Different doses of Pilates-based exercise therapy for chronic low back pain: a randomised controlled trial with economic evaluation.

OBJECTIVES: To evaluate the effectiveness and cost-utility of the addition of different doses of Pilates to an advice for non-specific chronic low back pain (NSCLBP) from a societal perspective. DESIGN: Randomised controlled trial with economic evaluation. SETTING: Physiotherapy clinic in São Paulo, Brazil. PARTICIPANTS: 296 patients with NSCLBP. INTERVENTIONS: All patients received advice and were randomly allocated to four groups (n=74 per group): booklet group (BG), Pilates once a week (Pilates group 1, PG1), Pilates twice a week (Pilates group 2, PG2) and Pilates three times a week (Pilates group 3, PG3). MAIN OUTCOME MEASURES: Primary outcomes were pain and disability at 6-week follow-up. RESULTS: Compared with the BG, all Pilates groups showed significant improvements in pain (PG1, mean difference (MD)=-1.2, 95% CI -2.2 to -0.3; PG2, MD=-2.3, 95% CI -3.2 to -1.4; PG3, MD=-2.1, 95% CI -3.0 to -1.1) and disability (PG1, MD=-1.9, 95% CI -3.6 to -0.1; PG2, MD=-4.7, 95% CI -6.4 to -3.0; PG3, MD=-3.3, 95% CI -5.0 to -1.6). Among the different doses, PG2 showed significant improvements in comparison with PG1 for pain (MD=-1.1, 95% CI -2.0 to -0.1) and disability (MD=-2.8, 95% CI -4.5 to -1.1). The cost-utility analysis showed that PG3 had a 0.78 probability of being cost-effective at a willingness-to-pay of £20 000 per quality-adjusted life-year gained. CONCLUSIONS: Adding two sessions of Pilates exercises to advice provided better outcomes in pain and disability than advice alone for patients with NSCLBP; non-specific elements such as greater attention or expectation might be part of this effect. The cost-utility analysis showed that Pilates three times a week was the preferred option. TRIAL REGISTRATION NUMBER: NCT02241538, Completed.

Psychological factors show limited association with the severity of Achilles tendinopathy.

BACKGROUND: This study aimed to investigate the association between psychosocial factors and the severity of Achilles tendinopathy, along with exploring their potential link to the pain's duration. METHODS: A cross-sectional study involving 111 individuals with Achilles tendon pain was conducted. METHODS: A cross-sectional study involving 111 individuals with Achilles tendon pain was conducted. Various psychological factors were assessed using the Pain Catastrophizing Scale, Chronic Pain Self-Efficacy Scale (CPSS), Tampa Scale for Kinesiophobia, and Hospital Anxiety and Depression Scale (HAD). Additionally, the severity of Achilles tendon pain was evaluated using the Victorian Institute of Sport Assessment-Achilles questionnaire (VISA-A-Br). Regression analyses were employed to determine the association of these psychosocial factors with pain severity and duration. RESULTS: Self-efficacy for chronic pain showed a slight association with Achilles tendon pain severity (ß = 0.42 [95% CI: 0.06 to 0.16], p = 0.001), explaining only 19% of the dependent variable. The other variables, including anxiety, depression, pain catastrophizing, and fear of movement, did not exhibit significant associations. CONCLUSION: The study suggests that psychological factors demonstrate limited association with the severity of Achilles tendinopathy. While self-efficacy for chronic pain was weakly associated, its clinical relevance remains uncertain. Future research, particularly longitudinal studies, should explore the influence of psychosocial factors on treatment adherence and response to enhance management strategies for Achilles tendon pain.

Is Pilates more effective and cost-effective than aerobic exercise in the treatment of patients with fibromyalgia syndrome? A randomized controlled trial with economic evaluation.

BACKGROUND: The aim of this study was to assess the effectiveness and cost-effectiveness of Pilates versus aerobic exercises in the treatment of patients with fibromyalgia syndrome from a societal perspective. METHODS: This two-arm randomized controlled trial with blinded assessor and economic evaluation included 98 patients diagnosed with fibromyalgia syndrome using the American College of Rheumatology 2010 criteria, aged between 20 and 75 years, and pain intensity ≥3 points in the Pain Numerical Rating Scale. Patients were randomly allocated into the aerobic or Pilates group. Treatment was performed twice a week for 8 weeks. The primary outcome was the impact of fibromyalgia measured 8 weeks after randomization. Cost-effectiveness and cost-utility analyses were conducted for the impact of fibromyalgia and quality-adjusted life-years (QALYs), respectively, with a 12-month time horizon. RESULTS: There was no difference between the groups for the impact of fibromyalgia (MD: 6.5 points; 95% CI: -1.8 to 14.9). The incremental cost-effectiveness ratio showed that 1-point increase in the impact of fibromyalgia was on average associated with a societal cost of £56 for the Pilates group compared to the aerobic group. The cost-utility analysis showed that the Pilates group had a 0.71 probability of being cost-effective at a willingness-to-pay of £30,000 per QALY gained. CONCLUSION: There was no significant difference between groups for the impact of fibromyalgia. Pilates was not cost-effective compared to aerobic exercises for the impact of fibromyalgia. However, Pilates seemed to be the preferred option of treatment considering QALYs, although it depends on the willingness-to-pay threshold. SIGNIFICANCE: Pilates showed to be a safe and effective alternative for the treatment of patients with fibromyalgia syndrome. Pilates presented similar results for the impact of fibromyalgia and superior results for pain relief compared to aerobic exercises, a highly recommended intervention for the treatment of fibromyalgia syndrome. Pilates was not cost-effective compared to aerobic exercises for the impact of fibromyalgia. However, Pilates seemed to be a cost-effective intervention for QALYs, depending on the decision-maker's willingness-to-pay threshold.

Economic evaluations of educational, physical, and psychological treatments for fibromyalgia: a systematic review with meta-analysis.

ABSTRACT: Nonpharmacological interventions are recommended for the treatment of fibromyalgia, but there is a lack of knowledge about the cost-effectiveness of these interventions. The aim of this study was to systematically review economic evaluations of educational, physical, and psychological interventions for the treatment of fibromyalgia. The search was performed in PUBMED, EMBASE, CINAHL, Cochrane Library, Physiotherapy Evidence Database, PsycINFO, EconLit, National Health Service Economic Evaluation Database, and Health Technology Assessment. Economic evaluations of educational, physical, and psychological interventions for adult patients with fibromyalgia were included. Primary outcomes were healthcare and societal costs, and quality-adjusted life-years, and secondary outcomes were any disease-specific clinical outcome. Costs and effects were pooled in a meta-analysis, when possible. Eleven studies were included, of which 7 compared a psychological intervention with another intervention or usual care/control. Over a 6-month time horizon, healthcare and societal costs of the psychological intervention were significantly lower than usual care (mean difference: $-2087, 95% confidence interval [CI]: -3061 to -1112; mean difference: $-2411, 95% CI: -3582 to -1240, respectively), and healthcare costs were significantly lower for the psychological intervention compared with a pharmacological intervention (mean difference: $-1443, 95% CI: -2165 to -721). Over a 12-month time horizon, healthcare costs for the psychological intervention were significantly lower than for usual care (mean difference: $-538, 95% CI: -917 to -158). Incremental cost-effectiveness ratios for quality-adjusted life-years and impact of fibromyalgia showed that the psychological intervention was cost-effective compared with other interventions and control conditions. There is a need of more economic evaluations conducted alongside randomized controlled trials with interventions recommended for the treatment of fibromyalgia, such as physical exercise.

Comparison between different health state utility instruments in patients with fibromyalgia.

BACKGROUND: Cost-utility analysis uses utility indexes to assess treatment effects. Some discrepancies between different utility indexes instruments are suggested and need to be identified in health conditions not yet investigated. OBJECTIVE: To compare different utility indexes instruments in Brazilian patients with fibromyalgia and identify variables associated with these instruments. METHODS: Impact of fibromyalgia (Fibromyalgia Impact Questionnaire [FIQ]) and utility indexes (Short-Form 6 Dimensions [SF-6D], EuroQol 5 Dimensions [EQ-5D], and EuroQol - Visual Analogue Scale [EQ-VAS]) were assessed in 97 patients with fibromyalgia at baseline, 8-week (after an exercise-based intervention), and 6- and 12-month follow-up. Construct validity and responsiveness of the utility indexes instruments were compared. Multiple regression models were used to verify the variables associated with the utility indexes instruments. RESULTS: Construct validity analysis showed that FIQ presented moderate correlation with the SF-6D, the EQ-5D, and the EQ-VAS (r=-0.43, -0.41, -0.30, respectively, all p < .01). There was a moderate correlation between the SF-6D and the EQ-5D (r = 0.51, p < .001), moderate correlation between the SF-6D and the EQ-VAS (r = 0.41, p < .001), and no correlation between the EQ-VAS and the EQ-5D. The EQ-5D was responsive at the 8-week and 6-month follow-up, the SF-6D was responsive only at 6-month follow-up and the EQ-VAS was not responsive. The FIQ was associated with the EQ-5D and the SF-6D indexes, and symptom duration and depression with the EQ-VAS index. CONCLUSION: The EQ-5D better assessed the clinical change in patients with fibromyalgia. Furthermore, impact of fibromyalgia, symptom duration, and depression seem to be associated with the utility indexes.

Analysis of the measurement properties of the Brazilian-Portuguese version of the Tampa Scale for Kinesiophobia-11 in patients with fibromyalgia.

OBJECTIVE: To analyze the measurement properties of the Brazilian-Portuguese version of the Tampa Scale for Kinesiophobia-11 in patients with fibromyalgia. METHODS: Assessment was made at three time points: baseline (n=130) and 15 days (n=54) and eight weeks after baseline (n=51). Data collected at baseline were used to assess internal consistency, criterion and construct validity, and ceiling and floor effects. Data collected at baseline and 15 days after baseline were used to assess reliability and measurement error, and data collected before and after an eight-week exercise-based physical therapy intervention were used to assess interpretability of change scores. RESULTS: The Tampa Scale for Kinesiophobia-11 showed adequate internal consistency (Cronbach's alpha=0.77; alpha if item deleted: 0.74-0.77), substantial reliability (intraclass correlation coefficient2,1=0.85; 95% confidence interval: 0.75, 0.90), good measurement error (standard error of measurement: 2.65 points), and a minimal detectable change (90% confidence) of 6.16 points. For validity, the Tampa Scale for Kinesiophobia-11 showed a positive and good correlation with the original Tampa Scale for Kinesiophobia (r=0.84, p<0.01), positive and moderate correlation with the Pain Catastrophizing Scale (r=0.55, p<0.01), positive and weak correlation with the Numerical Pain Rating Scale (r=0.25, p<0.01), positive and moderate correlation with the Beck Depression Inventory (r=0.39, p<0.01), and no correlation with the Patient-Specific Functional Scale (r=0.11, p=0.23). Kinesiophobia, pain, function, catastrophizing, and depression statistically improved after the eight-week intervention (p<0.01). CONCLUSION: The Tampa Scale for Kinesiophobia-11 is consistent, reliable, and appropriate to assess fear of movement in patients with fibromyalgia in the clinical context. Responsiveness of the Tampa Scale for Kinesiophobia-11 should be tested in future studies.

Different weekly frequencies of Pilates did not accelerate pain improvement in patients with chronic low back pain.

BACKGROUND: Recent evidence recommends Pilates for the treatment of chronic low back pain. However, it is still unknown if different weekly frequencies of Pilates can accelerate the improvement of symptoms in patients with chronic low back pain verified by a daily pain assessment. OBJECTIVE: To analyze whether different weekly frequencies of Pilates can accelerate pain reduction by 30%, 50%, and 100% in patients with non-specific chronic low back pain and the necessary number of weeks to reach these improvements. METHODS: Two hundred and twenty-two patients were randomized into three groups: Pilates group 1 received treatment once a week, Pilates group 2 received treatment twice a week, and Pilates group 3 received treatment three times a week. All groups received Pilates for six weeks. Pain intensity was measured daily before and after each intervention session using the Pain Numerical Rating Scale. The assessor was not blind. RESULTS: The survival analysis showed that all Pilates groups had a pain reduction of 30%, 50%, and 100% at the same speed during treatment. There was no difference between the different weekly frequencies of Pilates for any of the comparisons (p>0.05). After the first week of treatment, 44.6% of the patients in Pilates group 3 showed complete pain improvement, followed by 37.8% of the patients in Pilates group 2 and 29.7% in Pilates group 1. After the last week, 71.6% (Pilates group 1), 77% (Pilates group 2), and 78.4% (Pilates group 3) of the patients reported complete improvement of symptoms. CONCLUSION: Different weekly frequencies of Pilates did not accelerate pain improvement in patients with non-specific chronic low back pain. Registered in Clinical Trials Registry: NCT02241538 (https://clinicaltrials.gov/ct2/show/NCT02241538).

Examination of a Subgroup of Patients With Chronic Low Back Pain Likely to Benefit More From Pilates-Based Exercises Compared to an Educational Booklet.

OBJECTIVE: To investigate whether 2 previously published classification approaches, the updated treatment-based classification system and a Pilates subgroup defined by a preliminary clinical prediction rule, could identify patients with chronic low back pain who would benefit more from Pilates exercises compared to an educational booklet. DESIGN: Secondary analysis of a randomized controlled trial. METHODS: Two hundred twenty-two patients received advice and were randomly allocated to a group that received an educational booklet with no additional treatment (n = 74) or a group that received Pilates-based exercise treatment (n = 148) 2 or 3 times a week. At baseline, using a treatment-based classification system, patients were classified as having a good prognosis (positive movement control) or a poor prognosis. Similarly, using the Pilates clinical prediction rule, patients were classified as having a good prognosis (positive) or a poor prognosis (negative). The analysis was conducted using linear regression models to analyze the interaction between subgroup characteristics and treatment effect size, with changes in pain and disability from baseline to 6 weeks after randomization as dependent variables. RESULTS: None of the interaction terms for pain and disability were statistically significant. The treatment effect of Pilates versus an educational booklet was similar in all subgroups. CONCLUSION: The treatment-based classification system and the Pilates clinical prediction rule did not differentiate subgroups of patients with chronic low back pain who were more or less likely to benefit more from Pilates compared to an educational booklet. J Orthop Sports Phys Ther 2020;50(4):189-197. Epub 23 Aug 2019. doi:10.2519/jospt.2019.8839.

Exercise therapy in the treatment of tendinopathies of the lower limbs: a protocol of a systematic review.

BACKGROUND: Tendinopathies are specific degenerative conditions of the tendon characterized by pain and disability. The most common tendinopathies of the lower limbs are patellar, Achilles, gluteal, and proximal tendinopathy of the hamstring muscles. Exercise therapy has been studied for the treatment of these tendinopathies; however, different types of muscle contraction, exercise, dose, and intensity are found in the literature, which can make choosing the best treatment option difficult. The purpose of this systematic review is to analyze the available evidence about the effectiveness of exercise therapy in the treatment of patients with lower limb tendinopathies and the effects of different types of exercise therapy in the treatment of these patients. METHODS: The search strategy will be performed in the following databases: CENTRAL, MEDLINE, EMBASE, PEDro, SPORTDiscus, and CINAHL. The inclusion criteria of the studies will be randomized controlled trials with patients with one of the following tendinopathies: patellar, Achilles, gluteal, and proximal tendinopathy of the hamstring muscles. The primary outcomes will be pain and disability. The intervention will be exercise therapy, and the comparators will be different types of exercise, control groups, or any other type of intervention. DISCUSSION: Other systematic reviews have been published about the prescription of exercise therapy in the treatment of tendinopathies of the lower limbs. However, the results of these reviews are limited to only one type of tendinopathy or specific exercise. Because some of these reviews are also outdated, this systematic review will investigate whether exercise therapy is more effective than any other type of intervention and if there is a best form of exercise therapy, considering modality, dose, and intensity, for the treatment of lower limb tendinopathies. Furthermore, this study will present data related to the sample size, recruitment period, methodological quality, and visibility of the eligible studies. SYSTEMATIC REVIEW REGISTRATION: PROSPERO ( CRD42018093011 ).

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.

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.

Predictive factors for progression through the difficulty levels of Pilates exercises in patients with low back pain: a secondary analysis of a randomized controlled trial.

BACKGROUND: The progression through the difficulty levels of Pilates exercises is a subjective criterion, that depends on the therapist's experience and ability to identify the best moment to progress to the next level. OBJECTIVE: To identify the factors that interfere in the progression through the difficulty levels of the Pilates exercises in patients with chronic nonspecific low back pain. METHODS: Data from 139 patients with chronic nonspecific low back pain from a randomized controlled trial were used for statistical analysis using binary logistic regression. The dependent variable was the progression through the difficulty levels, and the independent variables were age, gender, educational level, low back pain duration, pain intensity, general disability, kinesiophobia, previous physical activity, and number of absences. RESULTS: The factors that interfered in the progression through the difficulty levels were previous physical inactivity (odds ratio [OR]=5.14, 95% confidence interval [CI]: 1.53-17.31), low educational level (OR=2.62, 95% CI: 1.12-6.10), more advanced age (OR=0.95, 95% CI: 0.92-0.98) and more absences (OR=0.63, 95% CI: 0.50-0.79). These variables explain 41% of the non-progression through the difficulty level of the exercises. CONCLUSION: Physical inactivity, low educational level, more advanced age and greater number of absences can be interfering factors in the progression through the difficulty levels of the Pilates exercises in patients with chronic nonspecific low back pain.

Comparação da satisfação, motivação, flexibilidade e dor muscular tardia entre método Pilates moderno e método Pilates instável / Comparación de la satisfacción, motivación, flexibilidad y dolor muscular tardío entre el método Pilates moderno y el método Pilates inestable / Comparison of satisfaction, motivation, flexibility and delayed onset muscle soreness between modern Pilates method and unstable Pilates method

RESUMO O objetivo deste estudo foi comparar a satisfação e motivação para a prática de exercício físico, flexibilidade e dor muscular tardia (DMT) em participantes saudáveis após exercícios de duas modalidades do método Pilates. Para isso, cinquenta participantes saudáveis realizaram uma sessão de exercícios do Pilates moderno e outra do Pilates instável. Foram avaliados os desfechos satisfação e motivação após as sessões, flexibilidade posterior do tronco e membros inferiores (banco de Wells) antes e após cada sessão, e DMT 24, 48 e 72 horas após cada sessão (Escala Numérica de Dor). Os resultados mostraram que não houve diferença estatisticamente significante entre as duas modalidades do Pilates para satisfação e motivação, flexibilidade e DMT 72 horas após a sessão (p>0,05). Para a DMT foi observada diferença estatisticamente significante entre as duas modalidades 24 horas (diferença entre as médias: -0,7; IC a 95%: -1,5 a 0,0) e 48 horas (diferença entre as médias: -0,8; IC a 95%: -1,4 a -0,2) após a sessão, com maior dor no Pilates instável. Como conclusão, as duas modalidades do Pilates apresentaram o mesmo nível de satisfação e motivação e ganho similar de flexibilidade. No entanto, o Pilates instável causou mais DMT após 24 e 48 horas, mas essa diferença não foi clinicamente relevante.

RESUMEN El objetivo de este estudio ha sido comparar la satisfacción y motivación para la práctica de ejercicio físico, flexibilidad y dolor muscular tardío (DMT) en participantes sanos después de ejercicios de dos modalidades del método Pilates. Para ello, cincuenta participantes sanos realizaron una sesión de ejercicios del Pilates moderno y otra del Pilates inestable. Se evaluaron los resultados de satisfacción y motivación después de las sesiones, flexibilidad posterior del tronco y miembros inferiores (banco de Wells) antes y después de cada sesión, y DMT 24, 48 y 72 horas después de cada sesión (Escala Numérica de Dolor). Los resultados mostraron que no hubo diferencia estadísticamente significativa entre las dos modalidades del Pilates para satisfacción y motivación, flexibilidad y DMT 72 horas después de la sesión (p>0.05). Para la DMT se observó diferencia estadísticamente significativa entre las dos modalidades 24 horas (diferencia entre las medias: -0.7, IC a 95%: -1.5 a 0.0) y 48 horas (diferencia entre las medias: -0.8, IC a 95%: -1.4 a -0.2) después de la sesión, con mayor dolor en el Pilates inestable. Como conclusión, las dos modalidades del Pilates presentaron el mismo nivel de satisfacción y motivación y benificio similar de flexibilidad. Sin embargo, el Pilates inestable causó más DMT después de 24 y 48 horas, pero esa diferencia no ha sido clínicamente relevante.

ABSTRACT The aim of our study was to compare the satisfaction and motivation for the practice of exercise, flexibility and delayed onset muscle soreness (DOMS) in healthy participants after exercises in two types of the Pilates method. For this, 50 healthy participants performed a session of exercises of modern Pilates and other of unstable Pilates. We evaluated the outcomes for satisfaction and motivation after sessions, posterior flexibility of the torso and lower extremities (sit-and-reach box) before and after each session, and DOMS 24, 48 and 72 hours after each session (Numeric Pain Rating Scale). Results showed no statistically significant difference between both types of Pilates for satisfaction and motivation, flexibility and DOMS 72 hours after the session (p>0.05). Regarding the DOMS we observed statistically significant difference between the two types 24 hours (difference between the means: -0.7; 95%CI: -1.5 to 0.0) and 48 hours (difference between means: -0.8; 95%CI: -1.4 to -0.2) after the session, with greater pain in unstable Pilates. As a conclusion, both categories of Pilates showed the same level of satisfaction and motivation and similar flexibility gain. However, unstable Pilates caused more DOMS after 24 and 48 hours, but this difference was not clinically relevant.