Measurement properties of the EQ-5D in children and adolescents: a systematic review protocol.

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.

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.

Feasibility, Usability, and Implementation Context of an Internet-Based Pain Education and Exercise Program for Chronic Musculoskeletal Pain: Pilot Trial of the ReabilitaDOR Program.

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.

Author Response to "The Therapeutic Alliance May Yet Prove Effective".

Author response to the JOSPT Letter to the Editor-in-Chief "The Therapeutic Alliance May Yet Prove Effective" J Orthop Sports Phys Ther 2021;51(10):527-528. doi:10.2519/jospt.2021.0203-R.

Interpretation of trial-based economic evaluations of musculoskeletal physical therapy interventions.

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.

Education With Therapeutic Alliance Did Not Improve Symptoms in Patients With Chronic Low Back Pain and Low Risk of Poor Prognosis Compared to Education Without Therapeutic Alliance: A Randomized Controlled Trial.

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.

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.

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.

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.

Effects of aerobic exercise in the treatment of older adults with chronic musculoskeletal pain: a protocol of a systematic review.

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.

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.

Cost-effectiveness of exercise therapy in the treatment of non-specific neck pain and low back pain: a systematic review with meta-analysis.

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.

Revisão sistemática sobre exercício no tratamento da dor lombar e pélvica gestacional / Systematic review about exercise in the treatment of pregnancy related lumbar/pelvic pain

Introdução: Várias revisões sistemáticas já foram realizadas com o objetivo de verificar o efeito de tratamentos combinados na melhora da dor lombar e pélvica gestacional. Porém, o efeito da terapia por exercícios no tratamento da dor lombar e pélvica gestacional ainda é incerto. Objetivos: Revisar as evidências de estudos controlados aleatorizados (ECAs) acerca da terapia por exercício na dor, incapacidade, recuperação e saúde geral em mulheres com dor lombar e pélvica gestacional. Métodos: Buscas foram realizadas no MEDLINE, EMBASE, CINAHL, CENTRAL e PEDro em fevereiro de 2018. Algumas palavras-chave utilizadas foram: randomized controlled trial, low back pain e exercise therapy. Apenas ECAs de mulheres com dor lombar e pélvica gestacional foram selecionados, cujo tratamento foi baseado em terapia por exercícios. Os estudos foram analisados de forma descritiva. Resultados: Pela análise dos 21 artigos elegíveis, não se pode confirmar que os exercícios são superiores ao não-tratamento, à intervenção mínima/cuidados usuais, e outros tipos de tratamento para dor lombar e pélvica gestacional. Essa limitação deve-se à grande heterogeneidade dos estudos elegíveis. Conclusão: Há evidência escassa e de baixa qualidade metodológica para a utilização de exercícios no tratamento da dor lombar e pélvica gestacional.

Introduction: Several systematic reviews have already been performed with the aim of verifying the effect of combined treatments on the improvement of gestational low back and pelvic pain. However, the effect of exercise therapy in the treatment of gestational low back and pelvic pain is still unclear. Objectives: To review the evidence from randomized controlled trials (RCTs) of exercise therapy on pain, disability, recovery and overall health in women with gestational low back and pelvic pain. Methods: Searches were conducted on MEDLINE, EMBASE, CINAHL, CENTRAL and PEDro in February 2018. Some keywords used were randomized controlled trial, low back pain and exercise therapy. Only RCTs of women with gestational low back and pelvic pain were selected, whose treatment was based on exercise therapy. Studies were analyzed descriptively. Results: Analyzing the 21 eligible studies, we may not confirm that exercises are superior to no treatment, minimal intervention/usual care, and other types of treatment for gestational low back and pelvic pain. This limitation is due to the high heterogeneity between the eligible studies. Conclusion: Evidence with good methodological quality is scarce for the use of exercises in the treatment of gestational low back and pelvic pain.

Can demographic and anthropometric characteristics predict clinical improvement in patients with chronic non-specific low back pain?

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 (ß=0.01 points, 95% CI=0.00 to 0.03, p=0.03) and pain intensity at baseline (ß=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 (ß=0.03 points, 95% CI=0.00 to 0.06, p=0.01) and disability at baseline (ß=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.

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.

Is Interferential Current Before Pilates Exercises More Effective Than Placebo in Patients With Chronic Nonspecific Low Back Pain?: A Randomized Controlled Trial.

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.

Effectiveness and Cost-Effectiveness of Different Weekly Frequencies of Pilates for Chronic Low Back Pain: Randomized Controlled Trial.

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.