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(Reference retrieved automatically from Web of Science through information on FAPESP grant and its corresponding number as mentioned in the publication by the authors.)

Cryotherapy associated with tailored land-based exercises for knee osteoarthritis: a protocol for a double-blind sham-controlled randomised trial

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Author(s):
Dantas, Lucas Ogura [1] ; Jorge, Ana Elisa Serafim [1] ; da Silva Serrao, Paula Regina Mendes [1] ; Aburquerque-Sendin, Francisco [2, 3] ; Salvini, Tania de Fatima [1]
Total Authors: 5
Affiliation:
[1] Univ Fed Sao Carlos, Dept Phys Therapy, Sao Carlos, SP - Brazil
[2] Univ Cordoba, Sociosanit Sci Radiol & Phys Med, Cordoba, Andalucia - Spain
[3] Univ Cordoba, Inst Maiomonides Invest Biomed Cordoba IMIBIC, Cordoba, Andalucia - Spain
Total Affiliations: 3
Document type: Journal article
Source: BMJ OPEN; v. 10, n. 6 2020.
Web of Science Citations: 0
Abstract

Introduction There is an unmet need to develop tailored therapeutic exercise protocols applying different treatment parameters and modalities for individuals with knee osteoarthritis (KOA). Cryotherapy is widely used in rehabilitation as an adjunct treatment due to its effects on pain and the inflammatory process. However, disagreement between KOA guidelines remains with respect to its recommendation status. The aim of this study is to verify the complementary effects of cryotherapy when associated with a tailored therapeutic exercise protocol for patients with KOA. Methods and analysis This study is a sham-controlled randomised trial with concealed allocation and intention-to-treat analysis. Assessments will be performed at baseline and immediately following the intervention period. To check for residual effects of the applied interventions, 3-month and 6-month follow-up assessments will be performed. Participants will be community members living with KOA divided into three groups: (1) the experimental group that will receive a tailored therapeutic exercise protocol followed by a cryotherapy session of 20 min; (2) the sham control group that will receive the same regimen as the first group, but with sham packs filled with dry sand and (3) the active treatment control group that will receive only the therapeutic exercise protocol. The primary outcome will be pain intensity according to a Visual Analogue Scale. Secondary outcomes will be the Western Ontario \& McMaster Universities Osteoarthritis Index; the Short-Form Health Survey 36; the 30-s Chair Stand Test; the Stair Climb test; and the 40-m fast-paced walk test. Ethics and dissemination The trial was approved by the Institutional Ethics Committee of Federal University of SAo Carlos, SAo Paulo, Brazil. Registration approval number: CAAE: 65966617.9.0000.5504. The results will be published in peer-reviewed journals. Trial registration number NCT03360500 (AU)

FAPESP's process: 17/00062-7 - DOES THE LASER THERAPY ASSOCIATED WITH THERAPEUTIC EXERCISES IMPROVE PAIN AND FUNCTION OF PATIENTS WITH KNEE OSTEOARTHRITIS? - A RANDOMIZED CONTROLED TRIAL
Grantee:Ana Elisa Serafim Jorge
Support Opportunities: Scholarships in Brazil - Post-Doctoral
FAPESP's process: 15/21422-6 - The effect of cryotherapy in pain control, function and quality of life in individuals with knew osteoarthritis: randomized clinical trial
Grantee:Lucas Ogura Dantas
Support Opportunities: Scholarships in Brazil - Doctorate (Direct)