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Background and Aims: Integration of care is lacking for chronic musculoskeletal pain patients. Network Pain Rehabilitation Limburg, a transmural health care network, has been designed to provide integrated rehabilitation care from a biopsychosocial perspective to improve patients' levels of functioning. This feasibility study aims to provide insight into barriers and facilitators for the development, implementation, and transferability., Methods: This study was conducted with a three-phase iterative and incremental design from October 2017 to October 2018. The network comprises two rehabilitation practices, and three local primary care networks, with a general practitioner together with, a mental health practice nurse, and a physiotherapist or exercise therapist. These stakeholders with a random sample of participating patients took part in evaluations, consisting of interviews, focus groups, and observations. Field notes and observations were recorded during meetings. The Consolidated Framework for Implementation Research guided data collection and analysis. Results were used to refine the next phase., Results: According to health care professionals, guidelines and treatment protocols facilitate consistency and transparency in collaboration, biopsychosocial language, and treatment. One mentioned barrier is the stigmatization of chronic pain by the general population. In regular care, approaches are often more biomedical than biopsychosocial, causing patients to resist participating. The current organization of health care acts as a barrier, complicating implementation between and within practices. Health care professionals were enthusiastic about the iterative, bottom-up development. A critical mass of participating organizations is needed for proper implementation., Conclusion: Network Pain Rehabilitation Limburg is feasible in daily practice if barriers are overcome and facilitators of development, implementation, and transferability are promoted. These findings will be used to refine Network Pain Rehabilitation Limburg. A large-scale process and effect evaluation will be performed. Our implementation strategies and results may assist other health care organizations aspiring to implement a transmural network using a similar model., Trail Registration: Registration number: NTR6654 or https://trialsearch.who.int/Trial2.aspx?TrialID=NTR6654., Competing Interests: IH, AK, and JV report grants from Health Insurance Companies CZ, VGZ and Achmea, during the conduct of the study. The other authors declare that there is no conflict of interest. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Aim: This study aims to gain more knowledge of the sensorimotor incongruence in patients with chronic nonspecific complaints of arm, neck and shoulder., Method: Seven patients and seven healthy controls performed a left/right judgment task, and tactile acuity was assessed by the two-point discrimination threshold at fingers and shoulders., Results & Conclusion: The results suggest a decreased tactile acuity in patients with chronic nonspecific complaints of arm, neck and shoulder and a faster reaction time at the painful arm, which might imply disturbed information processing of sensory and motor feedback. Due to the small sample size and low scores on the pain and disability questionnaires, these conclusions should be interpreted with care. Further research is recommended.

Background: No core set of measurement tools exists to collect data within clinical practice. Such data could be useful as reference data to guide treatment decisions and to compare patient characteristics or treatment results within specific treatment settings., Methods: The Dutch Dataset Pain Rehabilitation was developed which included the six domains of the IMMPACT core set and three new domains relevant in the field of rehabilitation (medical consumption, patient-specific goals and activities/participation). Between 2010 and 2013 the core set was implemented in 32 rehabilitation facilities throughout the Netherlands., Results: A total of 8200 adult patients with chronic pain completed the core set at first consultation with the rehabilitation physician. Adult patients (18-90 years) suffering from a long history of pain (38% >5 years) were referred. Patients had high medical consumption and less than half were working. Although patients were referred with diagnosis of low back pain or neck or shoulder pain, a large group (85%) had multisite pain (39% 2-5 painful body regions; 46% >5 painful body regions). Scores on psychosocial questionnaires were high, indicating high case complexity of referred patients. Reference data for subgroups based on gender, pain severity, pain locations and on pain duration are presented., Conclusions: The data from this clinical core set can be used to compare patient characteristics of patients of other treatment setting and/or scientific publications. As treatment success might depend on case complexity, which is high in the referred patients, the advantages of earlier referral to comprehensive multidisciplinary treatment were discussed., Significance: A detailed description of case complexity of patients with chronic pain referred for pain rehabilitation. Insight in case complexity of patients within subgroups on the basis of gender, pain duration, pain severity and pain location. These descriptions can be used as reference data for daily practice in the field of pain rehabilitation and can be used to evaluate, monitor and improve rehabilitation care in care settings nationwide as well as internationally., (© 2016 European Pain Federation - EFIC®.)

Objectives: The 0-10 Numeric Rating Scale (NRS) is often used in pain management. The aims of our study were to determine the cut-off points for mild, moderate, and severe pain in terms of pain-related interference with functioning in patients with chronic musculoskeletal pain, to measure the variability of the optimal cut-off points, and to determine the influence of patients' catastrophizing and their sex on these cut-off points. Methods: 2854 patients were included. Pain was assessed by the NRS, functioning by the Pain Disability Index (PDI) and catastrophizing by the Pain Catastrophizing Scale (PCS). Cut-off point schemes were tested using ANOVAs with and without using the PSC scores or sex as co-variates and with the interaction between CP scheme and PCS score and sex, respectively. The variability of the optimal cut-off point schemes was quantified using bootstrapping procedure. Results and conclusion: The study showed that NRS scores ≤ 5 correspond to mild, scores of 6-7 to moderate and scores ≥8 to severe pain in terms of pain-related interference with functioning. Bootstrapping analysis identified this optimal NRS cut-off point scheme in 90% of the bootstrapping samples. The interpretation of the NRS is independent of sex, but seems to depend on catastrophizing. In patients with high catastrophizing tendency, the optimal cut-off point scheme equals that for the total study sample, but in patients with a low catastrophizing tendency, NRS scores ≤ 3 correspond to mild, scores of 4-6 to moderate and scores ≥7 to severe pain in terms of interference with functioning. In these optimal cut-off schemes, NRS scores of 4 and 5 correspond to moderate interference with functioning for patients with low catastrophizing tendency and to mild interference for patients with high catastrophizing tendency. Theoretically one would therefore expect that among the patients with NRS scores 4 and 5 there would be a higher average PDI score for those with low catastrophizing than for those with high catastrophizing. However, we found the opposite. The fact that we did not find the same optimal CP scheme in the subgroups with lower and higher catastrophizing tendency may be due to chance variability.

Objectives: The aim of this trial was to evaluate the difference in treatment effect, at 26 and 52 weeks after the start of treatment, between cognitive behavioural therapy (CBT) and multidisciplinary rehabilitation treatment (MRT) for patients with chronic fatigue syndrome (CFS)., Design: Multicentre, randomized controlled trial of patients with CFS. Participants were randomly assigned to MRT or CBT., Setting: Four rehabilitation centres in the Netherlands., Subjects: A total of 122 patients participated in the trial., Main Outcome Measures: Primary outcomes were fatigue measured by the fatigue subscale of the Checklist Individual Strength and health-related quality of life measured by the Short-Form 36. Outcomes were assessed prior to treatment and at 26 and 52 weeks after treatment initiation., Results: A total of 114 participants completed the assessment at 26 weeks, and 112 completed the assessment at 52 weeks. MRT was significantly more effective than CBT in reducing fatigue at 52 weeks. The estimated difference in fatigue between the two treatments was -3.02 [95% confidence interval (CI) -8.07 to 2.03; P = 0.24] at 26 weeks and -5.69 (95% CI -10.62 to -0.76; P = 0.02) at 52 weeks. Patients showed an improvement in quality of life over time, but between-group differences were not significant., Conclusion: This study provides evidence that MRT is more effective in reducing long-term fatigue severity than CBT in patients with CFS. Although implementation in comparable populations can be recommended based on clinical effectiveness, it is advisable to analyse the cost-effectiveness and replicate these findings in another multicentre trial., (© 2015 The Association for the Publication of the Journal of Internal Medicine.)

Study Design: Cross-sectional study., Objective: To examine reference data for the Pain Disability Index (PDI) in Dutch and Canadian patient samples with a variety of musculoskeletal pain disorders and to test which potential factors are independently associated with the PDI score., Summary of Background Data: The PDI is a widely used generic instrument for measuring disability related to pain. It is unknown whether patients with spinal and other musculoskeletal diagnoses have different levels of disability when scored on the PDI., Methods: Patients were referred to secondary and tertiary care centers in the Netherlands and Alberta, Canada, between 2009 and 2013. All patients filled out a baseline questionnaire including demographics and the PDI. After first consultation with a medical doctor, diagnoses were set by the medical specialist. Univariate general linear models were used to examine correlations between PDI scores and age, sex, country of residence, diagnosis, and work status., Results: In total 6997 patients were included in this study: 1302 Canadian and 5695 Dutch patients. Mean PDI score of the total group was 37.8 ± 14.2. Reference values are presented and clustered into the following diagnostic groups: spinal nerve and intervertebral disc disorders; nonspecific back pain; rheumatic soft-tissue pain (widespread pain or fibromyalgia); spinal stenosis; and whiplash-associated disorder. The PDI score was significantly and relevantly associated with pain intensity (η explained variance from 20% to 25%), but not relevantly associated with age, sex, country of residence, and diagnostic group (η<3%). In the working subgroup, adding "current sick leave" as covariate increased the explained variance to 34%., Conclusion: Reference values of the PDI are presented. Patient ratings of disability on the PDI are relevantly associated with pain intensity and work status, but not with nationality or diagnostic group. Only minimal differences were identified between the various musculoskeletal diagnoses included., Level of Evidence: N/A.

Background: Evidence for effectiveness of transcutaneous electrical nerve stimulation (TENS) is still inconclusive. As heterogeneity of chronic pain patients might be an important factor for this lack of efficacy, identifying factors for a successful long-term outcome is of great importance., Methods: A prospective study was performed to identify variables with potential predictive value for 2 outcome measures on long term (6 months); (1) continuation of TENS, and (2) a minimally clinical important pain reduction of ≥ 33%. At baseline, a set of risk factors including pain-related variables, psychological factors, and disability was measured., Results: In a multiple logistic regression analysis, higher patient's expectations, neuropathic pain, no severe pain (< 80 mm visual analogue scale [VAS]) were independently related to long-term continuation of TENS. For the outcome "minimally clinical important pain reduction," the multiple logistic regression analysis indicated that no multisited pain (> 2 pain locations) and intermittent pain were positively and independently associated with a minimally clinical important pain reduction of ≥ 33%., Conclusion: The results showed that factors associated with a successful outcome in the long term are dependent on definition of successful outcome., (© 2014 World Institute of Pain.)

Objective: According to the Cognitive behavioral therapy (CBT) protocol for patients with Chronic Fatigue Syndrome (CFS), therapists are advised to categorize patients in relatively active and passive patients. However, evidence to support the differences in physical functioning between these subgroups is limited. Using the baseline data from a multicentre randomized controlled trial (FatiGo), the differences in actual and perceived physical functioning between active and passive patients with CFS were evaluated., Methods: Sixty patients, who received CBT during the FatiGo trial were included. Based on the expert opinion and using the definitions of subgroups defined in the CBT protocols, the therapist categorized the patient. Data from an activity monitor was used to calculate actual physical functioning, physical activity, daily uptime, activity fluctuations and duration of rest during daily life. Perceived physical functioning was assessed by measuring physical activity, physical functioning and functional impairment with the Checklist Individual Strength, Short Form-36 and Sickness-Impact Profile 8., Results: Relatively active patients have a significantly higher daily uptime and show significantly less fluctuations in activities between days. Passive patients experience a significantly lower level of physical functioning and feel more functionally impaired in their mobility. However, no significant differences were found in the other actual or perceived physical functioning indices., Conclusions: A clear difference in actual and perceived physical functioning between relatively active and passive patients with CFS as judged by their therapists could not be found. Future research is needed to form a consensus on how to categorize subgroups of patients with CFS., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Study Design: A cross-sectional study design was performed., Objective: To validate the pain disability index (PDI) extensively in 3 groups of patients with musculoskeletal pain., Summary of Background Data: The PDI is a widely used and studied instrument for disability related to various pain syndromes, although there is conflicting evidence concerning factor structure, test-retest reliability, and missing items. Additionally, an official translation of the Dutch language version has never been performed., Methods: For reliability, internal consistency, factor structure, test-retest reliability and measurement error were calculated. Validity was tested with hypothesized correlations with pain intensity, kinesiophobia, Rand-36 subscales, Depression, Roland-Morris Disability Questionnaire, Quality of Life, and Work Status. Structural validity was tested with independent backward translation and approval from the original authors., Results: One hundred seventy-eight patients with acute back pain, 425 patients with chronic low back pain and 365 with widespread pain were included. Internal consistency of the PDI was good. One factor was identified with factor analyses. Test-retest reliability was good for the PDI (intraclass correlation coefficient, 0.76). Standard error of measurement was 6.5 points and smallest detectable change was 17.9 points. Little correlations between the PDI were observed with kinesiophobia and depression, fair correlations with pain intensity, work status, and vitality and moderate correlations with the Rand-36 subscales and the Roland-Morris Disability Questionnaire., Conclusion: The PDI-Dutch language version is internally consistent as a 1-factor structure, and test-retest reliable. Missing items seem high in sexual and professional items. Using the PDI as a 2-factor questionnaire has no additional value and is unreliable.

Background: Non-adherence and drop-out are major problems in pain rehabilitation. For patients with various health problems, motivational interviewing (MI) has shown promising effects to tackle these problems. In chronic pain patients, the effectiveness of MI is however unknown. Therefore, a MI-based pre-pain rehabilitation intervention (MIP) addressing motivation, expectations, and beliefs has been developed to prepare eligible patients for rehabilitation treatment., Study Design: A parallel randomized controlled trial including two interventions: a motivational interviewing pre-pain rehabilitation intervention (MIP) and a usual care (UC) control arm. Follow-up will be 6 months after completion of rehabilitation treatment., Study Population: One hundred and sixty (n = 80 per arm) patients with chronic non-specific musculoskeletal pain visiting an outpatient rehabilitation department, who are eligible to participate in an outpatient cognitive behavioral pain rehabilitation program., Intervention: MIP consists of two sessions to prepare and motivate the patient for pain rehabilitation treatment and its bio psychosocial approach. UC consists of information and education about the etiology and the general rehabilitation approach of chronic pain. Both the MIP and UC contain two sessions of 45 to 60 minutes each., Objective: The aim of the current study is to evaluate the effectiveness of MIP compared to UC in terms of an increase in the long-term level of societal participation and decrease of drop-out during rehabilitation treatment.Main study endpoints: Primary outcome is the change in level of participation (according to the ICF-definition: 'involvement in a life situation') 6 months after completion of rehabilitation treatment. Secondary outcomes are adherence and treatment drop-out, disability, pain intensity, self-reported main complaints, (pain-specific) self-efficacy, motivation, and quality of life. Costs are calculated including the costs of the pre-treatment intervention, productivity losses, and healthcare utilization. Potential moderators and active ingredients of MI are explored. For the process evaluation, parameters such as MI fidelity, feasibility, and experiences are explored., Discussion: The results of this study will provide evidence on the effectiveness of this MI-based pre-treatment in pain rehabilitation. Furthermore, a cost-effectiveness analysis and exploration of moderating and working mechanisms of MI and an extensive process evaluation takes place., Trial Registration: Nederlands trial register NTR3065.

Background: Patients with chronic fatigue syndrome experience extreme fatigue, which often leads to substantial limitations of occupational, educational, social and personal activities. Currently, there is no consensus regarding the treatment. Patients try many different therapies to overcome their fatigue. Although there is no consensus, cognitive behavioural therapy is seen as one of the most effective treatments. Little is known about multidisciplinary rehabilitation treatment, a combination of cognitive behavioural therapy with principles of mindfulness, gradual increase of activities, body awareness therapy and pacing. The difference in effectiveness and cost-effectiveness between multidisciplinary rehabilitation treatment and cognitive behavioural therapy is as yet unknown. The FatiGo (Fatigue-Go) trial aims to compare the effects of both treatment approaches in outpatient rehabilitation on fatigue severity and quality of life in patients with chronic fatigue syndrome., Methods: One hundred twenty patients who meet the criteria of chronic fatigue syndrome, fulfil the inclusion criteria and sign the informed consent form will be recruited. Both treatments take 6 months to complete. The outcome will be assessed at 6 and 12 months after the start of treatment. Two weeks after the start of treatment, expectancy and credibility will be measured, and patients will be asked to write down their personal goals and score their current performance on these goals on a visual analogue scale. At 6 and 14 weeks after the start of treatment, the primary outcome and three potential mediators-self-efficacy, causal attributions and present-centred attention-awareness-will be measured. Primary outcomes are fatigue severity and quality of life. Secondary outcomes are physical activity, psychological symptoms, self-efficacy, causal attributions, impact of disease on emotional and physical functioning, present-centred attention-awareness, life satisfaction, patient personal goals, self-rated improvement and economic costs. The primary analysis will be based on intention to treat, and longitudinal analysis of covariance will be used to compare treatments., Discussion: The results of the trial will provide information on the effects of cognitive behavioural therapy and multidisciplinary rehabilitation treatment at 6 and 12 months follow-up, mediators of the outcome, cost-effectiveness, cost-utility, and the influence of treatment expectancy and credibility on the effectiveness of both treatments in patients with chronic fatigue syndrome., Trial Registration: Current Controlled Trials ISRCTN77567702.

Chronic neck pain is a common complaint in the Netherlands with a point prevalence of 14.3%. Patients with chronic neck pain are often referred to physiotherapy and, nowadays, are mostly treated with exercise therapy. It is, however, unclear which type of exercise therapy is to be preferred. Therefore, this study evaluates the effectiveness of behaviour graded activity (BGA) compared with conventional exercise (CE) for patients with chronic neck pain. Eligible patients with non-specific chronic neck were randomly allocated to either BGA or CE. Primary treatment outcome is the patient's global perceived effect concerning recovery from complaint and daily functioning. Outcome assessment was performed at baseline, and at 4, 9, 26, and 52 weeks after randomization. Effectiveness was examined with general estimating equations analyses. Baseline demographics and patient characteristics were well balanced between the two groups. Mean age was 45.7 (SD 12.4) years and the median duration of complaints was 60 months. The mean number of treatments was 6.6 (SD 3.0) in BGA and 11.2 (SD 4.1) in CE. No significant differences between treatments were found in their effectiveness of managing patients with chronic neck pain. In both BGA and CE some patients reported recovery from complaints and daily function but the proportion of recovered patients did not exceed 50% during the 12-month follow-up period. Both groups showed clinically relevant improvements in physical secondary outcomes. International Standard Randomised Controlled Trial Number: ISRCTN88733332.

Objective: To identify subgroups of workers absent from work due to low back pain who are more or less likely to return to work earlier as a result of a graded activity intervention, and to investigate whether this intervention is effective in reducing pain-related fears and if so, whether these reductions in pain-related fears mediate return to work., Methods: A subgroup analysis was conducted on data from a previous randomized controlled trial of 134 Dutch airline workers, which found that a behaviorally-oriented graded activity intervention was more effective than usual care in stimulating return to work. The subgroup analyses added interaction terms to a Cox regression model that described the relationship between treatment allocation and return to work over 12 months of followup. Furthermore, we studied the effects of graded activity on pain-related fears and added variables indicating a reduction in pain-related fears to the model in order to investigate their influence on return to work., Results: Statistically significant interactions were found for disability, fear-avoidance beliefs about physical activity, and fear-avoidance beliefs about work. No indication was found that the reduction in pain-related fears in the graded activity group mediated more favorable return-to-work results in this group., Conclusion: Workers who perceive their disability to be moderate and workers with moderate scores for fear-avoidance beliefs return to work more rapidly as a result of the graded activity intervention than workers with higher scores. The return to work of workers receiving the graded activity intervention is possibly independent from the reductions in pain-related fears caused by this intervention.

Our objective was to investigate whether behavioral graded activity (BGA) has particular benefit in specific subgroups of osteoarthritis (OA) patients. Two hundred participants with OA of hip or knee, or both (clinical American College of Rheumatology, ACR, criteria) participated in a randomized clinical trial on the efficacy of BGA compared to treatment according to the Dutch physiotherapy guideline (usual care; UC). Changes in pain (Visual Analog Scale, VAS), physical functioning (Western Ontario and McMaster Universities Osteoarthritis Index, WOMAC, and McMaster Toronto Arthritis Questionnaire, MACTAR), and patient global assessment were compared for specific subgroups. Subgroups were assigned by the median split method and were analyzed using analysis of covariance. Beneficial effects of BGA were found for patients with a relatively low level of physical functioning (p?0.03). Furthermore, beneficial effects of BGA in patients with a low level of internal locus of control were marginally significant (p = .05). Patients with a relatively low level of physical functioning benefit more from BGA compared to UC. Compared to UC, BGA is the preferred treatment option in patients with a low level of physical functioning.

Objective: To determine the effectiveness of a behavioral graded activity program (BGA) compared with usual care (UC; exercise therapy and advice) according to the Dutch guidelines for physiotherapy in patients with osteoarthritis (OA) of the hip and/or knee. The BGA intervention is intended to increase activity in the long term and consists of an exercise program with booster sessions, using operant treatment principles., Methods: We conducted a cluster randomized trial involving 200 patients with hip and/or knee OA. Primary outcome measures were pain (visual analog scale [VAS] and Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]), physical function (WOMAC), and patient global assessment, assessed at weeks 0, 13, 39, and 65. Secondary outcome measures comprised tiredness (VAS), patient-oriented physical function (McMaster Toronto Arthritis Patient Preference Disability Questionnaire [MACTAR]), 5-meter walking time, muscle strength, and range of motion. Data were analyzed according to intent-to-treat principle., Results: Both treatments showed short-term and long-term beneficial within-group effects. The mean differences between the 2 groups for pain and functional status were not statistically significant. Significant differences in favor of BGA were found for the MACTAR functional scale and 5-meter walking test at week 65., Conclusion: Because both interventions resulted in beneficial long-term effects, the superiority of BGA over UC has not been demonstrated. Therefore, BGA seems to be an acceptable method to treat patients with hip and/or knee OA, with equivalent results compared with UC.

Objectives: The present study evaluated the cost-effectiveness of a behavioral graded exercise therapy (GET) program compared with usual care (UC) in terms of the performance of daily activities by patients with chronic shoulder complaints in primary care., Methods: A total of 176 patients were randomly assigned either to GET (n=87) or to UC (n=89). Clinical outcomes (main complaints, shoulder disability [SDQ] and generic health-related quality of life [EQ-5D], and costs [intervention costs, direct health care costs, direct non-health-related costs, and indirect costs]) were assessed during the 12-week treatment period and at 52 weeks of follow-up., Results: Results showed that GET was more effective than UC in restoring daily activities as assessed by the main complaints instrument after the 12-week treatment period (p = .049; mean difference, 7.5; confidence interval [CI], 0.0-15.0). These effects lasted for at least 52 weeks (p = .025; mean difference 9.2; CI, 1.2-17.3). No statistically significant differences were found on the SDQ or EQ5D. GET significantly reduced direct health care costs (p = .000) and direct non-health care costs (p = .029). Nevertheless, total costs during the 1-year follow-up period were significantly higher (p = .001; GET = Euro 530 versus UC = Euro 377) due to the higher costs of the intervention. Incremental cost-effectiveness ratios for the main complaints (0-100), SDQ (0-100), and EQ-5D (-1.0-1.0) were Euro 7, Euro 74, and Euro 5278 per unit of improvement, respectively., Conclusions: GET proved to be more effective in the short- and long-term and reduces direct health care costs and direct non-health care costs but is associated with higher costs of the intervention itself.

The objective is to present the design of a randomized clinical trial (RCT) on the effectiveness and cost effectiveness of a behavioural graded activity programme compared with manual therapy in patients with sub-acute neck pain. Sub-acute is defined as pain existing for 4-12 weeks. The behavioural graded activity programme is a time-contingent increase in activities from baseline towards pre-determined goals. Manual therapy consists mainly of specific spinal mobilization techniques and exercises. The primary outcomes are global perceived effect and functional status. Secondary outcomes are kinesiophobia, distress, coping, depression and somatization. The intensity and persistence of the pain and its interference with activities are also assessed. Direct and indirect costs are measured by means of cost diaries. Measurements take place at baseline and 6 and 12 weeks after randomization. To assess the long-term effect, measurements will also take place after 6 and 12 months. Finally some challenges are discussed concerning the use of a behavioural graded activity programme, manual therapy and outcomes.

Objective: The intervention process was evaluated in a randomised clinical trial on the effectiveness of a behavioural Graded Exercise Therapy (GET) programme for patients with chronic shoulder complaints in primary care settings. This process evaluation was done for three reasons: first, to know whether the programme was performed as planned; second, to know whether or not this treatment is feasible in normal practice; third, to identify needs for improvement of the protocol to facilitate implication., Methods: We evaluated the extent to which the programme is being applied according to protocol, patient adherence to the programme and the suitability of the programme according to patients and physiotherapists. Twenty participating physiotherapists and 87 patients allocated to GET were asked to evaluate the intervention process. Furthermore, a sample of 10 patients, taken from the total number of 87 patients allocated to GET, was invited to take part in a focus group interview at the end of the study. We evaluated the intervention process using a treatment registration form filled in by the physiotherapists during treatment, evaluation forms filled in independently by physiotherapists and patients 26 weeks after the start of the treatment period, and information gathered during the focus group interview at the end of the study., Results: GET was applied according to protocol to an acceptable extent, and participating patients showed satisfactory adherence to the programme., Conclusions: Clinical effectiveness of GET in this trial is not influenced by flaws in the application of the programme or by lack of patient adherence., Practice Implications: The programme could be improved in terms of the process of goal-setting, and the implementation of GET could be facilitated if the programme is embedded in a multidisciplinary approach in primary care.

Transcutaneous electrical nerve stimulation (TENS) is a frequently applied therapy in chronic pain although evidence for effectiveness is inconclusive. Several types of TENS, based on different combinations of frequency, pulse duration and intensity, exist. The precise mechanism of action and the relevance of combinations of stimulus parameters are still unclear. To compare the effectiveness of three types of TENS we conducted a randomized, single blinded crossover trial. Patients received two times a 2-week period of daily TENS treatment, separated by a washout period of 2 weeks. In total, 180 chronic pain patients were randomized into three groups. In group 1, high frequency, low intensity TENS (HFT) was compared with high frequency, high intensity TENS (HIT). In groups 2 and 3, HFT and HIT were compared with a control TENS (COT). The order of applying the different modalities of TENS in each group was also randomized. Primary outcome was the patient's overall assessment of effectiveness and pain reduction (VAS). No differences were found in patient's assessment or pain reducing effect between the three groups, indicating no superiority of one type of TENS. In total, 56% continued TENS after the 2-week treatment period. At 6 months, 42% of all patients still used TENS. We concluded that there were no differences in effectiveness for the three types of TENS used in this study. Because no placebo group was included, no definite conclusions on effectiveness of TENS in general in the treatment of chronic pain could be made.

Background: Low back pain is a common medical and social problem frequently associated with disability and absence from work. However, data on effective return to work after interventions for low back pain are scarce., Objective: To determine the effectiveness of a behavior-oriented graded activity program compared with usual care., Design: Randomized, controlled trial., Setting: Occupational health services department of an airline company in the Netherlands., Patients: 134 workers who were absent from work because of low back pain were randomly assigned to either graded activity (n = 67) or usual care (n = 67)., Intervention: Graded activity, a physical exercise program based on operant-conditioning behavioral principles, to stimulate a rapid return to work., Measurements: Outcomes were the number of days of absence from work because of low back pain, functional status (Roland Disability Questionnaire), and severity of pain (11-point numerical scale)., Results: The median number of days of absence from work over 6 months of follow-up was 58 days in the graded activity group and 87 days in the usual care group. From randomization onward, graded activity was effective after 50 days of absence from work (hazard ratio, 1.9 [95% CI, 1.2 to 3.2]; P = 0.009). The graded activity group was more effective in improving functional status and pain than the usual care group. The effects, however, were small and not statistically significant., Conclusions: Graded activity was more effective than usual care in reducing the number of days of absence from work because of low back pain.

This paper discusses the rationale for and content of a newly developed treatment for shoulder complaints, and describes a randomised study which is currently being conducted to test effectiveness of the treatment. In current practice, approximately 50% of all patients with shoulder complaints mention limitations in the performance of daily activities and persisting pain after six months. To improve the functional ability of patients with chronic shoulder complaints, despite their pain, we have developed an operant behavioural and time-contingent graded exercise therapy programme for use in a primary care setting. We present the theory and conceptual model underlying this programme, report on its development and content, and describe the design of a randomised clinical trial to evaluate the programme's effectiveness and cost-effectiveness. One hundred and thirty-two patients who suffer from shoulder complaints for at least 3 months are being recruited in general practice. After inclusion in the study, patients are allocated randomly to the graded exercise therapy programme or to usual care. Questionnaires will be used to measure factors like severity of the main complaint, functional limitations of daily activities, perceived recovery, global health status, shoulder pain, generic health-related quality of life, and costs. These factors will be assessed at baseline, during treatment (6 weeks), and after treatment (12, 26, and 52 weeks).

Objective: To describe the comparison of multiple and single pain ratings in patients with complex regional pain syndrome type I (CRPS I)., Design: Correlation, agreement, and reliability analyses were performed between the average pain intensity measured 3 times a day over a course of 4 days and one single pain rating (designated the "recalled average" pain, as assessed by the patient) before treatment and at 1-, 3-, and 6-month periods after treatment., Patients: The patient population consisted of 54 patients with CRPS I in a randomized trial., Results: The results show that both measurements correlate and have excellent agreement. Furthermore, both ratings measure significant pain reduction after treatment; "recalled average" pain, however, reflects greater change in pain intensity., Conclusions: In patients with CRPS I a single pain rating is an accurate predictor of the average pain measured by a multiple pain-rating test. Moreover, both assessments are accurate enough to determine changes in pain over time with an effective treatment.

Low back pain is a major medical and social problem associated with disability, work absenteeism and high costs. Given the impact of the problem, there is a need for effective treatment interventions in occupational healthcare that aim at the prevention of chronic disability and the realisation of return to work. These so-called return-to-work (RTW) interventions are becoming increasingly popular. As well as questions concerning the effectiveness of RTW interventions, there are also important questions on the actual content and underlying concepts of these multifactorial intervention strategies. The purpose of this review is to examine the literature on the content and underlying concepts of RTW interventions for low back pain. A systematic literature search identified 14 randomised controlled trials (RCTs) evaluating the effects of 19 RTW interventions. The content and concepts of these RTW interventions are described, compared and discussed in this review. Further, the contents of the RTW interventions are classified by the use of predefined components (physical exercises, education, behavioural treatments and ergonomic measures). The identified RTW interventions varied with respect to the disciplines involved, the target population and the number and duration of sessions. The classification showed that physical exercises were a component of most of the selected interventions, followed by education, behavioural treatments and ergonomic measures. The most prevalent combination of components was the combination of physical exercises, behavioural treatment and education. However, the types of physical exercises, behavioural treatment and education varied widely among the RTW interventions. The described concepts for the physical exercises were an increase of muscle strength, coordination, range of motion of the spine and cardiovascular fitness, and a decrease of muscle tension. Education as a part of RTW interventions is believed to increase the understanding of patients regarding their disorder and treatment. Behavioural treatments were mainly based on the gate control theory of pain (psychophysiological processes are involved in pain perception) and/or the operant conditioning hypothesis (pain behaviour is determined by its consequences). No concepts were described for ergonomic measures. Finally, the plausibility of the described concepts is discussed. Future RCTs on this topic should evaluate the underlying concepts of the RTW intervention in addition to its effectiveness.

Reflex sympathetic dystrophy (RSD), also known as complex regional pain syndrome type I (CRPS I), is a disabling neuropathic pain syndrome. Controversy exists about the effectiveness of therapeutic interventions for the management of RSD/CRPS I. In order to ascertain appropriate therapies we conducted a review of existing randomized controlled trials of therapies for this disabling disease. Eligible trials were identified from the Cochrane, Pubmed, Embase and MEDLINE databases from 1966 through June 2000, from references in retrieved reports and from references in review articles. Twenty-six studies concerning treatment modalities were identified. Eighteen studies were randomized placebo-controlled trials and eight studies were randomized active-controlled trials. Three independent investigators reviewed articles for inclusion criteria using a 15-item checklist. Seventeen of the trials were of high quality according to the 15-item criteria. There was limited evidence for the effectiveness of these interventions because of the heterogeneity of treatment modalities. The search for trials concerning prevention of RSD/CRPS I resulted in two eligible studies. Both were of high quality and dealt with different interventions. There is limited evidence for their preventive effect., (Copyright 2002 European Federation of Chapters of the International Association for the Study of Pain.)

Objective: To present the design of a trial on the effectiveness of a behavioral-graded activity model., Design: Randomized clinical trial., Patients: Patients undergoing first-time lumbar disk surgery who still have low-back pain at the 6-week neurosurgical consultation., Interventions: A patient-tailored behavioral-graded activity program that is based on operant therapy. The key elements of this program are baseline measurements, goal-setting, and time-contingency. This program is compared with usual care in physiotherapy, which is pain-contingent., Outcome Measures: Primary measures are the patient's global impression of the effect and their functional status. Secondary measures are kinesiophobia, catastrophizing, pain, main complaint, range of motion, and relapses. The direct and indirect costs will also be assessed. The effect measures are rated before randomization and 3, 6, and 12 months later., Discussion: Several trials have been conducted on the effectiveness of behavioral treatments. Subjects were always patients with chronic low-back pain. In this trial, we apply such a treatment in patients after first-time disk surgery in a primary care setting.

Background: Activities and their importance for daily living vary widely between patients. Patient-specific measurement of functional status means that the evaluation is focused on activities that an individual patient selected as main complaints., Objective: To develop and to evaluate a patient-specific approach for measuring functional status in low back pain., Study Design: A cohort of 150 patients was measured at baseline and 12 weeks later., Methods: The feasibility of the patient-specific approach was evaluated in patients with nonspecific low back pain. We used effect size statistics to evaluate responsiveness in terms of sensitivity to change and specificity to change., Results: The selection procedure for the main complaint was feasible but labor intensive. The patient-specific approach was able to detect changes in complaints that were highly relevant for the patients. The patient-specific approach appeared to be more sensitive to change but less specific to change compared with other instruments., Conclusions: On the basis of this study it would be valuable to apply the patient-specific approach in future studies, also with the aim of further evaluation. In the meantime a number of practical problems of the method need to be resolved.

Study Design: A randomized clinical trial., Objectives: To assess the efficacy of motorized continuous traction for low back pain., Summary of Background Data: The available studies on the efficacy of lumbar traction do not allow clear conclusions because of severe methodologic flaws. The current trial aimed to overcome these shortcomings., Methods: Patients with at least 6 weeks of nonspecific low back pain were selected. High-dose traction was compared with sham (or low-dose) traction. Sham traction was given with a specially developed brace that becomes tighter in the back during traction. This was experienced as if real traction were exerted. The patients and the outcome assessor were unaware of treatment allocation. Outcome measures were: patient's global perceived effect, severity of main complaints, functional status, pain, range of motion, work absence, and medical treatment. Results for the outcome measures at 12 weeks and 6 months after randomization are presented., Results: One hundred and fifty-one patients were randomly allocated to one of the two treatment methods. Intention-to-treat analysis of the 12-week and 6-month results showed no statistically significant differences between the groups on all outcome measures: all 95% confidence intervals included the value zero. The number of patients lost to follow-up study was very low. Other analyses showed the same results., Conclusions: Most common flaws of earlier studies on traction therapy could be overcome. This trial did not support the claim that traction is efficacious for patients with low back pain.

Previous trials to assess the efficacy of lumbar traction for back pain have been methodologically flawed. To avoid these shortcomings, we conducted a randomised controlled trial in which high-dose traction was compared with sham traction. The sham traction was given with a specially developed brace that tightens in the back during traction. To the patient, the experience is that of traction. The patients and outcome assessor were blinded for the assigned treatment. 151 patients with at least six weeks of non-specific low back pain were randomised. Intention to treat analysis showed no differences between the groups on all outcome measures (patients' global perceived effect, severity of main complaints, functional status and pain); all 95% confidence intervals included the value zero. The number of withdrawals from treatment, loss to follow-up, and protocol deviations was low. Consequently, the per-protocol analysis showed results similar to the intention to treat analysis. Subgroup analyses did not show any group for which traction might seem promising. Our data do not support the claim that traction is effective for patients with low back pain.

Study Design: This study was a literature review of the quality of four disease-specific functional status questionnaires for patients with low back pain: Oswestry; Million; Roland; and Waddell disability questionnaire., Objectives: The questionnaires were evaluated in terms of general description, scale structure, reliability, validity, responsiveness, and clinical research applications., Summary of Background Data: Functional status is an outcome of great interest for clinical trials of low back pain., Methods: A computer-aided search was conducted of articles published between 1981 and 1993 and references given in selected relevant publications. Articles were selected if at least one of the four functional status questionnaires was used or if the authors gave relevant information about the methodology of these questionnaires., Results: There was not enough information available about the criteria of item selection used for the development of the questionnaires. The test-retest reproducibility of the questionnaires seemed satisfactory. The Oswestry and Roland disability questionnaires have been used and evaluated more frequently than the Million and Waddell. Therefore, we can be more certain about the validity and responsiveness of the former pair of questionnaires., Conclusion: In the absence of a gold standard, direct comparisons of evaluative functional status questionnaires in a single patient group are needed. Through direct comparisons, comparative validity and responsiveness can be assessed. Functional status measures are not currently used in many settings in which they would be valuable. It is important to encourage their wider use in clinical trials. Additional research is needed to compare and improve the existing questionnaires.

Objective: To present the design of a trial on the efficacy of lumbar traction., Design: Randomized clinical trial., Patients: Patients with a minimum of 6 wk, nonspecific low back pain., Intervention: High-dose, motorized, continuous traction with a force between 35% and 50% of the total body weight was compared with sham or low-dose traction with a force between 0 and 20% of body weight. The sham traction was given with a specially developed brace that becomes tighter in the back during traction. This is experienced by patients as if traction were exerted., Outcome Measures: Primary measures were the patient's global impression of the effect and the severity of three main complaints. Secondary effect measures were functional status, pain, range of motion, work absence and recurrences. The effect measures were rated before randomization and 4 wk, 12 wk and 6 months later., Conclusion: There have been a number of earlier trials on the efficacy of lumbar traction; they suffer, however, from severe methodological flaws. This trial aimed to avoid these shortcomings.