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.

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.

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.

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.

Do Patients with Chronic Spinal Pain and Comorbid Insomnia Have More Features of Central Sensitization? A Case-Control Study.

BACKGROUND: Chronic spinal pain (CSP) is a major public health problem worldwide, frequently related to sleep problems. Central sensitization (CS) may worsen the clinical picture of CSP patients with insomnia. The aim of this study was to compare self-reported and objectively measured clinical outcomes between insomniac CSP patients with comorbid insomnia with and without symptoms of CS. METHODS: A case-control study on baseline self-reported sleep, functioning, and psychological distress through online questionnaires. Objective sleep and physical activity parameters and pressure pain thresholds (PPTs) were assessed through polysomnography, actigraphy, and digital algometry, respectively. Independent sample t-test and Mann-Whitney U tests were used to examine possible differences in the outcome measures between the groups. RESULTS: Data from 123 participants were included and revealed no statistically significant group for objective sleep and physical activity parameters. The CS group, however, presented with worse self-reported sleep (quality sleep, insomnia severity, and dysfunctional beliefs about sleep), increased mental and physical fatigue, and higher psychological distress (anxiety and depressive symptoms), and reported lower PPTs. CONCLUSIONS: symptoms of CS may influence perceived sleep and affect functional health and well-being perception but do not seem to affect objective sleep and physical activity.

Relationship, differences, and agreement between objective and subjective sleep measures in chronic spinal pain patients with comorbid insomnia: a cross-sectional study.

ABSTRACT: Sleep disturbances are one of the most frequent reported problems in people with nonspecific chronic spinal pain (nCSP) and presents an additional treatment challenge. Interventions targeting sleep problems are mainly based on subjective sleep complaints and do not take objective sleep into consideration. The aim of this cross-sectional study was to evaluate the relationship and conformity between self-reported and objectively measured sleep parameters (ie, questionnaire vs polysomnography and actigraphy). The baseline data of 123 people with nCSP and comorbid insomnia who are participating in a randomized controlled trial were analyzed. Pearson correlations were used to investigate the relationship between objective and subjective sleep parameters. Differences between objective and subjective sleep parameters were analyzed using t tests. Bland-Altman analyses were performed to quantify and visualize agreement between the different measurement methods. Except for the significant moderate correlation between perceived time in bed (TIB) and actigraphic TIB ( r = 0.667, P < 0.001), all other associations between subjective and objective measures were rather weak ( r < 0.400). Participants underestimated their total sleep time (TST) (mean difference [MD] = -52.37 [-67.94, -36.81], P < 0.001) and overestimated sleep onset latency (SOL) (MD = 13.76 [8.33, 19.20], P < 0.001) in general. The results of this study suggest a discrepancy (differences and lack of agreement) between subjective and objective sleep parameters in people with nCSP and comorbid insomnia. No or weak associations were found between self-reported sleep and objectively measured sleep. Findings suggest that people with nCSP and comorbid insomnia tend to underestimate TST and overestimate SOL. Future studies are necessary to confirm our results.

Predictors for physical activity and its change after active physical therapy in people with spinal pain and insomnia: Secondary analysis of a randomized controlled trial.

BACKGROUND: In healthy people and people with nonspecific chronic spinal pain (nCSP) and/or insomnia, participation in physical activity on a regular basis has several physical and psychological health benefits. However, people with chronic conditions often tend to reduce physical activity participation which can lead to deconditioning over time. Currently, there are no known predictors for an (in)active lifestyle (before and after physical therapy treatment) in people with chronic spinal pain and comorbid insomnia. OBJECTIVE: To examine predictors of pre-treatment moderate-to-vigorous physical activity (MVPA) and to examine determinants for a change in MVPA in response to 14-weeks of active physical therapy treatment in people with nonspecific chronic spinal pain (nCSP) and comorbid insomnia. METHODS: Baseline data and post-treatment data were analyzed for 66 participants. A linear multiple regression analysis was conducted to examine which factors predict MVPA at baseline. Linear mixed-effects modeling was used to identify determinants for change in MVPA in response to an active physical therapy treatment. RESULTS: Physical fatigue (b = -0.9; 95%CI: -1.59, -0.15), less limitations in functioning as a result of emotional problems (b = 0.1; 95%CI: 0.03, 0.10), mental fatigue (b = -1.0; 95%CI: -1.67, -0.43), lower general sleep quality (b= 0.7; 95%CI: 0.22, 1.17), and body mass index (b = -0.5; 95%CI: -0.93, -0.16) were significant predictors of baseline MVPA. The regression model explained 33.3% of the total variance in baseline MVPA. The change of MVPA in response to the treatment ranged from a decrease of 17.5 to an increase of 16.6 hours per week. No determinants for change in MVPA after treatment could be identified. CONCLUSION: People with nCSP and comorbid insomnia are more likely to engage in MVPA if they report, at baseline, lower sleep quality, fewer limitations in functioning resulting from emotional problems, lower body mass index, as well as less physical and mental fatigue.

Combining Cognitive Behavioral Therapy for Insomnia and Chronic Spinal Pain Within Physical Therapy: A Practical Guide for the Implementation of an Integrated Approach.

Most people who have nonspecific chronic spinal pain (nCSP) report comorbid insomnia. However, in current treatment strategies for nCSP, insomnia is usually not addressed. Considering the bidirectional interaction between pain and sleep and its underlying psychophysiological mechanisms, insomnia may increase the risk of developing adverse physical and psychological health outcomes and should thus no longer be left untreated. As suggested by previous pilot studies, adding cognitive behavioral therapy for insomnia to the contemporary evidence-based biopsychosocial physical therapy approach may also improve pain outcomes in nCSP. This manuscript aims to provide practical guidelines on hybrid physical therapy, including the combination of the following components: (1) pain neuroscience education (eg, to reconceptualize pain) and cognition-targeted exercise therapy (eg, graded exposure to functional daily life movements), and (2) cognitive behavioral therapy for insomnia (sleep psychoeducation, behavioral and cognitive therapy, correction of sleep hygiene, and relaxation therapy) can be deployed for the management of patients who have chronic spinal pain. Impact. Due to the major impact sleep disturbances have on pain and disability, insomnia as a comorbidity should no longer be ignored when treating patients with chronic spinal pain.

Influence of education level on the effectiveness of pain neuroscience education: A secondary analysis of a randomized controlled trial.

BACKGROUND: Current evidence supports the use of pain neuroscience education (PNE) in several chronic pain populations. However, the effects of PNE at group level are rather small and little is known about the influence of personal factors (e.g. level of education [LoE]). OBJECTIVE: To examine whether the effectiveness of PNE differs in chronic spinal pain (CSP) patients with high LOE (at least a Bachelor's degree) versus lower educated patients. METHOD: A total of 120 Belgian CSP patients were randomly assigned to the experimental (PNE) or control group (biomedical-focused neck/back school). Participants within each group were further subcategorized based on highest achieved LoE. ANOVA and Bonferroni post-hoc analyses were used to evaluate differences in effectiveness of the interventions between higher and lower educated participants. RESULTS: No differences between higher and lower educated participants were identified for pain-related disability. Significant interactions (P < .05) were found for kinesiophobia and several illness perceptions components. Bonferroni post-hoc analysis revealed a significant improvement in kinesiophobia (P < .001 and P < .002, medium effect sizes) and perceived negative consequences (P < .001 and P < .008, small effect sizes) in the PNE groups. Only the higher education PNE group showed a significant improvement in perceived illness cyclicity (P = .003, small effect size). Post-treatment kinesiophobia was significant lower in the higher educated PNE group compared to the higher educated control group (p < .001). CONCLUSION: Overall, the exploratory findings suggest no clinical meaningful differences in effectiveness of PNE between higher and lower educated people. PNE is effective in improving kinesiophobia and several aspects of illness perceptions regardless of LoE.

The Association between Sleep and Chronic Spinal Pain: A Systematic Review from the Last Decade.

Chronic spinal pain, including both neck and low back pain, is a common disabling disorder in which sleep problems are frequently reported as a comorbidity. The complex processes of both sleep and chronic pain seem to have overlapping mechanisms, which may explain their often established bidirectional relationship. This systematic review aims to investigate the assumed association between sleep and chronic spinal pain by providing an overview of the literature from the last decade. Eligible studies were obtained by searching four databases (PubMed, Embase, Web of Science, and PsycARTICLES). Articles were found relevant if they included a human adult population and investigated the possible association between sleep parameters and chronic spinal pain. Only studies published after January 2009 were included, as this review aimed to provide an update of a previous literature overview on this topic. The quality of the studies was assessed by risk of bias and level of evidence. A total of twenty-seven studies (6 cohort, 5 case-control, and 16 cross-sectional studies) were included in this systematic review. The methodological quality of these studies was low to moderate. The majority of studies reported weak to moderate evidence for an association between sleep parameters and chronic spinal pain, with more severe pain accompanied by more disturbed sleep. Addressing frequently reported sleep problems in chronic spinal pain patients therefore appears to be a necessary complement to pain management to achieve optimal treatment outcomes.

Associates of Insomnia in People with Chronic Spinal Pain: A Systematic Review and Meta-Analysis.

Insomnia is a major problem in the chronic spinal pain (CSP) population and has a negative impact on health and well-being. While insomnia is commonly reported, underlying mechanisms explaining the relation between sleep and pain are still not fully understood. Additionally, no reviews regarding the prevention of insomnia and/or associated factors in people with CSP are currently available. To gain a better understanding of the occurrence of insomnia and associated factors in this population, we conducted a systematic review of the literature exploring associates for insomnia in people with CSP in PubMed, Web of Science and Embase. Three independent reviewers extracted the data and performed the quality assessment. A meta-analysis was conducted for every potential associate presented in at least two studies. A total of 13 studies were found eligible, which together identified 25 different potential associates of insomnia in 24,817 people with CSP. Twelve studies had a cross-sectional design. Moderate-quality evidence showed a significantly higher rate for insomnia when one of the following factors was present: high pain intensity, anxiety and depression. Low-quality evidence showed increased odds for insomnia when one of the following factors was present: female sex, performing no professional activities and physical/musculoskeletal comorbidities. Higher healthcare use was also significantly related to the presence of insomnia. One study showed a strong association between high levels of pain catastrophizing and insomnia in people with chronic neck pain. Last, reduced odds for insomnia were found in physically active people with chronic low back pain compared to inactive people with chronic low back pain. This review provides an overview of the available literature regarding potential associates of insomnia in people with CSP. Several significant associates of insomnia were identified. These findings can be helpful to gain a better understanding of the characteristics and potential origin of insomnia in people witch CSP, to identify people with CSP who are (less) likely to have insomnia and to determine directions of future research in this area.

Prevalence and risk factors of sleep disturbances in breast cancersurvivors: systematic review and meta-analyses.

BACKGROUND: Breast cancer remains the most frequently diagnosed malignancy among women worldwide, with rising incidence numbers. In Belgium, one out of eight women will be diagnosed with breast cancer. Fortunately, 80% of those breast cancer patients will still be alive 10 years after diagnosis due to improvements in screening and treatment strategies. However, an important portion of the breast cancer survivors (BCS) will face side effects, such as sleep disturbances, long after treatment ends. It has been demonstrated that untreated insomnia in BCS negatively impacts mood, physical symptoms, pain sensitivity, fatigue, and quality of life. Furthermore, insomnia is increasingly considered an independent risk factor for future depression in BCS. The importance of understanding sleep disturbances in cancer populations has been highlighted and recognized as warranting further research. Therefore, the purpose of this systematic review was to determine the prevalence and the risk factors for the development of sleep disturbances in BCS. METHODS: PubMed, Web of Science, and PEDro were systematically screened for studies encompassing data regarding the prevalence or risk factors of sleep disturbances in BCS. If possible, meta-analyses were performed. Subgroup analyses were undertaken based on the methodological quality, study design, type of sleep disturbance, and the use of a measurement tool with strong psychometric properties to investigate significant heterogeneity (I2 > 50%) across studies. RESULTS: A total of 27 studies were found eligible. The pooled estimate for sleep disturbances prevalence is 0.40 (95% confidence interval (CI) = [0.29-0.52], I2 = 100%, p < 0.00001) and ranged from 0.14 (95% CI = [0.04-0.24]) to 0.93 (95% CI = [0.91-0.95]). Subgroup analyses did not reduce the heterogeneity among studies. Meta-analyses were performed for seven risk factors. Significant differences for the odds of developing sleep disturbances were found for hot flashes (pooled OR (ORp) 2.25, 95% CI = [1.64-3.08], I2 = 0%, p = 0.90), race (ORp 2.31, 95% CI = [1.56-3.42], I2 = 0%, p = 0.47), and menopause (ORp 1.84, 95% CI = [1.11-3.06], I2 = 0%, p = 0.70). After withdrawing the studies that did not rely on the use of a measurement tool with strong psychometric properties, pain (ORp 2.31, 95% CI = [1.36-3.92], I2 = 27%, p = 0.25), depressive symptoms (ORp 3.20, 95% CI [2.32-4.42], I2 = 0%, p = 0.63), and fatigue (ORp 2.82, 95% CI = [1.98-4.02], I2 = 0%, p = 0.60) became significant as well, with a substantial decrease of heterogeneity. CONCLUSION: Prevalence for sleep disturbances ranged from 0.14 to 0.93 with the vast majority of the studies investigating insomnia and sleep-wake disturbances. High heterogeneity makes it difficult to draw firm conclusions. Pain, depressive symptoms, hot flashes, fatigue, non-Caucasian race, and menopausal status were significantly associated with increased odds for developing sleep disturbances.

Best Evidence Rehabilitation for Chronic Pain Part 3: Low Back Pain.

Chronic Low Back Pain (CLBP) is a major and highly prevalent health problem. Given the high number of papers available, clinicians might be overwhelmed by the evidence on CLBP management. Taking into account the scale and costs of CLBP, it is imperative that healthcare professionals have access to up-to-date, evidence-based information to assist them in treatment decision-making. Therefore, this paper provides a state-of-the-art overview of the best evidence non-invasive rehabilitation for CLBP. Taking together up-to-date evidence from systematic reviews, meta-analysis and available treatment guidelines, most physically inactive therapies should not be considered for CLBP management, except for pain neuroscience education and spinal manipulative therapy if combined with exercise therapy, with or without psychological therapy. Regarding active therapy, back schools, sensory discrimination training, proprioceptive exercises, and sling exercises should not be considered due to low-quality and/or conflicting evidence. Exercise interventions on the other hand are recommended, but while all exercise modalities appear effective compared to minimal/passive/conservative/no intervention, there is no evidence that some specific types of exercises are superior to others. Therefore, we recommend choosing exercises in line with the patient's preferences and abilities. When exercise interventions are combined with a psychological component, effects are better and maintain longer over time.

Chronic Pain in Breast Cancer Survivors: Nociceptive, Neuropathic, or Central Sensitization Pain?

INTRODUCTION: The differentiation between acute and chronic pain can be insufficient for appropriate pain management. The aim of this study was to evaluate the prevalence of the predominant pain type (nociceptive, neuropathic, or central sensitization [CS] pain) in breast cancer survivors (BCS) with chronic pain. The secondary aims were to examine (1) differences in health-related quality of life (HRQoL) between the different pain groups; and (2) the associations between patient-, disease-, and treatment-related factors and the different pain types. METHODS: To determine the prevalence of the predominant type of pain, a recently proposed classification system was used. BCS were asked to complete the VAS for pain, Douleur Neuropathique 4 Questionnaire, Margolis Pain Diagram, Central Sensitization Inventory, and Short Form 36 (SF-36). RESULTS: Ninety-one BCS participated, among whom 25.3% presented neuropathic pain, 18.7% nociceptive pain, and 15.4% CS pain. Mixed pain was found in 40.6%. A significant intergroup difference in HRQoL was found for SF-36 "general health" (P = 0.04). The odds for the presence of CS rather than nociceptive pain are 26 times higher in patients exposed to hormone therapy in comparison to the nonexposed (odds ratio 25.95, 95% confidence interval 1.33 to 504.37, P = 0.03). CONCLUSION: Neuropathic pain is most frequent in BCS. Strong associations were found between CS pain and hormone therapy.

The added value of cognitive behavioral therapy for insomnia to current best evidence physical therapy for chronic spinal pain: protocol of a randomized controlled clinical trial.

BACKGROUND: Insomnia is a highly prevalent and debilitating comorbidity that is often not addressed in therapy for chronic spinal pain (CSP). Given the close interaction between insomnia and CSP severity and related disability, targeting sleep problems during therapy could improve treatment outcomes in these patients. OBJECTIVE: Can cognitive behavioral therapy for insomnia (CBT-I) combined with the modern neuroscience approach (i.e. pain neuroscience education and cognition-targeted exercise therapy) reduce pain and improve sleep, physical activity and function in people with CSP and comorbid insomnia? METHODS: Participants: One-hundred-twenty participants with chronic spinal pain and comorbid insomnia Intervention: CBT-I combined with the modern neuroscience approach (experimental) compared to the modern neuroscience approach alone (control). Both interventions start with three sessions of pain neuroscience education, followed by six sessions of CBT-I and nine sessions of cognition-targeted exercise therapy in the experimental group, or 15 sessions of cognition-targeted exercise therapy in the control group. MEASUREMENTS: Primary outcome measure: self-reported pain severity (Brief Pain Inventory). SECONDARY OUTCOME MEASURES: pain sensitivity (pressure pain thresholds, and online questionnaires), sleep-related outcomes (home-based polysomnography and online questionnaires), physical activity (actigraphy), and function (online questionnaires). Online questionnaires will be completed at baseline, directly post-treatment, and at 3, 6 and 12 months post-treatment. Polysomnography, pressure pain thresholds and actigraphy will be carried out at baseline, post-treatment and at 12 months follow-up. DISCUSSION: Findings may provide (1) a novel therapeutic approach for people with CSP and comorbid insomnia to improve pain, sleep, physical activity and function, and (2) new treatment guidelines for professionals. TRIAL REGISTRATION: Clinicaltrials.gov NCT03482856 (https://clinicaltrials.gov/ct2/show/NCT03482856).

Risk factors of pain in breast cancer survivors: a systematic review and meta-analysis.

BACKGROUND: Breast cancer remains the number 1 lethal malignancy in women. With rising incidence and decreased mortality, the number of breast cancer survivors has increased. Consequently, sequelae, such as pain, are becoming more important. PURPOSE: The purpose of this study was to identify risk factors for the development of pain in breast cancer survivors. METHODS: PubMed and Web of Science were systematically screened for studies encompassing risk factors for the development of pain in breast cancer survivors. Meta-analyses were carried out for risk factors described in more than one article. Moderator analysis was performed in case of high heterogeneity (I 2 > 50%) across studies. RESULTS: Seventeen studies were found eligible. Meta-analyses were performed for 17 factors. Significant differences for the odds of developing chronic pain were found for BMI (overall OR: 1.34, 95%CI 1.08-1.67, p = 0.008), education (overall OR: 1.23, 95%CI 1.07-1.42, p = 0.005), lymphedema (overall OR: 2.58, 95%CI 1.93-3.46, p < 0.00001), smoking status (overall OR: 0.75, 95%CI 0.62-0.92, p = 0.005), axillary lymph node dissection (overall OR: 1.25, 95%CI 1.04-1.52, p = 0.02), chemotherapy (overall OR: 1.44, 95%CI 1.24-1.68, p < 0.00001), and radiotherapy (overall OR: 1.32, 95%CI 1.17-1.48, p < 0.00001). After performing moderator analyses for age, comorbidities, hormone therapy, and breast surgery, hormone therapy became a significant risk factor as well (overall OR: 1.33, 95%CI 1.15-1.54, p = 0.0001). CONCLUSION: BMI > 30, education < 12-13 years, lymphedema, not smoking, axillary lymph node dissection, chemotherapy, hormone therapy, and radiotherapy were significantly associated with higher odds for the development of chronic pain, with lymphedema being the biggest risk factor. Lack of uniformity across the studies in defining pain, follow-up, measurement tools, and cut-off values for the diagnosis of pain was noted, resulting in greater inter-study variability.