Search

Contains fulltext : 293486.pdf (Publisher’s version ) (Open Access) OBJECTIVES: To develop and validate approaches for mapping Oswestry Disability Index responses to 3-level version of EQ-5D utility values and to evaluate the impact of using mapped utility values on cost-utility results compared with published regression models. METHODS: Three response mapping approaches were developed in a random sample of 70% of 18 692 patients with low back pain: nonparametric approach (Non-p), nonparametric approach excluding logical inconsistencies (Non-peLI), and ordinal logistic regression (OLR). Performance was assessed in the remaining 30% using R-square (R(2)), root mean square error (RMSE), and mean absolute error (MAE). To evaluate whether MAEs and their 95% limits of agreement (LA) were clinically relevant, a minimally clinically important difference of 0.074 was used. Probabilities of cost-effectiveness estimated using observed and mapped utility values were compared in 2 economic evaluations. RESULTS: The Non-p performed the best (R(2) = 0.43; RMSE = 0.22; MAE = 0.03; 95% LA = -0.40 to 0.47) compared with the Non-peLI (R(2) = 0.07; RMSE = 0.29; MAE = -0.15; 95% LA = -0.63 to 0.34) and OLR (R(2) = 0.22; RMSE = 0.26; MAE = 0.02; 95% LA = -0.49 to 0.53). MAEs were lower than the minimally clinically important difference for the Non-p and OLR but not for the Non-peLI. Differences in probabilities of cost-effectiveness ranged from 1% to 4% (Non-p), 0.1% to 9% (Non-peLI), and 0.1% to 20% (OLR). CONCLUSIONS: Results suggest that the developed response mapping approaches are not valid for estimating individual patients' 3-level version of EQ-5D utility values, and-depending on the approach-may considerably affect cost-utility results. The developed approaches did not perform better than previously published regression-based models and are therefore not recommended for use in economic evaluations. 01 juni 2023

Objectives: To identify if a plausible theoretical construct exists for a test cluster in a group of patients with subacromial pain syndrome presenting with glenohumeral internal rotation deficit (GIRD); determine the intertester agreement and reliability of the proposed test cluster; determine if there are any meaningful relationships between the test cluster and the component tests for the entire sample; and determine if there are any differences in disability on the Dutch version of the shoulder pain and disability index between participants with a positive and negative test cluster. Methods: This study is a retrospective secondary analysis of data that were collected to determine the interrater agreement and reliability of clinical tests for assessment of patients with shoulder pain in primary care. Results: The test cluster total agreement and negative specific agreement was 87.8 and 90.4%, respectively. The prevalence-adjusted bias-adjusted kappa for the test cluster was substantial at 0.76. There were statistically significant meaningful relationships (≥0.50) between GIRD and the test cluster for Tester A (Phi = 0.71, p

Background: There is limited information about the agreement and reliability of clinical shoulder tests. Objectives: To assess the interrater agreement and reliability of clinical shoulder tests in patients with shoulder pain treated in primary care. Methods: Patients with a primary report of shoulder pain underwent a set of 21 clinical shoulder tests twice on the same day, by pairs of independent physical therapists. The outcome parameters were observed and specific interrater agreement for positive and negative scores, and interrater reliability (Cohen’s kappa (κ)). Positive and negative interrater agreement values of ≥0.75 were regarded as sufficient for clinical use. For Cohen’s κ, the following classification was used

OBJECTIVE: To assess the effectiveness of individualized physiotherapy in combination with rigid taping compared with individualized physiotherapy alone in patients with subacromial pain syndrome.DESIGN: A prospective randomized trial with concealed allocation.PATIENTS: A total of 140 patients between 18 and 65 years of age from primary physiotherapy settings.METHODS: The intervention group received individualized physiotherapy and shoulder taping. The control group received individualized physiotherapy only. Primary outcomes were: pain intensit (numerical rating scale) and functioning (Simple Shoulder Test). Secondary outcomes were: global perceived effect and patient-specific complaints. Data were collected at baseline, and at 4, 12 and 26 weeks' follow-up.RESULTS: During the 6-month follow-up period multilevel analysis showed a significant difference between groups favouring the control group on pain intensity (p = 0.02), but not on functioning. Regarding secondary outcomes, a significant difference between groups was found favouring the intervention group for global perceived effect (p = 0.02), but not for patient-specific complaints.CONCLUSION: Rigid shoulder taping, as used in this study, cannot be recommended for improving physiotherapy outcomes in people with subacromial pain syndrome.

Prospective cohort, test-retest design.Directional preference (DP) with centralization (CEN) and DP without CEN are common pain-pattern responses assessed by Mechanical Diagnosis and Therapy (MDT). Although there is evidence that MDT can reduce pain and disability in the short term by treating the patient with direction-specific exercises concordant with the patient's DP, the mechanism responsible for this is unclear.To determine whether clinical signs of impaired spinal control improve immediately after eliciting a DP-with-CEN response or a DP-without-CEN response in patients with nonspecific low back pain.Participants underwent a standardized MDT assessment and were classified into the following pain-pattern subgroups: DP with CEN, DP without CEN, or no DP. Clinical signs of impaired spinal control were assessed pre-MDT assessment and post-MDT assessment by an independent examiner. Four spinal control tests were conducted: aberrant lumbar movements while bending forward, the active straight leg raise (ASLR) test, the Trendelenburg test, and the prone instability test. Differences in spinal control pre-MDT assessment and post-MDT assessment were calculated for the 3 pain-pattern subgroups and compared with chi-square tests. We hypothesized that a larger proportion of patients in the DP-with-CEN subgroup would exhibit improved spinal control than patients categorized as DP without CEN or no DP.Of 114 patients recruited, 51 patients (44.7%) were categorized as DP with CEN, 23 (20.2%) as DP without CEN, and 40 (35.1%) as no DP. Before MDT assessment, between 28.9% (Trendelenburg test) and 63.7% (ASLR test) of patients showed impaired spinal control. After MDT assessment, a larger proportion of patients in the DP-with-CEN subgroup (43%) showed improvement than those in the no-DP subgroup (7%) on aberrant lumbar movements (P = .02). Likewise, more patients in the DP-with-CEN subgroup (50%) improved on the ASLR test than those in the no-DP subgroup (8%, P.01) or the DP-without-CEN subgroup (7%, P = .01). Changes in Trendelenburg test and prone instability test outcomes did not reach statistical significance.Immediately following MDT assessment, a larger proportion of patients with a DP-with-CEN pain pattern showed improvement in clinical signs of spinal control compared to patients with a DP-without-CEN or no-DP pain pattern. The current study was registered in the Dutch trial registry at http://www.trialregister.nl/trialreg/index.asp (NTR4246).Therapy, level 2b.

Objective In randomized controlled trials (RCTs), outcome variables are often patient-reported outcomes measured with questionnaires. Ideally, all available item information is used for score construction, which requires an item response theory (IRT) measurement model. However, in practice, the classical test theory measurement model (sum scores) is mostly used, and differences between response patterns leading to the same sum score are ignored. The enhanced differentiation between scores with IRT enables more precise estimation of individual trajectories over time and group effects. The objective of this study was to show the advantages of using IRT scores instead of sum scores when analyzing RCTs. Study Design and Setting Two studies are presented, a real-life RCT, and a simulation study. Both IRT and sum scores are used to measure the construct and are subsequently used as outcomes for effect calculation. Results The bias in RCT results is conditional on the measurement model that was used to construct the scores. A bias in estimated trend of around one standard deviation was found when sum scores were used, where IRT showed negligible bias. Conclusion Accurate statistical inferences are made from an RCT study when using IRT to estimate construct measurements. The use of sum scores leads to incorrect RCT results

tudy Design Prospective cohort study. Objective To report the clinical course of patients with MRI-confirmed lumbar disc herniation-related radicular noncentralizing pain who received transforaminal epidural steroid injections (TESIs) and mechanical diagnosis and therapy (MDT). Summary of Background Data Noncentralizing symptoms in patients with lumbar disc herniation are associated with poor outcome. Commonly used treatments for these patients include TESIs and MDT. No study has evaluated the outcome of combining both strategies. Methods Consecutive candidates for herniated lumbar disc surgery with noncentralizing chronic pain were eligible. Patients received TESIs followed by MDT. The primary outcomes were pain severity in the leg, disability (Roland–Morris Disability Questionnaire for Sciatica), and global perceived effect (GPE). Outcomes were measured at baseline, discharge, and 12 months. Linear mixed-models and McNemar's tests were used to analyze outcome data. Results Sixty-nine patients receive TESIs. After TESIs, symptoms were resolved completely in 11 patients (16%). In these patients, symptom resolution was maintained at 12 months. A second subgroup of 32 patients (46%) reported significantly less pain after TESIs and showed centralization with MDT reassessment (significant reductions in leg pain and disability [P

Background: Within epidemiology both mixed model analysis and Generalised Estimating Equations (GEE analysis) are frequently used to analyse longitudinal RCT data. With a continuous outcome, both methods lead to more or less the same results, but with a dichotomous outcome the results are totally different. The purpose of the present study is to evaluate the performance of a logistic mixed model analysis and a logistic GEE analysis and to give an advice which of the two methods should be used. Methods: Two real life RCT datasets with and without missing data were used to perform this evaluation. Regarding the logistic mixed model analysis also two different estimation procedures were compared to each other. Results: The regression coefficients obtained from the two logistic mixed model analyses were different from each other, but were always higher then the regression coefficients derived from a logistic GEE analysis. Because this also holds for the standard errors, the corresponding p-values were more or less the same. It was further shown that the effect estimates derived from a logistic mixed model analysis were an overestimation of the ‘real’ effect estimates. Conclusions: Although logistic mixed model analysis is widely used for the analysis of longitudinal RCT data, this article shows that logistic mixed model analysis should not be used when one is interested in the magnitude of the regression coefficients (i.e. effect estimates).

Study design Prospective cohort study. Background Although lumbar radiculopathy is regarded as a specific diagnosis, the most effective treatment strategy is unclear. Commonly used treatments include transforaminal epidural steroid injections (TESIs) and Mechanical Diagnosis & Therapy (MDT), but no studies have investigated the effectiveness of this combination. MDT differentiates pain centralization (C) from non-centralization (NC), which indicates good vs. poor prognostic validity respectively. Objective The main aims were 1) to determine changes in Mechanical Diagnosis and Therapy (MDT) pain response classifications after transforaminal epidural steroid injections (TESIs) in candidates for lumbar herniated disc surgery and 2) to evaluate differences in short and long term outcomes for patients with different pain response classifications. Methods Candidates for lumbar herniated disc surgery were assessed with a MDT protocol and their pain response classified as centralizing or peripheralizing. For this study,only patients were eligible who showed a peripheralizing pain response at intake. All patients then received TESIs and were reassessed and classified using the MDT protocol, into groups according to pain response (resolved, centralizing, peripheralizing with less pain and peripheralising with severe pain). After receiving targeted treatment based on pain response after TESIs, ranging from advice, MDT or surgery, follow-up assessments were completed at discharge and at 12 months. The primary outcomes were disability (Roland-Morris Disability Questionnaire [RMDQ] for Sciatica), pain severity in leg (visual analogue scale [VAS], 0-100) and global perceived effect (GPE). Linear mixed-models were used to determine between-groups differences in outcome. Results A total of 77 patients with lumbar disc herniation and peripheralizing symptoms were included. Patients received an average of 2 (SD 0.7) TESIs. After TESIs, 17 patients (22%) were classified as peripheralizing with continuing severe pain.These patients underwent surgery and were not further evaluated. Eleven (14%) patients were classified as resolved, 37 (48%) as centralizing with significant less pain, and 12 (16%) as peripheralizing with significant less pain. None of these patients underwent surgery. Resolved and centralizer subgroups had better outcomes in terms of VAS and RMDQ than the non-operated peripheralizers at discharge and at 12 months. The succes rates (GPE) for the resolved, centralizing, and peripheralizing with less pain patients were 100%, 100% and 33% respectively at short term, and 100%, 92% and 50% respectively at long term. Conclusion After TESIs, a peripheralizing pain pattern changed to resolved or centralizing in 62% of the patients. For the non-operated patients, those with a centralising pattern after TESIs reported better pain and disability outcomes than those with peripheralizing pattern at short and long term.

PURPOSE: Identifying relevant subgroups in patients with low back pain (LBP) is considered important to guide physical therapy practice and to improve outcomes. The aim of the present study was to assess the cost-effectiveness of a modified version of Delitto's classification-based treatment approach compared with usual physical therapy care in patients with sub-acute and chronic LBP with 1 year follow-up.METHODS: All patients were classified using the modified version of Delitto's classification-based system and then randomly assigned to receive either classification-based treatment or usual physical therapy care. The main clinical outcomes measured were; global perceived effect, intensity of pain, functional disability and quality of life. Costs were measured from a societal perspective. Multiple imputations were used for missing data. Uncertainty surrounding cost differences and incremental cost-effectiveness ratios was estimated using bootstrapping. Cost-effectiveness planes and cost-effectiveness acceptability curves were estimated.RESULTS: In total, 156 patients were included. The outcome analyses showed a significantly better outcome on global perceived effect favoring the classification-based approach, and no differences between the groups on pain, disability and quality-adjusted life-years. Mean total societal costs for the classification-based group were 2,287, and for the usual physical therapy care group 2,020. The difference was 266 (95% CI -720 to 1,612) and not statistically significant. Cost-effectiveness analyses showed that the classification-based approach was not cost-effective in comparison with usual physical therapy care for any clinical outcome measure.CONCLUSION: The classification-based treatment approach as used in this study was not cost-effective in comparison with usual physical therapy care in a population of patients with sub-acute and chronic LBP.

STUDY DESIGN: A randomized controlled trial.OBJECTIVE: To assess the effectiveness of Delitto's classification-based treatment approach compared with usual physical therapy care in patients with subacute or chronic low back pain.SUMMARY OF BACKGROUND DATA: No trial has evaluated this approach in patients with subacute and chronic low back pain.METHODS: Before randomization, all patients were classified by research physical therapists according to a modified version of Delitto's classification-based system. Randomization was computer-generated, with centralized allocation concealment. The statistician and the physical therapists were unblinded. Patients and assistants who collected follow-up questionnaires were blinded. Follow-up assessments were completed at 8, 26, and 52 weeks. The primary analysis was performed according to the intention-to-treat principle, using multilevel analysis. The main outcomes were global perceived effect, disability (Oswestry Disability Index, 0-100), and pain intensity (Numerical Rating Scale, 0-10). Secondary outcomes were quality of life, fear-avoidance beliefs, and psychosocial status. RESULTS.: A total of 156 patients were included (classification-based group, n = 74; usual physical therapy group, n = 82). There were no statistically significant differences between the treatment groups for any of the outcomes at any of the follow-up time points. After 8 weeks, patients in the classification-based group had greater global perceived effect scores; adjusted odds ratio of 1.01 (95% confidence interval [CI], 0.31 to 3.28), and higher adjusted Oswestry Disability Index and Numerical Rating Scale scores; mean adjusted differences of 0.48 points (95% CI, -4.59 to 3.63) and 0.49 points (95% CI, -1.34 to 0.37) respectively, but all differences were statistically nonsignificant.CONCLUSION: The classification-based system used in this study was not effective for improving physical therapy care outcomes in a population of patients with subacute and chronic low back pain.

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.

Prospective cohort study.To report the clinical course of patients with MRI-confirmed lumbar disc herniation-related radicular noncentralizing pain who received transforaminal epidural steroid injections (TESIs) and mechanical diagnosis and therapy (MDT).Noncentralizing symptoms in patients with lumbar disc herniation are associated with poor outcome. Commonly used treatments for these patients include TESIs and MDT. No study has evaluated the outcome of combining both strategies.Consecutive candidates for herniated lumbar disc surgery with noncentralizing chronic pain were eligible. Patients received TESIs followed by MDT. The primary outcomes were pain severity in the leg, disability (Roland-Morris Disability Questionnaire for Sciatica), and global perceived effect (GPE). Outcomes were measured at baseline, discharge, and 12 months. Linear mixed-models and McNemar's tests were used to analyze outcome data.Sixty-nine patients receive TESIs. After TESIs, symptoms were resolved completely in 11 patients (16%). In these patients, symptom resolution was maintained at 12 months. A second subgroup of 32 patients (46%) reported significantly less pain after TESIs and showed centralization with MDT reassessment (significant reductions in leg pain and disability [P 0.001]) and a satisfaction rate of 90% at 12 months. A third subgroup of 11 patients (16%) reported significantly less pain after TESIs but still showed noncentralization with MDT reassessment (significant reductions in leg pain and disability [P 0.05] and a satisfaction rate of 50% at 12 months). A fourth subgroup of 15 patients (22%) did not respond on TESIs and received an operative intervention.The results indicate that a course of TESIs followed by MDT may be able to avoid surgery in a substantial proportion of candidates for herniated lumbar disc surgery.

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.

Background A treatment-based classification algorithm for low back pain (LBP) was created to help clinicians select treatments to which people are most likely to respond. To allow the algorithm to classify all people with LBP, additional criteria can help therapists make decisions for people who do not clearly fit into a subgroup (ie, unclear classifications). Recent studies indicated that classifications are unclear for approximately 34% of people with LBP. Objective To guide improvements in the algorithm, it is imperative to determine whether people with unclear classifications are different from those with clear classifications. Design This study was a secondary analysis of data from 3 previous studies investigating the algorithm. Methods Baseline data from 529 people who had LBP were used (3 discrete cohorts). The primary outcome was type of classification, that is, clear or unclear. Univariate logistic regression was used to determine which participant variables were related to having an unclear classification. Results People with unclear classifications had greater odds of being older (odds ratio [OR]=1.01, 95% confidence interval [CI]=1.003–1.033), having a longer duration of LBP (OR=1.001, 95% CI=1.000–1.001), having had a previous episode(s) of LBP (OR=1.61, 95% CI=1.04–2.49), having fewer fear-avoidance beliefs related to both work (OR=0.98, 95% CI=0.96–0.99) and physical activity (OR=0.98, 95% CI=0.96–0.996), and having less LBP-related disability (OR=0.98, 95% CI=0.96–0.99) than people with clear classifications. Limitations Studies from which participant data were drawn had different inclusion criteria and clinical settings. Conclusions People with unclear classifications appeared to be less affected by LBP (less disability and fewer fear avoidance beliefs), despite typically having a longer duration of LBP. Future studies should investigate whether modifying the algorithm to exclude such people or provide them with different interventions improves outcomes.

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.

Background Shoulder problems are a common complaint of the musculoskeletal system. Physical therapists treat these patients with different modalities such as exercise, massage, and shoulder taping. Although different techniques have been described, the effectiveness of taping has not yet been established. The aim of this study is to assess the effectiveness and cost-effectiveness of usual physical therapy care in combination with a particular tape technique for subacromial impingement syndrome of the shoulder compared to usual physical therapy care without this tape technique in a primary healthcare setting. Methods and design An economic evaluation alongside a randomized controlled trial will be conducted. A sample of 140 patients between 18 and 65 years of age with a diagnosis of subacromial impingement syndrome (SAIS) as assessed by physical therapists will be recruited. Eligible patients will be randomized to either the intervention group (usual care in combination with the particular tape technique) or the control group (usual care without this tape technique). In both groups, usual care will consist of individualized physical therapy care. The primary outcomes will be shoulder-specific function (the Simple Shoulder Test) and pain severity (11-point numerical rating scale). The economic evaluation will be performed using a societal perspective. All relevant costs will be registered using cost diaries. Utilities (Quality Adjusted Life Years) will be measured using the EuroQol. The data will be collected at baseline, and 4, 12, and 26 weeks follow-up. Discussion This pragmatic study will provide information about the effectiveness and cost-effectiveness of taping in patients presenting with clinical signs of SAIS. Trial registration Trial registration number: NTR2575

Objectives: To identify signs and symptoms that should alert clinicians to the need for additional psychological assessment in patients with chronic low back pain (CLBP). Methods: In this prospective cohort study, 229 consecutive patients with CLBP who attended an outpatient rehabilitation center were assessed by psychologists and physical therapists before their treatment started. The signs and symptoms assessed by the physical therapists were compared with the assessments made by the psychologists, which were considered to be the reference standard (relevant psychological disturbances, yes or no). Univariable and multivariable regression methods were applied to investigate which signs and symptoms were associated with the reference standard. A receiver operator characteristic (ROC) curve was constructed to assess the overall accuracy of the final model. Results: The psychologists classified 53% of the patients as having relevant psychological disturbances. Univariable analysis revealed statistically significant differences (P

Background 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. Methods/Design 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. Discussion The present study will contribute to our knowledge about the effectiveness and cost-effectiveness of classification-based treatment in patients with LBP. Trial registration Trial registration number: NTR1176