Skip to main content
Top
Published in: BMC Musculoskeletal Disorders 1/2017

Open Access 01-12-2017 | Study protocol

Effectiveness of Aquatic Therapy vs Land-based Therapy for Balance and Pain in Women with Fibromyalgia: a study protocol for a randomised controlled trial

Authors: Sabela Rivas Neira, Amélia Pasqual Marques, Irene Pegito Pérez, Ramón Fernández Cervantes, Jamile Vivas Costa

Published in: BMC Musculoskeletal Disorders | Issue 1/2017

Login to get access

Abstract

Background

Fibromyalgia is a disease with an increasing incidence. It impairs the quality of life of patients and decreases their functional capacity. Aquatic therapy has already been used for managing the symptoms of this syndrome. However, aquatic therapy has only recently been introduced as a treatment modality for improving proprioception in fibromyalgia. The main objective of this study is to determine the effectiveness of two physiotherapy protocols, one in and one out of water, for improving balance and decreasing pain in women with fibromyalgia.

Methods/Design

The study protocol will be a single-blind randomised controlled trial. Forty women diagnosed with fibromyalgia will be randomly assigned into 2 groups: Aquatic Therapy (n = 20) or Land-based Therapy (n = 20). Both interventions include 60-min therapy sessions, structured into 4 sections: Warm-up, Proprioceptive Exercises, Stretching and Relaxation. These sessions will be carried out 3 times a week for 3 months. Primary outcomes are balance (static and dynamic) and pain (intensity and threshold). Secondary outcomes include functional balance, quality of life, quality of sleep, fatigue, self-confidence in balance and physical ability. Outcome measures will be evaluated at baseline, at the end of the 3-month intervention period, and 6-weeks post-treatment. Statistical analysis will be carried out using the SPSS 21.0 program for Windows and a significance level of p ≤ 0.05 will be used for all tests.

Discussion

This study protocol details two physiotherapy interventions in women with fibromyalgia to improve balance and decrease pain: aquatic therapy and land-based therapy. In current literature there is a lack of methodological rigour and a limited number of studies that describe physiotherapy protocols to manage fibromyalgia symptoms. High-quality scientific works are required to highlight physiotherapy as one of the most recommended treatment options for this syndrome.

Trial registration

Date of publication in ClinicalTrials.gov: 18/02/2016. ClinicalTrials.gov Identifier: NCT02695875.
Literature
1.
go back to reference Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, et al. The American College of Rheumatology 1990 criteria for the classification of fibromyalgia. Arthritis Rheum. 1990;33(2):160–72.CrossRefPubMed Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, et al. The American College of Rheumatology 1990 criteria for the classification of fibromyalgia. Arthritis Rheum. 1990;33(2):160–72.CrossRefPubMed
2.
go back to reference Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, et al. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res. 2010;62(5):600–10.CrossRef Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, et al. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res. 2010;62(5):600–10.CrossRef
3.
go back to reference Queiroz LP. Worldwide epidemiology of fibromyalgia. Curr Pain Headache Rep. 2013; doi: 10.1007/s11916-013-0356-5. Queiroz LP. Worldwide epidemiology of fibromyalgia. Curr Pain Headache Rep. 2013; doi: 10.1007/s11916-013-0356-5.
4.
go back to reference Carmona L, Ballina J, Gabriel R, Laffon A, EPISER Study Group. The burden of musculoskeletal diseases in the general population of Spain: results from a national survey. Ann Rheum Dis. 2001;60(11):1040–5.CrossRefPubMedPubMedCentral Carmona L, Ballina J, Gabriel R, Laffon A, EPISER Study Group. The burden of musculoskeletal diseases in the general population of Spain: results from a national survey. Ann Rheum Dis. 2001;60(11):1040–5.CrossRefPubMedPubMedCentral
5.
go back to reference Macfarlane GJ, Kronisch C, Dean LE, Atzeni F, Häuser W, Fluß E, et al. EULAR revised recommendations for the management of fibromyalgia. Ann Rheum Dis. 2016; doi: 10.1136/annrheumdis-2016-209724. Macfarlane GJ, Kronisch C, Dean LE, Atzeni F, Häuser W, Fluß E, et al. EULAR revised recommendations for the management of fibromyalgia. Ann Rheum Dis. 2016; doi: 10.1136/annrheumdis-2016-209724.
6.
go back to reference Ablin J, Fitzcharles MA, Buskila D, Shir Y, Sommer C, Häuser W. Treatment of fibromyalgia syndrome: recommendations of recent evidence-based interdisciplinary guidelines with special emphasis on complementary and alternative therapies. Evid Based Complement Alternat Med. 2013; doi: 10.1155/2013/485272. Ablin J, Fitzcharles MA, Buskila D, Shir Y, Sommer C, Häuser W. Treatment of fibromyalgia syndrome: recommendations of recent evidence-based interdisciplinary guidelines with special emphasis on complementary and alternative therapies. Evid Based Complement Alternat Med. 2013; doi: 10.1155/2013/485272.
7.
go back to reference Cadenas-Sánchez C, Ruiz-Ruiz J. Efecto de un programa de actividad física en pacientes con fibromialgia: revisión sistemática. Med Clin (Barc). 2014; doi: 10.1016/j.medcli.2013.12.010. Cadenas-Sánchez C, Ruiz-Ruiz J. Efecto de un programa de actividad física en pacientes con fibromialgia: revisión sistemática. Med Clin (Barc). 2014; doi: 10.1016/j.medcli.2013.12.010.
8.
go back to reference López-Rodrígeuz MM, Castro-Sánchez AM, Fernández-Martínez M, Matarán-Peñarrocha GA, Rodríguez-Ferrer ME. Comparación entre biodanza en medio acuático y stretching en la mejora de la calidad de vida y dolor en los pacientes con fibromialgia. Aten Primaria. 2012; doi: 10.1016/j.aprim.2012.03.002. López-Rodrígeuz MM, Castro-Sánchez AM, Fernández-Martínez M, Matarán-Peñarrocha GA, Rodríguez-Ferrer ME. Comparación entre biodanza en medio acuático y stretching en la mejora de la calidad de vida y dolor en los pacientes con fibromialgia. Aten Primaria. 2012; doi: 10.1016/j.aprim.2012.03.002.
9.
go back to reference Lima TB, Dias JM, Mazquin BF, da Silva CT, Noqueira RM, Marques AP, et al. The effectiveness of aquatic physical therapy in the treatment of fibromyalgia: a systematic review with meta-analysis. Clin Rehabil. 2013; doi: 10.1177/0269215513484772. Lima TB, Dias JM, Mazquin BF, da Silva CT, Noqueira RM, Marques AP, et al. The effectiveness of aquatic physical therapy in the treatment of fibromyalgia: a systematic review with meta-analysis. Clin Rehabil. 2013; doi: 10.1177/0269215513484772.
10.
go back to reference Arendt-Nielsen L, Graven-Nielsen T. Muscle pain: sensory implications and interaction with motor control. Clin J Pain. 2008; doi: 10.1097/AJP.0b013e31815b608f. Arendt-Nielsen L, Graven-Nielsen T. Muscle pain: sensory implications and interaction with motor control. Clin J Pain. 2008; doi: 10.1097/AJP.0b013e31815b608f.
11.
go back to reference Rutledge DN, Cherry BJ, Rose DJ, Rakovski C, Jones CJ. Do fall predictors in middle aged and older adults predict fall status in persons 50 + with fibromyalgia? An exploratory study. Res Nurs Health. 2010; doi: 10.1002/nur.20376. Rutledge DN, Cherry BJ, Rose DJ, Rakovski C, Jones CJ. Do fall predictors in middle aged and older adults predict fall status in persons 50 + with fibromyalgia? An exploratory study. Res Nurs Health. 2010; doi: 10.1002/nur.20376.
12.
go back to reference Russek LN, Fulk GD. Pilot study assessing balance in women with fibromyalgia syndrome. Physiother Theory Pract. 2009; doi: 10.3109/09593980802668050. Russek LN, Fulk GD. Pilot study assessing balance in women with fibromyalgia syndrome. Physiother Theory Pract. 2009; doi: 10.3109/09593980802668050.
13.
go back to reference Jones KD, Horak FB, Winters-Stone K, Irvine JM, Bennett RM. Fibromyalgia is associated with impaired balance and falls. J Clin Rheumatol. 2009; doi: 10.1097/RHU.0b013e318190f991. Jones KD, Horak FB, Winters-Stone K, Irvine JM, Bennett RM. Fibromyalgia is associated with impaired balance and falls. J Clin Rheumatol. 2009; doi: 10.1097/RHU.0b013e318190f991.
14.
go back to reference Jones KD, King LA, Mist SD, Bennett RM, Horak FB. Postural control deficits in people with fibromyalgia: a pilot study. Arthritis Res Ther. 2011; doi: 10.1186/ar3432. Jones KD, King LA, Mist SD, Bennett RM, Horak FB. Postural control deficits in people with fibromyalgia: a pilot study. Arthritis Res Ther. 2011; doi: 10.1186/ar3432.
15.
16.
go back to reference Muto LH, Sauer JF, Yuan SL, Sousa A, Mango PC, Marques AP. Postural control and balance self-efficacy in women with fibromyalgia: are there differences? Eur J Phys Rehabil Med. 2015;51(2):149–54.PubMed Muto LH, Sauer JF, Yuan SL, Sousa A, Mango PC, Marques AP. Postural control and balance self-efficacy in women with fibromyalgia: are there differences? Eur J Phys Rehabil Med. 2015;51(2):149–54.PubMed
17.
go back to reference Park JH, Mancini M, Carlso-Kuhta P, Nutt JG, Horak FB. Quantifying effects of age on balance and gait with inertial sensors in community-dwelling healthy adults. Exp Gerontol. 2016; doi: 10.1016/j.exger.2016.09.018. Park JH, Mancini M, Carlso-Kuhta P, Nutt JG, Horak FB. Quantifying effects of age on balance and gait with inertial sensors in community-dwelling healthy adults. Exp Gerontol. 2016; doi: 10.1016/j.exger.2016.09.018.
18.
go back to reference Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA. 1995;273(5):408–12.CrossRefPubMed Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA. 1995;273(5):408–12.CrossRefPubMed
19.
go back to reference Lanska DJ. The Romberg sign and early instruments for measuring postural sway. Semin Neurol. 2002;22(4):409–18.CrossRefPubMed Lanska DJ. The Romberg sign and early instruments for measuring postural sway. Semin Neurol. 2002;22(4):409–18.CrossRefPubMed
20.
go back to reference Podsiadlo D, Richardson S. The timed “Up & Go”: a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991;39(2):142–8.CrossRefPubMed Podsiadlo D, Richardson S. The timed “Up & Go”: a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991;39(2):142–8.CrossRefPubMed
25.
go back to reference Kiernan JA, Rajakumar N. Revisión de los principales sistemas: sistemas sensoriales generales. In: El sistema nervioso humano: una perspectiva anatómica. Barcelona, editor. Wolters Kluwer Health Lippincott Williams & Wilkins. 2014. p. 285–305. Kiernan JA, Rajakumar N. Revisión de los principales sistemas: sistemas sensoriales generales. In: El sistema nervioso humano: una perspectiva anatómica. Barcelona, editor. Wolters Kluwer Health Lippincott Williams & Wilkins. 2014. p. 285–305.
27.
go back to reference Shumway-Cook A, Brauser S, Woollacott M. Predicting the probability for falls in community-dwelling older adults using the Timed Up & Go Test. Phys Ther. 2000;80(9):896–903.PubMed Shumway-Cook A, Brauser S, Woollacott M. Predicting the probability for falls in community-dwelling older adults using the Timed Up & Go Test. Phys Ther. 2000;80(9):896–903.PubMed
28.
go back to reference Carlsson AM. Assessment of chronic pain. I. Aspects of the reliability and validity of the visual analogue scale. Pain. 1983;16(1):87–101.CrossRefPubMed Carlsson AM. Assessment of chronic pain. I. Aspects of the reliability and validity of the visual analogue scale. Pain. 1983;16(1):87–101.CrossRefPubMed
29.
go back to reference Staud R, Vierck CJ, Cannon R, Mauderli AP, Price DD. Abnormal sensitization and temporal summation of second pain (wind-up) in patients with fibromyalgia syndrome. Pain. 2001;91(1-2):165–75.CrossRefPubMed Staud R, Vierck CJ, Cannon R, Mauderli AP, Price DD. Abnormal sensitization and temporal summation of second pain (wind-up) in patients with fibromyalgia syndrome. Pain. 2001;91(1-2):165–75.CrossRefPubMed
30.
go back to reference Berg KO, Wood-Dauphinee SL, Williams JI, Maki B. Measuring balance in the elderly: validation of an instrument. Can J Public Health. 1992;83 Suppl 2:S7–11.PubMed Berg KO, Wood-Dauphinee SL, Williams JI, Maki B. Measuring balance in the elderly: validation of an instrument. Can J Public Health. 1992;83 Suppl 2:S7–11.PubMed
31.
go back to reference Bogle Thorbahn LD, Newton RA. Use of the Berg Balance Test to predict falls in elderly persons. Phys Ther. 1996;76(6):576–85.PubMed Bogle Thorbahn LD, Newton RA. Use of the Berg Balance Test to predict falls in elderly persons. Phys Ther. 1996;76(6):576–85.PubMed
32.
go back to reference Salgueiro M, García-Leiva JM, Ballesteros J, Hidalgo J, Molina R, Calandre EP. Validation of a Spanish version of the Revised Fibromyalgia Impact Questionnaire (FIQR). Health Qual Life Outcomes. 2013; doi: 10.1186/1477-7525-11-132. Salgueiro M, García-Leiva JM, Ballesteros J, Hidalgo J, Molina R, Calandre EP. Validation of a Spanish version of the Revised Fibromyalgia Impact Questionnaire (FIQR). Health Qual Life Outcomes. 2013; doi: 10.1186/1477-7525-11-132.
33.
go back to reference Monterde S, Salvat I, Montull S, Fernández-Ballart J. Validación de la versión española del Fibromyalgia Impact Questionnaire. Rev Esp Reumatol. 2004;31(9):507–13. Monterde S, Salvat I, Montull S, Fernández-Ballart J. Validación de la versión española del Fibromyalgia Impact Questionnaire. Rev Esp Reumatol. 2004;31(9):507–13.
34.
go back to reference Macías JA, Royuela A. La versión española del índice de calidad de sueño de Pittsburgh. Informaciones psiquiátricas. 1996;146:465–72. Macías JA, Royuela A. La versión española del índice de calidad de sueño de Pittsburgh. Informaciones psiquiátricas. 1996;146:465–72.
35.
go back to reference Munguía-Izquierdo D, Segura-Jiménez V, Camiletti-Moirón D, Pulido-Martos M, Alvarez-Gallardo IC, Romero A, et al. Multidimensional Fatigue Inventory: Spanish adaptation and psychometric properties for fibromyalgia patients. The Al-Andalus study Clin Exp Rheumatol. 2012;30(6):94–102.PubMed Munguía-Izquierdo D, Segura-Jiménez V, Camiletti-Moirón D, Pulido-Martos M, Alvarez-Gallardo IC, Romero A, et al. Multidimensional Fatigue Inventory: Spanish adaptation and psychometric properties for fibromyalgia patients. The Al-Andalus study Clin Exp Rheumatol. 2012;30(6):94–102.PubMed
36.
go back to reference Montilla-Ibáñez A, Martínez-Amat A, Lomas-Vega R, Cruz-Díaz D, Torre-Cruz MJ, Casuso-Pérez R, et al. The Activities-specific Balance Confidence scale: reliability and validity in Spanish patients with vestibular disorders. Disabil Rehabil. 2016;23:1–7.CrossRef Montilla-Ibáñez A, Martínez-Amat A, Lomas-Vega R, Cruz-Díaz D, Torre-Cruz MJ, Casuso-Pérez R, et al. The Activities-specific Balance Confidence scale: reliability and validity in Spanish patients with vestibular disorders. Disabil Rehabil. 2016;23:1–7.CrossRef
37.
go back to reference Lajoie Y, Girard A, Guay M. Comparision of the reaction time, the Berg Scale and the ABC in non-fallers and fallers. Arch Gerontol Geriatr. 2002;35(3):215–25.CrossRefPubMed Lajoie Y, Girard A, Guay M. Comparision of the reaction time, the Berg Scale and the ABC in non-fallers and fallers. Arch Gerontol Geriatr. 2002;35(3):215–25.CrossRefPubMed
38.
go back to reference Gutiérrez-Clavería M, Beroíza T, Cartagena C, Caviedes I, Céspedez J, Gutiérrez-Navas M, et al. Prueba de caminata de seis minutos. Rev Chil Enf Respir. 2009;25:15–24. Gutiérrez-Clavería M, Beroíza T, Cartagena C, Caviedes I, Céspedez J, Gutiérrez-Navas M, et al. Prueba de caminata de seis minutos. Rev Chil Enf Respir. 2009;25:15–24.
39.
40.
go back to reference Farrar JT, Young Jr JP, LaMoreaux L, Werth JL, Poole RM. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001;94(2):149–58.CrossRefPubMed Farrar JT, Young Jr JP, LaMoreaux L, Werth JL, Poole RM. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001;94(2):149–58.CrossRefPubMed
41.
go back to reference Gustafsson M, Gaston-Johansson F. Pain intensity and health locus of control: a comparison of patients with fibromyalgia syndrome and rheumatoid arthritis. Patient Educ Couns. 1996;29(2):179–88.CrossRefPubMed Gustafsson M, Gaston-Johansson F. Pain intensity and health locus of control: a comparison of patients with fibromyalgia syndrome and rheumatoid arthritis. Patient Educ Couns. 1996;29(2):179–88.CrossRefPubMed
42.
go back to reference Altman DG. Practical statistics for medical research. London: Chapman and Hall/CRC; 1990. Altman DG. Practical statistics for medical research. London: Chapman and Hall/CRC; 1990.
43.
go back to reference Kibar S, Yildiz HE, Ay S, Evcik D, Ergin ES. New approach in fibromyalgia exercise program: A preliminary syudy regarding the effectiveness of balance training. Arch Phys Med Rehabil. 2015; doi: 10.1016/j.apmr.2015.05.004. Kibar S, Yildiz HE, Ay S, Evcik D, Ergin ES. New approach in fibromyalgia exercise program: A preliminary syudy regarding the effectiveness of balance training. Arch Phys Med Rehabil. 2015; doi: 10.1016/j.apmr.2015.05.004.
44.
go back to reference Duruturk N, Tuzun EH, Culhaoglu B. Is balance exercise training as effective as aerobic exercise training in fibromyalgia syndrome? Rheumatol Int. 2015; doi: 10.1007/s00296-014-3159-z. Duruturk N, Tuzun EH, Culhaoglu B. Is balance exercise training as effective as aerobic exercise training in fibromyalgia syndrome? Rheumatol Int. 2015; doi: 10.​1007/​s00296-014-3159-z.
45.
go back to reference Castro-Sánchez AM, Matarán-Peñarrocha GA, Arroyo-Morales M, Saavedra-Hernández M, Fernández-Sola C, Moreno-Lorenzo C. Effects of myofascial release techniques on pain, physical function, and postural stability in patients with fibromyalgia: a randomized controlled trial. Clin Rehabil. 2011; doi: 10.1177/0269215511399476. Castro-Sánchez AM, Matarán-Peñarrocha GA, Arroyo-Morales M, Saavedra-Hernández M, Fernández-Sola C, Moreno-Lorenzo C. Effects of myofascial release techniques on pain, physical function, and postural stability in patients with fibromyalgia: a randomized controlled trial. Clin Rehabil. 2011; doi: 10.​1177/​0269215511399476​.
Metadata
Title
Effectiveness of Aquatic Therapy vs Land-based Therapy for Balance and Pain in Women with Fibromyalgia: a study protocol for a randomised controlled trial
Authors
Sabela Rivas Neira
Amélia Pasqual Marques
Irene Pegito Pérez
Ramón Fernández Cervantes
Jamile Vivas Costa
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Musculoskeletal Disorders / Issue 1/2017
Electronic ISSN: 1471-2474
DOI
https://doi.org/10.1186/s12891-016-1364-5

Other articles of this Issue 1/2017

BMC Musculoskeletal Disorders 1/2017 Go to the issue