Longitudinal Resilience and Risk Factors in Pediatric Postoperative Pain (LORRIS): Protocol for a Prospective Longitudinal Swiss University Children's Hospitals-Based Study.

INTRODUCTION: Chronic postsurgical pain (CPSP) is defined as pain that persists after a surgical procedure and has a significant impact on quality of life. Previous studies show the importance of psychological factors in CPSP, yet the majority of studies focused solely on negative emotions. This longitudinal observational study aims to broaden this knowledge base by examining the role of emotional state, emotion variability, emotion regulation and emotion differentiation on the child and the parent level for the development CPSP, and to describe pain and emotion-related trajectories following surgery. METHODS AND ANALYSIS: We intend to include 280 children and adolescents aged 8-18 years with a planned orthopaedic surgery and their parents. A total of five assessment time points is planned: 3 weeks before surgery (baseline), 2 weeks after surgery (post) and 3 months (follow-up (FU) 1), 6 months and 12 months after surgery. At baseline and post only, children and parents are asked to complete a daily diary thrice a day for a week where they rate their current emotional state and their pain severity (children only). Emotional state ratings will be used to calculate indices of emotion variability, emotion regulation and emotion differentiation. Children and parents will complete questionnaires at each time point, including measures on quality of life, social support, sleep, and symptoms of anxiety and depression.To predict development of CPSP, generalised linear regression models will be used, resulting in ORs and 95% CIs. Pearson product-moment correlations between predictors and outcomes will be evaluated at each time point. The primary outcome of the prediction model is CPSP at FU1. For the trajectory analysis, the classification method K-means for longitudinal data will be used to determine clusters in the data. ETHICS AND DISSEMINATION: The Ethics Committee of the Canton of Zurich, Switzerland, has approved the study (ID: 2023-01475). Participants will be compensated, and a dissemination workshop will be held. TRIAL REGISTRATION NUMBER: NCT05816174.

Animal-Assisted Psychotherapy for Pediatric Chronic Pain: Case Series of an Open Pilot Study to Test Initial Feasibility and Potential Efficacy.

Objective: Chronic pain is a common complaint in children and adolescents, placing an enormous burden on individuals, their families, and the healthcare system. New innovative approaches for the treatment of pediatric chronic pain (PCP) are clearly warranted, as drop-out rates in intervention studies are high and it can be difficult to engage patients with PCP in therapy. Here, animal-assisted interventions (AAIs) might be promising, since there is preliminary evidence for the approach in adults with chronic pain, and AAIs are generally known to foster the therapeutic motivation of patients. To date, however, AAIs have not been examined in pediatric chronic pain. Methods: The aim of this open pilot study was to examine the initial feasibility of recruitment and potential efficacy of an animal-assisted group psychotherapy (including horses, rabbits, chickens, goats, and a dog), providing case reports of three children with chronic pain. We applied a mixed-methods approach, including the conductance of semi-structured interviews and assessment of quantitative pre-post data with a focus on pain severity, avoidance behavior, pain acceptance, and ability to defocus from the pain. Results: The three participating girls (age: 9-12 years) reported chronic pain in the head and abdomen. The process of recruitment turned out to be challenging. All three children reported reduced pain-related disability and pain-related distress, as well as an increased ability to accept pain and to defocus from the pain. The qualitative data revealed that patients and their parents had a positive attitude towards AAIs. Conclusion: Our initial open pilot study is the first to investigate AAIs in the context of pediatric chronic pain. Notably, we had difficulties in the recruitment procedure, mostly due to the Covid-19 situation. Based on three case reports, we found some first indication that AAI approaches might be associated with symptom changes. Future randomized-control studies with larger sample sizes are clearly warranted. Clinicaltrialsgov Identifier: NCT04171336.

Sensory processing sensitivity in adolescents reporting chronic pain: an exploratory study.

Introduction: Sensory processing sensitivity (SPS) describes a genetically influenced trait characterized by greater depth of information processing, lower sensory threshold, and ease of overstimulation. It is hypothesized that SPS plays a crucial role in the context of chronic pain.Objectives: This exploratory study examined SPS as a correlate of pain intensity and pain-related disability in a sample of adolescents reporting chronic pain. Methods: Adolescents reporting chronic pain were contacted through social media and through specialized pain clinics. Participants completed online questionnaires on their levels of SPS, pain features, emotion regulation, and quality of life. A series of analysis of variances (ANOVAs) were calculated to detect differences between 3 SPS groups (ie, high, medium, and low sensitivity) regarding emotion regulation, quality of life, and pain features. Multiple linear regressions were conducted to predict pain intensity, pain-related disability, and quality of life. Results: In total, 103 participants completed the survey (68.9% female, Mage 17.9). Back pain was the most frequently reported pain location. Proportion of highly sensitive individuals was large (45.68%). The ANOVA revealed significant differences between sensitivity groups related to quality-of-life subscales, namely, for physical (F(2, 100) = 7.42, P < 0.001), emotional (F(2, 100) = 6.11, P < 0.001), and school functioning (F(2, 100) = 3.75, P = 0.03). High sensitivity was not predictive of pain but of health-related quality of life. Conclusions: Our results indicate that SPS is an important and prevalent characteristic to consider in the context of chronic pain in adolescents, specifically regarding the quality of life.

Chronic pain concepts of pediatricians: a qualitative survey.

Introduction: Chronic pain is a prevalent, yet underrecognized, condition in children and adolescents. A biopsychosocial framework has been widely adopted over the past decades and resulted in a new pain classification in the International Classification of Diseases, 11th revision (ICD-11). Nevertheless, little is known about pediatricians' pain concepts. Objectives: We explored pain concepts of Swiss pediatricians by means of a qualitative analysis. Method: A cross-sectional online survey was sent to clinically active Swiss pediatricians registered with the Swiss Society for Pediatrics. A case vignette of a girl with chronic musculoskeletal pain was presented and pediatricians were asked (1) what they think caused the pain, and (2) how they would explain the pain to the patient and their family. Structuring content analysis was applied to describe major themes within the answers. Results: The following main categories emerged: psychological factors, biological factors, unclear etiology, social context, disorder specific, and multifactorial. Most pediatricians reported the belief that psychological factors explained the pain. However, when explaining the pain to the patient, biological factors were reported most often. Conclusion: There is a discrepancy between pediatricians' conviction that chronic pain is mostly explained by psychological factors and their exploratory model towards patients that focuses on biological factors. Promoting the biopsychosocial framework of chronic pain is key to ensure timely and effective treatment. The new pain classification in the ICD-11 has the potential to increase the use of the biopsychosocial model.

Do expectations influence pain? Recognizing Irving Kirsch's contribution to our understanding of pain.

Pain is a universal experience that can take different forms, and it can be acute or chronic. Experimental pain, such as heat pain, can help us better understand the pain experience, as it induces transient, but robust central sensitization in participants. Central sensitization is considered a key underlying concept in the development and maintenance of chronic pain and is defined as an overly effective transmission of nociception in the central nervous system. Expectations can influence perceived pain intensity and treatment success. Irving Kirsch's work in the field of experimental pain has greatly contributed to our understanding of how expectations influence the pain experience. In this article, we present some of Kirsch's landmark studies in this area and discuss their (clinical) implications.

Distinct Cognitive Function Profiles Are Associated With a Higher Presurgery Symptom Burden in Patients With Breast Cancer.

BACKGROUND: Cancer-related cognitive impairment (CRCI) is a common symptom in patients with breast cancer. In our previous study of 397 women with breast cancer, we identified 3 groups of patients with distinct CRCI profiles (ie, high, moderate, and low-moderate attentional function). Compared with the other 2 classes, the low-moderate class was younger, had more comorbidities, and with lower functional status. OBJECTIVES: In this study, we expand on this work and evaluate for differences among these latent classes in the severity of psychological (depression and anxiety) and physical (fatigue, decrements in energy, sleep disturbance, and pain) symptoms before surgery. METHODS: Cancer-related cognitive impairment was assessed using the Attentional Functional Index from before through 6 months after surgery. Lower Attentional Functional Index scores indicate higher levels of CRCI. Psychological and physical symptoms were assessed with valid instruments. Parametric and nonparametric tests were used to evaluate for differences in symptom severity scores among the latent classes. RESULTS: Approximately 60% of patients experienced CRCI (ie, moderate and low-moderate classes). Significant differences were found among the 3 classes in the severity of trait and state anxiety, depressive symptoms, fatigue, and sleep disturbance (ie, high < moderate < low-moderate). In addition, compared with the other 2 classes, the low-moderate class reported higher pain interference scores. CONCLUSIONS: These findings suggest that women with clinically meaningful levels of persistent CRCI have a relatively high symptom burden before surgery. IMPLICATIONS FOR PRACTICE: Clinicians need to routinely perform preoperative assessments of CRCI and associated symptoms and initiate therapeutic interventions.

Pre-Surgery Demographic, Clinical, and Symptom Characteristics Associated with Different Self-Reported Cognitive Processes in Patients with Breast Cancer.

Cancer related cognitive impairment (CRCI) is a common and persistent symptom in breast cancer patients. The Attentional Function Index (AFI) is a self-report measure that assesses CRCI. AFI includes three subscales, namely effective action, attentional lapses, and interpersonal effectiveness, that are based on working memory, inhibitory control, and cognitive flexibility. Previously, we identified three classes of patients with distinct CRCI profiles using the AFI total scores. The purpose of this study was to expand our previous work using latent class growth analysis (LCGA), to identify distinct cognitive profiles for each of the AFI subscales in the same sample (i.e., 397 women who were assessed seven times from prior to through to 6 months following breast cancer surgery). For each subscale, parametric and non-parametric statistics were used to determine differences in demographic, clinical, and pre-surgical psychological and physical symptoms among the subgroups. Three-, four-, and two-classes were identified for the effective action, attentional lapses, and interpersonal effectiveness subscales, respectively. Across all three subscales, lower functional status, higher levels of anxiety, depression, fatigue, and sleep disturbance, and worse decrements in energy were associated with worse cognitive performance. These and other modifiable characteristics may be potential targets for personalized interventions for CRCI.

Estimating the prevalence of paediatric chronic pain in Switzerland: an online survey among paediatricians.

BACKGROUND: Chronic pain is a frequent complaint in children and adolescents, with great international variation in prevalence. Paediatricians are usually the first-line contact for pain problems in children and might refer patients to other specialists or pain clinics where available. Prevalence estimates of paediatric chronic pain and paediatricians' care experiences in Switzerland are currently lacking. OBJECTIVES: The aim of this study was to assess the prevalence of paediatric chronic pain in Swiss paediatrician practices and paediatricians' professional experience and confidence with, and care provision for patients with paediatric chronic pain. METHODS: Data were collected in 2019 using a cross-sectional online questionnaire among Swiss paediatricians. Ordinary least square regression analyses and Monte Carlo simulations were applied to estimate the prevalence rate of paediatric chronic pain. Explorative multivariate logistic regression analyses investigated whether sociodemographic and professional factors were associated with paediatricians' confidence in treating and experience with paediatric chronic pain. RESULTS: We included 337 paediatricians in our anonymised analyses. The prevalence rate of paediatric chronic pain in our sample was estimated to be between 2.54% and 3.89%. Twenty percent of paediatricians reported feeling confident in treating paediatric chronic pain, 77.2% had referred patients with paediatric chronic pain to another specialist and more than half had at least some experience with paediatric chronic pain. Experience and confidence with treating paediatric chronic pain were associated with male gender. CONCLUSION: Our study is the first to estimate the prevalence of paediatric chronic pain by means of a sample of Swiss paediatricians. The prevalence rate was considerably lower than other estimates. Given the lack of training and confidence with treating paediatric chronic pain reported by paediatricians, absence of awareness and resulting under-diagnosis is possible.

Greater than the sum of the parts: a qualitative content analysis of what constitutes a good treatment in the inpatient setting.

BACKGROUND: The evaluation of psychotherapy is guided by established concepts, such as efficacy and effectiveness, and acceptability. Although these concepts serve as valid proxies, little is known about corresponding criteria for those directly involved in this treatment. This study aimed to explore inpatients' and health professionals' definitions of a good treatment in the inpatient setting. METHODS: Fifteen semi-structured interviews were conducted in a private psychiatric clinic in Switzerland and structured by qualitative content analysis. Different subsamples of the inpatient setting (patients N = 5; psychiatrists N = 5; other health professionals N = 5) were interviewed. RESULTS: In total, 546 text passages were grouped in 10 superordinate categories and identified as relevant for the concept of a good treatment. Participants stressed patient-specific (i.e., new insights; basic attitudes), treatment-specific (i.e., therapy methods and expertise; treatment success; therapy setting), and relationship-based (i.e., communication and feedback; relationships within the clinical setting; overcoming challenges and hurdles) components that are indispensable for a good therapeutic process. Components that are related to the clinical inpatient setting (i.e., setting and organization of the clinic; code of conduct) were also highlighted. CONCLUSIONS: Patients' and health professionals' definitions of what constitutes a good treatment entails a wide array of aspects. The clinical setting is seen to offer unique components that are emphasized to have a healing effect.

Association of parental and adolescent emotion-related factors with adolescent chronic pain behaviors.

ABSTRACT: Chronic pain is a prevalent condition in youth, and the pain experience is strongly influenced by emotional processes. Studying emotion variability and regulation (ER) may help better understand pain behavior. As the development of emotion-related abilities predominantly takes place in the family context, examining ER within parent-adolescent dyads is important. We set out to test the association of parent and adolescent ER and adolescent emotional variability with adolescent pain behavior (ie, pain interference, activity avoidance, and activity engagement). A sample of 56 adolescents (Mage = 14.5, 85.7% women) with chronic pain and one of their parents (92.9% mothers) participated in this study. Adolescents completed baseline measures of average pain intensity, ER, and mean positive and negative affect. Furthermore, adolescents completed an electronic diary for 14 consecutive days, reporting on emotional state, activity avoidance, activity engagement, and pain interference. Parents completed measures of ER and their own history of pain. We performed a variable selection procedure, the least absolute shrinkage and selection operator method, to determine important predictors of adolescent pain behavior. Adolescent high positive affect was associated with more activity engagement, less pain interference, and less activity avoidance, indicating that positive affect might enhance the willingness to engage in activities in the presence of pain. Adolescent ER strategy emotional reappraisal and parents' own history of pain were predictors of less activity engagement. Parent ER was not related to adolescent ER. In conclusion, our results highlight the potential of enhancing positive affect as an intervention target for chronic pain.

Not really nice: a commentary on the recent version of NICE guidelines [NG193: chronic pain (primary and secondary) in over 16s: assessment of all chronic pain and management of chronic primary pain] by the Pain Net.

The National Institute for Health and Care Excellence should revise their recent guideline to take into account all the available evidence on the treatment of chronic primary pain.

Nonpharmacological Interventions for Pediatric Migraine: A Network Meta-analysis.

CONTEXT: Migraine is a common neurologic disorder in children and adolescents. However, a comparison of multiple nonpharmacological treatments is lacking. OBJECTIVE: To examine whether nonpharmacological treatments are more effective than waiting list and whether there are differences between interventions regarding efficacy. DATA SOURCES: Systematic review and network meta-analysis of studies in Medline, Cochrane, Embase, and PsycINFO published through August 5, 2019. STUDY SELECTION: Randomized controlled trials of nonpharmacological treatments in children and adolescents diagnosed with episodic migraine. DATA EXTRACTION: Effect sizes, calculated as standardized mean differences (SMDs) for the primary outcome efficacy, were assessed in a random-effects model. RESULTS: Twelve studies (N = 576) were included. When interventions were classified into groups on the basis of similarity of treatment components, self-administered treatments, biofeedback, relaxation, psychological treatments, and psychological placebos were significantly more effective than waiting list with effect sizes ranging between SMD = 1.14 (95% confidence interval, 0.09 to 2.19) for long-term psychological placebos to SMD = 1.44 (95% confidence interval, 0.26 to 2.62) for short-term self-administered treatments. However, when all interventions were examined individually (ie, 1 node per intervention), none were significantly more effective compared with waiting list, mainly because of lack of statistical power. LIMITATIONS: Because of our focus on pediatric migraine, only a small number of studies could be included. CONCLUSIONS: Our findings reveal that components of nonpharmacological interventions are effective in treating pediatric migraine. Some effects have to be interpreted carefully because they are based on small studies. Future researchers should identify factors associated with individual responses in large, multicentered studies.

Placebo Responses and Their Clinical Implications in Fibromyalgia: A Meta-Analysis Using SSRI and SNRI Trials.

Background: Fibromyalgia (FM) is a chronic primary pain condition, associated with widespread musculoskeletal pain, disturbed sleep, fatigue, cognitive dysfunction, and a range of comorbid conditions such as irritable bowel syndrome, and depression. Despite its high prevalence of 2% in the general population, FM continues to pose scientific and clinical challenges in definition, etiology, and day-to-day management. In terms of treatment, FM can be treated with selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs). Objective: Patients with FM and other chronic primary pain syndromes are known to experience substantial and clinically relevant placebo effects. An update of the placebo responses for various outcomes in the FM population and especially a discussion about clinical implications is therefore needed. Methods: We used data from a large data pool that includes randomized controlled trials (RCTs) examining within-placebo mean change scores of baseline vs. follow-up assessments in FM trials of SSRIs and SNRIs. The primary outcomes were pain, functional disability, and depression and using different scales. We assessed heterogeneity of included trials. Results: A total of 29 RCTs with N = 8,453 patients suffering from FM were included in our analysis. Within-placebo mean change scores of baseline vs. follow-up assessments were large for pain (mean change = 2.31, 95% CI: 0.42-4.21, p = 0.017), functional disability (mean change = 3.31, 95% CI: 2.37-4.26, p < 0.000), and depression (mean change = 1.55, 95% CI: 0.92-2.18, p < 0.000). Heterogeneity was found to be large for all outcomes. Impact: Our results provide preliminary evidence that placebo responses, which also consist of non-specific effects, might play a role in the treatment of FM. Furthermore, we highlight limitations of our analyses and make suggestions for future studies.

Talking to Children and Families about Chronic Pain: The Importance of Pain Education-An Introduction for Pediatricians and Other Health Care Providers.

Chronic pain in children and adolescents is a common and debilitating health problem. This narrative review will give a brief overview on what pediatric chronic pain is and what treatment options there are for children and adolescents. The specific emphasis will be on pediatric chronic pain education and communication: this narrative review aims to show how important a good patient-health care provider relationship is-it builds the foundation for successful communication-and how this relationship can be established. In addition, we will present five steps that health care providers can perform to explain pediatric chronic pain to patients and their parents and what to keep in mind in their clinical routine. Our review is intended for pediatricians and other health care providers who treat pediatric patients with chronic pain but might feel uncertain on how to best communicate with them.

Patient-appraised beneficial moments during inpatient psychiatric treatment.

BACKGROUND: Psychiatric inpatients receive a multidisciplinary treatment approach, covering psychiatry, nursing, occupational therapy, and psychology. Research findings reveal that the effectiveness of any treatment is associated with three types of factors: specific (e.g., treatment techniques), common (e.g., clinician-patient relationship, patients' expectations) and extra-therapeutic. However, there is little published research on the factors and events which inpatients themselves consider to be beneficial ('beneficial moments'). METHODS: Inpatients (N = 107) of a psychiatric clinic completed a questionnaire to elicit their appraisal of beneficial moments. A qualitative content analysis was applied. The coding procedure was conducted independently by two authors. RESULTS: Self-appraised beneficial moments were found in five areas: therapy-specific components (number of quotations, N = 204), positive relationships (N = 140), clinical setting and environment (N = 52), inpatients' new insights (N = 36), and factors unrelated to either therapy or the clinic (N = 30). In total, 44% of the quotations were related to specific factors, 49% to common factors, and 7% to extra-therapeutic factors. CONCLUSIONS: Inpatients judge both specific and common factors as crucial for the therapeutic benefit they gain during their stay at the clinic. Our results differ from meta-analytical findings, where the impact of specific factors on symptom improvement has shown to be much smaller (i.e., 17%) than appraised by patients in our study (i.e., 44%). Our study underlines the importance of a patient-centred care approach as well as shared decision making and patient-clinician communication. For clinical practice, knowledge of inpatients' perspectives on beneficial moments is crucial in order to reinforce precisely these therapeutic components.

Exposure to Parental Depressive Symptoms: A Longitudinal Analysis on the Association with Adolescents' Depressive Symptoms and Adjustment Problems.

OBJECTIVE: Parental depressive symptoms have been associated with depressive symptoms and adjustment problems in adolescents. However, longitudinal studies assessing both mothers' and fathers' depressive symptoms over time and their association with adolescents' outcomes are sparse. METHODS: Data were obtained from the Study of Early Child Care and Youth Development. A total of 1364 children and families were followed from the child's birth until the age of 15 years. Adolescents' depressive symptoms were evaluated via self-reported questionnaire at ages 11 to 15 years. Adjustment problems at 15 years of age were defined as high internalizing and/or externalizing problems. Parental depressive symptoms were assessed several times during the study period. Trajectories created using partitional clustering analyses were entered in logistic regression models to predict adolescents' outcomes. RESULTS: After adjusting for sociodemographic variables, adolescents' outcomes were associated with every additional time point of reported maternal (depressive symptoms: odds ratio [OR] = 1.2, p = 0.001; adjustment problems: OR = 1.1, p = 0.003) and paternal depressive symptoms (adjustment problems: OR = 1.2, p = 0.027). When maternal and paternal depressive symptom trajectories were combined, we found adolescents' depressive symptoms to be significantly associated with mother elevated and stable subclinical father scores (OR = 3.3, p = 0.003) and girls (OR = 5.4, p < 0.001). Adjustment problems were associated with father elevated and stable subclinical mother (OR = 1.9, p = 0.003) and mother elevated and stable subclinical father (OR = 2.1, p = 0.001) trajectories. CONCLUSION: Parental depressive symptoms are an important risk factor for adolescents' outcomes. This highlights the importance of continuously evaluating parents' mental status across child development. The cumulative effect of recurrent depressive symptoms and the combined parental trajectories are especially predictive for the development of adolescents' outcomes.

Efficacy, Safety, and Acceptability of Pharmacologic Treatments for Pediatric Migraine Prophylaxis: A Systematic Review and Network Meta-analysis.

Importance: Migraine is one of the most common neurologic disorders in children and adolescents. However, a quantitative comparison of multiple preventive pharmacologic treatments in the pediatric population is lacking. Objective: To examine whether prophylactic pharmacologic treatments are more effective than placebo and whether there are differences between drugs regarding efficacy, safety, and acceptability. Data Sources: Systematic review and network meta-analysis of studies in MEDLINE, Cochrane, Embase, and PsycINFO published through July 2, 2018. Study Selection: Randomized clinical trials of prophylactic pharmacologic treatments in children and adolescents diagnosed as having episodic migraine were included. Abstract, title, and full-text screening were conducted independently by 4 reviewers. Data Extraction and Synthesis: Data extraction was conducted according to Preferred Reporting Items for Systematic Reviews and Meta-Analysis network meta-analysis guidelines. Quality was assessed with the Cochrane Risk of Bias tool. Effect sizes, calculated as standardized mean differences for primary outcomes and risk ratios for discontinuation rates, were assessed in a random-effects model. Main Outcomes and Measures: Primary outcomes were efficacy (ie, migraine frequency, number of migraine days, number of headache days, headache frequency, or headache index), safety (ie, treatment discontinuation owing to adverse events), and acceptability (ie, treatment discontinuation for any reason). Results: Twenty-three studies (2217 patients) were eligible for inclusion. Prophylactic pharmacologic treatments included antiepileptics, antidepressants, calcium channel blockers, antihypertensive agents, and food supplements. In the short term (<5 months), propranolol (standard mean difference, 0.60; 95% CI, 0.03-1.17) and topiramate (standard mean difference, 0.59; 95% CI, 0.03-1.15) were significantly more effective than placebo. However, the 95% prediction intervals for these medications contained the null effect. No significant long-term effects for migraine prophylaxis relative to placebo were found for any intervention. Conclusions and Relevance: Prophylactic pharmacologic treatments have little evidence supporting efficacy in pediatric migraine. Future research could (1) identify factors associated with individual responses to pharmacologic prophylaxis, (2) analyze fluctuations of migraine attack frequency over time and determine the most clinically relevant length of probable prophylactic treatment, and (3) identify nonpharmacologic targets for migraine prophylaxis.

Emotional distress: Specifying a neglected part of chronic pain.

We argue that in all randomized controlled trials that investigate treatments for chronic pain emotional distress should be reported. In a majority of cases, pain intensity and pain-related disability are measured, yet-despite guidelines to the contrary-pain-related distress is not included. We suggest that the new extension code for chronic pain as incorporated in the ICD-11 will be well suited to fill this gap at minute additional effort for the participants.

The best treatment option(s) for adult and elderly patients with chronic primary musculoskeletal pain: a protocol for a systematic review and network meta-analysis.

BACKGROUND: Chronic primary musculoskeletal pain (CPMP) is one subcategory of the new classification of chronic primary pain for the upcoming ICD-11, defined as chronic pain in the muscles, bones, joints, or tendons that persists or recurs for more than 3 months and is associated with significant emotional distress or functional disability. An array of pharmacological, psychological, physical, complementary, and rehabilitative interventions is available for CPMP, for which previous research has demonstrated varying effect sizes with regard to effectiveness in pain reduction and other main outcomes. This highlights the need for the synthesis of all available evidence. The proposed network meta-analysis will compare all available interventions for CPMP to determine the best treatment option(s) with a focus on efficacy and safety of interventions. METHODS: We are interested in comparing interventions of the following types: psychological, pharmacological, physical, complementary, and rehabilitative interventions. We will include all randomized controlled trials that compare one intervention with another, or with a control group, in the treatment of CPMP. Primary efficacy outcomes will be pain intensity, emotional distress, and functional disability. Safety outcomes extracted will include proportion of patients with treatment-emergent adverse events, unwanted events, or drop-out rates due to side effects. Published and unpublished trials will be sought through the search of all relevant databases and trial registries. At least two independent reviewers of the team will select the references and extract data independently. We will assess the risk of bias of each individual study using the Cochrane risk of bias assessment tool. We will conduct a network meta-analysis to synthesize all evidence for each outcome. We will fit our model primarily within a Bayesian framework. DISCUSSION: CPMP is a disabling condition for which several interventions exist. To our knowledge, this is the first network meta-analysis to systematically compare all available evidence. This is required by national health institutions to inform their decisions about the best available treatment option(s) with regard to efficacy and safety outcomes. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42018096114.