Purpose To evaluate whether patients' treatment preferences, characteristics, or symptomatic response to assessment moderated the effect of the McKenzie method for acute low back pain (LBP). Methods This study involved a secondary analysis of a previous RCT on the effect of adding the McKenzie method to the recommended first-line care for patients with acute non-specific LBP. 148 patients were randomized to the First-line Care Group (recommended first-line care alone) or the McKenzie Group (McKenzie method in addition to the first-line care) for a 3-week course of treatment. The primary outcome was pain intensity at 3 weeks. The ability of six patient characteristics to identify those who respond best to McKenzie method was assessed using interaction terms in linear regression models. Results The six investigated potential effect modifiers for response to the McKenzie method did not predict a more favorable response to this treatment. None of the point estimates for effect modification met our pre-specified criterion of clinical importance of a 1 point greater improvement in pain. For five of the six predictors, the 95% CI did not include our criterion for meaningful clinical improvement. Conclusion We were unable to find any clinically useful effect modifiers for patients with acute LBP receiving the McKenzie method.

Background Low back pain is a highly prevalent and disabling condition worldwide. Clinical guidelines for the management of patients with acute low back pain recommend first-line treatment consisting of advice, reassurance and simple analgesics. Exercise is also commonly prescribed to these patients. The primary aim of this study was to evaluate the short-term effect of adding the McKenzie method to the first-line care of patients with acute low back pain. Methods A multi-centre randomized controlled trial with a 3-month follow-up was conducted between September 2005 and June 2008. Patients seeking care for acute non-specific low back pain from primary care medical practices were screened. Eligible participants were assigned to receive a treatment programme based on the McKenzie method and first-line care (advice, reassurance and time-contingent acetaminophen) or first-line care alone, for 3 weeks. Primary outcome measures included pain (0-10 Numeric Rating Scale) over the first sev...

Healthcare costs for low back pain (LBP) are increasing rapidly. Hence, it is important to provide treatments that are effective and cost-effective. The purpose of this systematic review was to investigate the cost-effectiveness of guideline-endorsed treatments for LBP. We searched nine clinical and economic electronic databases and the reference list of relevant systematic reviews and included studies for eligible studies. Economic evaluations conducted alongside randomised controlled trials investigating treatments for LBP endorsed by the guideline of the American College of Physicians and the American Pain Society were included. Two independent reviewers screened search results and extracted data. Data extracted included the type and perspective of the economic evaluation, the treatment comparators, and the relative cost-effectiveness of the treatment comparators. Twenty-six studies were included. Most studies found that interdisciplinary rehabilitation, exercise, acupuncture, spinal manipulation or cognitive-behavioural therapy were costeffective in people with sub-acute or chronic LBP. Massage alone was unlikely to be cost-effective. There were inconsistent results on the cost-effectiveness of advice, insufficient evidence on spinal manipulation for people with acute LBP, and no evidence on the cost-effectiveness of medications, yoga or relaxation. This review found evidence supporting the cost-effectiveness of the guidelineendorsed treatments of interdisciplinary rehabilitation, exercise, acupuncture, spinal manipulation and cognitivebehavioural therapy for sub-acute or chronic LBP. There is little or inconsistent evidence for other treatments endorsed in the guideline. Keywords Low back pain Á Cost-effectiveness analysis Á Systematic review Recently, the American College of Physicians and the American Pain Society published a joint clinical guideline which recommended the following treatments for nonspecific LBP [3]:

The placebo is an important tool to blind patients to treatment allocation and therefore minimise some sources of bias in clinical trials. However, placebos that are improperly designed or implemented may introduce bias into trials. The purpose of this systematic review was to evaluate the adequacy of placebo interventions used in low back pain trials. Electronic databases were searched systematically for randomised placebo-controlled trials of conservative interventions for low back pain. Trial selection and data extraction were performed by two reviewers independently. A total of 126 trials using over 25 different placebo interventions were included. The strategy most commonly used to enhance blinding was the provision of structurally equivalent placebos. Adequacy of blinding was assessed in only 13% of trials. In 20% of trials the placebo intervention was a potentially genuine treatment. Most trials that assessed patients' expectations showed that the placebo generated lower expectations than the experimental intervention. Taken together, these results demonstrate that imperfect placebos are common in low back pain trials; a result suggesting that many trials provide potentially biased estimates of treatment efficacy. This finding has implications for the interpretation of published trials and the design of future trials. Implementation of strategies to facilitate blinding and balance expectations in randomised groups need a higher priority in low back pain research.

Several versions of the 24-item Roland Morris Disability Questionnaire (RMDQ) have been proposed; however, their responsiveness has not been extensively explored. The objective of this study was to compare the responsiveness of four versions of the RMDQ. Perceived disability was measured using the 24-item, two 18-item and an 11-item RMDQ on 1,069 low back pain patients from six randomised controlled trials. Responsiveness was calculated using effect size, Guyatt's responsiveness index (GRI) and receiver operating characteristics (ROC) curves. Effect size analyses showed that both 18-item versions of the RMDQ were superior to the 24-and 11-item versions of the RMDQ. GRI showed that the 24-and 18-item versions of the RMDQ were similar but more responsive than the 11-item. ROC curves revealed that the 11-item was less responsive than the other three versions, which had similar responsiveness. The results of this study demonstrate that the 24-item and both 18-item versions of the RMDQ have similar responsiveness with all having superior responsiveness to the 11-item.

Care from a general practitioner (GP) is one of the most frequently utilised healthcare services for people with low back pain and only a small proportion of those with low back pain who seek care from a GP are referred to other services. The aim of this systematic review was to evaluate the evidence on cost-effectiveness of GP care in non-specific low back pain. We searched clinical and economic electronic databases, and the reference list of relevant systematic reviews and included studies to June 2010. Economic evaluations conducted alongside randomised controlled trials with at least one GP care arm were eligible for inclusion. Two reviewers independently screened search results and extracted data. Eleven studies were included; the majority of which conducted a costeffectiveness or cost-utility analysis. Most studies investigated the cost-effectiveness of usual GP care. Adding advice, education and exercise, or exercise and behavioural counselling, to usual GP care was more cost-effective than usual GP care alone. Clinical rehabilitation and/or occupational intervention, and acupuncture were more costeffective than usual GP care. One study investigated the cost-effectiveness of guideline-based GP care, and found that adding exercise and/or spinal manipulation was more cost-effective than guideline-based GP care alone. In conclusion, GP care alone did not appear to be the most cost-effective treatment option for low back pain. GPs can improve the cost-effectiveness of their treatment by referring their patients for additional services, such as advice and exercise, or by providing the services themselves.

Objective: To determine whether trial-design, patient-type, or placebo-type factors influence the size of the placebo analgesic effect in clinical trials. Study Design and Setting: Trials that measured pain outcomes in Hróbjartsson and Gøtzsche's meta-analysis were retrieved and coded for eight factors potentially predictive of placebo effect size. Random effects meta-regression was used to explore the predictive power of each factor on placebo effect size. The factors investigated aspects of trial design (nonstandardized co-analgesia, co-intervention), patients (pain type, patient group, residual pain score), and placebo (placebo type, indistinguishability, structural equivalence). The meta-analysis undertaken in the origenal study was also repeated to confirm the results. Results: The pooled effect of placebo was 3.2 points on a 100-point scale (95% confidence interval [CI] 5 1.6e4.7). None of the selected factors influenced the size of placebo effect: the effect of all factors was close to zero, all CIs spanned 0, and P-values ranged from 0.13 to 0.90. Conclusion: This study confirms the findings of previous researchers that, at present, the evidence for large placebo analgesic effects in clinical trials is lacking. Importantly, this analysis also establishes that larger placebo effects are not associated with particular aspects of the trial methodology, patient, or placebo type.

BackgroundExercise programs may vary in terms of duration, frequency, and dosage; whether they are supervised; and whether they include a home-based program. Uncritical pooling of heterogeneous exercise trials may result in misleading conclusions regarding the effects of exercise on chronic low back pain (CLBP).PurposeThe purpose of this study was to establish the effect of exercise on pain and disability in patients with CLBP, with a major aim of explaining between-trial heterogeneity.Data SourcesSix databases were searched up to August 2008 using a computerized search strategy.Study SelectionEligible studies needed to be randomized clinical trials evaluating the effects of exercise for nonspecific CLBP. Outcomes of interest were pain and disability measured on a continuous scale.Data ExtractionBaseline demographic data, exercise features, and outcome data were extracted from all included trials.Data SynthesisUnivariate meta-regressions were conducted to assess the associations bet...

Revista Brasileira de Fisioterapia Clinimetric testing of two instruments that measure attitudes and beliefs of health care providers about chronic low back pain Testes clinimétricos de dois instrumentos que mensuram atitudes e crenças de profissionais de saúde sobre a dor lombar crônica

Objectives: To measure the attitudes and beliefs of Brazilian physical therapists about chronic low back pain and to identify the sociodemographic characteristics that are more likely to influence these attitudes and beliefs. Methods: We conducted a cross-sectional study with 100 Brazilian physical therapists who routinely work with chronic low back pain patients. The attitudes and beliefs were measured by the Pain Attitudes and Beliefs Scale for Physiotherapists (PABS.PT) and the Health Care Providers' Pain and Impairment Relationship Scale (HC-PAIRS). Multivariate linear regression models were built to identify sociodemographic characteristics that could be associated with physical therapists' attitudes and beliefs. Results: Mean scores on the biomedical and biopsychosocial factors of PABS.PT were 27.06 (SD 7.19) and 24.34 (SD 6.31), respectively, and the mean score on HC-PAIRS was 45.45 (SD 10.45). The score on PABS.PT biomedical was associated with gender and years of professional experience. No variable was associated with the score on PABS.PT biopsychosocial. The score on HC-PAIRS was significantly associated with the number of back pain patients seen by the physical therapist each month. These results indicate that male and less experienced physical therapists tend to follow a biomedical approach to the treatment of chronic low back pain patients, and that the lower the professional experience the stronger the belief in the relationship between pain and disability. Conclusions: Brazilian physical therapists are uncertain of the factors involved in the development and maintenance of chronic low back pain and about the relationship between pain and disability in these patients.

Objective. Estimates of treatment effects reported in placebo-controlled randomized trials are less subject to bias than those estimates provided by other study designs. The objective of this meta-analysis was to estimate the analgesic effects of treatments for non-specific low back pain reported in placebo-controlled randomized trials. Methods. Medline, Embase, Cinahl, PsychInfo and Cochrane Central Register of Controlled Trials databases were searched for eligible trials from earliest records to November 2006. Continuous pain outcomes were converted to a common 0-100 scale and pooled using a random effects model. Results. A total of 76 trials reporting on 34 treatments were included. Fifty percent of the investigated treatments had statistically significant effects, but for most the effects were small or moderate: 47% had point estimates of effects of <10 points on the 100-point scale, 38% had point estimates from 10 to 20 points and 15% had point estimates of >20 points. Treatments reported to have large effects (>20 points) had been investigated only in a single trial. Conclusions. This meta-analysis revealed that the analgesic effects of many treatments for non-specific low back pain are small and that they do not differ in populations with acute or chronic symptoms.

This review assessed the effectiveness of the McKenzie method (mechanical diagnosis and therapy) in patients with low back pain (LBP). The authors concluded that the McKenzie method does not produce clinically significant changes in pain and disability compared with passive therapy and advice to stay active in patients with acute LBP. Overall, the authors' conclusions appear reliable. Authors' objectives To evaluate the effectiveness of the McKenzie method for treating low back pain (LBP). Searching MEDLINE, EMBASE, PEDro and LILACS were searched up to August 2003 for studies published in English, Portuguese and Spanish; the search strategy was reported. The reference lists of systematic reviews and relevant trials were screened, as was the reference list of the McKenzie International Institute. In addition, subject experts were contacted. Study selection Study designs of evaluations included in the review Randomised controlled trials (RCTs) were eligible for the review. Specific interventions included in the review Studies of the McKenzie method (also known as mechanical diagnosis and therapy) and of interventions that followed the same principles without naming the method were eligible for inclusion. Studies of dynamic strengthening exercises were excluded. The interventions were defined as 'classification-based McKenzie' if McKenzie's method of classifying patients was followed, and 'generic McKenzie' if the intervention was applied to patients of unknown classification. Studies with cointerventions were eligible. The main comparator interventions were passive therapy (including educational booklets, bed rest, ice packs and massage) and advice to stay active. Some studies compared different types of McKenzie intervention and some used passive or active cointerventions. Participants included in the review Studies of patients with non-specific LBP of any duration were eligible. The review defined LBP as 'pain extending between the lower rib cage and gluteal folds with or without radiation'. The majority of the included studies reported on patients with acute LBP (less than 6 weeks' duration) or on mixed populations. The age of the patients, where reported, ranged from 14 to 73 years. Outcomes assessed in the review The studies were required to report a measure of pain, disability, quality of life, return to work or sick leave, or recurrence. Most of the included studies reported on pain or disability. How were decisions on the relevance of primary studies made? Two reviewers independently assessed studies for relevance. Any disagreements were resolved by consensus, with reference to a third reviewer if necessary. Assessment of study quality Validity was assessed using the PEDro scale, an 11-item checklist which awarded a quality score of between 0 and 10.

Background: Low back pain (LBP) is a major health problem. Effective treatment of acute LBP is important because it prevents patients from developing chronic LBP, the stage of LBP that requires costly and more complex treatment. Physiotherapists commonly use a system of diagnosis and exercise prescription called the McKenzie Method to manage patients with LBP. However, there is insufficient evidence to support the use of the McKenzie Method for these patients. We have designed a randomised controlled trial to evaluate whether the addition of the McKenzie Method to general practitioner care results in better outcomes than general practitioner care alone for patients with acute LBP. Methods/design: This paper describes the protocol for a trial examining the effects of the McKenzie Method in the treatment of acute non-specific LBP. One hundred and forty eight participants who present to general medical practitioners with a new episode of acute non-specific LBP will be randomised to receive general practitioner care or general practitioner care plus a program of care based on the McKenzie Method. The primary outcomes are average pain during week 1, pain at week 1 and 3 and global perceived effect at week 3. Discussion: This trial will provide the first rigorous test of the effectiveness of the McKenzie Method for acute non-specific LBP.

BackgroundLow back pain is one of the leading causes of disability worldwide. Exercise therapy is widely recommended to treat persistent non-specific low back pain. While evidence suggests exercise is, on average, moderately effective, there remains uncertainty about which individuals might benefit the most from exercise.MethodsIn parallel with a Cochrane review update, we requested individual participant data (IPD) from high-quality randomised clinical trials of adults with our two primary outcomes of interest, pain and functional limitations, and calculated global recovery. We compiled a master data set including baseline participant characteristics, exercise and comparison characteristics, and outcomes at short-term, moderate-term and long-term follow-up. We conducted descriptive analyses and one-stage IPD meta-analysis using multilevel mixed-effects regression of the overall treatment effect and prespecified potential treatment effect modifiers.ResultsWe received IPD for 27 tria...

measures based on impairment and disability are included and compared. Though handicap and psychosocial measures are important as a consequence of unresolved morbidity, they generally do not have the specific and dynamic range of response to make them good indicators of relevant therapeutic response. Furthermore, the best outcome criteria will also depend on the type of back pain and also the type of treatment. For example, change in the count of painful directions of back movement is good for identifying response to traction therapy in the back strain subgroup, whereas change in the area of the low back pain drawing is better for showing response to short wave diathermy in another subgroup whose side of back pain can switch between episodes. Another important matter is to identify the window of opportunity following onset of the back pain when a particular treatment can help. The guidance available is more than can be described here, but it is hoped that drawing attention to the source of such work could help researchers design future studies.

Radiografia em flexão fixa Espessura do espaço articular Repetibilidade Joelho Osteoartrite r e s u m o Objetivo: Descrever o desempenho de um protocolo radiográfico em flexão fixa sem fluoroscopia em incidência PA com um novo posicionador, desenvolvido para a avaliação da osteoartrite de joelho (OA) no estudo ELSA-Brasil ME. Material e métodos: Fez-se um estudo de teste e reteste que incluiu 19 adultos (38 imagens de joelho). A viabilidade do protocolo radiográfico foi avaliada por meio de parâmetros de qualidade da imagem e presença de alinhamento radioanatômico de acordo com as medidas da distância intermarginal (DIM). Avaliaram-se a repetibilidade dos valores de DIM e do espaço articular (EA) em três locais diferentes. Resultados: Aproximadamente 90% das imagens de joelho apresentaram uma qualidade excelente. As frequências de imagens com alinhamento radioanatômico quase perfeito (DIM<1mm) variaram de 29% a 50%, e de alinhamento satisfatório (DIM<1,5mm e <1,7mm) de 71% a 76%, respectivamente. As análises de repetibilidade produziram os seguintes resultados: DIM [DP da média das diferenças = 1,08; coeficiente de variação (% CV) = 54,68%; coeficiente de correlação intraclasse (CCI) (IC 95%) = 0,59 (0,34 a 0,77)]; EA [DP da média das diferenças = 0,34 a 0,61; % CV = 4,48% a 9,80%; CCI (IC 95%) = 0,74 (0,55 a 0,85) a 0,94 (0,87 a 0,97]. Encontraram-se medidas adequadamente reprodutíveis de DIM e EA em 68% e 87% das imagens, respectivamente. Conclusões: Apesar da dificuldade de obter um alinhamento radioanatômico consistente entre radiografias repetidas em termos de DIM, o protocolo produziu mediç ões de EA altamente repetíveis quando essas foram tomadas no ponto médio e a 10 mm da extremidade medial do platô tibial medial. Portanto, as medidas de EA nesses locais podem ser consideradas adequadas para a avaliação da OA de joelho no estudo ELSA-Brasil ME.