The cost-effectiveness of a treatment based classification system for low back pain: design of a randomised controlled trial and economic evaluation

<p>Abstract</p> <p>Background</p> <p>Systematic reviews have shown that exercise therapy and spinal manipulation are both more effective for low back pain (LBP) than no treatment at all. However, the effects are at best modest. To enhance the clinical outcomes, recommendations are to improve the patient selection process, and to identify relevant subgroups to guide clinical decision-making. One of the systems that has potentials to improve clinical decision-making is a treatment-based classification system that is intended to identify those patients who are most likely to respond to direction-specific exercises, manipulation, or stabilisation exercises.</p> <p>Methods/Design</p> <p>The primary aim of this randomised controlled trial will be to assess the effectiveness of a classification-based system. A sample of 150 patients with subacute and chronic LBP who attend a private physical therapy clinic for treatment will be recruited. At baseline, all participants will undergo a standard evaluation by trained research physical therapists and will be classified into one of the following subgroups: direction-specific exercises, manipulation, or stabilisation. The patient will not be informed about the results of the examination. Patients will be randomly assigned to classification-based treatment or usual care according to the Dutch LBP guidelines, and will complete questionnaires at baseline, and 8, 26, and 52 weeks after the start of the treatment. The primary outcomes will be general perceived recovery, functional status, and pain intensity. Alongside this trial, an economic evaluation of cost-effectiveness and cost-utility will be conducted from a societal perspective.</p> <p>Discussion</p> <p>The present study will contribute to our knowledge about the effectiveness and cost-effectiveness of classification-based treatment in patients with LBP.</p> <p>Trial registration</p> <p>Trial registration number: NTR1176</p

Subgrouping patients with low back pain

Tulder, M.W. van [Promotor]Vet, H.C.W. de [Promotor]Ostelo, R.W.J.G. [Copromotor

The reliability of nonorganic sign-testing and the Waddell score in patients with chronic low back pain

STUDY DESIGN. An observational prospective cohort study. OBJECTIVES. To determine the reliability of nonorganic sign-testing in patients with chronic low back pain (CLBP), and to identify determinants of diagnostic disagreement. SUMMARY OF BACKGROUND DATA. For the assessment of behavioral responses to examination, Waddell et al published "the Waddell score" in 1980. The Waddell score consists of 8 nonorganic signs, divided into 5 categories. The overall score is positive if at least 3 of the categories are scored positive. Although the Waddell score is widely used, little is known about its reliability. METHODS. Two observers examined 126 consecutive patients with CLBP referred for rehabilitation. Cohen's κ was used to compute the interobserver and intraobserver reliability of the sign maneuvers, categories and Waddell score. Cronbach's α was calculated for the 5 categories and 8 signs to determine internal consistency. χ tests were applied to determine the possible influence of clinical characteristics on interobserver reliability. RESULTS. Interobserver reliability varied from 0.33 to 0.74 for the sign maneuvers and categories, and was 0.48 and 0.49 for the overall Waddell score. Intraobserver reliability varied from 0.43 to 0.84 for the sign maneuvers and categories, and was 0.65 and 0.68 for the overall Waddell score. Internal consistency varied from 0.65 to 0.72 for the categories and from 0.71 to 0.78 for the signs. Determinants of diagnostic disagreement did not exceed levels of significance (P < 0.05). CONCLUSION. For trained observers of a population of patients with CLBP in a rehabilitation setting, the interobserver reliability of the Waddell score was moderate and the intraobserver reliability was good. No influence of clinical characteristics was found on interobserver reliability. To optimize the homogeneity and variability of the Waddell score, we recommend summing up the individual signs instead of summing up the categories. © 2008 Lippincott Williams & Wilkins, Inc

Multidisciplinary biopsychosocial rehabilitation for chronic low back pain

Background Low back pain (LBP) is responsible for considerable personal suffering worldwide. Those with persistent disabling symptoms also contribute to substantial costs to society via healthcare expenditure and reduced work productivity. While there are many treatment options, none are universally endorsed. The idea that chronic LBP is a condition best understood with reference to an interaction of physical, psychological and social influences, the 'biopsychosocial model', has received increasing acceptance. This has led to the development of multidisciplinary biopsychosocial rehabilitation (MBR) programs that target factors from the different domains, administered by healthcare professionals from different backgrounds. Objectives To review the evidence on the effectiveness of MBR for patients with chronic LBP. The focus was on comparisons with usual care and with physical treatments measuring outcomes of pain, disability and work status, particularly in the long term. Search methods We searched the CENTRAL, MEDLINE, EMBASE, PsycINFO and CINAHL databases in January and March 2014 together with carrying out handsearches of the reference lists of included and related studies, forward citation tracking of included studies and screening of studies excluded in the previous version of this review. Selection criteria All studies identified in the searches were screened independently by two review authors; disagreements regarding inclusion were resolved by consensus. The inclusion criteria were published randomised controlled trials (RCTs) that included adults with non-specific LBP of longer than 12 weeks duration; the index intervention targeted at least two of physical, psychological and social or work-related factors; and the index intervention was delivered by clinicians from at least two different professional backgrounds. Data collection and analysis Two review authors extracted and checked information to describe the included studies, assessed risk of bias and performed the analyses. We used the Cochrane risk of bias tool to describe the methodological quality. The primary outcomes were pain, disability and work status, divided into the short, medium and long term. Secondary outcomes were psychological functioning (for example depression, anxiety, catastrophising), healthcare service utilisation, quality of life and adverse events. We categorised the control interventions as usual care, physical treatment, surgery, or wait list for surgery in separate meta-analyses. The first two comparisons formed our primary focus. We performed meta-analyses using random-effects models and assessed the quality of evidence using the GRADE method. We performed sensitivity analyses to assess the influence of the methodological quality, and subgroup analyses to investigate the influence of baseline symptom severity and intervention intensity. Main results From 6168 studies identified in the searches, 41 RCTs with a total of 6858 participants were included. Methodological quality ratings ranged from 1 to 9 out 12, and 13 of the 41 included studies were assessed as low risk of bias. Pooled estimates from 16 RCTs provided moderate to low quality evidence that MBR is more effective than usual care in reducing pain and disability, with standardised mean differences (SMDs) in the long term of 0.21 (95% CI 0.04 to 0.37) and 0.23 (95% CI 0.06 to 0.4) respectively. The range across all time points equated to approximately 0.5 to 1.4 units on a 0 to 10 numerical rating scale for pain and 1.4 to 2.5 points on the Roland Morris disability scale (0 to 24). There was moderate to low quality evidence of no difference on work outcomes (odds ratio (OR) at long term 1.04, 95% CI 0.73 to 1.47). Pooled estimates from 19 RCTs provided moderate to low quality evidence that MBR was more effective than physical treatment for pain and disability with SMDs in the long term of 0.51 (95% CI -0.01 to 1.04) and 0.68 (95% CI 0.16 to 1.19) respectively. Across all time points this translated to approximately 0.6 to 1.2 units on the pain scale and 1.2 to 4.0 points on the Roland Morris scale. There was moderate to low quality evidence of an effect on work outcomes (OR at long term 1.87, 95% CI 1.39 to 2.53). There was insufficient evidence to assess whether MBR interventions were associated with more adverse events than usual care or physical interventions. Sensitivity analyses did not suggest that the pooled estimates were unduly influenced by the results from low quality studies. Subgroup analyses were inconclusive regarding the influence of baseline symptom severity and intervention intensity. Authors' conclusions Patients with chronic LBP receiving MBR are likely to experience less pain and disability than those receiving usual care or a physical treatment. MBR also has a positive influence on work status compared to physical treatment. Effects are of a modest magnitude and should be balanced against the time and resource requirements of MBR programs. More intensive interventions were not responsible for effects that were substantially different to those of less intensive interventions. While we were not able to determine if symptom intensity at presentation influenced the likelihood of success, it seems appropriate that only those people with indicators of significant psychosocial impact are referred to MBR

Multidisciplinary biopsychosocial rehabilitation for chronic low back pain: Cochrane systematic review and meta-analysis

Objective To assess the long term effects of multidisciplinary biopsychosocial rehabilitation for patients with chronic low back pain. Design Systematic review and random effects meta-analysis of randomised controlled trials. Data sources Electronic searches of Cochrane Back Review Group Trials Register, CENTRAL, Medline, Embase, PsycINFO, and CINAHL databases up to February 2014, supplemented by hand searching of reference lists and forward citation tracking of included trials. Study selection criteria Trials published in full; participants with low back pain for more than three months; multidisciplinary rehabilitation involved a physical component and one or both of a psychological component or a social or work targeted component; multidisciplinary rehabilitation was delivered by healthcare professionals from at least two different professional backgrounds; multidisciplinary rehabilitation was compared with a non-multidisciplinary intervention. Results Forty one trials included a total of 6858 participants with a mean duration of pain of more than one year who often had failed previous treatment. Sixteen trials provided moderate quality evidence that multidisciplinary rehabilitation decreased pain (standardised mean difference 0.21, 95% confidence interval 0.04 to 0.37; equivalent to 0.5 points in a 10 point pain scale) and disability (0.23, 0.06 to 0.40; equivalent to 1.5 points in a 24 point Roland-Morris index) compared with usual care. Nineteen trials provided low quality evidence that multidisciplinary rehabilitation decreased pain (standardised mean difference 0.51, -0.01 to 1.04) and disability (0.68, 0.16 to 1.19) compared with physical treatments, but significant statistical heterogeneity across trials was present. Eight trials provided moderate quality evidence that multidisciplinary rehabilitation improves the odds of being at work one year after intervention (odds ratio 1.87, 95% confidence interval 1.39 to 2.53) compared with physical treatments. Seven trials provided moderate quality evidence that multidisciplinary rehabilitation does not improve the odds of being at work (odds ratio 1.04, 0.73 to 1.47) compared with usual care. Two trials that compared multidisciplinary rehabilitation with surgery found little difference in outcomes and an increased risk of adverse events with surgery. Conclusions Multidisciplinary biopsychosocial rehabilitation interventions were more effective than usual care (moderate quality evidence) and physical treatments (low quality evidence) in decreasing pain and disability in people with chronic low back pain. For work outcomes, multidisciplinary rehabilitation seems to be more effective than physical treatment but not more effective than usual care

The cross-sectional construct validity of the Waddell Score

BACKGROUND: In 1980 the Waddell score, consisting of 8 non-organic or behavioural signs, was developed to measure illness behaviour in patients with low back pain. There is some debate about whether the Waddell score is a valid screening instrument for illness behaviour and psychological distress, or whether it merely reflects elevated pain levels and diminished functional physical capacities. OBJECTIVE: The purpose of this study was to examine the construct validity of the Waddell score. METHODS: In this cross-sectional study, a total of 20 hypotheses about the associations between the Waddell score and measures from different domains were formulated a priori, based on a Medline database search (1980-2010). These hypotheses were tested in a sample of 229 patients with chronic low back pain who attended an outpatient rehabilitation centre. RESULTS: The percentage of hypotheses that were confirmed for the association between the Waddell score and the domain pain was 100%, for the domain physical 80%, for the domain illness behaviour 80% and 50% for the domain psychological. Correlation coefficients and kappa values varied between 0.06 and 0.44 for the measures that were expected to be associated with the Waddell score. CONCLUSION: Most of our challenging a priori hypotheses were accepted, and the Waddell score was found to have satisfactory cross-sectional construct validity. However, the presence of Waddell signs does not indicate exactly what the specific problems are and must therefore be conceptualized and understood in the total clinical picture of the patient. The association between the Waddell score and measures from different domains is weak. The Waddell score cannot be regarded as a straightforward psychological "screener". © 2012 Lippincott Williams & Wilkins, Inc