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Contains fulltext : 305139.pdf (Publisher’s version ) (Open Access), BACKGROUND: Chronic low-back pain (CLBP) is the leading cause of years lived with disability. Physiotherapy is the most common treatment option for CLBP, but effects are often unsatisfactory. Virtual reality (VR) offers possibilities to enhance the effectiveness of physiotherapy treatment. Primary aim was to develop and test a personalized VR intervention integrated within a physiotherapy treatment for patients with CLBP. METHODS: This study describes an intervention development process using mixed methods design that followed the Medical Research Council (MRC) framework. This involved a cocreation process with patients, physiotherapists, and researchers. A draft intervention was constructed based on a literature review and focus groups, and subsequently tested in a feasibility study and evaluated in focus groups. Focus group data were analyzed using thematic analysis. This intervention development process resulted in a final intervention. RESULTS: Focus group data showed that VR and physiotherapy can strengthen each other when they are well integrated, and that VR needs to be administered under the right conditions including flawless technology, physiotherapists with sufficient affinity and training, and the right expectations from patients. The draft intervention was considered feasible after evaluation by four patients and three physiotherapists and was further complemented by expanding the training for physiotherapists and improving the protocols for physiotherapists and patients. The final intervention consisted of a 12-week physiotherapy treatment with three integrated VR modules: pain education, physical exercise, and relaxation. CONCLUSION: Using the MRC framework in cocreation with the end users, a personalized VR intervention integrated within a physiotherapy treatment for patients with CLBP was developed. This intervention was found to be feasible and will subsequently be evaluated for (cost-)effectiveness in a cluster randomized controlled trial.

Item does not contain fulltext, BACKGROUND: Chronic low back pain (CLBP) is the most common chronic pain condition worldwide. Currently, primary care physiotherapy is one of the main treatment options, but effects of this treatment are small. Virtual Reality (VR) could be an adjunct to physiotherapy care, due to its multimodal features. The primary aim of this study is to assess the (cost-)effectiveness of physiotherapy with integrated multimodal VR for patients with complex CLBP, compared to usual primary physiotherapy care. METHODS: A multicenter, two-arm, cluster randomized controlled trial (RCT) including 120 patients with CLBP from 20 physiotherapists will be conducted. Patients in the control group will receive 12 weeks of usual primary physiotherapy care for CLBP. Patients in the experimental group will receive treatment consisting of 12 weeks of physiotherapy with integrated, immersive, multimodal, therapeutic VR. The therapeutic VR consists of the following modules: pain education, activation, relaxation and distraction. The primary outcome measure is physical functioning. Secondary outcome measures include pain intensity, pain-related fears, pain self-efficacy and economic measures. Effectiveness of the experimental intervention compared to the control intervention on primary and secondary outcome measures will be analyzed on an intention-to-treat principle, using linear mixed-model analyses. DISCUSSION: This pragmatic, multicenter cluster randomized controlled trial, will determine the clinical and cost-effectiveness of physiotherapy with integrated, personalized, multimodal, immersive VR in favor of usual physiotherapy care for patients with CLBP. TRIAL REGISTRATION: This study is prospectively registered at ClinicalTrials.gov (identifier: NCT05701891).

Contains fulltext : 296672.pdf (Publisher’s version ) (Open Access), BACKGROUND: Although reduced work ability is a substantial problem among people with inflammatory arthritis (IA), work ability is an underexposed area in clinical practice. Evidence on vocational interventions in IA is limited, but favourable results of delivery by a physiotherapist (PT) warrant the need for further research. Therefore, we aim to evaluate the (cost-)effectiveness of a multimodal, PT-led, vocational intervention in (self-)employed people with IA compared to usual care. METHODS: This randomized controlled trial will include 140 people with rheumatoid arthritis (RA) or axial spondyloarthritis (axSpA) who are (self-)employed and have reduced work ability (Work Ability Index - Single Item Scale (WAS) ≤ 7/10) and/or RA/axSpA related sick leave (≤ 6 months). Participants will be randomized 1:1 to the intervention or control condition (usual care). The intervention, delivered by primary care PTs, will be personalized to each patient, consisting of 10 to 21 sessions over 12 months. The intervention will be multimodal, comprising of 1) exercise therapy and a physical activity plan, 2) education/self-management support, 3) work-roadmap to guide participants in finding relevant other care, with optionally 4) online self-management course and 5) workplace examination. Assessments will be performed at baseline and after 3, 6, and 12 months. The primary outcome measure of effectiveness is work ability, as measured with the WAS at 12 months. For the cost-effectiveness analysis, the EuroQol (EQ-5D-5L), self-reported healthcare use, sick leave and productivity while at work will be used to estimate the trial based cost-utility from a societal perspective. A process evaluation, including assessments of adherence and treatment fidelity, will be undertaken using the registrations of the PTs and semi-structured interviews at 12 months follow-up in a random sample of the intervention group. DISCUSSION: The results of this study will provide insights in the (cost-)effectiv

Item does not contain fulltext, It is widely accepted that psychosocial prognostic factors should be addressed by clinicians in their assessment and management of patient suffering from low back pain (LBP). On the other hand, an overview is missing how these factors are addressed in clinical LBP guidelines. Therefore, our objective was to summarize and compare recommendations regarding the assessment and management of psychosocial prognostic factors for LBP chronicity, as reported in clinical LBP guidelines. We performed a systematic search of clinical LBP guidelines (PROSPERO registration number 154730). This search consisted of a combination of previously published systematic review articles and a new systematic search in medical or guideline-related databases. From the included guidelines, we extracted recommendations regarding the assessment and management of LBP which addressed psychosocial prognostic factors (ie, psychological factors ["yellow flags"], perceptions about the relationship between work and health, ["blue flags"], system or contextual obstacles ["black flags") and psychiatric symptoms ["orange flags"]). In addition, we evaluated the level or quality of evidence of these recommendations. In total, we included 15 guidelines. Psychosocial prognostic factors were addressed in 13 of 15 guidelines regarding their assessment and in 14 of 15 guidelines regarding their management. Recommendations addressing psychosocial factors almost exclusively concerned "yellow" or "black flags," and varied widely across guidelines. The supporting evidence was generally of very low quality. We conclude that in general, clinical LBP guidelines do not provide clinicians with clear instructions about how to incorporate psychosocial factors in LBP care and should be optimized in this respect. More specifically, clinical guidelines vary widely in whether and how they address psychosocial factors, and recommendations regarding these factors generally require better evidence support. This emphasizes a need f

BACKGROUND: We recently developed a model of stratified exercise therapy, consisting of (i) a stratification algorithm allocating patients with knee osteoarthritis (OA) into one of the three subgroups ('high muscle strength subgroup' representing a post-traumatic phenotype, 'low muscle strength subgroup' representing an age-induced phenotype, and 'obesity subgroup' representing a metabolic phenotype) and (ii) subgroup-specific exercise therapy. In the present study, we aimed to test the construct validity of this algorithm. METHODS: Data from five studies (four exercise therapy trial cohorts and one cross-sectional cohort) were used to test the construct validity of our algorithm by 63 a priori formulated hypotheses regarding three research questions: (i) are the proportions of patients in each subgroup similar across cohorts? (15 hypotheses); (ii) are the characteristics of each of the subgroups in line with their proposed underlying phenotypes? (30 hypotheses); (iii) are the effects of usual exercise therapy in the 3 subgroups in line with the proposed effect sizes? (18 hypotheses). RESULTS: Baseline data from a total of 1211 patients with knee OA were analyzed for the first and second research question, and follow-up data from 584 patients who were part of an exercise therapy arm within a trial for the third research question. In total, the vast majority (73%) of the hypotheses were confirmed. Regarding our first research question, we found similar proportions in each of the three subgroups across cohorts, especially for three cohorts. Regarding our second research question, subgroup characteristics were almost completely in line with the proposed underlying phenotypes. Regarding our third research question, usual exercise therapy resulted in similar, medium to large effect sizes for knee pain and physical function for all three subgroups. CONCLUSION: We found mixed results regarding the construct validity of our stratification algorithm. On the one hand, it is a

It is widely accepted that psychosocial prognostic factors should be addressed by clinicians in their assessment and management of patient suffering from low back pain (LBP). On the other hand, an overview is missing how these factors are addressed in clinical LBP guidelines. Therefore, our objective was to summarize and compare recommendations regarding the assessment and management of psychosocial prognostic factors for LBP chronicity, as reported in clinical LBP guidelines. We performed a systematic search of clinical LBP guidelines (PROSPERO registration number 154730). This search consisted of a combination of previously published systematic review articles and a new systematic search in medical or guideline-related databases. From the included guidelines, we extracted recommendations regarding the assessment and management of LBP which addressed psychosocial prognostic factors (ie, psychological factors ["yellow flags"], perceptions about the relationship between work and health, ["blue flags"], system or contextual obstacles ["black flags") and psychiatric symptoms ["orange flags"]). In addition, we evaluated the level or quality of evidence of these recommendations. In total, we included 15 guidelines. Psychosocial prognostic factors were addressed in 13 of 15 guidelines regarding their assessment and in 14 of 15 guidelines regarding their management. Recommendations addressing psychosocial factors almost exclusively concerned "yellow" or "black flags," and varied widely across guidelines. The supporting evidence was generally of very low quality. We conclude that in general, clinical LBP guidelines do not provide clinicians with clear instructions about how to incorporate psychosocial factors in LBP care and should be optimized in this respect. More specifically, clinical guidelines vary widely in whether and how they address psychosocial factors, and recommendations regarding these factors generally require better evidence support. This emphasizes a need f

Background: The concept of osteoarthritis (OA) heterogeneity is evolving and gaining renewed interest. According to this concept, distinct subtypes of OA need to be defined that will likely require recognition in research design and different approaches to clinical management. Although seemingly plausible, a wide range of views exist on how best to operationalize this concept. The current project aimed to provide consensus-based definitions and recommendations that together create a framework for conducting and reporting OA phenotype research. Methods: A panel of 25 members with expertise in OA phenotype research was composed. First, panel members participated in an online Delphi exercise to provide a number of basic definitions and statements relating to OA phenotypes and OA phenotype research. Second, panel members provided input on a set of recommendations for reporting on OA phenotype studies. Results: Four Delphi rounds were required to achieve sufficient agreement on 11 definitions and statements. OA phenotypes were defined as subtypes of OA that share distinct underlying pathobiological and pain mechanisms and their structural and functional consequences. Reporting recommendations pertaining to the study characteristics, study population, data collection, statistical analysis, and appraisal of OA phenotype studies were provided. Conclusions: This study provides a number of consensus-based definitions and recommendations relating to OA phenotypes. The resulting framework is intended to facilitate research on OA phenotypes and increase combined efforts to develop effective OA phenotype classification. Success in this endeavor will hopefully translate into more effective, differentiated OA management that will benefit a multitude of OA patients.

OBJECTIVES: Knee osteoarthritis (OA) is characterized by its heterogeneity, with large differences in clinical characteristics between patients. Therefore, a stratified approach to exercise therapy, whereby patients are allocated to homogeneous subgroups and receive a stratified, subgroup-specific intervention, can be expected to optimize current clinical effects. Recently, we developed and pilot tested a model of stratified exercise therapy based on clinically relevant subgroups of knee OA patients that we previously identified. Based on the promising results, it is timely to evaluate the (cost-)effectiveness of stratified exercise therapy compared with usual, "nonstratified" exercise therapy. METHODS: A pragmatic cluster randomized controlled trial including economic and process evaluation, comparing stratified exercise therapy with usual care by physical therapists (PTs) in primary care, in a total of 408 patients with clinically diagnosed knee OA. Eligible physical therapy practices are randomized in a 1:2 ratio to provide the experimental (in 204 patients) or control intervention (in 204 patients), respectively. The experimental intervention is a model of stratified exercise therapy consisting of (a) a stratification algorithm that allocates patients to a "high muscle strength subgroup," "low muscle strength subgroup," or "obesity subgroup" and (b) subgroup-specific, protocolized exercise therapy (with an additional dietary intervention from a dietician for the obesity subgroup only). The control intervention will be usual best practice by PTs (i.e., nonstratified exercise therapy). Our primary outcome measures are knee pain severity (Numeric Rating Scale) and physical functioning (Knee Injury and Osteoarthritis Outcome Score subscale daily living). Measurements will be performed at baseline, 3-month (primary endpoint), 6-month (questionnaires only), and 12-month follow-up, with an additional cost questionnaire at 9 months. Intention-to-treat, multilevel, regre

Background: The concept of osteoarthritis (OA) heterogeneity is evolving and gaining renewed interest. According to this concept, distinct subtypes of OA need to be defined that will likely require recognition in research design and different approaches to clinical management. Although seemingly plausible, a wide range of views exist on how best to operationalize this concept. The current project aimed to provide consensus-based definitions and recommendations that together create a framework for conducting and reporting OA phenotype research. Methods: A panel of 25 members with expertise in OA phenotype research was composed. First, panel members participated in an online Delphi exercise to provide a number of basic definitions and statements relating to OA phenotypes and OA phenotype research. Second, panel members provided input on a set of recommendations for reporting on OA phenotype studies. Results: Four Delphi rounds were required to achieve sufficient agreement on 11 definitions and statements. OA phenotypes were defined as subtypes of OA that share distinct underlying pathobiological and pain mechanisms and their structural and functional consequences. Reporting recommendations pertaining to the study characteristics, study population, data collection, statistical analysis, and appraisal of OA phenotype studies were provided. Conclusions: This study provides a number of consensus-based definitions and recommendations relating to OA phenotypes. The resulting framework is intended to facilitate research on OA phenotypes and increase combined efforts to develop effective OA phenotype classification. Success in this endeavor will hopefully translate into more effective, differentiated OA management that will benefit a multitude of OA patients.

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