Management of low back pain and lumbosacral radicular syndrome: the Guideline of the Royal Dutch Society for Physical Therapy (KNGF).

BACKGROUND: Significant progress and new insights have been gained since the Dutch Physical Therapy guideline on low back pain (LBP) in 2013 and the Cesar en Mensendieck guideline in 2009, necessitating an update of these guidelines. AIM: To update and develop an evidence-based guideline for the comprehensive management of LBP and lumbosacral radicular syndrome (LRS) without serious specific conditions (red flags) for Dutch physical therapists and Cesar and Mensendieck Therapists. DESIGN: Clinical practice guideline. SETTING: Inpatient and outpatient. POPULATION: Adults with LBP and/or LRS. METHODS: Clinically relevant questions were identified based on perceived barriers in current practice of physical therapy. All clinical questions were answered using published guidelines, systematic reviews, narrative reviews or systematic reviews performed by the project group. Recommendations were formulated based on evidence and additional considerations, as described in the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Evidence-to-Decision framework. Patients participated in every phase. RESULTS: The guideline describes a comprehensive assessment based on the International Classification of Functioning, Disability and Health (ICF) Core Set for LBP and LRS, including the identification of alarm symptoms and red flags. Patients are assigned to three treatment profiles (low, moderate and high risk of persistent symptoms) based on prognostic factors for persistent LBP. The guideline recommends offering simple and less intensive support to people who are likely to recover quickly (low-risk profile) and more complex and intensive support to people with a moderate or high risk of persistent complaints. Criteria for initiating and discontinuing physical therapy, and referral to a general practitioner are specified. Recommendations are formulated for information and advice, measurement instruments, active and passive interventions and behavior-oriented treatment. CONCLUSIONS: An evidence based physical therapy guideline for the management of patients with LBP and LRS without red flags for physical therapists and Cesar and Mensendieck therapists was developed. Cornerstones of physical therapy assessment and treatment are risk stratification, shared decision-making, information and advice, and exercises. CLINICAL REHABILITATION IMPACT: This guideline provides guidance for clinicians and patients to optimize treatment outcomes in patients with LBP and LRS and offers transparency for other healthcare providers and stakeholders.

Mapping Oswestry Disability Index Responses to EQ-5D-3L Utility Values: Are Cost-Utility Results Valid?

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 (R2), 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 (R2 = 0.43; RMSE = 0.22; MAE = 0.03; 95% LA = -0.40 to 0.47) compared with the Non-peLI (R2 = 0.07; RMSE = 0.29; MAE = -0.15; 95% LA = -0.63 to 0.34) and OLR (R2 = 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.

Can EQ-5D-3L utility values of low back pain patients be validly predicted by the Oswestry Disability Index for use in cost-effectiveness analyses?

PURPOSE: To assess whether regression modeling can be used to predict EQ-5D-3L utility values from the Oswestry Disability Index (ODI) in low back pain (LBP) patients for use in cost-effectiveness analysis. METHODS: EQ-5D-3L utility values of LBP patients were estimated using their ODI scores as independent variables using regression analyses, while adjusting for case-mix variables. Six different models were estimated: (1) Ordinary Least Squares (OLS) regression, with total ODI score, (2) OLS, with ODI item scores as continuous variables, (3) OLS, with ODI item scores as ordinal variables, (4) Tobit model, with total ODI score, (5) Tobit model, with ODI item scores as continuous variables, and (6) Tobit model, with ODI item scores as ordinal variables. The models' performance was assessed using explained variance (R2) and root mean squared error (RMSE). The potential impact of using predicted instead of observed EQ-5D-3L utility values on cost-effectiveness outcomes was evaluated in two empirical cost-effectiveness analysis. RESULTS: Complete individual patient data of 18,692 low back pain patients were analyzed. All models had a more or less similar R2 (range 45-52%) and RMSE (range 0.21-0.22). The two best performing models produced similar probabilities of cost-effectiveness for a range of willingness-to-pay (WTP) values compared to those based on the observed EQ-5D-3L values. For example, the difference in probabilities ranged from 2 to 5% at a WTP of 50,000 €/QALY gained. CONCLUSION: Results suggest that the ODI can be validly used to predict low back pain patients' EQ-5D-3L utility values and QALYs for use in cost-effectiveness analyses.

Interrater agreement and reliability of clinical tests for assessment of patients with shoulder pain in primary care.

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: <0.20 poor, 0.21-0.40 fair, 0.41-0.60 moderate, 0.61-0.80 good, 0.81-1.00 very good reliability. Participating clinics were randomized in two groups; with or without a brief practical session on how to conduct the tests. Results: A total of 113 patients were assessed in 12 physical therapy practices by 36 physical therapists. Positive and negative interrater agreement values were both sufficient for 1 test (the Full Can Test), neither sufficient for 5 tests, and only sufficient for either positive or negative agreement for 15 tests. Interrater reliability was fair for 11 tests, moderate for 9 tests, and good for 1 test (the Full Can Test). An additional brief practical session did not result in better agreement or reliability. Conclusion: Clinicians should be aware that interrater agreement and reliability for most shoulder tests is questionable and their value in clinical practice limited.

Agreement and reliability of a symptom modification test cluster for patients with subacromial pain syndrome.

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 < .01) and Tester B (Phi = 0.82, p < .01). No differences in disability were identified between those with a positive and negative test cluster. CONCLUSION: The test cluster described in this study may be a reliable means of identifying a subgroup of patients with subacromial pain syndrome related to GIRD. Future research should look to validate this test cluster prospectively.

Physicians using spinal manipulative treatment in The Netherlands: a description of their characteristics and their patients.

BACKGROUND: Various health care professionals apply Spinal Manipulative Treatment (SMT) in daily practice. While the characteristics of chiropractors and manual therapists and the characteristics of their patient populations are well described, there is little research about physicians who use SMT techniques. A distinct group of physicians in The Netherlands has been trained in musculoskeletal (MSK) medicine, which includes the use of SMT. Our objective was to describe the characteristics of these physicians and their patient population. METHODS: All registered MSK physicians were approached with questionnaires and telephone interviews to collect data about their characteristics. Data about patient characteristics were extracted from a web-based register. In this register physicians recorded basic patient data (age, gender, the type and duration of the main complaint, concomitant complaints and the type of referral) at the first consultation. Patients were invited to fill in web-based questionnaires to provide baseline data about previous treatments and the severity of their main complaint. Functional impairment was measured with Patient Reported Outcome Measures (PROMs). RESULTS: Questionnaires were sent to 138 physicians of whom 90 responded (65%). Most physicians were trained in MSK medicine after a career in other medical specialities. They reported to combine their SMT treatment with a variety of diagnostic and treatment options part of which were only permissible for physicians, such as prescription medication and injections. The majority of patients presented with complaints of long duration (62.1% > 1 year), most frequently low back pain (48.1%) or neck pain (16.9%), with mean scores of 6.0 and 6.2, respectively, on a 0 to10 numerical rating scale (NRS) for pain intensity. Mean scores on all PROMs showed moderate impairment. Patients most frequently reported previous treatment by physical therapists (68.1%), manual therapists (37.7%) or chiropractors (17.0%). CONCLUSION: Our study showed that MSK physicians in The Netherlands used an array of SMT techniques. They embedded their SMT techniques in a broad array of other diagnostic and treatment options, part of which were limited to medical doctors. Most patients consulted MSK physicians with spinal pain of long duration with moderate functional impairment.

Rigid shoulder taping with physiotherapy in patients with subacromial pain syndrome: A randomized controlled trial.

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.

Inter-rater reliability of a modified version of Delitto et al.'s classification-based system for low back pain: a pilot study.

STUDY DESIGN: Observational inter-rater reliability study. OBJECTIVES: To examine: (1) the inter-rater reliability of a modified version of Delitto et al.'s classification-based algorithm for patients with low back pain; (2) the influence of different levels of familiarity with the system; and (3) the inter-rater reliability of algorithm decisions in patients who clearly fit into a subgroup (clear classifications) and those who do not (unclear classifications). METHODS: Patients were examined twice on the same day by two of three participating physical therapists with different levels of familiarity with the system. Patients were classified into one of four classification groups. Raters were blind to the others' classification decision. In order to quantify the inter-rater reliability, percentages of agreement and Cohen's Kappa were calculated. RESULTS: A total of 36 patients were included (clear classification n = 23; unclear classification n = 13). The overall rate of agreement was 53% and the Kappa value was 0·34 [95% confidence interval (CI): 0·11-0·57], which indicated only fair inter-rater reliability. Inter-rater reliability for patients with a clear classification (agreement 52%, Kappa value 0·29) was not higher than for patients with an unclear classification (agreement 54%, Kappa value 0·33). Familiarity with the system (i.e. trained with written instructions and previous research experience with the algorithm) did not improve the inter-rater reliability. CONCLUSION: Our pilot study challenges the inter-rater reliability of the classification procedure in clinical practice. Therefore, more knowledge is needed about factors that affect the inter-rater reliability, in order to improve the clinical applicability of the classification scheme.

Transforaminal epidural steroid injections influence Mechanical Diagnosis and Therapy (MDT) pain response classification in candidates for lumbar herniated disc surgery.

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.

The Influence of Centralization and Directional Preference on Spinal Control in Patients With Nonspecific Low Back Pain.

STUDY DESIGN: Prospective cohort, test-retest design. BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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). LEVEL OF EVIDENCE: Therapy, level 2b.

Transforaminal epidural steroid injections followed by mechanical diagnosis and therapy to prevent surgery for lumbar disc herniation.

STUDY 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 < 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. CONCLUSION: 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.

What characterizes people who have an unclear classification using a treatment-based classification algorithm for low back pain? A cross-sectional study.

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.

A randomized controlled trial on the effectiveness of a classification-based system for subacute and chronic low back pain.

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.

Cost-effectiveness of a classification-based system for sub-acute and chronic low back pain.

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.

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".

Identification of patients with chronic low back pain who might benefit from additional psychological assessment.

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<0.05) between the 2 patient groups (relevant psychological disturbances, yes or no) for 10 of the 17 signs and symptoms. Multivariate analysis yielded a screening instrument consisting of the following 4 signs and symptoms: presence of Waddell signs, elevated scores on the pain drawing, absence of a directional preference, and daily use of analgesic medication for CLBP [area under the ROC curve, 0.81 (95% confidence interval: 0.75, 0.87)]. DISCUSSION: This study established a clinically useful screening instrument for the identification of patients with CLBP who might benefit from additional psychological assessment in an outpatient rehabilitation setting. Further research is needed to confirm our preliminary results.

Taping patients with clinical signs of subacromial impingement syndrome: the design of a randomized controlled trial.

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 NUMBER: NTR2575.

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

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 NUMBER: NTR1176.

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 kappa was used to compute the interobserver and intraobserver reliability of the sign maneuvers, categories and Waddell score. Cronbach's alpha was calculated for the 5 categories and 8 signs to determine internal consistency. Chi2 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.