K.; PASSARO, A. C.; ARNONE, A. C.; FULLER, R.. Joint loading decreased by inexpensive and minimalist footwear in elderly women with knee osteoarthritis during stair descent. ARTHRITIS CARE & RESEARCH, v. 64, n. 3, p. 368-374, . (11/01640-8)
TROMBINI-SOUZA, FRANCIS; MATIAS, ALESSANDRA B.; YOKOTA, MARIANE; BUTUGAN, MARCO K.; GOLDENSTEIN-SCHAINBERG, CLAUDIA; FULLER, RICARDO; SACCO, ISABEL C. N.. Long-term use of minimal footwear on pain, self-reported function, analgesic intake, and joint loading in elderly women with knee osteoarthritis: A randomized controlled trial. CLINICAL BIOMECHANICS, v. 30, n. 10, p. 1194-1201, . (11/03300-0, 11/01640-8, 11/03069-6)
TROMBINI-SOUZA, FRANCIS; FULLER, RICARDO; MATIAS, ALESSANDRA; YOKOTA, MARIANE; BUTUGAN, MARCO; GOLDENSTEIN-SCHAINBERG, CLAUDIA; SACCO, ISABEL C. N.. 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. BMC MUSCULOSKELETAL DISORDERS, v. 13, . (11/03300-0, 11/01640-8, 11/03069-6)
Academic Publications
(References retrieved automatically from State of São Paulo Research Institutions)
SOUZA, Francis Trombini de. The therapeutic effect of a flexible and non-heeled shoe on the clinical, functional and gait biomechanical aspects of elderly women with knee osteoarthritis: a randomized clinical trial. 2013. Doctoral Thesis - Universidade de São Paulo (USP). Faculdade de Medicina (FM/SBD) São Paulo.

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