Effectiveness and cost-effectiveness of the modified Pilates method versus aerobic exercise in the treatment of patients with fibromyalgia: protocol for a randomized controlled trial

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Abstract

Background

Fibromyalgia is characterized by chronic generalized pain, fatigue, sleep disorders and other symptoms. Physical exercise is recommended as the first choice of non-pharmacological therapy. Thus, the aim of this study is to evaluate the effectiveness and cost-effectiveness of modified Pilates exercises compared to aerobic exercises in the treatment of patients with fibromyalgia.

Methods

In this randomized controlled trial with blinded assessor, 98 patients who meet the fibromyalgia classification criteria of the American College of Rheumatology 2010, aged between 20 and 75 years, and with pain intensity greater than or equal to 3 points in the Pain Numerical Rating Scale, will be randomly divided into Aerobic Group (aerobic exercises on treadmills or stationary bikes) and Pilates Group (modified Pilates exercises), and treated twice a week for eight weeks on the Center for Excellence in Clinical Research in Physical Therapy at Universidade Cidade de São Paulo, Brazil. The following outcomes will be evaluated by a blinded assessor at baseline, eight weeks, six months, and 12 months after randomization: impact of fibromyalgia assessed by the Fibromyalgia Impact Questionnaire, pain intensity by the Pain Numerical Rating Scale, kinesiophobia by the Tampa Scale of Kinesiophobia, specific disability by the Patient-Specific Functional Scale, functional capacity by the 6-min Walk Test, quality of sleep by the Pittsburgh Sleep Quality Index, and health-related quality of life by EQ-5D-3L and SF-6D questionnaires.

Discussion

It is expected that the Pilates exercises will be more effective than aerobic exercises in improving clinical outcomes and that this improvement will be maintained over the medium to long term. This study aims to clarify whether the Pilates method can be incorporated into the clinical practice of physical therapists treating patients with fibromyalgia. The study will also provide information on which exercise will be most cost-effective, information that can be used by insurers and public health systems.

Trial registration

This study was prospectively registered at the Clinical Trials Registry ( NCT03050606) in February 2017.

Electronic supplementary material

The online version of this article (10.1186/s41927-018-0051-6) contains supplementary material, which is available to authorized users.

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Most cited references 34

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EULAR evidence-based recommendations for the management of fibromyalgia syndrome.

F Dincer, F Blotman, H Bliddal … (2008)

To develop evidence-based recommendations for the management of fibromyalgia syndrome. A multidisciplinary task force was formed representing 11 European countries. The design of the study, including search strategy, participants, interventions, outcome measures, data collection and analytical method, was defined at the outset. A systematic review was undertaken with the keywords "fibromyalgia", "treatment or management" and "trial". Studies were excluded if they did not utilise the American College of Rheumatology classification criteria, were not clinical trials, or included patients with chronic fatigue syndrome or myalgic encephalomyelitis. Primary outcome measures were change in pain assessed by visual analogue scale and fibromyalgia impact questionnaire. The quality of the studies was categorised based on randomisation, blinding and allocation concealment. Only the highest quality studies were used to base recommendations on. When there was insufficient evidence from the literature, a Delphi process was used to provide basis for recommendation. 146 studies were eligible for the review. 39 pharmacological intervention studies and 59 non-pharmacological were included in the final recommendation summary tables once those of a lower quality or with insufficient data were separated. The categories of treatment identified were antidepressants, analgesics, and "other pharmacological" and exercise, cognitive behavioural therapy, education, dietary interventions and "other non-pharmacological". In many studies sample size was small and the quality of the study was insufficient for strong recommendations to be made. Nine recommendations for the management of fibromyalgia syndrome were developed using a systematic review and expert consensus.

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Deriving a preference-based single index from the UK SF-36 Health Survey.

John Brazier, Tim Usherwood, Rosemary Harper … (1998)

This article presents the results of a study to derive a preference-based single index from the SF-36. The study was an attempt to reconcile a profile health status measure, the SF-36, with the "quality adjusted life years" approach. The study undertook a parsimonious restructuring of the SF-36 using explicit criteria to form the SF-6D health state classification. A sample of multidimensional health states defined by this classification were valued by a convenience sample of health professionals, managers, and patients, who responded to a set of visual analogue scale ratings and standard gamble questions, with highly complete and consistent answers. Statistical models were estimated to predict single index scores for all 9000 health states defined by the new classification. The resultant algorithms can be applied to existing SF-36 data sets and used in the assessment of the cost-effectiveness of health technologies. This preliminary work forms the basis of a larger study currently being undertaken in the UK.

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Clinimetric testing of three self-report outcome measures for low back pain patients in Brazil: which one is the best?

Jane Latimer, C Maher, I Ferreira … (2008)

Translation, cross-cultural adaptation, and clinimetric testing of self-report outcome measures. The aims of this investigation were to perform the translation and cross-cultural adaptation of the Patient-Specific Functional Scale (PSFS) into Brazilian-Portuguese and to perform a head-to-head comparison of the clinimetric properties of the Brazilian-Portuguese versions of the PSFS, the Roland-Morris Disability Questionnaire (RMDQ) and the Functional Rating Index (FRI). To date, there is no Brazilian-Portuguese version of the PSFS available and no head-to-head comparison of the Brazilian-Portuguese versions of the PSFS, RMDQ, and FRI has been undertaken. The PSFS was translated and adapted into Brazilian-Portuguese. The PSFS, the RMDQ, and the FRI were administered to 99 patients with low back pain to evaluate internal consistency, reproducibility, ceiling and floor effects, construct validity, internal and external responsiveness. To fully test the construct validity and external responsiveness of these measures, it was necessary to cross-culturally adapt the Pain Numerical Rating Scale and the Global Perceived Effect Scale. All measures demonstrated high levels of internal consistency (Cronbach's alpha range = 0.88-0.90) and reproducibility (Intraclass Correlation Coefficient 2,1 range = 0.85-0.94). High correlations among the disability-related measures were observed (Pearson's r ranging from 0.51 to 0.71). No ceiling or floor effects were detected. The PSFS was consistently more responsive than the other measures in both the internal responsiveness and external responsiveness analyses. The results from this study demonstrate that the Brazilian-Portuguese versions of the RMDQ, the FRI and the PSFS have similar clinimetric properties to each other and to the original English versions. Of allthe measures tested in this study the PSFS seems the most responsive. These measures will enable international comparisons to be performed, and encourage researchers to include Portuguese speakers in their clinical trials.

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Author and article information

Contributors

Katherinne Ferro Moura Franco: +551121781214 , katherinneferro@gmail.com

Yuri Rafael dos Santos Franco: yrfranco@hotmail.com

Evany Maira Espírito Santo Salvador: evanysalvador@gmail.com

Bruna Cristina Brajon do Nascimento: brunabrajon@gmail.com

Gisela Cristiane Miyamoto: gfisio_miyamoto@hotmail.com

Cristina Maria Nunes Cabral: cristina.cabral@unicid.edu.br

Journal

Journal ID (nlm-ta): BMC Rheumatol

Journal ID (iso-abbrev): BMC Rheumatol

Title: BMC rheumatology

Publisher: BioMed Central (London )

ISSN (Electronic): 2520-1026

Publication date (Electronic): 18 January 2019

Publication date PMC-release: 18 January 2019

Publication date Collection: 2019

Volume: 3

Electronic Location Identifier: 2

Affiliations

[1 ]ISNI 0000 0001 0298 4494, GRID grid.412268.b, Master’s and Doctoral Program in Physical Therapy, , Universidade Cidade de São Paulo, ; Rua Cesário Galeno 475, São Paulo SP, CEP: 03071-000 Brazil

[2 ]ISNI 0000 0001 0298 4494, GRID grid.412268.b, Physical Therapy Department, , Universidade Cidade de São Paulo, ; Rua Cesário Galeno 475, São Paulo SP, CEP: 03071-000 Brazil

Article

Publisher ID: 51

DOI: 10.1186/s41927-018-0051-6

PMC ID: 6390629

PubMed ID: 30886990

SO-VID: 1fa5b47f-fd5b-4937-a283-c6869be0a9a2

License:

Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

History

Date received : 25 September 2018

Date accepted : 13 December 2018

Funding

Funded by: FundRef http://dx.doi.org/10.13039/501100001807, Fundação de Amparo à Pesquisa do Estado de São Paulo;

Award ID: 2016/12962-0

Award ID: 2015/21590-6

Award Recipient : Katherinne Ferro Moura Franco Cristina Maria Nunes Cabral

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Keywords: pilates method,aerobic exercise,economic evaluation

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Keywords: pilates method, aerobic exercise, economic evaluation

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Effectiveness and cost-effectiveness of the modified Pilates method versus aerobic exercise in the treatment of patients with fibromyalgia: protocol for a randomized controlled trial

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Abstract

Background

Methods

Discussion

Trial registration

Electronic supplementary material

Related collections

Point-of-Care Testing for Infectious Diseases Super Collection

Most cited references 34

EULAR evidence-based recommendations for the management of fibromyalgia syndrome.

Deriving a preference-based single index from the UK SF-36 Health Survey.

Clinimetric testing of three self-report outcome measures for low back pain patients in Brazil: which one is the best?

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Cited by 4

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