Acceptability, usability and feasibility of experienced sampling method in chronic secondary pain syndromes.

Background: In chronic pain syndromes, symptoms can fluctuate and change over time. Standard questionnaires cannot register these fluctuations. Nonetheless, the experience sampling method (ESM) is developed to collect momentary measurements of everyday complaints, tracing fluctuations in symptoms and disabling factors over time. Although valuable information can be collected in this way, assessment may also be a burden. This study aimed to investigate the acceptability, usability, and feasibility of ESM in chronic secondary pain syndromes, in a single-center study in the Netherlands. Methods: A prospective observational study with repeated measurements was conducted in patients with chronic secondary neuropathic and musculoskeletal pain syndromes, including small fiber neuropathy, spinal cord injury, and rheumatoid disorder. Results: Thirty-four participants were included and filled in the ESM, of whom 19 were diagnosed with small fiber neuropathy, 11 with spinal cord injury, and 4 with a rheumatoid disorder. The mean age was 54.7 ± 13.9 years (range: 23-77) of whom 52.9% were female. In total, 19 participants filled in the general and user-friendliness evaluation about the acceptability and usability of the ESM. The general evaluation showed no influence of ESM on participants' social contacts (mean 1.47, SD 1.12), activities (mean 1.74, SD 1.44), and mood (mean 1.89, SD 1.59). The answers options of ESM were a good representation of the experiences of participants (mean 4.58, SD 1.77). Regarding feasibility, the overall response rate for answering the beep signals of ESM was 44.5% in total. The missing rate per person varied from 13% to 97% with a median of 54.1%. Conclusion: The general evaluation and the user-friendliness revealed sufficient outcomes in favor of the ESM application. ESM seems a promising measurement tool to use in secondary chronic pain syndromes.

Living with small fiber neuropathy: insights from qualitative focus group interviews.

OBJECTIVE: Small fiber neuropathy (SFN) is characterized by chronic neuropathic pain and autonomic dysfunction. Currently, symptomatic pharmacological treatment is often insufficient and frequently causes side effects. SFN patients have a reduced quality of life. However, little is known regarding whether psycho-social variables influence the development and maintenance of SFN-related disability and complaints. Additional knowledge may have consequences for the treatment of SFN. For example, factors such as thinking, feeling, and behavior are known to play roles in other chronic pain conditions. The aim of this study was to obtain further in-depth information about the experience of living with SFN and related chronic pain. METHODS: Fifteen participants with idiopathic SFN participated in a prospective, semi-structured, qualitative, focus group interview study. The focus groups were audio-recorded, transcribed, and analyzed cyclically after each interview. RESULTS: The following main themes were identified: "pain appraisal", "coping", "social, work, and health environment", and "change in identity". Catastrophic thoughts and negative emotions were observed. Living with SFN resulted in daily limitations and reduced quality of life. CONCLUSIONS: Given the results, it can be concluded that an optimal treatment should include biological, psychological, and social components.

Exploring the feasibility of a network of organizations for pain rehabilitation: What are the lessons learned?

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.

Implementation of health education interventions at Dutch music schools.

A randomized controlled trial was conducted comparing the effects of a biopsychosocial course (PRESTO-Play) vs. physical activity promotion (PRESTO-Fit) to reduce disability related to musculoskeletal disorders in music students. The current study provides an external validation and a formative and process evaluation, allowing for a better interpretation of results. First, a group of experts was asked to complete a structured evaluation of design and content of the trial. Second, quantitative and qualitative data were analysed from different stakeholders (students, therapists and conservatory staff) using questionnaires, logs, field notes and emails to evaluate fidelity, dose delivered, dose received, reach and context. Results are presented descriptively. Two authors independently identified key responses that were merged into themes. Although no difference in disability was found between interventions, closer evaluation revealed that participants in PRESTO-Play reported that they learned about prevention of physical complaints and were more satisfied with course contents compared with PRESTO-Fit. Study design and contents of the interventions were found to be valid, with an appropriate dose delivered. Feedback from students and logs suggested that behavioural change and psychosocial principles in PRESTO-Play might have not been implemented optimally. Only moderate fidelity in both groups and too little contrast between interventions could have influenced results. Low attendance rates and a presumed lack of generalization further decreased possible effectiveness. Context greatly influenced implementation. Implementing a future health course with closer collaboration with the institution could optimize accessibility and communication, encourage attendance and enhance motivation for behavioural change.

The (cost-)effectiveness and cost-utility of a novel integrative care initiative for patients with chronic musculoskeletal pain: the pragmatic trial protocol of Network Pain Rehabilitation Limburg.

BACKGROUND: Rehabilitation care for patients with chronic musculoskeletal pain (CMP) is not optimally organized. The Network Pain Rehabilitation Limburg 2.0 (NPRL2.0) provides integrated care with a biopsychosocial approach and strives to improve the Quadruple Aim outcomes: pain-related disability of patients with CMP; experiences of care of patients with CMP; meaning in the work of healthcare professionals; and healthcare costs. Firstly, in this study, the effectiveness (with regard to the functioning and participation of patients) of primary care for patients with CMP will be assessed, comparing care organized following the NPRL2.0 procedure with usual care. Secondly, the cost-effectiveness and cost-utility with regard to health-related quality of life and healthcare costs will be assessed. And thirdly, the effect of duration of participation in a local network in primary care will be studied. METHODS: In this pragmatic study, it is expected that two local networks with 105 patients will participate in the prospective cohort study and six local networks with 184 patients in the stepped-wedge based design. Healthcare professionals in the local networks will recruit patients. INCLUSION CRITERIA: age ≥ 18 years; having CMP; willing to improve functioning despite pain; and adequate Dutch literacy. EXCLUSION CRITERIA: pregnancy; and having a treatable medical or psychiatric disease. Patients will complete questionnaires at baseline (T1), 3 months (T2), 6 months (T3), and 9 months (T4). Questionnaires at T1 and T4 will include the Pain Disability Index and Short Form Health Survey. Questionnaires at T1, T2, T3, and T4 will include the EQ-5D-5L, and iMTA Medical Consumption and Productivity Cost Questionnaires. Outcomes will be compared using linear mixed-model analysis and costs will be compared using bootstrapping methods. DISCUSSION: NPRL2.0 is a multidimensional, complex intervention, executed in daily practice, and therefore needing a pragmatic study design. The current study will assess NPRL2.0 with respect to the Quadruple Aim outcomes: patient health and costs. This will provide more information on the (cost-) effectiveness of the organization of care in a network structure regarding patients with CMP. The other two Quadruple Aim outcomes will be examined alongside this study. Trial registration Netherlands Trial Register: NL7643. https://www.trialregister.nl/trial/7643 .

Serial measurements in COVID-19-induced acute respiratory disease to unravel heterogeneity of the disease course: design of the Maastricht Intensive Care COVID cohort (MaastrICCht).

INTRODUCTION: The course of the disease in SARS-CoV-2 infection in mechanically ventilated patients is unknown. To unravel the clinical heterogeneity of the SARS-CoV-2 infection in these patients, we designed the prospective observational Maastricht Intensive Care COVID cohort (MaastrICCht). We incorporated serial measurements that harbour aetiological, diagnostic and predictive information. The study aims to investigate the heterogeneity of the natural course of critically ill patients with a SARS-CoV-2 infection. METHODS AND ANALYSIS: Mechanically ventilated patients admitted to the intensive care with a SARS-CoV-2 infection will be included. We will collect clinical variables, vital parameters, laboratory variables, mechanical ventilator settings, chest electrical impedance tomography, ECGs, echocardiography as well as other imaging modalities to assess heterogeneity of the course of a SARS-CoV-2 infection in critically ill patients. The MaastrICCht is also designed to foster various other studies and registries and intends to create an open-source database for investigators. Therefore, a major part of the data collection is aligned with an existing national intensive care data registry and two international COVID-19 data collection initiatives. Additionally, we create a flexible design, so that additional measures can be added during the ongoing study based on new knowledge obtained from the rapidly growing body of evidence. The spread of the COVID-19 pandemic requires the swift implementation of observational research to unravel heterogeneity of the natural course of the disease of SARS-CoV-2 infection in mechanically ventilated patients. Our study design is expected to enhance aetiological, diagnostic and prognostic understanding of the disease. This paper describes the design of the MaastrICCht. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the medical ethics committee (Medisch Ethische Toetsingscommissie 2020-1565/3 00 523) of the Maastricht University Medical Centre+ (Maastricht UMC+), which will be performed based on the Declaration of Helsinki. During the pandemic, the board of directors of Maastricht UMC+ adopted a policy to inform patients and ask their consent to use the collected data and to store serum samples for COVID-19 research purposes. All study documentation will be stored securely for fifteen years after recruitment of the last patient. The results will be published in peer-reviewed academic journals, with a preference for open access journals, while particularly considering deposition of the manuscripts on a preprint server early. TRIAL REGISTRATION NUMBER: The Netherlands Trial Register (NL8613).

The Dutch version of the self-report Child Activity and Limitations Interview in adolescents with chronic pain.

PURPOSE: To assess the factor structure, related constructs and internal consistency of the Child Activity Limitation Interview 21-Child version for use in Dutch-language countries. METHODS: Cross-sectional validation study: After forward and back translation of the Dutch version of the Child Activity Limitation Interview 21-Child adolescents (11-21 years old) with chronic musculoskeletal pain completed an assessment. The assessment contained the Dutch Child Activity Limitation Interview, and questionnaires about demographics, pain intensity, functional disability, anxiety and depression. Internal consistency and construct validity were evaluated through exploratory factor analysis (principal axis factoring with oblique rotation) and hypotheses testing using pain intensity, activity limitations, anxiety and depression as comparative constructs. RESULTS: Seventy-four adolescents completed the assessment. Exploratory factor analysis resulted in a two-factor structure, explaining 50% of the variance. Internal consistency was good (Cronbach's α = 0.91 total scale, α = 0.90 Factor 1, α = 0.80 Factor 2). All nine hypotheses were confirmed. CONCLUSION: The Dutch version can be used to assess pain-related disability in Dutch-speaking adolescents comparable to the study sample. Scores on both subscales provide insight into the severity of the pain-related disability in both daily routine and more physically vigorous activities. Implications for Rehabilitation Chronic pain is a disabling disorder which not only impacts physically but restricts quality of life. This study provides clinicians a questionnaire to measure pain-related disability and quantify the impact of pain on the daily living of adolescents. The advantage of the Dutch version of the Child Activity and Limitations Interview over other measurements is that it can distinguish limitations in daily activities from more physically vigorous activities.

Dutch version of the Fear of Pain Questionnaire for adolescents with chronic pain.

BACKGROUND: Fear of pain is important in the development and maintenance of chronic pain. The Fear of Pain Questionnaire-Child version has been developed to assess pain related fear in children and adolescents. OBJECTIVE: Translating the original questionnaire into Dutch, and investigating internal consistency and construct validity to enable use in the Dutch pain rehabilitation setting for treatment and research. METHODS: Cross-sectional validation study: After forward and back translation of the FOPQ-C, adolescents (11-22 years old) with chronic musculoskeletal pain completed an assessment containing the Dutch Fear of Pain Questionnaire, and questionnaires about demographics, pain catastrophizing, functional disability, and pain intensity. Internal consistency and construct validity were evaluated through exploratory factor analysis (principal axis factoring with oblique rotation) and hypotheses testing using pain catastrophizing, functional disability, and pain intensity as comparative constructs. RESULTS: Eighty-six adolescents completed the assessment. Exploratory factor analysis resulted in a two-factor structure, explaining 43% of the variance. Internal consistency was strong (Cronbach's α = 0.92 total scale, α = 0.88 factor 1, and α = .86 factor 2). Five out of 6 hypotheses were confirmed. CONCLUSIONS: The Dutch version demonstrated good internal consistency and good construct validity in a population of adolescents with chronic musculoskeletal pain. Implications for rehabilitation The Fear of Pain Questionnaire-Child version was developed to measure fear of pain and avoidance in children and adolescents with chronic pain. Identification of fear of pain and activities that are being avoided are important during screening and assessment of the adolescent for chronic pain rehabilitation treatment. The presence of fear of pain and/or avoidance behavior is important information to shape and target multidisciplinary rehabilitation treatment.

Study protocol for a multicentre randomized controlled trial on effectiveness of an outpatient multimodal rehabilitation program for adolescents with chronic musculoskeletal pain (2B Active).

BACKGROUND: Chronic musculoskeletal pain (CMP) in adolescents can influence functioning and well-being, and has negative consequences for families and society as well. According to the Fear Avoidance Model, fear of movement and pain catastrophizing can influence the occurrence and maintenance of chronic pain complaints and functional disability. Primary objective is to evaluate the effectiveness of a multimodal rehabilitation program in reducing functional disability for adolescents with CMP compared with care as usual. METHODS/DESIGN: Pragmatic multicentre parallel group randomized controlled trial. Randomization by minimization (ratio 1:1) and treatment allocation will be concealed, computer-generated and performed by an independent organization. After randomization, data collection and researchers remain blinded. Inclusion of 124 adolescents and their parents is intended. This sample size is based on a 25 % difference in group mean on the primary outcome, with α = 5 %, ß = 80 % and expected 15 % loss to follow up. Study population are adolescents (12-21 years) with CMP with an indication for outpatient rehabilitation treatment in the Netherlands. The intervention group receives a Multimodal Rehabilitation Program (MRP), a multidisciplinary outpatient individual rehabilitation program. MRP consists of 2 different treatment approaches: A graded exposure module or a combination module of graded exposure and physical training. Selection of a module depends on the needs of the patient. To both modules a parent module is added. The control group receives care as usual, which is the care currently provided in Dutch rehabilitation centres. Treatment duration varies between 7 and 16 weeks, depending on treatment allocation. Self-reported measurements are at baseline, and at 2, 4, 10 and 12 months after start of treatment. Intention to treat analysis for between group differences on all outcome variables will be performed. Primary outcome is functional disability (Functional Disability Inventory). Secondary outcome variables are fear of pain, catastrophizing, perceived harmfulness, pain intensity, depressive symptoms, and quality of life. Total direct and indirect costs and health related quality of life will be measured. Process evaluation focuses on protocol adherence, patient centeredness and treatment expectations. DISCUSSION: A pragmatic approach was chosen, to ensure that results obtained are most applicable to daily practice. TRIAL REGISTRATION: Clinicaltrials.gov ID: NCT02181725 (7 February 2014). Funded by Fonds Nuts Ohra, Stichting Vooruit, and Adelante.

The Musician as (In)Active Athlete?: Exploring the Association Between Physical Activity and Musculoskeletal Complaints in Music Students.

OBJECTIVE: Musicians are often compared to athletes because of the physical exertion required to play music. The aim of this study was to explore the physical activity level of music students and to study its relationship with musculoskeletal complaints. A second goal was to assess associations between physical activity and pain, quality of life, and disability. METHODS: This cross-sectional study among third- and fourth-year music students used an electronic survey including measures for physical activity (SQUASH-Short Questionnaire to Assess Health-enhancing physical activity), musculoskeletal complaints (DMQ-Dutch Musculoskeletal Questionnaire), disability (DASH-Disability Arm, Shoulder, Hand questionnaire) and quality of life (Short Form-12). Students were classified as compliers or non-compliers with moderate- and vigorous-intensity physical activity recommendations. Statistical analysis was done using (non)parametric tests (t-test, Pearson chi-square test, Mann-Whitney U-test) and correlational testing. RESULTS: Participants were 132 students, 63.6% female, with a median age of 23 yrs (range 21.3-25.0). 67% reported musculoskeletal complaints in the past 7 days. Their median physical activity level was 6,390 MET-min/wk, and 62% and 10% of the students accomplished recommendations for moderate-intensity and vigorous-intensity physical activity levels, respectively. No significant differences were found in prevalence of musculoskeletal complaints between students who met moderate- or vigorous-intensity physical activity recommendations and students who did not. Physical activity level was not associated with musculoskeletal complaints (r=0.12, p=0.26). Higher pain intensity was associated with a lower quality of life (r=-0.53 p<0.01) and higher disability (r=0.43, p<0.01). CONCLUSIONS: Music students are mainly involved in light- to moderate-intensity physical activities and rarely in vigorous-intensity activities. No correlation was found between physical activity level in the past months and musculoskeletal complaints in music students.

PREvention STudy On preventing or reducing disability from musculoskeletal complaints in music school students (PRESTO): protocol of a randomised controlled trial.

INTRODUCTION: Up to 87% of professional musicians develop work-related complaints of the musculoskeletal system during their careers. Music school students are at specific risk for developing musculoskeletal complaints and disabilities. This study aims to evaluate the effectiveness of a biopsychosocial prevention program to prevent or reduce disabilities from playing-related musculoskeletal disorders. Secondary objectives are evaluation of cost-effectiveness and feasibility. METHODS: Healthy, first or second year students (n=150) will be asked to participate in a multicentre, single-blinded, parallel-group randomised controlled trial. Students randomised to the intervention group (n=75) will participate in a biopsychosocial prevention program that addresses playing-related health problems and provides postural training according to the Mensendieck or Cesar methods of postural exercise therapy, while incorporating aspects from behavioural change theories. A control group (n=75) will participate in a program that stimulates a healthy physical activity level using a pedometer, which conforms to international recommendations. No long-term effects are expected from this control intervention. Total follow-up duration is two years. The primary outcome measure is disability (Disabilities of Arm, Shoulder and Hand questionnaire). The secondary outcome measures are pain, quality of life and changes in health behaviour. Multilevel mixed-effect logistic or linear regression analyses will be performed to analyse the effects of the program on the aforementioned outcome measurements. Furthermore, cost-effectiveness, cost-utility and feasibility will be analysed. DISCUSSION: It is believed that this is the first comprehensive randomised controlled trial on the effect and rationale of a biopsychosocial prevention program for music students.