The Effect of a Pain Educational Video Upon Child Pain-Related Memory and the Moderating Role of Parental Pain- and Non-Pain-Attending Verbalizations: An Experimental Lab-Based Study.

OBJECTIVES: Early memories of pain contribute to fear and may underlie the maintenance and development of chronic pain into adulthood. Accordingly, understanding determinants that may impact children's pain memory development is key. This study examined (a) the effect of a brief engaging pain educational video in healthy children before undergoing an experimental pain task upon children's recalled pain intensity and pain-related fear and (b) the moderating role of parental pain- and non-pain-attending verbalizations before and after the pain task. METHODS: Seventy-seven children (8-15 years old) participated in an experimental heat pain task, including actual heat pain stimuli delivered through a thermode on their forearm. Children were randomized to the experimental group (i.e., watching a pain educational video) or the control group (i.e., no video). Children's recalled pain intensity and pain-related fear were elicited 2 weeks later. RESULTS: Findings showed that recalled pain intensity (but not recalled pain-related fear) of children who watched the pain educational video was significantly lower compared to the control group (p = .028). Further, parental pain-attending verbalizations before the pain task moderated the impact of the video upon children's recalled pain intensity (p = .038). Specifically, children in the control group, but not the experimental group, whose parents used less pain-attending verbalizations recalled higher pain intensity, whereas children whose parents used more pain-attending verbalizations recalled lower pain intensity. CONCLUSIONS: As children's pain memories have important implications for pain assessment, treatment, and health across the lifespan, these findings might have important implications for the prevention of development or maintenance of maladaptive pain-related outcomes.

Diet can exert both analgesic and pronociceptive effects in acute and chronic pain models: a systematic review of preclinical studies.

BACKGROUND: Although diet is an essential aspect of human health, the link between diet and pain is still not well understood. Preclinical animal research provides information to understand underlying mechanisms that allow identifying the needs for human research. OBJECTIVES: This study aims to give a systematic overview of the current evidence from preclinical studies regarding the analgesic and pronociceptive effects of various diets in non-neuropathic, non-cancer, or non-visceral acute and chronic pain models. STUDY DESIGN: A systematic Review. SETTING: This study examined studies that investigate the analgesic and pronociceptive effects of various diets in non-neuropathic, non-cancer, or non-visceral acute and chronic pain models. METHODS: This review was conducted following the PRISMA guidelines and was registered in PROSPERO with the registration number CRD42019133473. The certainty of evidence was examined by a modified GRADE approach. RESULTS: After the screening process twenty-four eligible papers were included in this review. Nineteen studies examined acute pain, nine studies chronic inflammatory pain, and four studies assessed both acute and chronic pain models. LIMITATIONS: Due to the heterogeneity of the included studies, a meta-analysis was not included in this study. CONCLUSIONS: In animal models, excessive saturated, monounsaturated or omega-6 polyunsaturated fat ingestion and diets rich in fats and carbohydrates can decrease pain sensitivity in acute nociceptive pain, whereas it can induce mechanical allodynia and heat hyperalgesia in chronic inflammatory pain. Additionally, diets rich in anti-inflammatory ingredients, as well as a calorie-restricted diet can promote recovery from primary mechanical allodynia and heat hyperalgesia in chronic inflammatory pain.

The Impact of Parental Presence on Their Children During Painful Medical Procedures: A Systematic Review.

OBJECTIVE: Whether parental presence during their children's painful medical procedures is advantageous with regard to children's pain-related outcomes is questionable. Research on this topic is equivocal, and additional questions, such as whether levels of parental involvement may play a role as well, remain to be addressed. The purpose of this systematic review is to summarize and critically appraise the literature on the impact of parental presence vs absence during their children's painful medical procedures on the child's pain-related outcomes. METHODS: The review protocol was registered on Prospero (ID CRD42018116614). A systematic search in PubMed, Web of Science, and PsycArticles resulted in 22 eligible studies incorporating 2,157 participants. Studies were considered eligible if they included children (≤18 years old) undergoing a painful medical procedure and compared parental presence and/or involvement with parental absence during the procedure. RESULTS: The children's pain-related outcomes included self-reported pain intensity, self-reported fear, anxiety and distress, observed pain-related behavior, and physiological parameters. Overall, evidence points in the direction of beneficial effects of parental presence vs absence with regard to children's self-reported pain intensity and physiological parameters, whereas mixed findings were recorded for children's self-reported fears, anxiety and distress, and observed pain-related behaviors. CONCLUSIONS: To provide clear recommendations on how to involve the parent during the procedure, as well as for which type of children and parents parental presence has the best effects, further research is needed, as indicated in this review.

Electroencephalography During Nociceptive Stimulation in Chronic Pain Patients: A Systematic Review.

BACKGROUND: With its high temporal resolution, electroencephalography (EEG), a technique that records electrical activity of cortical neuronal cells, is a potentially suitable technique to investigate human somatosensory processing. By using EEG, the processing of (nociceptive) stimuli can be investigated, along with the functionality of the nociceptive pathway. Therefore, it can be applied in chronic pain patients to objectify whether changes have occurred in nociceptive processing. Typically, so-called event-related potential (ERP) recordings are used, where EEG signals are recorded in response to specific stimuli and characterized by latency and amplitude. OBJECTIVE: To summarize whether differences in somatosensory processing occur between chronic pain patients and healthy controls, measured with ERPs, and determine whether this response is related to the subjective pain intensity. DESIGN: Systematic review. SETTING AND METHODS: PubMed, Web of Science, and Embase were consulted, and 18 case-control studies were finally included. SUBJECTS: The chronic pain patients suffered from tension-type headache, back pain, migraine, fibromyalgia, carpal tunnel syndrome, prostatitis, or complex regional pain syndrome. RESULTS: Chronic neuropathic pain patients showed increased latencies of the N2 and P2 components, along with a decreased amplitude of the N2-P2 complex, which was also obtained in FM patients with small fiber dysfunction. The latter also showed a decreased amplitude of the N2-P3 and N1-P1 complex. For the other chronic pain patients, the latencies and the amplitudes of the ERP components did not seem to differ from healthy controls. One paper indicated that the N2-P3 peak-to-peak amplitude correlates with the subjective experience of the stimulus. CONCLUSIONS: Differences in ERPs with healthy controls can mostly be found in chronic pain populations that suffer from neuropathic pain or where fiber dysfunction is present. In chronic pain populations with other etiological mechanisms, limited differences were found or agreed upon across studies.

Does Pain Neuroscience Education and Cognition-Targeted Motor Control Training Improve Cervical Motor Output? Secondary Analysis of a Randomized Clinical Trial.

BACKGROUND: In the context of interventions aimed at reducing pain, disability, and maladaptive pain cognitions in chronic neck pain, it is hypothesized that patients who have greater symptom reduction possibly also demonstrate greater improvement in cervical motor output. Therefore, the aim of this study was to examine the effect of pain neuroscience education plus cognition-targeted motor control training on cervical motor output. METHODS: Impairments in cervical motor output were measured in 64 subjects with chronic neck pain using standardized tests. Cervical muscle strength, cervical mobility, balance, and cervical neuromuscular control were derived. To assess the differences between groups in response to treatment, a random-intercept linear mixed-models analysis, applying a diagonal covariance matrix, was used. RESULTS: A significant treatment × time interaction effect was found for neuromuscular control of the deep cervical flexors, favoring the experimental treatment at 3 months' follow-up (mean group difference: 1.982; 95% confidence interval 0.779, 3.185; large effect size d = 0.82). Significant main effects of time were found for the neuromuscular capacity of scapulothoracic muscles and for cervical mobility. No significant effects were found for balance, cervical muscle strength, or endurance of cervical flexors. CONCLUSION: Pain neuroscience education combined with cognition-targeted motor control training is not more effective than biomedically focused education and exercise therapy for improving cervical motor output in people with chronic neck pain. Our findings question the relative importance of factors such as pain, disability, and maladaptive pain cognitions on cervical motor output and the need to address it in treatment.

The Influence of Treatment Expectations on Clinical Outcomes and Cortisol Levels in Patients With Chronic Neck Pain: An Experimental Study.

BACKGROUND: The role of contextual factors like pre-existing treatment expectations has been established. However, the effect of verbally delivered treatment expectations in patient-therapist communication has not been considered, nor has the role of cortisol changes within the placebo/nocebo response in people with chronic neck pain. OBJECTIVE: To examine the effect of verbally delivered treatment expectations on clinical outcomes in physical therapy practice and to determine if changes in cortisol levels are associated with changes in neck pain and disability. METHODS: Eighty-three patients with chronic neck pain were randomly allocated to 3 different verbally delivered expectations (positive, negative, neutral) during physical therapy interventions. MAIN OUTCOME MEASURES: salivary cortisol, pain and disability, and cervical range of motion. RESULTS: Pain significantly improved in the positive (P < 0.001) and neutral (P < 0.001) expectations groups. For salivary cortisol levels, a significant increase was observed in response to treatment in the neutral (P = 0.045) and negative (P < 0.001) expectations groups. No significant correlations were found between changes in salivary cortisol levels and the change in pain in the neutral and negative expectations groups. CONCLUSIONS: Physical therapists treating people with chronic neck pain should be attentive when communicating the expected treatment effects to their patients. Whereas verbally delivered positive or neutral expectations may be beneficial for pain-related measures, giving negative expectations may result in a lack of a treatment response on pain. Cortisol levels increased in response to verbally delivered neutral and negative expectations, in the absence of a nocebo effect. This questions the presumed role of cortisol in the nocebo effect.

Convergent Validity of the Dutch Central Sensitization Inventory: Associations with Psychophysical Pain Measures, Quality of Life, Disability, and Pain Cognitions in Patients with Chronic Spinal Pain.

OBJECTIVE: Symptoms of central sensitization (CS) have been described in patients with chronic spinal pain (CSP). Although a gold standard to diagnose CS is lacking, psychophysical pain measures are often used. The Central Sensitization Inventory (CSI) is proposed as an alternative method and indirect tool for the evaluation of CS symptomatology. The aim of the current study was to evaluate the convergent validity of the CSI by investigating the association with psychophysical pain measures and self-reported measures of current pain intensity, quality of life, disability, and catastrophizing in CSP patients. METHODS: One hundred sixteen patients with nonspecific CSP were included in the present study. Patients completed the CSI, were subjected to pressure pain thresholds (PPTs) and a conditioned pain modulation (CPM) paradigm, and completed questionnaires for current pain intensity, quality of life, pain disability, and pain catastrophizing. RESULTS: Higher CSI scores were weakly correlated with lower PPTs (-0.276 ≤ r ≤ -0.237; all P ≤ 0.01) and not with CPM efficacy (r = 0.017; P = 0.858). Higher CSI scores were moderately correlated with higher current pain intensity (r = 0.320; P < 0.001), strongly correlated with lower physical (r = -0.617; P < 0.001) and emotional (r = -0.635; P < 0.001) quality of life, and moderately correlated with higher pain disability (r = 0.472; P < 0.001) and higher pain catastrophizing (r = 0.464; P < 0.001). CONCLUSION: The CSI was weakly associated with PPTs and not with CPM efficacy in CSP patients. Moderate to strong associations were found with current pain intensity, quality of life, disability, and catastrophizing. The current results illustrate that the CSI does not reflect a direct measure of CS, yet is a representation of general distress, possible originating from CS symptoms.

In the spine or in the brain? Recent advances in pain neuroscience applied in the intervention for low back pain.

Conservative, surgical and pharmacological strategies for chronic low back pain (CLBP) management offer at best modest effect sizes in reducing pain and related disability, indicating a need for improvement. Such improvement may be derived from applying contemporary pain neuroscience to the management of CLBP. Current interventions for people with CLBP are often based entirely on a "biomedical" or "psychological" model without consideration of information concerning underlying pain mechanisms and contemporary pain neuroscience. Here we update readers with our current understanding of pain in people with CLBP, showing that CLBP is not limited to spinal impairments, but is also characterised by brain changes, including functional connectivity reorganisation in several brain regions and increased activation in brain regions of the so-called 'pain matrix' (or 'pain connectome'). Indeed, in a subgroup of the CLBP population brain changes associated with the presence of central sensitisation are seen. Understanding the role of these brain changes in CLBP improves our understanding not only of pain symptoms, but also of prevalent CLBP associated comorbidities such as sleep disturbances and fear avoidance behaviour. Applying contemporary pain neuroscience to improve care for people with CLBP includes identifying relevant pain mechanisms to steer intervention, addressing sleep problems and optimising exercise and activity interventions. This approach includes cognitively preparing patients for exercise therapy using (therapeutic) pain neuroscience education, followed by cognition-targeted functional exercise therapy.

Sex Differences in Patients with Chronic Pain Following Whiplash Injury: The Role of Depression, Fear, Somatization, Social Support, and Personality Traits.

BACKGROUND: Chronic whiplash-associated disorders (chronic WAD) cover a large variety of clinical manifestations that can occur after a whiplash injury. Women have an increased risk of developing chronic WAD, and it is suggested that psychosocial factors are related to long-term pain and functioning following whiplash injury and persistence of chronic pain. This leads to the question whether there are sex differences in psychosocial factors in chronic WAD. METHODS: This study included 117 subjects who had experienced a whiplash injury at least 3 months before the start of the study (mean duration of pain: 67.29 ± 63.86 months, range: 297 months). They were selected as chronically symptomatic, by excluding those who had recovered from their whiplash injury. Psychosocial aspects (including depression, fear, somatization, social support, and personality traits) were assessed by validated questionnaires, and sex differences were tested using a univariate analysis of variance (ANCOVA), with age and time from whiplash injury as covariates. RESULTS: No differences in depression, fear, somatization, discrepancy in social support personality trait, Neck Disability Index scores, physical functioning, bodily pain, or general health were present between women and men with chronic WAD. Women with chronic WAD reported higher levels of emotional support in problem situations and social companionship. CONCLUSION: Except for emotional support in problem situations and social companionship, psychosocial factors do not differ between men and women with chronic WAD. These findings imply little to no risk for sex bias in studies investigating psychosocial issues in patients with chronic WAD.

Efficacy of a modern neuroscience approach versus usual care evidence-based physiotherapy on pain, disability and brain characteristics in chronic spinal pain patients: protocol of a randomized clinical trial.

BACKGROUND: Among the multiple conservative modalities, physiotherapy is a commonly utilized treatment modality in managing chronic non-specific spinal pain. Despite the scientific progresses with regard to pain and motor control neuroscience, treatment of chronic spinal pain (CSP) often tends to stick to a peripheral biomechanical model, without targeting brain mechanisms. With a view to enhance clinical efficacy of existing physiotherapeutic treatments for CSP, the development of clinical strategies targeted at 'training the brain' is to be pursued. Promising proof-of-principle results have been reported for the effectiveness of a modern neuroscience approach to CSP when compared to usual care, but confirmation is required in a larger, multi-center trial with appropriate evidence-based control intervention and long-term follow-up.The aim of this study is to assess the effectiveness of a modern neuroscience approach, compared to usual care evidence-based physiotherapy, for reducing pain and improving functioning in patients with CSP. A secondary objective entails examining the effectiveness of the modern neuroscience approach versus usual care physiotherapy for normalizing brain gray matter in patients with CSP. METHODS/DESIGN: The study is a multi-center, triple-blind, two-arm (1:1) randomized clinical trial with 1-year follow-up. 120 CSP patients will be randomly allocated to either the experimental (receiving pain neuroscience education followed by cognition-targeted motor control training) or the control group (receiving usual care physiotherapy), each comprising of 3 months treatment. The main outcome measures are pain (including symptoms and indices of central sensitization) and self-reported disability. Secondary outcome measures include brain gray matter structure, motor control, muscle properties, and psychosocial correlates. Clinical assessment and brain imaging will be performed at baseline, post-treatment and at 1-year follow-up. Web-based questionnaires will be completed at baseline, after the first 3 treatment sessions, post-treatment, and at 6 and 12-months follow-up. DISCUSSION: Findings may provide empirical evidence on: (1) the effectiveness of a modern neuroscience approach to CSP for reducing pain and improving functioning, (2) the effectiveness of a modern neuroscience approach for normalizing brain gray matter in CSP patients, and (3) factors associated with therapy success. Hence, this trial might contribute towards refining guidelines for good clinical practice and might be used as a basis for health authorities' recommendations. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02098005.

Proinflammatory Dietary Intake Relates to Pain Sensitivity in Chronic Nonspecific Low Back Pain: A Case-Control Study.

Nonspecific chronic low back pain (nCLBP) has been associated with nutrition. Yet, it is not clear how nutritional factors and nCLBP relate to one another. Therefore, the aim of the present study was to investigate differences in diet quality and dietary intake levels between nCLBP patients and healthy controls (HCs) and explore the association between nutritional factors and pain sensitivity in nCLBP. In this case-control study, 106 participants (ie, n = 53 nCLBP and n = 53 HCs) were recruited and completed a 3-day food diary to assess their dietary intake, which allowed to generate individual diet quality scores (ie, the Healthy Eating Index-2015 and Dietary Inflammatory Index). Additionally, each participant underwent an experimental pain assessment (quantitative sensory testing) and filled out self-reported pain questionnaires. Compared to HCs, the nCLBP group showed significantly lower diet quality, higher inflammatory scores, and a lower intake of total protein, total fat, dietary fiber, omega-3 fatty acids, vitamin B6, vitamin A, beta-carotene, vitamin E, and magnesium. Pain sensitivity mainly showed a negative correlation with nutritional intakes known for anti-inflammatory properties (ie, vitamins E, D, A, B6, B12, and zinc). Interestingly, total fat, cholesterol, saturated, and monounsaturated fat intakes were found to be inversely associated with pain sensitivity. Overall, patients with nCLBP have a lower diet quality, eat more proinflammatory, have less intake of nutrients known for their anti-inflammatory and antioxidative properties, and drink less water compared to HCs. Accordingly, pain sensitivity was mainly found to be positively associated with proinflammatory dietary intake. PERSPECTIVE: This study emphasizes the association between a proinflammatory diet and nCLBP. Among nCLBP patients, positive association between increased pain sensitivity and the proinflammatory potential of a diet, highlighting the potential for individualized pain management strategies and leading to the development of novel therapeutic methods.

Impaired Carbohydrate Metabolism among Women with Chronic Low Back Pain and the Role of Dietary Carbohydrates: A Randomized Controlled Cross-Over Experiment.

Background: Impaired glucose regulation is suggested to be related to chronic low back pain (CLBP), although it is not clear how they interact with each other. Thus, the primary aim of this study was to investigate differences in postprandial glycemic responses (PPGRs) (the first sign of impaired glucose metabolism) to high- (sucrose) and low-glycemic index (GI) (isomaltulose) beverages in normoglycemic women with CLBP and healthy controls (HCs) and explore whether any group that showed greater PPGRs to high-GI beverage intake would benefit when the high-GI beverage was replaced with a low-GI beverage. Secondly, this study aimed to explore the association between PPGR and pain in patients with CLBP. Methods: This study was registered at clinicaltrials.org (NCT04459104) before the start of the study. In this study, 53 CLBP patients and 53 HCs were recruited. After 11-12 h of fasting, each participant randomly received isomaltulose or sucrose. Blood glucose levels were measured during the fasting state and 15, 30, 45, 60, 90, and 120 min after the beverage intake, and each participant underwent experimental pain measures. Results: Compared to the HCs, the CLBP group showed significantly higher PPGRs to sucrose (p < 0.021). Additionally, the CLBP group showed a significantly higher decrease in PPGR (p = 0.045) when comparing PPGR to sucrose with PPGR to isomaltulose. Correlation analysis revealed a positive association between self-reported pain sensitivity and PPGR to sucrose, while there was no association found between any experimental pain measures and glycemic responses. Conclusions: Overall, these findings suggest that normoglycemic CLBP patients might have a higher risk of developing impaired glucose tolerance than the HCs and might benefit more when high-GI foods are replaced with low-GI ones.

Exploring Interactions Between Sex, Pain Characteristics, Disability, and Quality of Life in People With Chronic Spinal Pain: A Structural Equation Model.

In people with nonspecific chronic spinal pain (nCSP), disability and quality of life are associated with clinical, cognitive, psychophysical, and demographic variables. However, evidence regarding the interactions between these variables is only limited to this population. Therefore, this study aims to explore path models explaining the multivariate contributions of such variables to disability and quality of life in people with nCSP. This secondary analysis uses baseline data from a randomized controlled trial including 120 participants with nCSP. Structural equation modeling was used to explore path models for the Pain Disability Index (PDI), the Short Form 36-item physical (SF-36 PC), and mental (SF-36 MC) component scores. All models included sex, pain catastrophizing, kinesiophobia, hypervigilance, and pain intensity. Additionally, the PDI and SF-36 PC models included pressure pain thresholds (PPTs) at the dominant pain site (ie, neck or low back). Significant associations were found between sex, pain cognitions, pain intensity, and PPTs. Only pain catastrophizing significantly directly influenced the PDI (P ≤ .001) and SF-36 MC (P = .014), while the direct effects on the SF-36 PC from kinesiophobia (P = .008) and pain intensity (P = .006) were also significant. However, only the combined effect of all pain cognitions on the SF-36 PC was mediated by pain intensity (P = .019). Our findings indicate that patients' pain-related cognitions have an adverse effect on their physical health-related quality of life via a negative influence on their pain intensity in people with nCSP. PERSPECTIVE: This secondary analysis details a network analysis confirming significant interactions between sex, pain cognitions, pain intensity, and PPTs in relation to disability and health-related quality of life in people with chronic spinal pain. Moreover, its findings establish the importance of pain cognitions and pain intensity for these outcomes. TRIALS REGISTRATION: Clinicaltrials.gov (NCT02098005).

The bidirectional relationship between sleep problems and chronic musculoskeletal pain: a systematic review with meta-analysis.

ABSTRACT: Chronic musculoskeletal pain and sleep problems/disorders exhibit a recognized bidirectional relationship; yet, systematic investigations of this claim, particularly in a prospective context, are lacking. This systematic review with meta-analysis aimed to synthesize the literature on the prospective associations between sleep problems/disorders and chronic musculoskeletal pain. A comprehensive search across 6 databases identified prospective longitudinal cohort studies in adults examining the relationship between sleep problems/disorders and chronic musculoskeletal pain. Random-effects meta-analyses, using the Hartung-Knapp adjustment for 95% confidence intervals (CIs), were conducted, and all results were presented as odds ratios (ORs). Certainty of evidence was evaluated using the Grading of Recommendations, Assessment, Development, and Evaluations approach. Including 16 articles from 11 study populations (116,746 participants), meta-analyses indicated that sleep problems at baseline may heighten the risk of chronic musculoskeletal pain in both short term (OR 1.64, 95% CI 1.01-2.65) and long term (OR 1.39, 95% CI 1.21-1.59). The evidence for different sleep problem categories was very uncertain. Chronic musculoskeletal pain at baseline may increase the risk of short-term sleep problems (OR 1.56, 95% CI 1.02-2.38), but long-term evidence was very uncertain. The impact of only local or only widespread pain on short-term sleep problems was very uncertain, whereas widespread pain may elevate the risk of long-term sleep problems (OR 2.0, 95% CI 1.81-2.21). In conclusion, this systematic review with meta-analysis suggests that sleep problems are associated with an increased risk of chronic musculoskeletal pain, but the bidirectional nature of this relationship requires further investigation.

The Role of Anxiety and Depression in Shaping the Sleep-Pain Connection in Patients with Nonspecific Chronic Spinal Pain and Comorbid Insomnia: A Cross-Sectional Analysis.

(1) Background: This exploratory study aims to explore the relationship between nonspecific chronic spinal pain (nCSP) and insomnia symptoms, by examining the interconnections, strengths, and directional dependence of the symptoms. In addition, we aim to identify the key symptoms of the nCSP-insomnia relationship and shed light on the bidirectional nature of this relationship. (2) Methods: This study is a secondary analysis of the baseline data (cross-sectional) from a randomized controlled trial, which examined the added value of Cognitive Behavioral Therapy for Insomnia (CBT-I) combined with cognition-targeted exercise therapy, conducted in collaboration with the Universiteit Gent and Vrije Universiteit Brussel (Belgium). One hundred and twenty-three nCSP patients with comorbid insomnia were recruited through the participating hospitals, advertisements, announcements in local newspapers, pharmacies, publications from support groups, and primary care. To explore the interconnections and directionality between symptoms and the strengths of the relationships, we estimated a regularized Gaussian graphical model and a directed acyclic graph. (3) Results: We found only one direct, but weak, link between sleep and pain, namely, between average pain and difficulties maintaining sleep. (4) Conclusions: Despite the lack of strong direct links between sleep and pain, pain and sleep seem to be indirectly linked via anxiety and depression symptoms, acting as presumable mediators in the network of nCSP and comorbid insomnia. Furthermore, feeling slowed down and fatigue emerged as terminal nodes, implying their role as consequences of the network.

Integration of Cognitive Behavioral Therapy for Insomnia in Best-Practice Care for Patients With Knee Osteoarthritis and Insomnia: A Randomized Controlled Trial Protocol.

OBJECTIVE: Knee osteoarthritis (KOA) is a common musculoskeletal problem worldwide and its key symptom is pain. Guidelines recommend incorporating comorbidity-specific therapies into patient-centered care. Patients diagnosed with KOA frequently have insomnia, which is associated with higher-pain severity. For this reason, this study protocol outlines the methodology of a randomized controlled trial (RCT) investigating the effectiveness of cognitive behavioral therapy for insomnia (CBTi) combined with best-practice KOA care (BPC) compared to best-practice KOA care and lifestyle education. METHODS: A 2-arm RCT in patients with KOA and insomnia is conducted, in which a total of 128 patients are randomly allocated to an intervention or control group. The experimental intervention consists of 12 sessions of physical therapist-led BPC with an additional 6 sessions of CBTi. The control intervention also receives BPC, which is supplemented with 6 general lifestyle information sessions. The primary outcome is the between-group difference in change in pain severity at 6 months after intervention. Secondary outcomes are pain-related outcomes, sleep-related outcomes, symptoms of anxiety and depression, level of physical activity and function, perceived global improvement, biomarkers of inflammation, and health-related quality of life. Assessments are conducted at baseline, immediately after intervention, and 3, 6, and 12 months after intervention. Furthermore, a cost-utility analysis for the proposed intervention will be performed alongside the RCT. IMPACT: This is the first RCT investigating the clinical and cost-effectiveness of a physical therapist-led intervention integrating CBTi into BPC in patients with KOA and insomnia. The results of this trial will add to the growing body of evidence on the effectiveness of individualized and comorbidity-specific KOA care, which can inform clinical decision-making and assist policymakers and other relevant stakeholders in optimizing the care pathway for patients with KOA.

Cognitive Behavioral Therapy for Insomnia in Pain Management for Nonspecific Chronic Spinal Pain: A Randomized Clinical Trial.

Importance: Insomnia is highly prevalent in patients with nonspecific chronic spinal pain (nCSP). Given the close interaction between insomnia and pain, targeting sleep problems during therapy could improve treatment outcomes. Objective: To evaluate the effectiveness of cognitive behavioral therapy for insomnia (CBTi) integrated in best-evidence pain management (BEPM) vs BEPM only in patients with nCSP and insomnia. Design, Setting, and Participants: A multicenter randomized clinical trial with 1-year follow-up was conducted between April 10, 2018, and April 30, 2022. Data and statistical analysis were performed between May 1, 2022, and April 24, 2023. Patients with nCSP and insomnia were evaluated using self-report and at-home polysomnography, to exclude underlying sleep pathologic factors. Participants were treated at the University Hospital Brussels or University Hospital Ghent, Belgium. Intention-to-treat analysis was performed. Interventions: Participants were randomized to either CBTi-BEPM or BEPM only. Both groups received 18 treatment sessions over 14 weeks. The CBTi-BEPM treatment included 6 CBTi sessions and 12 BEPM sessions. The BEPM treatment included pain neuroscience education (3 sessions) and exercise therapy (9 sessions in the CBTi-BEPM group, 15 sessions in the BEPM-only group). Main Outcomes and Measures: The primary outcome was change in mean pain intensity (assessed with Brief Pain Inventory [BPI]) at 12 months after the intervention. Exploratory secondary outcomes included several pain- and sleep-related outcomes. Blinded outcome assessment took place at baseline, posttreatment, and at 3-, 6-, and 12-month follow-up. Results: A total of 123 patients (mean [SD] age, 40.2 [11.18] years; 84 women [68.3%]) were included in the trial. In 99 participants (80.5%) with 12-month BPI data, the mean pain intensity at 12 months decreased by 1.976 points (reduction of 40%) in the CBTi-BEPM group and 1.006 points (reduction of 24%) points in the BEPM-only group. At 12 months, there was no significant difference in pain intensity change between groups (mean group difference, 0.970 points; 95% CI, -0.051 to 1.992; Cohen d, 2.665). Treatment with CBTi-BEPM resulted in a response for BPI average pain with a number needed to treat (NNT) of 4 observed during 12 months. On a preliminary basis, CBTi-BEPM was, consistently over time and analyses, more effective than BEPM only for improving insomnia severity (Cohen d, 4.319-8.961; NNT for response ranging from 2 to 4, and NNT for remission ranging from 5 to 12), sleep quality (Cohen d, 3.654-6.066), beliefs about sleep (Cohen d, 5.324-6.657), depressive symptoms (Cohen d, 2.935-3.361), and physical fatigue (Cohen d, 2.818-3.770). No serious adverse effects were reported. Conclusions and Relevance: In this randomized clinical trial, adding CBTi to BEPM did not further improve pain intensity reduction for patients with nCSP and comorbid insomnia more than BEPM alone. Yet, as CBTi-BEPM led to significant and clinically important changes in insomnia severity and sleep quality, CBTi integrated in BEPM should be considered in the treatment of patients with nCSP and comorbid insomnia. Further research can investigate the patient characteristics that moderate the response to CBTi-BEPM in terms of pain-related outcomes, as understanding of these moderators may be of utmost clinical importance. Trial Registration: Clinical Trials.gov Identifier: NCT03482856.

Personalized Multimodal Lifestyle Intervention as the Best-Evidenced Treatment for Chronic Pain: State-of-the-Art Clinical Perspective.

Chronic pain is the most prevalent disease worldwide, leading to substantial disability and socioeconomic burden. Therefore, it can be regarded as a public health disease and major challenge to scientists, clinicians and affected individuals. Behavioral lifestyle factors, such as, physical (in)activity, stress, poor sleep and an unhealthy diet are increasingly recognized as perpetuating factors for chronic pain. Yet, current management options for patients with chronic pain often do not address lifestyle factors in a personalized multimodal fashion. This state-of-the-art clinical perspective aims to address this gap by discussing how clinicians can simultaneously incorporate various lifestyle factors into a personalized multimodal lifestyle intervention for individuals with chronic pain. To do so the available evidence on (multimodal) lifestyle interventions targeting physical (in)activity, stress, sleep and nutritional factors, specifically, was reviewed and synthetized from a clinical point of view. First, advise is provided on how to design a personalized multimodal lifestyle approach for a specific patient. Subsequently, best-evidence recommendations on how to integrate physical (in)activity, stress, sleep and nutritional factors as treatment targets into a personalized multimodal lifestyle approach are outlined. Evidence supporting such a personalized multimodal lifestyle approach is growing, but further studies are needed.