The joint association of insomnia disorder and lifestyle on the risk of activity-limiting spinal pain: the HUNT Study.

OBJECTIVES: To investigate whether the combination of multiple healthy lifestyle factors modify the well-established association between insomnia disorder and risk of activity-limiting spinal pain. METHODS: We conducted a prospective study of 10,228 individuals who participated in two surveys over ∼11 years and were free of chronic pain in the neck, upper back, and lower back at baseline. Adjusted risk ratios (RRs) were calculated for the risk of activity-limiting chronic spinal pain (i.e., pain that impairs daily activities at work or leisure time) at follow-up associated with the joint association of insomnia disorder and the combination of five lifestyle factors (body mass index, leisure time physical activity, alcohol consumption, diet, and smoking) at baseline. RESULTS: Our data indicate an additive interaction between insomnia disorder and lifestyle on risk of activity-limiting spinal pain, i.e., compared with participants without insomnia disorder and the best lifestyle score, participants with insomnia disorder and the worst lifestyle score had a RR of activity-limiting spinal pain of 3.57 (95 % CI: 2.65-4.80); participants with insomnia disorder and the best lifestyle score had a RR of 1.56 (95 % CI: 0.97-2.50); and those without insomnia disorder and the worst lifestyle score had a RR of 1.32 (95 % CI: 1.12-1.55). CONCLUSIONS: Poor lifestyle behaviour amplifies the adverse effect of insomnia disorder on the risk of activity-limiting chronic spinal pain.

The Role of Pain Duration and Pain Intensity on the Effectiveness of App-Delivered Self-Management for Low Back Pain (selfBACK): Secondary Analysis of a Randomized Controlled Trial.

Background: Clinical guidelines for nonspecific low back pain (LBP) recommend self-management tailored to individual needs and capabilities as a first-line treatment. Mobile health solutions are a promising method for delivering tailored self-management interventions to patients with nonspecific LBP. However, it is not clear if the effectiveness of such self-management interventions depends on patients' initial pain characteristics. High pain intensity and long-term symptoms of LBP have been associated with an unfavorable prognosis, and current best evidence indicates that long-term LBP (lasting more than 3 months) requires a more extensive treatment approach compared to more acute LBP. The artificial intelligence-based selfBACK app supports tailored and evidence-based self-management of nonspecific LBP. In a recent randomized controlled trial, we showed that individuals who received the selfBACK app in addition to usual care had lower LBP-related disability at the 3-month follow-up compared to those who received usual care only. This effect was sustained at 6 and 9 months. Objective: This study aims to explore if the baseline duration and intensity of LBP influence the effectiveness of the selfBACK intervention in a secondary analysis of the selfBACK randomized controlled trial. Methods: In the selfBACK trial, 461 adults (18 years or older) who sought care for nonspecific LBP in primary care or at an outpatient spine clinic were randomized to receive the selfBACK intervention adjunct to usual care (n=232) or usual care alone (n=229). In this secondary analysis, the participants were stratified according to the duration of the current LBP episode at baseline (≤12 weeks vs >12 weeks) or baseline LBP intensity (≤5 points vs >5 points) measured by a 0-10 numeric rating scale. The outcomes were LBP-related disability measured by the Roland-Morris Disability Questionnaire (0- to 24-point scale), average LBP intensity, pain self-efficacy, and global perceived effect. To assess whether the duration and intensity of LBP influenced the effect of selfBACK, we estimated the difference in treatment effect between the strata at the 3- and 9-month follow-ups with a 95% CI. Results: Overall, there was no difference in effect for patients with different durations or intensities of LBP at either the 3- or 9-month follow-ups. However, there was suggestive evidence that the effect of the selfBACK intervention on LBP-related disability at the 3-month follow-up was largely confined to people with the highest versus the lowest LBP intensity (mean difference between the intervention and control group -1.8, 95% CI -3.0 to -0.7 vs 0.2, 95% CI -1.1 to 0.7), but this was not sustained at the 9-month follow-up. Conclusions: The results suggest that the intensity and duration of LBP have negligible influence on the effectiveness of the selfBACK intervention on LBP-related disability, average LBP intensity, pain self-efficacy, and global perceived effect.

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.

Group-delivered cognitive behavioural therapy versus waiting list in the treatment of insomnia in primary care: study protocol for a pragmatic, multicentre randomized controlled trial.

BACKGROUND: Insomnia is common in the general population and is a risk factor for ill-health, which highlights the importance of treating insomnia effectively and cost-efficiently. Cognitive-behavioural therapy for insomnia (CBT-I) is recommended as first-line treatment due to its long-term effectiveness and few side-effects, but its availability is limited. The aim of this pragmatic, multicentre randomized controlled trial is to investigate the effectiveness of group-delivered CBT-I in primary care compared to a waiting-list control group. METHODS: A pragmatic multicentre randomized controlled trial will be conducted with about 300 participants recruited across 26 Healthy Life Centres in Norway. Participants will complete online screening and provide consent before enrolment. Those who meet the eligibility criteria will be randomized to a group-delivered CBT-I or to a waiting list according to a 2:1 ratio. The intervention consists of four two-hour sessions. Assessments will be performed at baseline, 4 weeks, 3- and 6 months post-intervention, respectively. The primary outcome is self-reported insomnia severity at 3 months post-intervention. Secondary outcomes include health-related quality of life, fatigue, mental distress, dysfunctional beliefs and attitudes about sleep, sleep reactivity, 7-day sleep diaries, and data obtained from national health registries (sick leave, use of relevant prescribed medications, healthcare utilization). Exploratory analyses will identify factors influencing treatment effectiveness, and we will conduct a mixed-method process evaluation to identify facilitators and barriers of participants' treatment adherence. The study protocol was approved by the Regional Committee for Medical and Health Research ethics in Mid-Norway (ID 465241). DISCUSSION: This large-scale pragmatic trial will investigate the effectiveness of group-delivered cognitive behavioural therapy versus waiting list in the treatment of insomnia, generating findings that are generalizable to day-to-day treatment of insomnia in interdisciplinary primary care services. The trial will identify those who would benefit from the group-delivered therapy, and will investigate the rates of sick leave, medication use, and healthcare utilization among adults who undergo the group-delivered therapy. TRIAL REGISTRATION: The trial was retrospectively registered in the ISRCTN registry (ISRCTN16185698).

The joint effect of sleep duration and insomnia symptoms on the risk of recurrent spinal pain: The HUNT study.

Although sleep quantity and quality appear to be interrelated, most previous studies have considered sleep duration and insomnia symptoms as distinct entities. We therefore examined whether there is a joint effect of sleep duration and long-term changes in insomnia symptoms on the risk of recurrent chronic spinal pain. We performed a prospective study of 8,788 participants who participated in three surveys over ∼22 years and reported chronic spinal pain at the first, second, or both surveys. Adjusted risk ratios (RRs) were calculated for the risk of recurrent spinal pain at the last survey associated with self-reported sleep duration at the first survey and changes in insomnia symptoms between the two first surveys. Compared to participants with normal sleep duration (7-9 h) and no insomnia symptoms at the two first surveys, participants with insomnia symptoms over the same period had RRs of spinal pain of 1.33 (95% CI 1.26-1.41) in the last survey if they reported normal sleep duration and 1.50 (95% CI 1.34-1.67) if they reported short sleep (≤6 h). The corresponding RRs for spinal pain for participants who improved their sleep symptoms were 1.09 (95% CI 1.00-1.19) for those with normal sleep and 1.13 (95% CI 0.88-1.45) for those with short sleep. In conclusion, people who reported insomnia symptoms over ∼10 years in combination with short sleep had a particularly increased risk of recurrent spinal pain. Improvement in insomnia symptoms was associated with a favorable prognosis.

Are Work Demand, Support and Control Associated with Work Ability and Disability during Back Pain Treatment? A Prospective Explorative Study.

BACKGROUND: Low back pain is a multifactorial disease with consequences for work ability and social participation. Improved integration of the work domain in health care management is needed. The aim of this study was to explore the relation between working conditions with outcome of low back pain treatment. METHODS: Observational study of 41 patients attending physiotherapy for low back pain. Work demands, support and control were registered at baseline and work ability and disability also at baseline, with follow up after three and nine months. We used mixed-effects models to estimate the longitudinal associations between working conditions and outcome. RESULTS: Higher work demands were related to reduced work ability (-1.1 points, 95% CI: -2.1 to -0.1) and slightly increased disability (5.6 points, 95% CI: 0.5 to 10.7). Lack of social support from colleagues was associated with reduced work ability (-2.7 points, 95% CI: -0.2 to 1.5) and disability (14.0 points, 95% CI: 4.9 to 23.1). CONCLUSIONS: This explorative study found associations between work demands and support, and work ability and disability outcome. Screening for psychosocial working conditions may influence the work ability and disability treatment outcome. The results need replication in larger samples and may indicate that patients seeking primary care management for low back pain should be screened for work demands, support and control.

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.

Effectiveness of App-Delivered, Tailored Self-management Support for Adults With Lower Back Pain-Related Disability: A selfBACK Randomized Clinical Trial.

Importance: Lower back pain (LBP) is a prevalent and challenging condition in primary care. The effectiveness of an individually tailored self-management support tool delivered via a smartphone app has not been rigorously tested. Objective: To investigate the effectiveness of selfBACK, an evidence-based, individually tailored self-management support system delivered through an app as an adjunct to usual care for adults with LBP-related disability. Design, Setting, and Participants: This randomized clinical trial with an intention-to-treat data analysis enrolled eligible individuals who sought care for LBP in a primary care or an outpatient spine clinic in Denmark and Norway from March 8 to December 14, 2019. Participants were 18 years or older, had nonspecific LBP, scored 6 points or higher on the Roland-Morris Disability Questionnaire (RMDQ), and had a smartphone and access to email. Interventions: The selfBACK app provided weekly recommendations for physical activity, strength and flexibility exercises, and daily educational messages. Self-management recommendations were tailored to participant characteristics and symptoms. Usual care included advice or treatment offered to participants by their clinician. Main Outcomes and Measures: Primary outcome was the mean difference in RMDQ scores between the intervention group and control group at 3 months. Secondary outcomes included average and worst LBP intensity levels in the preceding week as measured on the numerical rating scale, ability to cope as assessed with the Pain Self-Efficacy Questionnaire, fear-avoidance belief as assessed by the Fear-Avoidance Beliefs Questionnaire, cognitive and emotional representations of illness as assessed by the Brief Illness Perception Questionnaire, health-related quality of life as assessed by the EuroQol-5 Dimension questionnaire, physical activity level as assessed by the Saltin-Grimby Physical Activity Level Scale, and overall improvement as assessed by the Global Perceived Effect scale. Outcomes were measured at baseline, 6 weeks, 3 months, 6 months, and 9 months. Results: A total of 461 participants were included in the analysis; the population had a mean [SD] age of 47.5 [14.7] years and included 255 women (55%). Of these participants, 232 were randomized to the intervention group and 229 to the control group. By the 3-month follow-up, 399 participants (87%) had completed the trial. The adjusted mean difference in RMDQ score between the 2 groups at 3 months was 0.79 (95% CI, 0.06-1.51; P = .03), favoring the selfBACK intervention. The percentage of participants who reported a score improvement of at least 4 points on the RMDQ was 52% in the intervention group vs 39% in the control group (adjusted odds ratio, 1.76; 95% CI, 1.15-2.70; P = .01). Conclusions and Relevance: Among adults who sought care for LBP in a primary care or an outpatient spine clinic, those who used the selfBACK system as an adjunct to usual care had reduced pain-related disability at 3 months. The improvement in pain-related disability was small and of uncertain clinical significance. Process evaluation may provide insights into refining the selfBACK app to increase its effectiveness. Trial Registration: ClinicalTrials.gov Identifier: NCT03798288.

Genetic variants related to physical activity or sedentary behaviour: a systematic review.

BACKGROUND: Research shows that part of the variation in physical activity and sedentary behaviour may be explained by genetic factors. Identifying genetic variants associated with physical activity and sedentary behaviour can improve causal inference in physical activity research. The aim of this systematic review was to provide an updated overview of the evidence of genetic variants associated with physical activity or sedentary behaviour. METHODS: We performed systematic literature searches in PubMed and Embase for studies published from 1990 to April 2020 using keywords relating to "physical activity", "exercise", "sedentariness" and "genetics". Physical activity phenotypes were either based on self-report (e.g., questionnaires, diaries) or objective measures (e.g., accelerometry, pedometer). We considered original studies aiming to i) identify new genetic variants associated with physical activity or sedentary behaviour (i.e., genome wide association studies [GWAS]), or ii) assess the association between known genetic variants and physical activity or sedentary behaviour (i.e., candidate gene studies). Study selection, data extraction, and critical appraisal were carried out by independent researchers, and risk of bias and methodological quality was assessed for all included studies. RESULTS: Fifty-four out of 5420 identified records met the inclusion criteria. Six of the included studies were GWAS, whereas 48 used a candidate gene approach. Only one GWAS and three candidate gene studies were considered high-quality. The six GWAS discovered up to 10 single nucleotide polymorphisms (SNPs) associated with physical activity or sedentariness that reached genome-wide significance. In total, the candidate gene studies reported 30 different genes that were associated (p < 0.05) with physical activity or sedentary behaviour. SNPs in or close to nine candidate genes were associated with physical activity or sedentary behaviour in more than one study. CONCLUSION: GWAS have reported up to 10 loci associated with physical activity or sedentary behaviour. Candidate gene studies have pointed to some interesting genetic variants, but few have been replicated. Our review highlights the need for high-quality GWAS in large population-based samples, and with objectively assessed phenotypes, in order to establish robust genetic instruments for physical activity and sedentary behaviour. Furthermore, consistent replications in GWAS are needed to improve credibility of genetic variants. TRIAL REGISTRATION: Prospero CRD42019119456 .

Usability and Acceptability of an App (SELFBACK) to Support Self-Management of Low Back Pain: Mixed Methods Study.

BACKGROUND: Self-management is the key recommendation for managing nonspecific low back pain (LBP). However, there are well-documented barriers to self-management; therefore, methods of facilitating adherence are required. Smartphone apps are increasingly being used to support self-management of long-term conditions such as LBP. OBJECTIVE: The aim of this study was to assess the usability and acceptability of the SELFBACK smartphone app, designed to support and facilitate self-management of non-specific LBP. The app provides weekly self-management plans, comprising physical activity, strength and flexibility exercises, and patient education. The plans are tailored to the patient's characteristics and symptom progress by using case-based reasoning methodology. METHODS: The study was carried out in 2 stages using a mixed-methods approach. All participants undertook surveys, and semistructured telephone interviews were conducted with a subgroup of participants. Stage 1 assessed an app version with only the physical activity component and a web questionnaire that collects information necessary for tailoring the self-management plans. The physical activity component included monitoring of steps recorded by a wristband, goal setting, and a scheme for sending personalized, timely, and motivational notifications to the user's smartphone. Findings from Stage 1 were used to refine the app and inform further development. Stage 2 investigated an app version that incorporated 3 self-management components (physical activity, exercises, and education). A total of 16 participants (age range 23-71 years) with ongoing or chronic nonspecific LBP were included in Stage 1, and 11 participants (age range 32-56 years) were included in Stage 2. RESULTS: In Stage 1, 15 of 16 participants reported that the baseline questionnaire was easy to answer, and 84% (13/16) found the completion time to be acceptable. Overall, participants were positive about the usability of the physical activity component but only 31% (5/16) found the app functions to be well integrated. Of the participants, 90% (14/16) were satisfied with the notifications, and they were perceived as being personalized (12/16, 80%). In Stage 2, all participants reported that the web questionnaire was easy to answer and the completion time acceptable. The physical activity and exercise components were rated useful by 80% (8/10), while 60% (6/10) rated the educational component useful. Overall, participants were satisfied with the usability of the app; however, only 50% (5/10) found the functions to be well integrated, and 20% (2/10) found them to be inconsistent. Overall, 80% (8/10) of participants reported it to be useful for self-management. The interviews largely reinforced the survey findings in both stages. CONCLUSIONS: This study has demonstrated that participants considered the SELFBACK app to be acceptable and usable and that they thought it would be useful for supporting self-management of LBP. However, we identified some limitations and suggestions useful to guide further development of the SELFBACK app and other mobile health interventions.

A digital decision support system (selfBACK) for improved self-management of low back pain: a pilot study with 6-week follow-up.

BACKGROUND: Very few of the publicly available apps directed towards self-management of low back pain (LBP) have been rigorously tested and their theoretical underpinnings seldom described. The selfBACK app was developed in collaboration with end-users and clinicians and its content is supported by best evidence on self-management of LBP. The objectives of this pilot study were to investigate the basis for recruitment and screening procedures for the subsequent randomized controlled trial (RCT), to test the inclusion process in relation to questionnaires and app installation, and finally to investigate the change in primary outcome over time. METHODS: This single-armed pilot study enrolled 51 participants who had sought help for LBP of any duration from primary care (physiotherapy, chiropractic, or general practice) within the past 8 weeks. Participants were screened for eligibility using the PROMIS-Physical-Function-4a questionnaire. Participants were asked to use the selfBACK app for 6 weeks. The app provided weekly tailored self-management plans targeting physical activity, strength and flexibility exercises, and education. The construction of the self-management plans was achieved using case-based reasoning (CBR) methodology to capture and reuse information from previous successful cases. Participants completed the primary outcome pain-related disability (Roland-Morris Disability Questionnaire [RMDQ]) at baseline and 6-week follow-up along with a range of secondary outcomes. Metrics of app use were collected throughout the intervention period. RESULTS: Follow-up data at 6 weeks was obtained for 43 participants. The recruitment procedures were feasible, and the number needed to screen was acceptable (i.e., 1.6:1). The screening questionnaire was altered during the pilot study. The inclusion process, answering questionnaires and app installation, were feasible. The primary outcome (RMDQ) improved from 8.6 (SD 5.1) at baseline to 5.9 (SD 4.0) at 6-week follow-up (change score 1.8, 95% CI 0.7 to 2.9). Participants spent on average 134 min (range 0-889 min) using the app during the 6-week period. CONCLUSION: The recruitment, screening, and inclusion procedures were feasible for the subsequent RCT with a small adjustment. The improvement on the RMDQ from baseline to follow-up was small. Time pattern of app usage varied considerably between the participants. TRIAL REGISTRATION: NCT03697759. Registered on August 10, 2018. https://clinicaltrials.gov/ct2/show/NCT03697759.

Influence of sleep problems and co-occurring musculoskeletal pain on long-term prognosis of chronic low back pain: the HUNT Study.

BACKGROUND: We investigated the influence of sleeplessness and number of insomnia symptoms on the probability of recovery from chronic low back pain (LBP), and the possible interplay between sleeplessness and co-occurring musculoskeletal pain on this association. METHODS: The study comprised data on 3712 women and 2488 men in the Norwegian HUNT study who reported chronic LBP at baseline in 1995-1997. A modified Poisson regression model was used to calculate adjusted risk ratios (RRs) for the probability of recovery from chronic LBP at follow-up in 2006-2008, associated with sleep problems and co-occurring musculoskeletal pain at baseline. RESULTS: Compared with persons without sleeplessness, persons who often/always experienced sleeplessness had a lower probability of recovery from chronic LBP (RR 0.65, 95% CI 0.57 to 0.74 in women and RR 0.81, 95% CI 0.69 to 0.95 in men). Although there was no clear evidence of statistical interaction between sleeplessness and co-occurring musculoskeletal pain, women and men who often/always experienced sleeplessness and had ≥5 additional chronic pain sites had RRs of recovery of 0.40 (95% CI 0.33 to 0.48) and 0.59 (95% CI 0.45 to 0.78), respectively, compared with persons without sleeplessness and 1-2 chronic pain sites. CONCLUSION: These findings suggest that preventing or reducing sleep problems among people with chronic LBP may have the potential of improving the long-term prognosis of this condition, also among those with several additional pain sites.

An App-Delivered Self-Management Program for People With Low Back Pain: Protocol for the selfBACK Randomized Controlled Trial.

BACKGROUND: Low back pain (LBP) is prevalent across all social classes, in all age groups, and across industrialized and developing countries. From a global perspective, LBP is considered the leading cause of disability and negatively impacts everyday life and well-being. Self-management is a recommended first-line treatment, and mobile apps are a promising platform to support self-management of conditions like LBP. In the selfBACK project, we have developed a digital decision support system made available for the user via an app intended to support tailored self-management of nonspecific LBP. OBJECTIVE: The trial aims to evaluate the effectiveness of using the selfBACK app to support self-management in addition to usual care (intervention group) versus usual care only (control group) in people with nonspecific LBP. METHODS: This is a single-blinded, randomized controlled trial (RCT) with two parallel arms. The selfBACK app provides tailored self-management plans consisting of advice on physical activity, physical exercises, and educational content. Tailoring of plans is achieved by using case-based reasoning (CBR) methodology, which is a branch of artificial intelligence. The core of the CBR methodology is to use data about the current case (participant) along with knowledge about previous and similar cases to tailor the self-management plan to the current case. This enables a person-centered intervention based on what has and has not been successful in previous cases. Participants in the RCT are people with LBP who consulted a health care professional in primary care within the preceding 8 weeks. Participants are randomized to using the selfBACK app in addition to usual care versus usual care only. We aim to include a total of 350 participants (175 participants in each arm). Outcomes are collected at baseline, 6 weeks, and 3, 6, and 9 months. The primary end point is difference in pain-related disability between the intervention group and the control group assessed by the Roland-Morris Disability Questionnaire at 3 months. RESULTS: The trial opened for recruitment in February 2019. Data collection is expected to be complete by fall 2020, and the results for the primary outcome are expected to be published in fall 2020. CONCLUSIONS: This RCT will provide insights regarding the benefits of supporting tailored self-management of LBP through an app available at times convenient for the user. If successful, the intervention has the potential to become a model for the provision of tailored self-management support to people with nonspecific LBP and inform future interventions for other painful musculoskeletal conditions. TRIAL REGISTRATION: ClinicalTrial.gov NCT03798288; https://clinicaltrials.gov/ct2/show/NCT03798288. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/14720.

Long-term changes in body weight and physical activity in relation to all-cause and cardiovascular mortality: the HUNT study.

BACKGROUND: Most previous studies have relied on single measurements of body weight and physical activity and have not considered the interplay between long-term changes in body weight and physical activity in relation to mortality. The aim of the current study was therefore to examine the joint effect of changes in body weight and leisure-time physical activity over a period of ~ 10 years on all-cause and cardiovascular mortality. METHODS: The study population comprised 34,257 individuals who participated in the first (1984-86) and second (1995-97) waves of the HUNT Study, and were followed up through the Norwegian Cause of Death Registry until December 31st, 2013. We used Cox regression to estimate hazard ratios (HR) with 95% confidence intervals (CI) of death associated with changes in body weight and leisure-time physical activity. RESULTS: Compared to the reference group with stable weight who were long-term physically active, people who gained ≥5% of their weight had a HR for all-cause mortality of 1.54 (95% CI: 1.28-1.85) if they were long-term physically inactive; a HR of 1.23 (1.09-1.40) if they became physically active, and a HR of 1.00 (95% CI 0.94-1.06) if they were long-term physically active. The corresponding HRs for cardiovascular mortality were 1.57 (95% CI 1.17-2.12), 1.28 (95% CI 1.04-1.58) and 1.06 (95% CI 0.96-1.16), respectively. Long-term physical inactivity was associated with increased all-cause (HR 1.29; 95% CI 1.08-1.53) and cardiovascular (HR 1.37; 95% CI 1.05-1.79) mortality among those who were weight stable. CONCLUSIONS: The risk of all-cause and cardiovascular mortality is particularly evident among people who gain weight while remaining inactive during a ~ 10 year period. However, participants who remained physically active had the lowest risk of premature mortality, regardless of maintenance or increase in weight. These findings suggest that there is an interplay between long-term changes in body weight and physical activity that should receive particular attention in the prevention of premature mortality.

Longitudinal associations of kinematics and fear-avoidance beliefs with disability, work ability and pain intensity in persons with low back pain.

BACKGROUND: Impaired lumbar movement has cross-sectionally been associated with low back pain (LBP); however, the consequence of impaired movement on disability and pain in persons with LBP is poorly understood. Furthermore, fear-avoidance beliefs (FAB) may influence spinal movement, but the relation between fear-avoidance and kinematics is unclear. OBJECTIVES: To investigate the longitudinal associations of kinematics and FAB with disability, work ability and pain in patients with LBP. Further, to explore associations between FAB and kinematics. DESIGN: Prospective observational study. METHOD: Kinematic measures were performed on 44 persons with LBP at baseline, three and nine months. Motion sensors identified range-of-motion and velocity during a spinal flexion/extension. FAB, disability, work ability and pain were reported at all time points using questionnaires. RESULTS: Increased range-of-motion was weakly associated with less disability (-0.14 points, 95% CI -0.22 to -0.06). Velocity was not associated with disability, work ability or pain. Higher FAB of physical activity were associated with more disability (1.50 points, 95% CI 0.51 to 2.49) and pain (0.37 points, 95% CI 0.11 to 0.62). Higher work-related FAB was associated with lower work ability (-0.37 points, 95% CI -0.68 to -0.05). Moreover, higher FAB showed weak associations with lower velocity in the initial movement phase (-3.3°/s, 95% CI -6.1 to -0.5). CONCLUSIONS: Of the kinematic measures, only range-of-motion was related to disability. Higher FAB was weakly associated with all self-reported outcomes and with lower velocity only at the initial flexion phase. However, the magnitude of these associations suggest marginal clinical importance.

Improved cardiorespiratory fitness after occupational rehabilitation in merged diagnostic groups.

BACKGROUND: Various occupational inpatient rehabilitation programs are established in Norway. This study aimed to assess change in cardiorespiratory fitness, pain, anxiety, depression, and quality of life in persons on long-term sick leave due to musculoskeletal-, mental or unspecific disorders after participation in multicomponent inpatient occupational rehabilitation. METHODS: Twenty-five women and five men (mean age 45.2 years, SD 6.7, range 30-57) volunteered to participate in the study. The participants attended either 8 or 17 full days of occupational multicomponent rehabilitation including physical exercise, cognitive behavioral therapy in the form of acceptance and commitment therapy (ACT), and development of a tailored plan for return to work. Cardiorespiratory fitness was assessed by the Åstrand/Ryhming cycle test at the start and end of rehabilitation program, and at one-year follow-up. Changes in somatic and mental health were measured by questionnaires up to 4 months after start of the program. RESULTS: Linear mixed models showed that the maximal oxygen uptake increased by 1.1 mL°kg-1°min- 1 during the rehabilitation program and by 3.7 mL°kg-1°min- 1 at one-year follow-up. There were minor improvements in somatic and mental health, and quality of life. CONCLUSIONS: This study indicates that occupational inpatient multicomponent rehabilitation including physical exercise and ACT may promote a long-term increase in physical exercise that is sufficient to induce a significant increase in cardiorespiratory fitness. TRIAL REGISTRATION: The current study is not registered, but is part of a larger trial registered at clinicaltrials.gov (No.: NCT01926574, registered 21. Aug 2013).

The influence of multisite pain and psychological comorbidity on prognosis of chronic low back pain: longitudinal data from the Norwegian HUNT Study.

OBJECTIVES: This study aimed to investigate the prospective influence of multisite pain, depression, anxiety, self-rated health and pain-related disability on recovery from chronic low back pain (LBP). SETTING: The data is derived from the second (1995-1997) and third (2006-2008) wave of the Nord-Trøndelag Health Study (HUNT) in Norway. PARTICIPANTS: The study population comprises 4484 women and 3039 men in the Norwegian HUNT Study who reported chronic LBP at baseline in 1995-1997. PRIMARY OUTCOME MEASURES: The primary outcome was recovery from chronic LBP at the 11-year follow-up. Persons not reporting pain and/or stiffness for at least three consecutive months during the last year were defined as recovered. A Poisson regression model was used to estimate adjusted risk ratios (RRs) with 95% CIs. RESULTS: At follow-up, 1822 (40.6%) women and 1578 (51.9%) men reported recovery from chronic LBP. The probability of recovery was inversely associated with number of pain sites (P-trend<0.001). Compared with reporting 2-3 pain sites, persons with only LBP had a slightly higher probability of recovery (RR 1.10, 95% CI 0.98 to 1.22 in women and RR 1.10, 95% CI 1.01 to 1.21 in men), whereas people reporting 6-9 pain sites had substantially lower probability of recovery (RR 0.58, 95% CI 0.52 to 0.63 in women and RR 0.70, 95% CI 0.63 to 0.79 in men). Poor/not so good self-rated general health, symptoms of anxiety and depression, and pain-related disability in work and leisure were all associated with reduced probability of recovery, but there was no statistical interaction between multisite pain and these comorbidities. CONCLUSIONS: Increasing number of pain sites was inversely associated with recovery from chronic LBP. In addition, factors such as poor self-rated health, psychological symptoms and pain-related disability may further reduce the probability of recovery from chronic LBP.