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Introduction: Considering the prospects of increased prevalence and disability due to neck and low back pain, it is relevant to investigate the care processes adopted, to assist future public policies and decision-making for a better allocation of resources. Objective: the aim of this study was to estimate the costs arising from inpatient and outpatient care of individuals with Neck Pain (NP) and Low Back Pain (LBP) in Brazil, between 2010 and 2019., Methods: This is a cost-of-illness study from the perspective of the Brazilian public health system, based on health conditions with high prevalence (neck and low back pain). Data were presented descriptively using absolute and relative values., Results: Between 2010 and 2019, the health system spent more than $600 million (R$ 2.3 billion) to treat NP and LBP in adults, and LBP accounted for most of the expenses. Female had higher absolute expenses in inpatient care and in the outpatient system., Conclusion: Our study showed that the costs with NP and LBP in Brazil were considerable. Female patients had higher outpatient costs and male patients had higher hospitalization costs. Healthcare expenses were concentrated for individuals between 34 and 63 years of age.

Introduction: The EQ-5D-Y-3L is a generic measure of health-related quality of life in children and adolescents. Although the Brazilian-Portuguese EQ-5D-Y-3L version is available, there is no value set for it, hampering its use in economic evaluations. This study aimed to elicit a Brazilian EQ-5D-Y-3L value set based on preferences of the general adult population., Methods: Two independent samples of adults participated in an online discrete choice experiment (DCE) survey and a composite time trade-off (cTTO) face-to-face interview. The framing was "considering your views for a 10-year-old child". DCE data were analyzed using a mixed-logit model. The 243 DCE predicted values were mapped into the observed 28 cTTO values using linear and non-linear mapping approaches with and without intercept. Mapping approaches' performance was assessed to estimate the most valid method to rescale DCE predicted values using the model fit (R 2 ), Akaike Information Criteria (AIC), root mean squared error (RMSE), and mean absolute error (MAE)., Results: A representative sample of 1376 Brazilian adults participated (DCE, 1152; cTTO, 211). The linear mapping without intercept (R 2 = 96%; AIC, - 44; RMSE, 0.0803; MAE, - 0.0479) outperformed the non-linear without intercept (R 2 = 98%; AIC, - 63; RMSE, 0.1385; MAE, - 0.1320). Utilities ranged from 1 (full health) to - 0.0059 (the worst health state). Highest weights were assigned to having pain or discomfort (pain/discomfort), followed by walking about (mobility), looking after myself (self-care), doing usual activities (usual activities), and feeling worried, sad, or unhappy (anxiety/depression)., Conclusion: This study elicited the Brazilian EQ-5D-Y-3L value set using a mixed-logit DCE model with a power parameter based on a linear mapping without intercept, which can be used to estimate the quality-adjusted life-years for economic evaluations of health technologies targeting the Brazilian youth population., (© 2024. The Author(s).)

Background: One strategy to prevent adverse effects resulting from chemotherapy treatment is to perform physical exercises during treatment. However, there is still no consensus on the best type and intensity of exercise, nor when it should be started. Most studies have been carried out in patients with breast cancer, usually a few weeks after starting chemotherapy, on an outpatient basis 2 to 3 times a week. The main differences in our study are that we carried out physical training in hospitalized patients undergoing a cycle of chemotherapy for cancer treatment and that this training was carried out 5 times a week and was not restricted to a specific type of cancer., Objective: We aimed to evaluate the effects of aerobic training on symptoms related to chemotherapy (nausea, vomiting, asthenia, and sensation of weakness), fatigue, mobility, clinical complications, and length of hospital stay of patients during the drug treatment cycle. We also evaluated patient satisfaction with the proposed intervention, the adverse effects of aerobics training, and the cost-effectiveness of this intervention., Methods: This is a controlled and randomized trial with blinded evaluation that will include 94 hospitalized patients with cancer for 1 or more cycles of chemotherapy. The intervention group will perform aerobic training during a cycle of chemotherapy. The control group will receive a booklet with guidelines for staying active during the hospitalization period. The groups will be compared using a linear mixed model for fatigue, mobility, and chemotherapy-related symptoms before and after the intervention. The length of hospital stay will also be compared between groups using Kaplan-Meier survival analysis. The incidence of complications will be compared using the χ 2 test. Cost-effectiveness and cost-utility analyses will be performed for the impact of exercise and quality-adjusted life years with the EQ-5D-3L-21 quality of life trials. The implementation variables (acceptability, suitability, and feasibility) will be evaluated by frequencies., Results: The clinical trial registration was approved in March 2023. Recruitment and data collection for the trial are ongoing, and the results of this study are likely to be published in late 2025., Conclusions: Chemotherapy has side effects that negatively impact the quality of life of patients with cancer. Aerobic exercise can reduce these side effects in a simple and inexpensive way. The field of work of physical therapists could be expanded to oncology if the intervention works., Trial Registration: Registro Brasileiro de Ensaios Clínicos RBR-6b4zwx3; https://tinyurl.com/39c4c7wz., International Registered Report Identifier (irrid): DERR1-10.2196/60828., (©William de Lima Selles, Gisela Cristiane Miyamoto, Elinaldo da Conceição Santos, Cibelle Regina Lima Carmo, Giovanni Marini Moura, Giovanna Marques Frascoli Santos, Giovanna dos Santos Lopes, Diego Wisnieski Silva, Leticia Jeremias Ferreira Pereira, Adriana Claudia Lunardi. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 20.08.2024.)

Background: Biomechanical alterations in patients with low back pain (LBP), as reduced range of motion or strength, do not appear to be exclusively related to the trunk. Thus, studies have investigated biomechanical changes in the hip, due to the proximity of this joint to the low back region. However, the relationship between hip biomechanical changes in patients with LBP is still controversial and needs to be summarized. Therefore, the aim of this study was to systematically review observational studies that used biomechanical assessments in patients with non-specific LBP., Methods: The search for observational studies that evaluated hip biomechanical variables (i.e., range of motion, kinematic, strength, and electromyography) in adults with non-specific acute, subacute, and chronic LBP was performed in the PubMed, Embase, Cinahl and Sportdiscus databases on February 22 nd , 2024. Four blocks of descriptors were used: 1) type of study, 2) LBP, 3) hip and 4) biomechanical assessment. Two independent assessors selected eligible studies and extracted the following data: author, year of publication, country, study objective, participant characteristics, outcomes, and results. The methodological quality of the studies was assessed using the Epidemiological Appraisal Instrument and classified as low, moderate, and high. Due to the heterogeneity of the biomechanical assessment and, consequently, of the results among eligible studies, a descriptive analysis was performed., Results: The search strategy returned 338 articles of which 54 were included: nine articles evaluating range of motion, 16 evaluating kinematic, four strength, seven electromyography and 18 evaluating more than one outcome. The studies presented moderate and high methodological quality. Patients with LBP, regardless of symptoms, showed a significant reduction in hip range of motion, especially hip internal rotation, reduction in the time to perform functional activities such as sit-to-stance-to-sit, sit-to-stand or walking, greater activation of the hamstrings and gluteus maximus muscles and weakness of the hip abductor and extensor muscles during specific tests and functional activities compared to healthy individuals., Conclusion: Patients with LBP present changes in range of motion, task execution, activation, and hip muscle strength when compared to healthy individuals. Therefore, clinicians must pay greater attention to the assessment and management of the hip during the treatment of these patients., Systematic Review Registration: International Prospective Register of Systematic Reviews (PROSPERO) (CRD42020213599)., (© 2024. The Author(s).)

Abstract: Studies suggest a high economic burden among children and adolescents with musculoskeletal pain. There is no summary in the literature on the overall economic burden of musculoskeletal pain in children and adolescents. The aim of this systematic review of cost-of-illness studies was to synthesize the economic burden of musculoskeletal pain in children and adolescents. We conducted electronic searches on MEDLINE, EMBASE, CINAHL, EconLit, NHSEED, and HTA databases. We included cost-of-illness studies that estimated healthcare, patient/family, lost productivity, and/or societal costs in children and adolescents with musculoskeletal pain. The risk of bias was assessed with the Consolidated Health Economic Evaluation Reporting Standards checklist. All values were adjusted to the same reference year (2021) and converted to American Dollar. We included 45 cost-of-illness studies (n = 665,623). Twenty-two studies estimated the annual healthcare costs that ranged from $143 to $41,379 per patient. Nine studies estimated the annual patient/family costs that ranged from $287 to $27,972 per patient. Seven studies estimated the annual lost productivity costs that ranged from $124 to $4671 per patient. Nine studies estimated the annual societal costs that ranged from $1095 to $69,351 per patient. Children and adolescents with juvenile idiopathic arthritis and musculoskeletal pain had higher annual incremental healthcare costs than those without these conditions (mean difference: $3800 higher, 95% confidence interval [CI]: 50-7550; mean difference: $740 higher, 95% CI: 470-1,010, respectively). In conclusion, the estimated annual economic burden of children and adolescents with musculoskeletal pain ranged from $124 to $69,351., (Copyright © 2023 International Association for the Study of Pain.)

Background: Although the EQ-5D instruments have been initially designed for adult populations, there are new studies evaluating and applying these instruments to children and adolescents. The EuroQol Group adapted and created two versions designed for these groups, i.e., the EQ-5D-Y versions. The measurement properties of the EQ-5D have been systematically reviewed in different health conditions. However, there is a lack of a proper systematic assessment including the studies' risk of bias and focusing on recent studies assessing the EQ-5D instruments in children and adolescents. The lack of a systematic assessment of the EQ-5D versions does not allow us to have a comprehensive evaluation of the validity, reliability, and responsiveness of these instruments among children and adolescents. This systematic review aims to critically appraise and summarize the evidence on the measurement properties of the EQ-5D instruments (self-reported version - answered by children and adolescents; and proxy versions - versions reported by parents, caregivers, or health professionals) in children and adolescents., Methods: A systematic review searching the following electronic databases: MEDLINE, EMBASE, CINAHL, EconLit, National Health Service Economic Evaluation Database (NHS-EED), Health Technology Assessment (HTA) database. Two independent reviewers will screen titles and abstracts and select full texts for eligibility. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology will be followed to conduct three main assessment steps: risk of bias, quality criteria for measurement properties, and evidence synthesis., Discussion: This systematic review will provide comprehensive information about the evidence regarding the measurement properties of EQ-5D instruments in children and adolescents of different settings and countries., Systematic Review Registration: Open Science Framework with Registration https://osf.io/r8kt9/ and PROSPERO: CRD42020218382., (© 2024. The Author(s).)

Question: How much are the reductions in pain intensity and improvements in physical function from Pilates exercise mediated by changes in pain catastrophising and kinesiophobia?, Design: This was a secondary causal mediation analysis of a four-arm randomised controlled trial testing Pilates exercise dosage (once, twice or thrice per week) against a booklet control., Participants: Two hundred and fifty-five people with chronic low back pain., Data Analysis: All analyses were conducted in R software (version 4.1.2) following a preregistered analysis plan. A directed acyclic graph was constructed to identify potential pre-treatment mediator-outcome confounders. For each mediator model, we estimated the intervention-mediator effect, the mediator-outcome effect, the total natural indirect effect (TNIE), the pure natural direct effect (PNDE), and the total effect (TE)., Results: Pain catastrophising mediated the effect of Pilates exercise compared with control on the outcomes pain intensity (TNIE MD -0.21, 95% CI -0.47 to -0.03) and physical function (TNIE MD -0.64, 95% CI -1.20 to -0.18). Kinesiophobia mediated the effect of Pilates exercise compared with control on the outcomes pain intensity (TNIE MD -0.31, 95% CI -0.68 to -0.02) and physical function (TNIE MD -1.06, 95% CI -1.70 to -0.49). The proportion mediated by each mediator was moderate (21 to 55%)., Conclusion: Reductions in pain catastrophising and kinesiophobia partially mediated the pathway to improved pain intensity and physical function when using Pilates exercise for chronic low back pain. These psychological components may be important treatment targets for clinicians and researchers to consider when prescribing exercise for chronic low back pain., (Copyright © 2023 Australian Physiotherapy Association. Published by Elsevier B.V. All rights reserved.)

Background: Although clinical practice guidelines recommend pain education as the first-line option for the management of chronic musculoskeletal pain, there is a lack of pain education programmes in healthcare. Thus, digital health programmes can be an effective tool for implementing pain education strategies for public health. This trial will aim to analyse the implementation and effectiveness outcomes of three online pain science education strategies in the Brazilian public health system (SUS) for individuals with chronic musculoskeletal pain., Methods: We will conduct a hybrid type III effectiveness-implementation randomised controlled trial with economic evaluation. We will include adult individuals with chronic musculoskeletal pain, recruited from primary healthcare in the city of Guarapuava, Brazil. Individuals will be randomised to three implementation groups receiving a pain science education intervention (EducaDor) but delivered in different modalities: group 1) synchronous online; group 2) asynchronous videos; and group 3) interactive e-book only. Implementation outcomes will include acceptability, appropriateness, feasibility, adoption, fidelity, penetration, sustainability, and costs. We will also assess effectiveness outcomes, such as pain, function, quality of life, sleep, self-efficacy, and adverse effects. Cost-effectiveness and cost-utility analyses will be conducted from the SUS and societal perspectives. The evaluations will be done at baseline, post-intervention (10 weeks), and 6 months., Discussion: This study will develop and implement a collaborative intervention model involving primary healthcare professionals, secondary-level healthcare providers, and patients to enhance self-management of chronic pain. In addition to promoting better pain management, this study will also contribute to the field of implementation science in public health by generating important insights and recommendations for future interventions., Trial Registration: ClinicalTrials.gov (NCT05302180; 03/29/2022)., (© 2023. The Author(s).)

Objective: To explore whether using a single matched or composite outcome might affect the results of previous randomized controlled trials (RCTs) testing exercise for non-specific low back pain (NSLBP). The first objective was to explore whether a single matched outcome generated greater standardized mean differences (SMDs) when compared with the original unmatched primary outcome SMD. The second objective was to explore whether a composite measure, composed of matched outcomes, generated a greater SMD when compared with the original primary outcome SMD., Design: We conducted exploratory secondary analyses of data., Setting: Seven RCTs were included, of which 2 were based in the USA (University research clinic, Veterans Affairs medical center) and the UK (primary care clinics, nonmedical centers). One each were based in Norway (clinics), Brazil (primary care), and Japan (outpatient clinics)., Participants: The first analysis comprised 1) 5 RCTs (n=1033) that used an unmatched primary outcome but included (some) matched outcomes as secondary outcomes, and the second analysis comprised 2) 4 RCTs (n=864) that included multiple matched outcomes by developing composite outcomes (N=1897)., Intervention: Exercise compared with no exercise., Main Outcome Measures: The composite consisted of standardized averaged matched outcomes. All analyses replicated the RCTs' primary outcome analyses., Results: Of 5 RCTs, 3 had greater SMDs with matched outcomes (pooled effect SMD 0.30 [95% confidence interval {CI} 0.04, 0.56], P=.02) compared with an unmatched primary outcome (pooled effect SMD 0.19 [95% CI -0.03, 0.40] P=.09). Of 4 composite outcome analyses, 3 RCTs had greater SMDs in the composite outcome (pooled effect SMD 0.28 [95% CI 0.05, 0.51] P=.02) compared with the primary outcome (pooled effect SMD 0.24 [95% CI -0.04, 0.53] P=.10)., Conclusions: These exploratory analyses suggest that using an outcome matched to exercise treatment targets in NSLBP RCTs may produce greater SMDs than an unmatched primary outcome. Composite outcomes could offer a meaningful way of investigating superiority of exercise than single domain outcomes., (Copyright © 2022 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)

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., (© 2022 European Pain Federation - EFIC ®.)

Background: The aims of this study were twofold: (1) to compare the body image and tactile acuity of patients with fibromyalgia and asymptomatic participants, and (2) to investigate the effects of an 8-week exercise-based intervention (aerobic or Pilates exercises) on the body image, tactile acuity, and pain intensity in patients with fibromyalgia., Methods: A cross-sectional study and a secondary analysis of a randomized controlled trial were carried out, which assessed the following outcomes in 24 patients with fibromyalgia and 24 asymptomatic participants: subjective body image (Drawing Test), tactile acuity (Two-Point Discrimination Test), limb circumference (Cirtometry), and pain (Pain Numerical Rating Scale). After the assessment, the 24 patients with fibromyalgia were randomly allocated to one of the intervention groups: aerobic or Pilates., Results: There was no significant difference in the tactile acuity of the cervical, lumbar, hands, and feet regions between the participants with fibromyalgia and the asymptomatic participants (p > 0.05). However, patients with fibromyalgia showed changes in subjective body image when the drawings were compared to the cirtometry measurements. After the intervention, there was no significant difference between aerobic exercise and Pilates for pain and tactile acuity in the cervical, lumbar, hands, and feet regions of patients with fibromyalgia (p > 0.05)., Conclusions: Patients with fibromyalgia presented altered perception in subjective body image but not on tactile acuity, when compared to asymptomatic participants. In addition, there was no difference between aerobic exercise and Pilates for pain and tactile acuity in these patients., (© 2022 World Institute of Pain.)

Background: Internet-based self-management programs and telerehabilitation initiatives have increased and have been extensively used for delivering health care in many areas. These programs overcome common barriers that patients face with traditional face-to-face health care, such as travel expenditures, lack of time, and high demand on the public health system. During the COVID-19 pandemic, this mode of web-based health care delivery had become more popular. However, there is still a lack of studies testing this mode of delivery in low- and middle-income countries. To gain a better understanding of the context, feasibility, and factors involved in the implementation of a web-based program, pilot and implementation studies are necessary. These studies can better inform whether a strategy is feasible, acceptable, and adequate for its purposes and for optimizing resource allocation., Objective: This study aims to evaluate the feasibility, usability, and implementation context of a self-management internet-based program based on exercises and pain education (ReabilitaDOR) in people with chronic musculoskeletal pain and to compare this program with a program using only a web-based self-management booklet., Methods: The study design was a parallel pilot study of a prospectively registered, assessor-blinded, 2-arm randomized controlled trial with economic evaluation. This study was performed using waiting lists of physiotherapy and rehabilitation centers and advertisements on social media networks. The participants were 65 patients with chronic musculoskeletal pain aged between 18 and 60 years. The effects of an 8-week telerehabilitation program based on exercises and pain education (intervention group) were compared with those of a program based only on a web-based self-management booklet (control group). The main outcome measures were implementation outcomes of patients' perceptions of acceptability, appropriateness, feasibility, and usability of the program and the societal costs and feasibility of the main trial at 8-week posttreatment follow-up. Adverse events were also analyzed., Results: In total, 56 participants were analyzed at the 8-week follow-up. The intervention group showed responses with a mean of 4.5 (SD 0.6) points for acceptability, 4.5 (SD 0.5) points for appropriateness, and 4.5 (SD 0.6) points for feasibility measured on a 1 to 5 scale. All patients in the intervention group showed satisfactory responses to the system usability outcome. There is satisfactory evidence for the feasibility of the main trial. For costs related to the interventions, health care, patients, and loss of productivity at 8 weeks, we found a total expenditure of US $278.30 per patient in the intervention group and US $141.52 per patient in the control group. No adverse events were reported during the intervention period., Conclusions: We found that the ReabilitaDOR program is feasible, appropriate, and acceptable from the users' implementation perspective. This system was considered usable by all the participants, and the main trial seemed feasible. Cost data were viable to be collected, and the program is likely to be safe., Trial Registration: ClinicalTrials.gov NCT04274439; https://clinicaltrials.gov/ct2/show/NCT04274439., (©Iuri Fioratti, Gisela Cristiane Miyamoto, Junior Vitorino Fandim, Camila Pereira Pontes Ribeiro, Geovana Domingues Batista, Gabriella Evangelista Freitas, Andressa Santos Palomo, Felipe José Jandré dos Reis, Leonardo Oliveira Pena Costa, Christopher G Maher, Bruno Tirotti Saragiotto. Originally published in JMIR Formative Research (https://formative.jmir.org), 30.08.2022.)

Background: As resources for healthcare are scarce, decision-makers increasingly rely on economic evaluations when making reimbursement decisions about new health technologies, such as drugs, procedures, devices, and equipment. Economic evaluations compare the costs and effects of two or more interventions. Musculoskeletal disorders have a high prevalence and result in high levels of disability and high costs worldwide. Because physical therapy interventions are usually the first line of treatment for musculoskeletal disorders, economic evaluations of such interventions are becoming increasingly important for stakeholders in the field of physical therapy, including physical therapists, decision-makers, and reseachers. However, economic evaluations are relatively difficult to interpret for the majority of stakeholders., Objective: To support physical therapists, decision-makers, and researchers in the field of physical therapy interpreting trial-based economic evaluations and translating the results of such studies to clinical practice., Methods: The design, analysis, and interpretation of economic evaluations performed alongside randomized controlled trials are discussed. To further illustrate and explain these concepts, we use a case study assessing the cost-effectiveness of exercise therapy compared to standard advice in patients with musculoskeletal disorders., Conclusions: Economic evaluations are increasingly being used in healthcare decision-making. Therefore, it is of utmost importance that their design, conduct, and analysis are state-of-the-art and that their interpretation is adequate. This masterclass will help physical therapists, decision-makers, and researchers in the field of physical therapy to critically appraise the quality and results of trial-based economic evaluations and to apply the results of such studies to their own clinical practice and setting., Competing Interests: Conflict of Interest The authors declare no conflicts of interest., (Copyright © 2021 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier España, S.L.U. All rights reserved.)

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., (Copyright © 2021 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier España, S.L.U. All rights reserved.)

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., (Copyright © 2021 International Association for the Study of Pain.)

Objectives: To compare the effectiveness of an education intervention with or without the addition of the therapeutic alliance to no education intervention in patients with nonspecific chronic low back pain (LBP) and low risk of poor prognosis., Design: Randomized controlled trial. Randomization was performed using randomly generated numbers., Methods: Two hundred twenty-two patients with nonspecific chronic LBP and low risk of poor prognosis from 2 university physical therapy services in Taubaté, Brazil were randomized into 3 groups: education plus therapeutic alliance, education only, and no education. Primary outcomes were pain (measured with the numeric pain-rating scale) and patient-specific disability (measured with the Patient-Specific Functional Scale), assessed 1 month after randomization. The patients, therapists, and assessors were not blinded due to the nature of the intervention and self-reported outcomes., Results: Patients were recruited between November 2015 and February 2017. There was a loss of 17 (7.6%) follow-up assessments at 1 month, 28 (12.6%) at 6 months, and 31 (13.9%) at 12 months after randomization, and intention-to-treat analyses were conducted. There were no significant differences in pain between groups. However, there was a significant improvement in patient-specific disability for the education-plus-therapeutic alliance and education-only groups compared to no education after 1 month (mean difference, -1.41; 95% confidence interval: -2.31, -0.51 and -0.95; 95% confidence interval: -1.85, -0.04, respectively)., Conclusion: An education intervention did not provide clinically relevant improvements in patient-specific disability and did not influence pain in patients with nonspecific chronic LBP and low risk of poor prognosis. Additionally, there was no difference between interventions with or without emphasis on the therapeutic alliance. J Orthop Sports Phys Ther 2021;51(8):392-400. Epub 7 May 2021. doi:10.2519/jospt.2021.9636 .

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 coefficient 2,1 =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., (Copyright © 2020 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier España, S.L.U. All rights reserved.)

Background: Running is one of the most popular and accessible physical activities in the world. However, running-related injuries are unfortunately very common. Scientific evidence is limited and scarce regarding (cost-)effectiveness and implementation process of interventions for running-related injuries prevention. Thus, the objective of this study will be to investigate the effectiveness, cost-effectiveness and implementation process of a running-related injury prevention program (RunIn3)., Methods: This is the protocol of a pragmatic hybrid type 1 randomized controlled trial. There will be 530 runners over 18 years old, without running-related injuries in the last 3 months from São Paulo, Brazil. This program will be delivered online with two broad actions: (1) to provide feedback on individual training characteristics and running-related injury risk; and (2) providing/enhancing knowledge, skills and self-efficacy on running-related injury preventive behaviors. The primary outcome will be the proportion of runners reporting running-related injuries. The secondary outcomes will be preventive behaviors, direct and indirect costs, and implementation outcomes. The main effectiveness analysis on the primary outcome will be performed using linear probability mixed models in order to allow outcome changes over time and to yield the absolute risk reduction between-groups., Discussion: The main hypothesis of this study is that the RunIn3 program will be effective in reducing the running-related injury risk and in promoting preventive behavior, either by increasing the frequency of healthy behaviors or by reducing the frequency of risk behaviors. Moreover, if the RunIn3 program is effective in reducing the running-related injuries risk, we believe that this effect would go alongside with a reduction of societal costs., Trail Registration: Clinicaltrials.gov (NCT03892239) Registered 5 February 2019 - Prospectively registered, https://clinicaltrials.gov/ct2/show/NCT03892239., Competing Interests: The authors declare that they have no competing interest of any nature., (© 2021 The Authors. Published by Elsevier Inc.)

Background: Chronic musculoskeletal pain is one of the main causes of years lived with disability and generates the highest cost of health care among chronic pain conditions. Internet-based treatments have been shown to be an alternative for the treatment of musculoskeletal conditions, in addition to reducing barriers such as travel, high demands on the public health system, lack of time, lack of insurance coverage for private care, and high costs for long-term treatment. The aim of this clinical trial is to develop and test the effectiveness and cost-effectiveness of, an internet-based self-management program based on pain education and exercise for people with chronic musculoskeletal pain., Methods: This is a prospectively registered, assessor-blinded, two-arm randomised controlled trial with economic evaluation comparing the Internet-based pain education and exercise intervention with a control group that will receive an online booklet. One hundred and sixty patients will be recruited from Sao Paulo, Brazil. Follow-ups will be conducted in post-treatment, 6 and 12 months after randomisation. The conduct of the study, as well as the evaluations and follow-ups will be carried out entirely remotely, through online platforms and telephone calls. The primary outcome will be pain intensity at post-treatment (8 weeks) measured using the 11-item Pain Numerical Rating Scale. Secondary outcomes will be biopsychosocial factors presents in the chronic musculoskeletal pain condition. Costs due to chronic musculoskeletal pain will be also measured, and cost-effectiveness analysis from a societal perspective will performed., Discussion: Our hypothesis is that internet-based pain education and exercise will be better than an online booklet in reducing pain and improving biopsychosocial outcomes in patients with chronic musculoskeletal pain. In addition, we believe that there will be good acceptance of patients for the internet-based intervention and that internet-based intervention will be more cost effective than the online booklet., Trial Registration: The study was prospectively registered at ClinicalTrials.gov ( NCT04274439 , registered 18 February 2020).

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)., (Copyright © 2019 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier Editora Ltda. All rights reserved.)

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 .

Background: Chronic musculoskeletal pain affects the quality of life of older adults by interfering in their ability to perform activities of daily living. Aerobic exercise programs have been used in the treatment of various health conditions, including musculoskeletal disorders. However, there is still little evidence on the effects of aerobic exercise for the treatment of older adults with chronic musculoskeletal pain. Thus, the objective of this study is to assess the effects of aerobic exercise in improving pain and function of older adults with chronic pain as a consequence of different chronic musculoskeletal conditions., Methods: The databases to be used in the search are PubMed, EMBASE, CINAHL, PEDro, and Cochrane Central Register of Controlled Trials (CENTRAL). Randomized controlled trials that used aerobic exercise in the treatment of older adults with chronic musculoskeletal pain will be included. Primary outcomes will be pain and function. We will use the PEDro scale to evaluate the methodological quality and statistical description of each included study, and the strength of the recommendations will be summarized using GRADE., Discussion: The results of this systematic review will provide a synthesis of the current evidence on the effects of aerobic exercise in the treatment of older adults with chronic musculoskeletal pain. In addition, this information can help health professionals in decision-making about the use of aerobic exercise in the treatment of older adults with chronic musculoskeletal pain., Ethics and Dissemination: This systematic review was recorded prospectively, and the results will be part of a doctoral thesis to be published in a peer-reviewed international journal and possibly presented at international conferences., Systematic Review Registration: PROSPERO, CRD42019118903.

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 ).

Objective: To investigate the cost-effectiveness of exercise therapy in the treatment of patients with non-specific neck pain and low back pain., Design: Systematic review of economic evaluations., Data Sources: The search was performed in 5 clinical and 3 economic electronic databases., Eligibility Criteria for Selecting Studies: We included economic evaluations performed alongside randomised controlled trials. Differences in costs and effects were pooled in a meta-analysis, if possible, and incremental cost-utility ratios (ICUR) were descriptively analysed., Results: Twenty-two studies were included. On average, exercise therapy was associated with lower costs and larger effects for quality-adjusted life-year (QALY) in comparison with usual care for subacute and chronic low back pain from a healthcare perspective (based on ICUR). Exercise therapy had similar costs and effect for QALY in comparison with other interventions for neck pain from a societal perspective, and subacute and chronic low back pain from a healthcare perspective. There was limited or inconsistent evidence on the cost-effectiveness of exercise therapy compared with usual care for neck pain and acute low back pain, other interventions for acute low back pain and different types of exercise therapy for neck pain and low back pain., Conclusions: Exercise therapy seems to be cost-effective compared with usual care for subacute and chronic low back pain. Exercise therapy was not (more) cost-effective compared with other interventions for neck pain and low back pain. The cost-utility estimates are rather uncertain, indicating that more economic evaluations are needed., Registration: PROSPERO, CRD42017059025., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2019. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

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., Competing Interests: This study was approved by the Research Ethics Committee of Universidade Cidade de São Paulo (CAAE: 51328215.1.0000.0064). To participate in this study all participants will give consent and sign the Informed Consent Form, before baseline assessment.The subject in pictures appearing in the additional file has provided written consent to appear in the figures.The authors declare that they have no competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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., Competing Interests: Competing interests: GCM is an instructor of NeoPilates courses., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Objective: To identify potential prognostic factors that may predict clinical improvement of patients treated with different physical therapy interventions in the short-term., Methods: This is a prospective cohort study. A total of 616 patients with chronic non-specific low back pain treated with interventions commonly used by physical therapists were included. These patients were selected from five randomized controlled trials. Multivariate linear regression models were used to verify if sociodemographic characteristics (age, gender, and marital status), anthropometric variables (height, body mass, and body mass index), or duration of low back pain, pain intensity at baseline, and disability at baseline could be associated with clinical outcomes of pain intensity and disability four weeks after baseline., Results: The predictive variables for pain intensity were age (β=0.01 points, 95% CI=0.00 to 0.03, p=0.03) and pain intensity at baseline (β=0.23 points, 95% CI=0.13 to 0.33, p=0.00), with an explained variability of 4.6%. Similarly, the predictive variables for disability after four weeks were age (β=0.03 points, 95% CI=0.00 to 0.06, p=0.01) and disability at baseline (β=0.71 points, 95% CI=0.65 to 0.78, p=0.00), with an explained variability of 42.1%., Conclusion: Only age, pain at baseline and disability at baseline influenced the pain intensity and disability after four weeks of treatment. The beta coefficient for age was statistically significant, but the magnitude of this association was very small and not clinically important., (Copyright © 2018 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier Editora Ltda. All rights reserved.)

Objective: To determine whether interferential current (IFC) before Pilates exercises is more effective than placebo in patients with chronic nonspecific low back pain., Design: Two-arm randomized controlled trial, with a blinded assessor, and 6 months follow-up., Setting: Clinic of a school of physical therapy., Participants: The random sample consisted of patients (N=148) of both sexes, with age between 18 and 80 years and chronic nonspecific low back pain. In addition, participants were recruited by disclosure of the treatment in the media., Interventions: Patients were allocated into 2 groups: active IFC + Pilates or placebo IFC + Pilates. In the first 2 weeks, patients were treated for 30 minutes with active or placebo IFC. In the following 4 weeks, 40 minutes of Pilates exercises were added after the application of the active or placebo IFC. A total of 18 sessions were offered during 6 weeks., Main Outcome Measures: The primary outcome measures were pain intensity, pressure pain threshold, and disability measured at 6 weeks after randomization., Results: No significant differences were found between the groups for pain (0.1 points; 95% confidence interval, -0.9 to 1.0 points), pressure pain threshold (25.3kPa; 95% confidence interval, -4.4 to 55.0kPa), and disability (0.4 points; 95% confidence interval, -1.3 to 2.2). However, there was a significant difference between baseline and 6-week and 6-month follow-ups in the intragroup analysis for all outcomes (P<.05), except pressure pain threshold in the placebo IFC + Pilates group., Conclusions: These findings suggest that active IFC before Pilates exercise is not more effective than placebo IFC with respect to the outcomes assessed in patients with chronic nonspecific low back pain., (Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)

Background: The Pilates method has been recommended to patients with low back pain, but the evidence on effectiveness is inconclusive. In addition, there is still no evidence for the cost-effectiveness of this method or for the ideal number of sessions to achieve the highest effectiveness., Objective: The aim of this study will be to investigate the effectiveness and cost-effectiveness of the Pilates method with different weekly frequencies in the treatment of patients with nonspecific low back pain., Design: This is a randomized controlled trial with blinded assessor., Setting: This study will be conducted at a physical therapy clinic in São Paulo, Brazil., Participants: Two hundred ninety-six patients with nonspecific low back pain between the ages of 18 and 80 years will be assessed and randomly allocated to 4 groups (n=74 patients per group)., Intervention: All groups will receive an educational booklet. The booklet group will not receive additional exercises. Pilates group 1 will follow a Pilates-based program once a week, Pilates group 2 will follow the same program twice a week, and Pilates group 3 will follow the same program 3 times a week. The intervention will last 6 weeks., Measurements: A blinded assessor will evaluate pain, quality-adjusted life-years, general and specific disability, kinesiophobia, pain catastrophizing, and global perceived effect 6 weeks, 6 months, and 12 months after randomization., Limitations: Therapists and patients will not be blinded., Conclusions: This will be the first study to investigate different weekly frequencies of treatment sessions for nonspecific low back pain. The results of this study will contribute to a better definition of treatment programs for this population., (© 2016 American Physical Therapy Association.)

Background: Chronic low back pain is one of the four most common diseases in the world with great socioeconomic impact. Supervised exercise therapy is one of the treatments suggested for this condition; however, the recommendation on the best type of exercise is still unclear. The Pilates method of exercise is effective in reducing pain and disability in these patients, as well as the analgesia promoted by interferential current. Currently, the literature lacks information on the efficacy of the association of these two techniques in the short- and medium-term than performing one of the techniques isolated. The objective of this study will be to evaluate the efficacy of adding interferential current to the Pilates method exercises for the treatment of patients with chronic nonspecific low back pain in the short- and medium-term., Methods/design: This study will be a randomized controlled trial with two arms and blinded evaluator, conducted at an outpatient Physical Therapy Department in Brazil. Patients with nonspecific chronic low back pain and pain equal to or greater than 3 in the Pain Numerical Rating Scale (0/10) will be randomly assigned to one of two groups: Group with active interferential current + Pilates (n = 74) will be submitted to the active interferential current associated to the modified Pilates exercises, and Group with sham interferential current + Pilates (n = 74) will be submitted to the sham interferential current associated with the modified Pilates exercises during 18 sessions. The outcomes pain intensity, pressure pain threshold, general and specific disability, global perceived effect and kinesiophobia will be evaluated by a blinded assessor at baseline, six weeks and six months after randomization., Discussion: Because of the study design, blinding of the participants and the therapists involved in the study will not be possible. The results of this study could contribute to the process of clinical decision- making for the improvement of pain and disability in participants with nonspecific chronic low back pain., Trial Registration: ClinicalTrials.gov NCT01919268.

Objective: To systematically review the available evidence on the efficacy of the Pilates method in patients with chronic nonspecific low back pain., Method: Searches were performed in MEDLINE, EMBASE, PEDro, SciELO, LILACS, CINAHL and CENTRAL in March 2013. Randomized controlled trials that tested the effectiveness of the Pilates method (against a nontreatment group, minimal intervention or other types of interventions) in adults with chronic low back pain were included regardless the language of publication. The outcome data were extracted from the eligible studies and were combined using a meta-analysis approach., Results: The searches identified a total of 1,545 articles. From these, eight trials were considered eligible, and seven trials were combined in the meta-analysis. The comparison groups were as follows: Pilates versus other types of exercises (n=2 trials), and Pilates versus no treatment group or minimal intervention (n=4 trials) for short term pain; Pilates versus minimal intervention for short-term disability (n=4).We determined that Pilates was not better than other types of exercises for reducing pain intensity. However, Pilates was better than a minimal intervention for reducing short-term pain and disability (pain: pooled mean difference=1.6 points; 95% CI 1.4 to 1.8; disability: pooled mean difference=5.2 points; 95% CI 4.3 to 6.1)., Conclusions: Pilates was better than a minimal intervention for reducing pain and disability in patients with chronic low back pain. Pilates was not better than other types of exercise for short-term pain reduction.

Background: The Pilates method has been used to improve function and reduce pain in patients with chronic nonspecific low back pain, although there is little scientific evidence that describes its efficacy., Objective: The purpose of this study was to investigate the effectiveness of the addition of modified Pilates exercises to minimal intervention in patients with chronic low back pain., Design: A randomized controlled trial was conducted., Setting: The study was done in an outpatient physical therapy department in Brazil., Patients: Eighty-six patients with chronic nonspecific low back pain participated in the study., Intervention: All participants received an education booklet containing information about low back pain and were randomly allocated to receive 12 sessions, over 6 weeks, of exercises based upon Pilates principles (n=43) or of education alone (n=43)., Measurements: Primary outcomes were pain intensity and disability measured at 6 weeks and 6 months. Secondary outcomes were patient-specific functional disability, global impression of recovery, and kinesiophobia measured at 6 weeks and 6 months. All outcomes were measured by a blinded assessor in all time points., Results: There was no loss to follow-up at any of the time points. Improvements were observed in pain (mean difference=2.2 points, 95% confidence interval [CI]=1.1 to 3.2), disability (mean difference=2.7 points, 95% CI=1.0 to 4.4), and global impression of recovery (mean difference=-1.5 points, 95% CI=-2.6 to -0.4) in favor of the Pilates group after intervention, but these differences were no longer statistically significant at 6 months., Limitations: Treatment provider and participants could not be blinded to the interventions., Conclusions: The addition of modified Pilates exercises to an educational booklet provides small benefits compared with education alone in patients with chronic nonspecific low back pain; however, these effects were not sustained over time.

Objective: There is little high-quality evidence on the efficacy of the Pilates-based exercises for the treatment of chronic nonspecific low back pain. Therefore, the objective of this paper is to present a study protocol to investigate the efficacy of adding Pilates-based exercises to a minimum intervention in patients with chronic non-specific low back pain., Methods: This randomized controlled trial will recruit 86 patients of both sexes, aged between 18 and 60 years, with chronic non-specific low back pain. The participants will be randomly allocated into 2 treatment groups: the Booklet Group, which will receive a booklet with postural orientations, and the Pilates Group, which will receive the same booklet in addition to a Pilates-based exercises program. The general and specific functional capacities of the patient, kinesiophobia, pain intensity, and the global perceived effect will be evaluated by a blinded assessor before randomization and at 6 weeks and 6 months after randomization. In addition, the expectations of the participants and their confidence in the treatment will be evaluated before the randomization and after the first treatment session, respectively., Conclusions: It is hoped that the results of this study will provide high-quality evidence on the usefulness of Pilates-based exercises in the treatment of chronic non-specific low back pain.