DE-PASS best evidence statement (BESt): determinants of adolescents' device-based physical activity and sedentary behaviour in settings: a systematic review and meta-analysis.

BACKGROUND: Although physical activity (PA) is associated with significant health benefits, only a small percentage of adolescents meet recommended PA levels. This systematic review with meta-analysis explored the modifiable determinants of adolescents' device-based PA and/or sedentary behaviour (SB), evaluated in previous interventions and examined the associations between PA/SB and these determinants in settings. METHODS: A search was conducted on five electronic databases, including papers published from January 2010 to July 2023. Randomized Controlled Trials (RCTs) or Controlled Trials (CTs) measuring adolescents' device-based PA/SB and their modifiable determinants at least at two time points: pre- and post-intervention were considered eligible. PA/SB and determinants were the main outcomes. Modifiable determinants were classified after data extraction adopting the social-ecological perspective. Robust Bayesian meta-analyses (RoBMA) were performed per each study setting. Outcomes identified in only one study were presented narratively. The risk of bias for each study and the certainty of the evidence for each meta-analysis were evaluated. The publication bias was also checked. PROSPERO ID: CRD42021282874. RESULTS: Fourteen RCTs (eight in school, three in school and family, and one in the family setting) and one CT (in the school setting) were included. Fifty-four modifiable determinants were identified and were combined into 33 broader determinants (21 individual-psychological, four individual-behavioural, seven interpersonal, and one institutional). RoBMAs revealed none or negligible pooled intervention effects on PA/SB or determinants in all settings. The certainty of the evidence of the impact of interventions on outcomes ranged from very low to low. Narratively, intervention effects in favour of the experimental group were detected in school setting for the determinants: knowledge of the environment for practicing PA, d = 1.84, 95%CI (1.48, 2.20), behaviour change techniques, d = 0.90, 95%CI (0.09, 1.70), choice provided, d = 0.70, 95%CI (0.36, 1.03), but no corresponding effects on PA or SB were found. CONCLUSIONS: Weak to minimal evidence regarding the associations between the identified modifiable determinants and adolescents' device-based PA/SB in settings were found, probably due to intervention ineffectiveness. Well-designed and well-implemented multicomponent interventions should further explore the variety of modifiable determinants of adolescents' PA/SB, including policy and environmental variables.

Neonatal jaundice detection in low-resource Mexican settings: possibilities and barriers for innovation with mobile health.

BACKGROUND: Neonatal jaundice is a common condition that can lead to brain damage and disabilities when severe cases go undetected. Low- and middle-income countries often lack accurate methods for detecting neonatal jaundice and rely on visual assessment, resulting in a higher incidence of adverse consequences. Picterus Jaundice Pro (Picterus JP), an easy-to-use and affordable smartphone-based screening device for the condition, has demonstrated higher accuracy than visual assessment in Norwegian, Philippine and Mexican newborns. This study aimed to identify the barriers and facilitators to implementing Picterus JP in public health services in low-income settings in Mexico by exploring the current process of neonatal jaundice detection and stakeholders' perspectives in that context. METHODS: Qualitative data collection techniques, including one focus group, 15 semi-structured interviews and four observations, were employed in urban and rural health facilities in Oaxaca, Mexico. The participants included medical doctors, nurses and health administrators. The data were analysed by thematic analysis guided by the Consolidated Framework for Implementation Research. RESULTS: The analysis yielded four main themes: (I) the current state of neonatal care and NNJ detection, (II) the needs and desires for enhancing NNJ detection, (III) the barriers and facilitators to implementing Picterus JP in the health system and (IV) HCWs' expectations of Picterus JP. The findings identify deficiencies in the current neonatal jaundice detection process and the participants' desire for a more accurate method. Picterus JP was perceived as easy to use, useful and compatible with the work routine, but barriers to adoption were identified, including internet deficiencies and costs. CONCLUSIONS: The introduction of Picterus JP as a supporting tool to screen for neonatal jaundice is promising but contextual barriers in the setting must be addressed for successful implementation. There is also an opportunity to optimise visual assessment to improve detection of neonatal jaundice.

Incidence of sick leave and disability pension in adults with musculoskeletal pain and co-occurring long-term conditions: data from the Norwegian HUNT study and national registries.

BACKGROUND: Musculoskeletal pain is one of the leading causes of work productivity loss. Long-term conditions (LTCs) commonly occur alongside musculoskeletal pain. However, the incidence of sick leave and disability pension according to LTC status in people with musculoskeletal pain has not been previously described. METHODS: Working-age participants (20-65 years) with persistent musculoskeletal pain who participated in the HUNT3 Study (1995-97) were included. Twenty-five LTCs were classified into 8 LTC groups according to the International Classification of Diseases version 11. Data on sickness and disability benefits were obtained from the National Insurance Database and linked to the HUNT3 data using participants' personal identification number. Age-adjusted incidence rates (IRs) (per 10,000 person-years) and hazard ratios (HRs) of sick leave during 5-year follow-up and disability pension during ~ 25-year follow-up were estimated with 95% confidence intervals (CIs) and presented according to LTC status. RESULTS: Overall, 11,080 participants with musculoskeletal pain were included. Of those, 32% reported one LTC and 45% reported ≥ 2 LTCs. During the follow up period, 1,312 participants (12%) received disability pension due to musculoskeletal conditions. The IR of sick leave and disability pension due to musculoskeletal conditions increased with number of LTCs. Specifically, the IR of sick leave was 720 (95% CI 672 to 768) in participants without any LTCs and 968 (95% CI 927 to 1,009) if they had ≥ 2 LTCs. The IRs of disability pension were 87 (95% CI 75 to 98) and 167 (95% CI 154 to 179) among those with no LTCs and ≥ 2 LTCs, respectively. The incidence of sick leave and disability pension due to musculoskeletal conditions was largely similar across LTCs, although the incidence of disability pension was somewhat higher among people with sleep disorders (IR: 223, 95% CI 194 to 252). CONCLUSIONS: Among people with persistent musculoskeletal pain, the incidence of prematurely leaving the work force due to musculoskeletal conditions was twice as high for those with multiple LTCs compared to those without any LTCs. This was largely irrespective of the type of LTC, indicating that the number of LTCs are an important feature when evaluating work participation among people with musculoskeletal pain.

The interplay between multisite pain and insomnia on the risk of anxiety and depression: the HUNT study.

BACKGROUND: Chronic musculoskeletal pain and insomnia frequently co-occur and are known independent risk factors for anxiety and depression. However, the interplay between these two conditions on the risk of anxiety and depression has not been explored. METHODS: A population-based prospective study of 18,301 adults in the Norwegian HUNT Study without anxiety or depression at baseline (2006-2008). We calculated adjusted risk ratios (RRs) with 95% confidence intervals (CIs) for anxiety and/or depression at follow-up (2017-2019), associated with i) number of chronic pain sites, and ii) chronic pain and insomnia symptoms jointly. RESULTS: At follow-up, 2155 (11.8%) participants reported anxiety and/or depression. The number of pain sites was positively associated with risk of anxiety and/or depression (Ptrend, < 0.001). Compared to people without chronic pain and insomnia symptoms, people with ≥5 pain sites and no insomnia symptoms had a RR of 1.52 (95% CI: 1.28 to 1.81) for anxiety and/or depression, those with no chronic pain but with insomnia had a RR of 1.78 (95% CI: 1.33 to 2.38), whereas the RR among people with both ≥5 pain sites and insomnia was 2.42 (95% CI: 1.85 to 3.16). We observed no synergistic effect above additivity for the combination of ≥5 pain sites and insomnia on risk of anxiety and/or depression. CONCLUSIONS: This study shows that people with multisite chronic pain who also suffer from insomnia are at a particularly high risk for anxiety and/or depression, suggesting that insomnia symptoms are important contributors to the association between multisite pain and common mental health problems.

Vibration testing: Optimizing methods to improve reliability.

INTRODUCTION: In this study we assessed the test-retest reliability of a Rydel-Seiffer tuning fork and an electronic vibrameter with hand-held and fixed probes. METHODS: Fifty healthy volunteers were assessed twice in the upper and lower limb 15 minutes apart. Reliability was assessed by intraclass correlation coefficient (ICC) and standard error of measurement (SEM). The effect of stimulus parameters on vibration disappearance threshold (VDT) was assessed by analysis of variance. RESULTS: All 3 tools showed good reliability (ICCs = 0.65-0.95). Vibrameter recordings with the fixed probe showed high variability. The vibrameter was more sensitive in detecting body-site and age differences in vibration thresholds than the tuning fork. Significantly higher VDT was observed when higher starting amplitudes and slower rates of change were used. DISCUSSION: The hand-held vibrameter is a superior tool to monitor vibration sense. The stimulus amplitude and rate of change are important to control as they alter VDT. Muscle Nerve 59:229-235, 2019.

Conditioned Pain Modulation (CPM) is Reduced in Irritable Bowel Syndrome: A Systematic Review and Meta-Analysis of CPM and the Role of Psychological Factors.

This systematic review summarises evidence assessing endogenous pain inhibition in people with irritable bowel syndrome (IBS) compared with healthy controls using conditioned pain modulation (CPM) and offset analgesia (OA). Evidence regarding the role of psychological variables is also examined. The review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Four electronic databases were searched to retrieve studies assessing CPM or OA in adults diagnosed with IBS according to the ROME II/III criteria. Standardized mean differences were calculated for each study and a random effects model was used for meta-analysis. Eleven studies were included, 5 of which reported results on the relationship between CPM and psychological variables. None of the studies assessed OA. The risk of bias assessment found a lack of assessor blinding in all studies. The pooled effect estimate was 0.90 (95% CI, 0.40-1.40) indicating a significantly lower CPM effect in people with IBS compared with controls. This effect was reduced to 0.51 when 1 outlier was excluded from the analysis. In addition, reduced CPM responses were significantly correlated with higher anxiety (r=0.17 to 0.64), stress (r=0.63), and pain catastrophizing (r=0.38) in people with IBS; however, the evidence available was limited and the strength of these associations variable. Depression was not found to be associated with CPM in these IBS cohorts. The results of this review suggest that people with IBS, as a group, demonstrate reduced pain inhibition measured by CPM. The preliminary evidence about the association between psychological factors and CPM warrants further investigations.

An Artificial Intelligence-Based App for Self-Management of Low Back and Neck Pain in Specialist Care: Process Evaluation From a Randomized Clinical Trial.

BACKGROUND: Self-management is endorsed in clinical practice guidelines for the care of musculoskeletal pain. In a randomized clinical trial, we tested the effectiveness of an artificial intelligence-based self-management app (selfBACK) as an adjunct to usual care for patients with low back and neck pain referred to specialist care. OBJECTIVE: This study is a process evaluation aiming to explore patients' engagement and experiences with the selfBACK app and specialist health care practitioners' views on adopting digital self-management tools in their clinical practice. METHODS: App usage analytics in the first 12 weeks were used to explore patients' engagement with the SELFBACK app. Among the 99 patients allocated to the SELFBACK interventions, a purposive sample of 11 patients (aged 27-75 years, 8 female) was selected for semistructured individual interviews based on app usage. Two focus group interviews were conducted with specialist health care practitioners (n=9). Interviews were analyzed using thematic analysis. RESULTS: Nearly one-third of patients never accessed the app, and one-third were low users. Three themes were identified from interviews with patients and health care practitioners: (1) overall impression of the app, where patients discussed the interface and content of the app, reported on usability issues, and described their app usage; (2) perceived value of the app, where patients and health care practitioners described the primary value of the app and its potential to supplement usual care; and (3) suggestions for future use, where patients and health care practitioners addressed aspects they believed would determine acceptance. CONCLUSIONS: Although the app's uptake was relatively low, both patients and health care practitioners had a positive opinion about adopting an app-based self-management intervention for low back and neck pain as an add-on to usual care. Both described that the app could reassure patients by providing trustworthy information, thus empowering them to take actions on their own. Factors influencing app acceptance and engagement, such as content relevance, tailoring, trust, and usability properties, were identified. TRIAL REGISTRATION: ClinicalTrials.gov NCT04463043; https://clinicaltrials.gov/study/NCT04463043.

Interplay between chronic widespread pain and lifestyle factors on the risk of type 2 diabetes: longitudinal data from the Norwegian HUNT Study.

INTRODUCTION: Chronic widespread pain (CWP) and diabetes commonly co-occur; however, it is unclear whether CWP infers an additional risk for diabetes among those with known risk factors for type 2 diabetes. We aimed to examine if CWP magnifies the effect of adverse lifestyle factors on the risk of diabetes. RESEARCH DESIGN AND METHODS: The study comprised data on 25 528 adults in the Norwegian HUNT Study without diabetes at baseline (2006-2008). We calculated adjusted risk ratios (RRs) with 95% CIs for diabetes at follow-up (2017-2019), associated with CWP and body mass index (BMI), physical activity, and insomnia symptoms. The relative excess risk due to interaction (RERI) was calculated to investigate the synergistic effect between CWP and adverse lifestyle factors. RESULTS: Compared with the reference group without chronic pain and no adverse lifestyle factors, those with BMI ≥30 kg/m2 with and without CWP had RRs for diabetes of 10.85 (95% CI 7.83 to 15.05) and 8.87 (95% CI 6.49 to 12.12), respectively; those with physical activity <2 hours/week with and without CWP had RRs for diabetes of 2.26 (95% CI 1.78 to 2.88) and 1.54 (95% CI 1.24 to 1.93), respectively; and those with insomnia symptoms with and without CWP had RRs for diabetes of 1.31 (95% CI 1.07 to 1.60) and 1.27 (95% CI 1.04 to 1.56), respectively. There was little evidence of synergistic effect between CWP and BMI ≥30 kg/m2 (RERI=1.66, 95% CI -0.44 to 3.76), low physical activity (RERI=0.37, 95% CI -0.29 to 1.03) or insomnia symptoms (RERI=-0.09, 95% CI -0.51 to 0.34) on the risk of diabetes. CONCLUSIONS: These findings show no clear interaction between CWP and adverse lifestyle factors on the risk of diabetes.

Effect of an Artificial Intelligence-Based Self-Management App on Musculoskeletal Health in Patients With Neck and/or Low Back Pain Referred to Specialist Care: A Randomized Clinical Trial.

Importance: Self-management is a key element in the care of persistent neck and low back pain. Individually tailored self-management support delivered via a smartphone app in a specialist care setting has not been tested. Objective: To determine the effect of individually tailored self-management support delivered via an artificial intelligence-based app (SELFBACK) adjunct to usual care vs usual care alone or nontailored web-based self-management support (e-Help) on musculoskeletal health. Design, Setting, and Participants: This randomized clinical trial recruited adults 18 years or older with neck and/or low back pain who had been referred to and accepted on a waiting list for specialist care at a multidisciplinary hospital outpatient clinic for back, neck, and shoulder rehabilitation. Participants were enrolled from July 9, 2020, to April 29, 2021. Of 377 patients assessed for eligibility, 76 did not complete the baseline questionnaire, and 7 did not meet the eligibility criteria (ie, did not own a smartphone, were unable to take part in exercise, or had language barriers); the remaining 294 patients were included in the study and randomized to 3 parallel groups, with follow-up of 6 months. Interventions: Participants were randomly assigned to receive app-based individually tailored self-management support in addition to usual care (app group), web-based nontailored self-management support in addition to usual care (e-Help group), or usual care alone (usual care group). Main Outcomes and Measures: The primary outcome was change in musculoskeletal health measured by the Musculoskeletal Health Questionnaire (MSK-HQ) at 3 months. Secondary outcomes included change in musculoskeletal health measured by the MSK-HQ at 6 weeks and 6 months and pain-related disability, pain intensity, pain-related cognition, and health-related quality of life at 6 weeks, 3 months, and 6 months. Results: Among 294 participants (mean [SD] age, 50.6 [14.9] years; 173 women [58.8%]), 99 were randomized to the app group, 98 to the e-Help group, and 97 to the usual care group. At 3 months, 243 participants (82.7%) had complete data on the primary outcome. In the intention-to-treat analysis at 3 months, the adjusted mean difference in MSK-HQ score between the app and usual care groups was 0.62 points (95% CI, -1.66 to 2.90 points; P = .60). The adjusted mean difference between the app and e-Help groups was 1.08 points (95% CI, -1.24 to 3.41 points; P = .36). Conclusions and Relevance: In this randomized clinical trial, individually tailored self-management support delivered via an artificial intelligence-based app adjunct to usual care was not significantly more effective in improving musculoskeletal health than usual care alone or web-based nontailored self-management support in patients with neck and/or low back pain referred to specialist care. Further research is needed to investigate the utility of implementing digitally supported self-management interventions in the specialist care setting and to identify instruments that capture changes in self-management behavior. Trial Registration: ClinicalTrials.gov Identifier: NCT04463043.

A Systematic Review of the Variation in Pain Catastrophizing Scale Reference Scores Based on Language Version and Country in Patients with Chronic Primary (Non-specific) Pain.

INTRODUCTION: This systematic review aimed to investigate variations of reference scores for the Pain Catastrophizing Scale (PCS) between language versions and between countries in patients with chronic primary pain (CPP) or chronic primary pain, not otherwise specified (CPP-NOS). METHODS: Electronic searches of the Ovid/Embase, Ovid/MEDLINE, and Ovid/PsycINFO databases were conducted to retrieve studies assessing PCS scores in adults with CPP or CPP-NOS proposed by the International Classification of Diseases, Eleventh Revision for any country where the translated PCS was available. The protocol for this systematic review was prospectively registered on the International Prospective Register of Systematic Reviews 2018 (registration number: CRD 42018086719). RESULTS: A total of 3634 articles were screened after removal of duplicates. From these, 241 articles reporting on 32,282 patients with chronic pain were included in the review. The mean (± standard deviation) weighted PCS score across all articles was 25.04 ± 12.87. Of the 12 language versions and 21 countries included in the review, the weighted mean PCS score in Asian languages or Asian countries was significantly higher than that in English, European, and other languages or Western and other countries. The highest mean score of the weighted PCS based on language was in Japanese (mean 33.55), and the lowest was in Russian (mean 20.32). The highest mean score of the weighted PCS based on country was from Japan (mean 33.55), and the lowest was from Australia (mean 19.80). CONCLUSION: The weighted PCS scores for people with CPP or CPP-NOS were significantly higher in Asian language versions/Asian countries than in English, European and other language versions or Western and other countries.

Our previous research has indicated that the clinical significance of the Pain Catastrophizing Scale (PCS) score would vary across different language versions and different countries (Ikemoto et al. in Eur J Pain 2020; 24(7):1228­1241. https://doi.org/10.1002/ejp.1587 ). This systematic review investigated cross-cultural differences in the PCS score between different languages and countries among patients with chronic primary pain. From 241 articles reporting on 32,282 patients with chronic primary pain, involving 12 language versions and 21 countries, the weighted mean PCS score in Asian languages or Asian countries was significantly higher than that in English, European and other languages or Western and other countries. Given the variations of PCS scores in different contexts, a universal comparison PCS reference or a cutoff score should not be used to compare different cultures even when a sample has the same pain condition.

Is low intensity exercise sufficient to induce exercise-induced pain threshold modulation in people with persistent pain?

OBJECTIVES: We investigated whether a 12-min walk test (12MWT) yielded exercise-induced pain threshold modulation (EIPM) within people with persistent pain and whether baseline self-report and pain sensitivity measures differed according to these responses. DESIGN: Cross-sectional study. METHODS: Two cohorts (tertiary/community) (n = 88) with persistent pain underwent pressure pain threshold (PPT) testing before and after a 12MWT to determine exercise-induced pain threshold modulation responses. Baseline self-report (pain severity, pain distribution, psychological distress, sleep) and baseline widespread pain sensitivity (WPS) (high/low) were recorded. Within and between-group differences were analysed using paired t-tests and repeated measure analyses of covariance. Individual EIPM responses were categorised as hyperalgesic, no change and hypoalgesic responses. Differences in baseline self-report and pain sensitivity measures between EIPM categories were investigated. RESULTS: No significant within- or between-group differences in PPT following the 12MWT were detected (p > 0.05). Individual responses showed that up to 30% of the community and 44% of the tertiary cohort demonstrated >20% change in PPT (in either direction). Significant differences were shown in pain distribution (p = 0.002) and baseline WPS (p = 0.001) between people with hyperalgesic, no change, hypoalgesic responses. People with 4-5 pain regions were more likely hyperalgesic (χ2 = 9.0, p = 0.003); people with low baseline WPS were more likely to demonstrate no change (p = 0.002). CONCLUSION: Low or self-selected intensity exercise was insufficient to induce exercise-induced pain modulation at group level. Individual responses were variable with pain distribution and baseline WPS differing between responses. Future research could evaluate responses and associated factors in larger samples with high baseline pain sensitivity specifically.

DE-PASS Best Evidence Statement (BESt): modifiable determinants of physical activity and sedentary behaviour in children and adolescents aged 5-19 years-a protocol for systematic review and meta-analysis.

INTRODUCTION: Physical activity among children and adolescents remains insufficient, despite the substantial efforts made by researchers and policymakers. Identifying and furthering our understanding of potential modifiable determinants of physical activity behaviour (PAB) and sedentary behaviour (SB) is crucial for the development of interventions that promote a shift from SB to PAB. The current protocol details the process through which a series of systematic literature reviews and meta-analyses (MAs) will be conducted to produce a best-evidence statement (BESt) and inform policymakers. The overall aim is to identify modifiable determinants that are associated with changes in PAB and SB in children and adolescents (aged 5-19 years) and to quantify their effect on, or association with, PAB/SB. METHODS AND ANALYSIS: A search will be performed in MEDLINE, SportDiscus, Web of Science, PsychINFO and Cochrane Central Register of Controlled Trials. Randomised controlled trials (RCTs) and controlled trials (CTs) that investigate the effect of interventions on PAB/SB and longitudinal studies that investigate the associations between modifiable determinants and PAB/SB at multiple time points will be sought. Risk of bias assessments will be performed using adapted versions of Cochrane's RoB V.2.0 and ROBINS-I tools for RCTs and CTs, respectively, and an adapted version of the National Institute of Health's tool for longitudinal studies. Data will be synthesised narratively and, where possible, MAs will be performed using frequentist and Bayesian statistics. Modifiable determinants will be discussed considering the settings in which they were investigated and the PAB/SB measurement methods used. ETHICS AND DISSEMINATION: No ethical approval is needed as no primary data will be collected. The findings will be disseminated in peer-reviewed publications and academic conferences where possible. The BESt will also be shared with policy makers within the DE-PASS consortium in the first instance. SYSTEMATIC REVIEW REGISTRATION: CRD42021282874.

Subtypes of insomnia and the risk of chronic spinal pain: the HUNT study.

OBJECTIVE: To examine the association between subtypes of insomnia and the risk of chronic spinal pain. METHODS: The study comprised 16,401 participants without chronic spinal pain at baseline who were followed for ∼11 years. People were categorized into 'no insomnia symptoms', 'subthreshold insomnia', and 'insomnia'. Insomnia was defined according to the diagnostic classification system requiring both daytime and nighttime symptoms, and further categorized into subtypes based on nighttime symptoms (ie, sleep onset latency [SOL-insomnia], wake after sleep onset [WASO-insomnia], early morning awakening [EMA-insomnia], or combinations of these). Subthreshold insomnia comprised those with only daytime impairment or one or more nighttime symptoms. Chronic spinal pain was defined as pain in either 'neck', 'low back', or 'upper back', or a combination of these. RESULTS: In multivariable regression analysis using people without insomnia as reference, people with subthreshold insomnia or insomnia had relative risks (RRs) of chronic spinal pain of 1.29 (95% confidence interval [CI] 1.21-1.38) and 1.50 (95% CI 1.34-1.68), respectively. The RRs for people with one nighttime symptom were 1.30 (95% CI 0.83-2.05) for WASO-insomnia, 1.32 (95% CI 1.06-1.65) for EMA-insomnia, and 1.70 (95% CI 1.32-2.18) for SOL-insomnia, respectively. Combinations of nighttime insomnia symptoms gave RRs from 1.45 (95% CI 1.08-1.94) for WASO + EMA-insomnia to 1.72 (95% CI 1.36-2.19) for all nighttime symptoms (SOL + WASO + EMA-insomnia). CONCLUSIONS: These findings suggest that the risk of chronic spinal pain is highest among persons with insomnia subtypes characterized by sleep onset latency or among those having insomnia symptoms in all parts of the sleep period.

Individually tailored self-management app-based intervention (selfBACK) versus a self-management web-based intervention (e-Help) or usual care in people with low back and neck pain referred to secondary care: protocol for a multiarm randomised clinical trial.

INTRODUCTION: Low back pain (LBP) and neck pain (NP) are common and costly conditions. Self-management is a key element in the care of persistent LBP and NP. Artificial intelligence can be used to support and tailor self-management interventions, but their effectiveness needs to be ascertained. The aims of this trial are (1) to evaluate the effectiveness of an individually tailored app-based self-management intervention (selfBACK) adjunct to usual care in people with LBP and/or NP in secondary care compared with usual care only, and (2) to compare the effectiveness of selfBACK with a web-based self-management intervention without individual tailoring (e-Help). METHODS AND ANALYSIS: This is a randomised, assessor-blind clinical trial with three parallel arms: (1) selfBACK app adjunct to usual care; (2) e-Help website adjunct to usual care and (3) usual care only. Patients referred to St Olavs Hospital, Trondheim (Norway) with LBP and/or NP and accepted for assessment/treatment at the multidisciplinary outpatient clinic for back or neck rehabilitation are invited to the study. Eligible and consenting participants are randomised to one of the three arms with equal allocation ratio. We aim to include 279 participants (93 in each arm). Outcome variables are assessed at baseline (before randomisation) and at 6-week, 3-month and 6-month follow-up. The primary outcome is musculoskeletal health measured by the Musculoskeletal Health Questionnaire at 3 months. A mixed-methods process evaluation will document patients' and clinicians' experiences with the interventions. A health economic evaluation will estimate the cost-effectiveness of both interventions' adjunct to usual care. ETHICS AND DISSEMINATION: The trial is approved by the Regional Committee for Medical and Health Research Ethics in Central Norway (Ref. 2019/64084). The results of the trial will be published in peer-review journals and presentations at national and international conferences relevant to this topic. TRIAL REGISTRATION NUMBER: NCT04463043.

Number of Chronic Nighttime Insomnia Symptoms and Risk of Chronic Widespread Pain and Pain-Related Disability: The HUNT Study.

STUDY OBJECTIVES: To examine the association between the number of chronic nighttime insomnia symptoms and the risk of chronic widespread pain (CWP) and pain-related disability. METHODS: A prospective study of 10,847 participants in the Norwegian HUNT Study without chronic musculoskeletal pain at baseline in 2006-2008. We used a modified Poisson regression model to estimate adjusted risk ratios (RRs) with a 95% confidence interval (CI) for CWP and pain-related disability at follow-up in 2017-2019 associated with insomnia and number of nighttime insomnia symptoms at baseline. Chronic insomnia was defined according to the current classification system and grouped into three categories based on the number of reported nighttime symptoms (ie, difficulty initiating sleep, trouble maintaining sleep and early morning awakenings). RESULTS: Compared to the reference group of people without insomnia, people with insomnia had RRs for CWP and pain-related disability of 1.64 (1.26-2.14) and 1.63 (1.37-1.94), respectively. When people with insomnia were categorized based on the number of nighttime symptoms, people who reported one, two, or three nighttime symptoms had RRs of CWP of 1.19 (95% CI 0.80-1.78), 1.78 (95 CI 1.13-2.80) and 3.08 (95% CI 1.93-4.92), respectively, compared to people without insomnia. The corresponding RRs for pain-related disability were 1.49 (95% CI 1.17-1.89), 1.46 (95% CI 2.04-2.05), and 2.46 (95% CI 1.76-3.42). CONCLUSION: These findings indicate that people with insomnia characterized by symptoms in all phases of the sleep period have a substantially increased risk of CWP and pain-related disability.

A systematic review of cross-cultural validation of the pain catastrophizing scale.

BACKGROUND: Although it has been suggested that the different cultural and social environments between countries contribute to variations in pain catastrophizing (PC), an international comparison of PC in patients with chronic pain has not yet been reported. Prior to undertaking this comparison, a cross-cultural assessment of the pain catastrophizing scale (PCS) was undertaken to explore the different factor structures among each translated version of the PCS. METHODS: The protocol for this systematic review was prospectively registered on International Prospective Register of Systematic Reviews 2018 (CRD 42018086719). Electronic searches were conducted in the following databases: Ovid/Embase, Ovid/MEDLINE and Ovid/PsycINFO, and then 19 articles (16 language versions) were included in this review. Based on the COSMIN check list, we investigated language translation followed by five domains of cross-cultural validation: structural validity, internal consistency, test-retest reliability and hypotheses testing for construct validity in each study. RESULTS: We found that (a) there were inconsistent structural models among each translated version, leading to variant subdomain structures for rumination, magnification and helplessness; (b) all languages versions showed sufficient internal consistency when assessing whole items and (c) the correlation coefficients between pain intensities and total scores of the PCS among each sample of chronic pain varied across the studies. CONCLUSIONS: These results indicate that the total score of the PCS could be compared across each translated version, however, caution is warranted when each subdomain of the PCS is compared between countries. SIGNIFICANCE: Although the pain catastrophizing scale has been translated into approximately 20 languages, methodological quality during their translation process has not been systematically assessed. We found that all languages versions showed sufficient internal consistency when assessing whole items, however, there were inconsistent structural models among each translated version, leading to variant subdomain structures for rumination, magnification and helplessness.

From acute to persistent low back pain: a longitudinal investigation of somatosensory changes using quantitative sensory testing-an exploratory study.

INTRODUCTION: Chronic low back pain (LBP) is commonly associated with generalised pain hypersensitivity. It is suggested that such somatosensory alterations are important determinants for the transition to persistent pain from an acute episode of LBP. Although cross-sectional research investigating somatosensory function in the acute stage is developing, no longitudinal studies designed to evaluate temporal changes have been published. OBJECTIVES: This exploratory study aimed to investigate the temporal development of somatosensory changes from the acute stage of LBP to up to 4 months from onset. METHODS: Twenty-five people with acute LBP (<3 weeks' duration) and 48 pain-free controls were prospectively assessed at baseline using quantitative sensory testing with the assessor blinded to group allocation, and again at 2 and 4 months. Psychological variables were concurrently assessed. People with acute LBP were classified based on their average pain severity over the previous week at 4 months as recovered (≤1/10 numeric rating scale) or persistent (≥2/10 numeric rating scale) LBP. RESULTS: In the persistent LBP group, (1) there was a significant decrease in pressure pain threshold between 2 and 4 months (P < 0.013), and at 4 months, pressure pain threshold was significantly different from the recovered LBP group (P < 0.001); (2) a trend towards increased temporal summation was found at 2 months and 4 months, at which point it exceeded 2 SDs beyond the pain-free control reference value. Pain-related psychological variables were significantly higher in those with persistent LBP compared with the recovered LBP group at all time points (P < 0.05). CONCLUSION: Changes in mechanical pain sensitivity occurring in the subacute stage warrant further longitudinal evaluation to better understand the role of somatosensory changes in the development of persistent LBP. Pain-related cognitions at baseline distinguished persistent from the recovered LBP groups, emphasizing the importance of concurrent evaluation of psychological contributors in acute LBP.

The long-term reliability of static and dynamic quantitative sensory testing in healthy individuals.

Quantitative sensory tests (QSTs) have been increasingly used to investigate alterations in somatosensory function in a wide range of painful conditions. The interpretation of these findings is based on the assumption that the measures are stable and reproducible. To date, reliability of QST has been investigated for short test-retest intervals. The aim of this study was to investigate the long-term reliability of a multimodal QST assessment in healthy people, with testing conducted on 3 occasions over 4 months. Forty-two healthy people were enrolled in the study. Static and dynamic tests were performed, including cold and heat pain threshold (CPT, HPT), mechanical wind-up [wind-up ratio (WUR)], pressure pain threshold (PPT), 2-point discrimination (TPD), and conditioned pain modulation (CPM). Systematic bias, relative reliability and agreement were analysed using repeated measure analysis of variance, intraclass correlation coefficients (ICCs3,1) and SE of the measurement (SEM), respectively. Static QST (CPT, HPT, PPT, and TPD) showed good-to-excellent reliability (ICCs: 0.68-0.90). Dynamic QST (WUR and CPM) showed poor-to-good reliability (ICCs: 0.35-0.61). A significant linear decrease over time was observed for mechanical QST at the back (PPT and TPD) and for CPM (P < 0.01). Static QST were stable over a period of 4 months; however, a small systematic decrease over time has been observed for mechanical QST. Dynamic QST showed considerable variability over time; in particular, CPM using PPT as the test stimulus did not show adequate reliability, suggesting that this test paradigm may be less useful for monitoring individuals over time.

Prognostic value of quantitative sensory testing in low back pain: a systematic review of the literature.

Quantitative sensory testing (QST) measures have recently been shown to predict outcomes in various musculoskeletal and pain conditions. The aim of this systematic review was to summarize the emerging body of evidence investigating the prognostic value of QST measures in people with low back pain (LBP). The protocol for this review was prospectively registered on the International Prospective Register of Systematic Reviews. An electronic search of six databases was conducted from inception to October 2015. Experts in the field were contacted to retrieve additional unpublished data. Studies were included if they were prospective longitudinal in design, assessed at least one QST measure in people with LBP, assessed LBP status at follow-up, and reported the association of QST data with LBP status at follow-up. Statistical pooling of results was not possible due to heterogeneity between studies. Of 6,408 references screened after duplicates removed, three studies were finally included. None of them reported a significant association between the QST measures assessed and the LBP outcome. Three areas at high risk of bias were identified which potentially compromise the validity of these results. Due to the paucity of available studies and the methodological shortcomings identified, it remains unknown whether QST measures are predictive of outcome in LBP.

Early changes in somatosensory function in spinal pain: a systematic review and meta-analysis.

Alterations in sensory processing have been demonstrated in chronic low back and neck pain. However, it has not been yet systematically summarized how early these changes occur in spinal pain. This systematic review examines the available literature measuring somatosensory function in acute (<6 weeks) and subacute (6-12 weeks) spinal pain. The protocol for this review has been registered on the International Prospective Register of Systematic Reviews (PROSPERO). An electronic search of 4 databases was conducted to retrieve studies assessing somatosensory function by quantitative sensory testing in adults with spinal pain of up to 12 weeks duration. Two reviewers independently screened the studies and assessed the risk of bias. Studies were grouped according to spinal pain condition (whiplash injury, idiopathic neck pain, and nonspecific low back pain), and, where possible, meta-analyses were performed for comparable results. Fifteen studies were included. Sources of bias included lack of assessor blinding, unclear sampling methods, and lack of control for confounders. We found that: (1) there is consistent evidence for thermal and widespread mechanical pain hypersensitivity in the acute stage of whiplash, (2) there is no evidence for pain hypersensitivity in the acute and subacute stage of idiopathic neck pain, although the body of evidence is small, and (3) hyperalgesia and spinal cord hyperexcitability have been detected in early stages of nonspecific low back pain, although evidence about widespread effects are conflicting. Future longitudinal research using multiple sensory modalities and standardized testing may reveal the involvement of somatosensory changes in the development and maintenance of chronic pain.