Cognitive functional therapy with or without movement sensor biofeedback versus usual care for chronic, disabling low back pain (RESTORE): a randomised, controlled, three-arm, parallel group, phase 3, clinical trial.

BACKGROUND: Low back pain is the leading cause of years lived with disability globally, but most interventions have only short-lasting, small to moderate effects. Cognitive functional therapy (CFT) is an individualised approach that targets unhelpful pain-related cognitions, emotions, and behaviours that contribute to pain and disability. Movement sensor biofeedback might enhance treatment effects. We aimed to compare the effectiveness and economic efficiency of CFT, delivered with or without movement sensor biofeedback, with usual care for patients with chronic, disabling low back pain. METHODS: RESTORE was a randomised, controlled, three-arm, parallel group, phase 3 trial, done in 20 primary care physiotherapy clinics in Australia. We recruited adults (aged ≥18 years) with low back pain lasting more than 3 months with at least moderate pain-related physical activity limitation. Exclusion criteria were serious spinal pathology (eg, fracture, infection, or cancer), any medical condition that prevented being physically active, being pregnant or having given birth within the previous 3 months, inadequate English literacy for the study's questionnaires and instructions, a skin allergy to hypoallergenic tape adhesives, surgery scheduled within 3 months, or an unwillingness to travel to trial sites. Participants were randomly assigned (1:1:1) via a centralised adaptive schedule to usual care, CFT only, or CFT plus biofeedback. The primary clinical outcome was activity limitation at 13 weeks, self-reported by participants using the 24-point Roland Morris Disability Questionnaire. The primary economic outcome was quality-adjusted life-years (QALYs). Participants in both interventions received up to seven treatment sessions over 12 weeks plus a booster session at 26 weeks. Physiotherapists and patients were not masked. This trial is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12618001396213. FINDINGS: Between Oct 23, 2018 and Aug 3, 2020, we assessed 1011 patients for eligibility. After excluding 519 (51·3%) ineligible patients, we randomly assigned 492 (48·7%) participants; 164 (33%) to CFT only, 163 (33%) to CFT plus biofeedback, and 165 (34%) to usual care. Both interventions were more effective than usual care (CFT only mean difference -4·6 [95% CI -5·9 to -3·4] and CFT plus biofeedback mean difference -4·6 [-5·8 to -3·3]) for activity limitation at 13 weeks (primary endpoint). Effect sizes were similar at 52 weeks. Both interventions were also more effective than usual care for QALYs, and much less costly in terms of societal costs (direct and indirect costs and productivity losses; -AU$5276 [-10 529 to -24) and -8211 (-12 923 to -3500). INTERPRETATION: CFT can produce large and sustained improvements for people with chronic disabling low back pain at considerably lower societal cost than that of usual care. FUNDING: Australian National Health and Medical Research Council and Curtin University.

Association of back pain with all-cause and cause-specific mortality among older men: a cohort study.

OBJECTIVE: We evaluated whether more severe back pain phenotypes-persistent, frequent or disabling back pain-are associated with higher mortality among older men. METHODS: In this secondary analysis of a prospective cohort, the Osteoporotic Fractures in Men (MrOS) study, we evaluated mortality rates by back pain phenotype among 5215 older community-dwelling men (mean age, 73 years, SD = 5.6) from six U.S. sites. The primary back pain measure used baseline and year five back pain questionnaire data to characterize participants as having: no back pain; non-persistent back pain; infrequent persistent back pain; or frequent persistent back pain. Secondary measures of back pain from year five questionnaire included disabling back pain phenotypes. The main outcomes measured were all-cause and cause-specific mortality. RESULTS: After the year five exam, during up to 18 years of follow-up (mean follow-up=10.3 years), there were 3513 deaths (1218 cardiovascular, 764 cancer, 1531 other). A higher proportion of men with frequent persistent back pain versus no back pain died (78% versus 69%; sociodemographic-adjusted HR = 1.27, 95%CI=1.11-1.45). No association was evident after further adjusting for health-related factors such as self-reported general health and comorbid chronic health conditions (fully-adjusted HR = 1.00; 95%CI=0.86-1.15). Results were similar for cardiovascular mortality and other mortality, but we observed no association of back pain with cancer mortality. Secondary back pain measures including back-related disability were associated with increased mortality risk that remained statistically significant in fully-adjusted models. CONCLUSION: While frequent persistent back pain was not independently associated with mortality in older men, additional secondary disabling back pain phenotypes were independently associated with increased mortality. Future investigations should evaluate whether improvements in disabling back pain effect general health and well-being or mortality.

Goal setting in people with low back pain attending an education and exercise program (GLA:D Back) and the impact of demographic factors.

BACKGROUND: Individual goal setting is a fundamental element in self-management supportive interventions, serving to guide actions and enhance motivation for engagement. Despite this, little is known about the goals people with back pain have and to what extent these differ across genders, age groups and geographical location. This study aimed to elucidate this by first describing individual goals set by Danish and Canadian participants in a self-management intervention for people with back pain using the ICF framework; then, determining what proportion of these goals met criteria for being specific, measurable, acceptable, and time bound, and finally, by investigating differences between countries, sexes, and age groups. METHODS: In a cross-sectional study conducted August 2018 to June 2020, 394 Danish and 133 Canadian (Alberta Province) participants defined their individual goals of participating in a self-management programme involving patient education and supervised exercises. The goals were linked to the ICF framework. Distribution of goals was compared between countries, sexes, and age groups. RESULTS: Goals most often related to the ICF component of 'Activity and Participation'. The most prevalent goals were "Walking" (DK: 20%; CA: 15%) and "Maintaining a body position" (DK: 17%; CA: 22%). Only few goals differed between populations, age and sex. All elements of SMART goal setting were recorded for 88% of Danish and 94% of Alberta participants. CONCLUSIONS: People with low back pain attending a self-management programme established goals according to the SMART criteria and focused primarily on activity. Goals were similar across countries and showed few differences across sex and age groups. The high number of different goals points to the need for individualised person-centred care.

Prevalence and consequences of spinal pain among people with type 1 and type 2 diabetes mellitus in Denmark.

PURPOSE: To describe 1-week and 1-year prevalence of spinal pain and its consequences in relation to leisure activity, work-life, and care-seeking in people with type 1 and 2 diabetes mellitus (DM). METHODS: A cross-sectional survey including adults diagnosed with DM from two Danish secondary care centres. Using the Standardised Nordic Questionnaire, spinal pain prevalence (cervical, thoracic, lumbar) and its consequences were evaluated (proportions, 95% confidence intervals) and compared to the general population. RESULTS: Among 3767 people, 1-week and 1-year spinal pain prevalence were 11.6-32.4 and 18.5-49.6%, respectively, highest for lumbar pain (24.6-49.6%). The prevalence was similar between DM types for cervical and thoracic pain, but higher in type 2 for lumbar spine. Women had higher pain prevalence across spinal regions and DM types, while cervical and thoracic pain estimates were higher for age < 60 vs. ≥ 60. Within the past year, > 50% reported pain > 30 days, high proportions had reduced their activities (leisure time, 43.7-63.9%; work, 20.7-33.3%), 13.3-28.1% reported sick-leave > 30 days, and 44.3-48.5% had sought care due to spinal pain. CONCLUSION: Spinal pain is common in people with type 1 and 2 DM, resulting in considerable consequences for work/leisure activities, sick-leave, and healthcare utilisation as compared to the general population.

Surgical trends and regional variation in Danish patients diagnosed with lumbar spinal stenosis between 2002 and 2018: a retrospective registry-based study of 83,783 patients.

BACKGROUND: Lumbar spinal stenosis (LSS) is the most common reason for spine surgery in older people. However, surgery rates vary widely both internationally and nationally. This study compared patient and sociodemographic characteristics, geographical location and comorbidity between surgically and non-surgically treated Danish patients diagnosed with LSS from 2002 to 2018 and described variations over time. METHODS: Diagnostic ICD-10 codes identifying patients with LSS and surgical procedure codes for decompression with or without fusion were retrieved from the Danish National Patient Register. Patients ≥ 18 years who had been admitted to private or public hospitals in Denmark between 2002 and 2018 were included. Data on age, sex, income, retirement status, geographical region and comorbidity were extracted. A multivariable logistic regression model was used to calculate the relative risk for surgically versus non-surgically treated LSS patients using the total population and subsequently divided into three time periods. Variations over time were displayed graphically. RESULTS: A total of 83,783 unique patients with an LSS diagnosis were identified, and of these, 38,362 (46%) underwent decompression surgery. Compared to those who did not receive surgery, the surgically treated patients were more likely to be aged 65-74 years, were less likely to have comorbidities, had higher income and were more likely to reside in the northern part of Denmark. Patients aged 65-74 years remained more likely to receive surgery over time, although the difference between age groups eventually diminished, as older patients (aged ≥ 75) were increasingly more likely to undergo surgery. Large variations and differences in the relative risk of surgery were observed within and between the geographical regions. The likelihood of receiving surgery varied up to threefold between regions. CONCLUSION: Danish patients with LSS who receive surgery differ in a number of respects from those not receiving surgery. Patients aged 65 to 74 years were more likely to receive surgery than other age groups, and LSS surgical patients were healthier, more often retired and had higher incomes than those not undergoing surgery. There were considerable variations in the relative risk of surgery between and within geographical regions.

Similar improvements in patient-reported outcomes for non-specific low back pain patients with and without lumbar spinal stenosis symptoms following a structured education and exercise therapy program.

BACKGROUND: People with nonspecific low back pain (NSLBP) can also experience overlapping symptoms of lumbar spinal stenosis (LSS), but the impact on treatment outcomes is unknown. This study investigated differences in treatment outcomes for disability, back pain intensity, and leg pain intensity following an education and exercise therapy program for NSLBP patients with and without comorbid LSS symptoms. METHODS: This was a longitudinal analysis of 655 Danish participants in the GLA:D® Back program; an education and exercise therapy program for people with persistent NSLBP. Participants were classified as having comorbid LSS symptoms based on self-report. Linear mixed models were used to assess differences in change in disability (Oswestry Disability Index [0-100]) and back and leg pain intensity (Numeric Rating Scale [0-10]) at 3-, 6-, and 12-months between those with and without LSS symptoms. RESULTS: 28% of participants reported LSS symptoms. No certain differences in change in disability or back pain intensity improvement were observed at any time-point between those with and without LSS symptoms. Participants with LSS symptoms had slightly greater improvement in leg pain intensity at 6- (-0.7, 95% CI -1.2 to -0.2) and 12-months (-0.6, 95% CI -1.2 to -0.1). CONCLUSION: Compared to those without LSS symptoms, patients with persistent NSLBP and LSS symptoms can expect similar improvements in disability and back pain intensity, and slightly greater improvements in leg pain intensity with treatment. Therefore, education and exercise therapy programs designed for NSLBP are likely helpful for those also experiencing LSS symptoms.

Characteristics associated with comorbid lumbar spinal stenosis symptoms in people with knee or hip osteoarthritis: an analysis of 9,136 good life with osteoArthritis in Denmark (GLA:D®) participants.

BACKGROUND: Previous studies have found that lumbar spinal stenosis (LSS) often co-occurs with knee or hip OA and can impact treatment response. However, it is unclear what participant characteristics may be helpful in identifying individuals with these co-occurring conditions. The aim of this cross-sectional study was to explore characteristics associated with comorbid symptoms of lumbar spinal stenosis (LSS) in people with knee or hip osteoarthritis (OA) enrolled in a primary care education and exercise program. METHODS: Sociodemographic, clinical characteristics, health status measures, and a self-report questionnaire on the presence of LSS symptoms was collected at baseline from the Good Life with osteoArthritis in Denmark primary care program for knee and hip OA. Cross-sectional associations between characteristics and the presence of comorbid LSS symptoms were assessed separately in participants with primary complaint of knee and hip OA, using domain-specific logistic models and a logistic model including all characteristics. RESULTS: A total of 6,541 participants with a primary complaint of knee OA and 2,595 participants with a primary complaint of hip OA were included, of which 40% and 50% reported comorbid LSS symptoms, respectively. LSS symptoms were associated with similar characteristics in knee and hip OA. Sick leave was the only sociodemographic variable consistently associated with LSS symptoms. For clinical characteristics, back pain, longer symptom duration and bilateral or comorbid knee or hip symptoms were also consistently associated. Health status measures were not consistently related to LSS symptoms. CONCLUSION: Comorbid LSS symptoms in people with knee or hip OA undergoing a primary care treatment program of group-based education and exercise were common and associated with a similar set of characteristics. These characteristics may help to identify people with co-occurring LSS and knee or hip OA, which can be used to help guide clinical decision-making.

One step at a time. Shaping consensus on research priorities and terminology in telehealth in musculoskeletal pain: an international modified e-Delphi study.

BACKGROUND: Telehealth has emerged as an alternative model for treatment delivery and has become an important component of health service delivery. However, there is inconsistency in the use of terminologies and a lack of research priorities in telehealth in musculoskeletal pain. The purpose of this international, multidisciplinary expert panel assembled in a modified three-round e-Delphi survey is to achieve a consensus on research priorities and for the standard terminology for musculoskeletal pain telehealth practice. METHODS: In this international modified e-Delphi survey, we invited an expert panel consisting of researchers, clinicians, consumer representatives, industry partners, healthcare managers, and policymakers to participate in a three-round e-Delphi. Expert panels were identified through the Expertscape website, PubMed database, social media, and a snowball approach. In Round 1, potential research priorities and terminologies were presented to panel members. Panel members rated the agreement of each research priority on a 5-point Likert scale and an 11-point numerical scale, and each terminology on a 5-point Likert scale for the "telehealth in musculoskeletal pain " field over rounds. At least 80% of the panel members were required to agree to be deemed a consensus. We analyzed the data descriptively and assessed the stability of the results using the Wilcoxon matched-pairs signed rank test. RESULTS: We performed an international e-Delphi survey from February to August 2022. Of 694 invited people, 160 panel members participated in the first round, 133 in the second round (83% retention), and 134 in the third round (84% retention). Most of the panel members were researchers 76 (47%), clinicians 57 (36%), and consumer representatives 9 (6%) of both genders especially from Brazil 31 (19%), India 22 (14%), and Australia 19 (12%) in the first round. The panel identified fourteen telehealth research priorities spanned topics including the development of strategies using information and communication technology, telehealth implementation services, the effectiveness and cost-effectiveness of telehealth interventions, equity of telehealth interventions, qualitative research and eHealth literacy in musculoskeletal pain conditions from an initial list of 20 research priorities. The consensus was reached for "digital health" and "telehealth" as standard terminologies from an initial list of 37 terminologies. CONCLUSION: An international, multidisciplinary expert consensus recommends that future research should consider the 14 research priorities for telehealth musculoskeletal pain reached. Additionally, the terms digital health and telehealth as the most appropriate terminologies to be used in musculoskeletal telehealth research. REGISTER: Open Science Framework ( https://osf.io/tqmz2/ ).

Multimorbidity and co-occurring musculoskeletal pain do not modify the effect of the SELFBACK app on low back pain-related disability.

BACKGROUND: SELFBACK, an artificial intelligence (AI)-based app delivering evidence-based tailored self-management support to people with low back pain (LBP), has been shown to reduce LBP-related disability when added to usual care. LBP commonly co-occurs with multimorbidity (≥ 2 long-term conditions) or pain at other musculoskeletal sites, so this study explores if these factors modify the effect of the SELFBACK app or influence outcome trajectories over time. METHODS: Secondary analysis of a randomized controlled trial with 9-month follow-up. Primary outcome is as follows: LBP-related disability (Roland Morris Disability Questionnaire, RMDQ). Secondary outcomes are as follows: stress/depression/illness perception/self-efficacy/general health/quality of life/physical activity/global perceived effect. We used linear mixed models for continuous outcomes and logistic generalized estimating equation for binary outcomes. Analyses were stratified to assess effect modification, whereas control (n = 229) and intervention (n = 232) groups were pooled in analyses of outcome trajectories. RESULTS: Baseline multimorbidity and co-occurring musculoskeletal pain sites did not modify the effect of the SELFBACK app. The effect was somewhat stronger in people with multimorbidity than among those with LBP only (difference in RMDQ due to interaction, - 0.9[95 % CI - 2.5 to 0.6]). Participants with a greater number of long-term conditions and more co-occurring musculoskeletal pain had higher levels of baseline disability (RMDQ 11.3 for ≥ 2 long-term conditions vs 9.5 for LBP only; 11.3 for ≥ 4 musculoskeletal pain sites vs 10.2 for ≤ 1 additional musculoskeletal pain site); along with higher baseline scores for stress/depression/illness perception and poorer pain self-efficacy/general health ratings. In the pooled sample, LBP-related disability improved slightly less over time for people with ≥ 2 long-term conditions additional to LBP compared to no multimorbidity and for those with ≥4 co-occurring musculoskeletal pain sites compared to ≤ 1 additional musculoskeletal pain site (difference in mean change at 9 months = 1.5 and 2.2, respectively). All groups reported little improvement in secondary outcomes over time. CONCLUSIONS: Multimorbidity or co-occurring musculoskeletal pain does not modify the effect of the selfBACK app on LBP-related disability or other secondary outcomes. Although people with these health problems have worse scores both at baseline and 9 months, the AI-based selfBACK app appears to be helpful for those with multimorbidity or co-occurring musculoskeletal pain. TRIAL REGISTRATION: NCT03798288 . Date of registration: 9 January 2019.

Exceeding 2-h sedentary time per day is not associated with moderate to severe spinal pain in 11- to 13-year-olds: a cross-sectional analysis.

Neck, mid-back and low back pain, collectively known as spinal pain, become more common with increasing age across childhood and adolescence. A common belief among the general community is that sedentary time, including screen time, in adolescents is associated with spinal pain. We aimed to investigate whether exceeding 2-h of sedentary time per day is associated with moderate to severe spinal pain in a sample of Danish adolescents aged 11-13 years. We performed a cross-sectional analysis of the SPACE study baseline data (2010). Adolescents self-reported their spinal pain (outcome) via the Young Spine Questionnaire and duration of engagement in sedentary behaviours (exposure). We provide estimates of associations as odds ratios with 95% confidence intervals, stratified by age and sex. The sample comprised 1,303 adolescents (48.7% female, mean age 12.5 years, range 10.9-14.3 years). Approximately 9 out of 10 adolescents exceeded 2-h sedentary time on weekdays outside of school (88.9%) and weekend days (89.9%). Close to one-quarter, 23.3% (95%CI: 21.0-25.6), of participants experienced moderate to severe spinal pain. We found no association between exceeding 2-h sedentary time per day and experiencing moderate to severe spinal pain; odds ratios ranged from 0.34 (95%CI: 0.04-3.20) to 4.65 (95%CI: 0.26-82.44).Conclusion: We found no association between exceeding 2- or 5-h of sedentary time per day and moderate to severe spinal pain in this sample of 11-13-year-old Danish adolescents. Our cross-sectional analysis does not consider the longitudinal or complex sequences of events necessary to address predictive or causal questions. What is Known: • Up to a third of adolescents experience moderate to severe spinal pain, predisposing them to chronic spinal pain in adulthood. • Frequent and excessive sedentary time is associated with poor overall health in adolescents; there is conflicting evidence to suggest whether it is also related to spinal pain. What is New: • We found no association between sedentary time and moderate to severe spinal pain in 11- to 13-year-old Danes.

Spinal pain in childhood: prevalence, trajectories, and diagnoses in children 6 to 17 years of age.

This study aimed to investigate the trajectories of spinal pain frequency from 6 to 17 years of age and describe the prevalence and frequency of spinal pain and related diagnoses in children following different pain trajectories. First through fifth-grade students from 13 primary schools were followed for 5.5 years. Occurrences of spinal pain were reported weekly via text messages. Children reporting spinal pain were physically evaluated and classified using International Classification of Disease criteria. Trajectories of spinal pain frequency were modeled from age 6 to 17 years with latent class growth analysis. We included data from 1556 children (52.4% female, mean (SD) baseline age = 9.1 (1.9) years) and identified 10,554 weeks of spinal pain in 329,756 weeks of observation. Sixty-three percent of children reported one or more occurrences of spinal pain. We identified five trajectories of spinal pain frequency. Half the children (49.8%) were classified as members of a "no pain" trajectory. The remaining children followed "rare" (27.9%), "rare, increasing" (14.5%), "moderate, increasing" (6.5%), or "early-onset, decreasing" (1.3%) spinal pain trajectories. The most common diagnoses in all trajectory groups were non-specific (e.g., "back pain"). Tissue-specific diagnoses (e.g., muscle strain) were less common and pathologies (e.g., fracture) were rare.  Conclusion: From childhood through adolescence, spinal pain was common and followed heterogeneous courses comprising stable, increasing, and early-onset trajectories. These findings accord with recommendations from adult back pain guidelines that most children with spinal pain can be reassured that they do not have a serious disease and encouraged to stay active. What is Known: • Spinal pain imposes a large burden on individuals and society. • Although many people first experience the condition in childhood, little is known about the developmental trajectories of spinal pain from childhood to adolescence. What is New: • Data from 1556 children and 329,756 participant weeks showed five unique spinal pain trajectories from 6 to 17 years: most children rarely reported spinal pain, while one in five followed increasing or early-onset trajectories. • Most pain occurrences were non-specific; pathological diagnoses were rare.

Prevalence of multimorbid degenerative lumbar spinal stenosis with knee or hip osteoarthritis: a systematic review and meta-analysis.

BACKGROUND: Musculoskeletal multimorbidity is common and coexisting lumbar spinal stenosis (LSS) with knee or hip osteoarthritis (OA) has been reported. The aim of this review was to report the prevalence of multimorbid degenerative LSS with knee or hip OA based on clinical and/or imaging case definitions. METHODS: Literature searches were performed in MEDLINE, EMBASE, CENTRAL, and CINAHL up to May 2021. Studies involving adults with cross-sectional data to estimate the prevalence of co-occurring LSS with knee or hip OA were included. Study selection, data extraction, and risk of bias assessment were performed independently by two reviewers. Results were stratified according to index and comorbid condition, and by case definitions (imaging, clinical, and combined). RESULTS: Ten studies from five countries out of 3891 citations met the inclusion criteria. Sample sizes ranged from 44 to 2,857,999 (median 230) and the mean age in the included studies range from 61 to 73 years (median 66 years). All studies were from secondary care or mixed settings. Nine studies used a combined definition of LSS and one used a clinical definition. Imaging, clinical, and combined case definitions of knee and hip OA were used. The prevalence of multimorbid LSS and knee or hip OA ranged from 0 to 54%, depending on the specified index condition and case definitions used. Six studies each provided prevalence data for index LSS and comorbid knee OA (prevalence range: 5 to 41%) and comorbid hip OA (prevalence range: 2 to 35%). Two studies provided prevalence data for index knee OA and comorbid LSS (prevalence range 17 to 54%). No studies reporting prevalence data for index hip OA and comorbid LSS were found. Few studies used comparable case definitions and all but one study were rated as high risk of bias. CONCLUSIONS: There is evidence that multimorbid LSS with knee or hip OA occurs in people (0 to 54%), although results are based on studies with high risk of bias and surgical populations. Variability in LSS and OA case definitions limit the comparability of studies and prevalence estimates should therefore be interpreted with caution. REVIEW REGISTRATION: PROSPERO ( CRD42020177759 ).

Reliability of reporting differences in degenerative MRI findings of the lumbar spine from the supine to the upright position.

OBJECTIVE: To determine the inter-rater reliability of identifying differences and types of differences in lumbar degenerative findings comparing supine and upright MRI. MATERIALS AND METHODS: Fifty-nine participants, low back pain patients (LBP) with or without leg pain and no-LBP individuals were consecutively enrolled to receive supine and upright MRI of the lumbar spine. Three raters independently evaluated the MRIs for degenerative spinal pathologies and compared for differences. Presence/absence of degenerative findings were recorded for all supine and upright images, and then differences from the supine to the upright positions were classified into no-change, appeared, disappeared, worsened, or improved at each individual disc level. Reliability and agreement were calculated using Gwet's agreement coefficients (AC1 or AC2) and absolute agreement. RESULTS: Inter-rater reliability of evaluating differences in eight degenerative lumbar findings comparing the supine and upright MRI position, ranged from 0.929 to 0.996 according to Gwet's agreement coefficients (AC2). The total number of positive MRI findings in the supine position ranged from 270 to 453, with an average of 366 per rater. Observed differences from supine to upright MRI ranged from 18 to 80, with an average of 56 per rater. CONCLUSION: Inter-rater reliability was found overall acceptable for classification of differences in eight types of degenerative pathology observed with supine and upright MRI of the lumbar spine. Results were primarily driven by high numbers and high reliability of rating negative findings, whereas agreement regarding positive findings and positive positional differences was lower.

Using Intervention Mapping to Develop a Decision Support System-Based Smartphone App (selfBACK) to Support Self-management of Nonspecific Low Back Pain: Development and Usability Study.

BACKGROUND: International guidelines consistently endorse the promotion of self-management for people with low back pain (LBP); however, implementation of these guidelines remains a challenge. Digital health interventions, such as those that can be provided by smartphone apps, have been proposed as a promising mode of supporting self-management in people with chronic conditions, including LBP. However, the evidence base for digital health interventions to support self-management of LBP is weak, and detailed descriptions and documentation of the interventions are lacking. Structured intervention mapping (IM) constitutes a 6-step process that can be used to guide the development of complex interventions. OBJECTIVE: The aim of this paper is to describe the IM process for designing and creating an app-based intervention designed to support self-management of nonspecific LBP to reduce pain-related disability. METHODS: The first 5 steps of the IM process were systematically applied. The core processes included literature reviews, brainstorming and group discussions, and the inclusion of stakeholders and representatives from the target population. Over a period of >2 years, the intervention content and the technical features of delivery were created, tested, and revised through user tests, feasibility studies, and a pilot study. RESULTS: A behavioral outcome was identified as a proxy for reaching the overall program goal, that is, increased use of evidence-based self-management strategies. Physical exercises, education, and physical activity were the main components of the self-management intervention and were designed and produced to be delivered via a smartphone app. All intervention content was theoretically underpinned by the behavior change theory and the normalization process theory. CONCLUSIONS: We describe a detailed example of the application of the IM approach for the development of a theory-driven, complex, and digital intervention designed to support self-management of LBP. This description provides transparency in the developmental process of the intervention and can be a possible blueprint for designing and creating future digital health interventions for self-management.

Physical Activity Advice for Prevention and Rehabilitation of Low Back Pain- Same or Different? A Study on Device-Measured Physical Activity and Register-Based Sickness Absence.

Purpose We lack knowledge on whether the advice of "being physically active" should be the same for prevention and rehabilitation of low back pain (LBP). Sickness absence is a key outcome for LBP prevention and rehabilitation. We investigated the associations between physical activity and long-term sickness absence (LTSA) among employees with and without LBP. Methods Between 2011 and 2013, 925 Danish employees wore a Actigraph GTX3 accelerometer for 1-5 workdays to measure physical activity and reported LBP in past 7 days. Employees were followed for 4 years to determine their first register-based LTSA event (≥ 6 consecutive weeks). Results Among employees with LBP, increasing moderate-to-vigorous-intensity physical activity at work by 20 min and decreasing the remaining behaviors at work (ie., sitting, standing and light-intensity activity) by 20 min was associated with 38% (95% CI 17%; 63%) higher LTSA risk. Increasing light-intensity activity at work by 20 min and decreasing 20 min from the remaining behaviors was associated with 18% (95% CI 4%; 30%) lower risk. During leisure, increasing moderate-to-vigorous-intensity activity by 20 min or standing by 40 min was associated with 26% (95% CI 3%; 43%) lower and 37% (95% CI 0%; 87%) higher risk, respectively. Among employees without LBP, we found no such associations. Conclusions The physical activity advice ought to be different for LBP prevention and rehabilitation to reduce LTSA risk, and specified by domain and activity intensity. At work, employees with LBP should be advised to spend time on light-intensity physical activity and limit their time on moderate-to-vigorous-intensity physical activity. During leisure, employees should spend time on moderate-to-vigorous-intensity physical activity.

Surgery rates for lumbar spinal stenosis in Denmark between 2002 and 2018: a registry-based study of 43,454 patients.

BACKGROUND AND PURPOSE: Over the last decades, many countries have shown increased surgery rates for lumbar spinal stenosis (LSS), but little information is available from Denmark. We describe the development in diagnosis and surgery of LSS in Denmark between 2002 and 2018. PATIENTS AND METHODS: We collected diagnostic ICD10-codes and surgical procedure codes from private and public hospitals in Denmark from the Danish National Patient Register. Patients diagnosed with LSS and those with surgical procedure codes for decompression surgery with or without fusion were identified. Annual surgery rates were stratified by age, sex, and type of surgery. RESULTS: During these 17 years, 132,138 patients diagnosed with LSS and 43,454 surgical procedures for LSS were identified. The number of surgical procedures increased by 144%, from 23 to 56 per 100,000 inhabitants. The proportion of patients diagnosed with LSS who received surgery was about 33%, which was almost stable over time. Decompression without fusion increased by 128% from 18 to 40 per 100,000 inhabitants and decompression with fusion increased by 199%, from 5 to 15 per 100,000. INTERPRETATION: Both the prevalence of LSS diagnoses and LSS surgery rates more than doubled in Denmark between 2002 and 2018. However, the proportion of patients diagnosed with LSS who received surgery remained stable. Decompression surgery with fusion increased at a higher rate than decompression without fusion, although recent evidence suggests no advantage of decompression plus fusion over decompression alone.

Low-value care in musculoskeletal health care: Is there a way forward?

BACKGROUND: Low-value care that wastes resources and harms patients is prevalent in health systems everywhere. METHODS: As part of an invited keynote presentation at the Pain in Motion IV conference held in Maastricht, Holland, in May 2022, we reviewed evidence for low-value care in musculoskeletal conditions and discussed possible solutions. RESULTS: Drivers of low-value care are diverse and affect patients, clinicians, and health systems everywhere. We show that low-value care for back pian, neck pain, and osteoarthritis is prevalent in all professional groups involved in caring for people who seek care for these conditions. Implementation efforts that aim to reverse low-value care seem to work better if designed using established conceptual and theoretical frameworks. CONCLUSION: Low-value care is prevalent in the care of people with musculoskeletal conditions. Reducing low-value care requires behaviour change among patients and clinicians as well as in health systems. There is evidence that behaviour change can be facilitated through good conceptual and theoretical frameworks but not convincing evidence that it changes patient outcomes.

The Danish Spinal Cord Injury Shoulder (DanSCIS) cohort: methodology and primary results.

STUDY DESIGN: Cross-sectional study. OBJECTIVES: To describe the socio-demographics, injury characteristics, prevalence of shoulder and neck symptoms, weekly participation in leisure time physical activity (LTPA) and quality of life (QoL) of individuals with spinal cord injury in Denmark (SCI). SETTING: Nation-wide community survey, Denmark. METHODS: Individuals with SCI for >2 years were included from three SCI rehabilitation departments. Questionnaire data regarding socio-demographic details, SCI injury characteristics, medical history, shoulder and neck symptoms, LTPA and QoL were collected. RESULTS: Of 2454 potential participants, 1517 (62%) responded to the survey (mean age = 56.2, SD 16.1, 37% female, 42% tetraplegia, 23% complete SCI, mean time since injury = 16.9, SD 13.5). 75% used some form of assistive mobility device. Responders and non-responders showed no sex or injury type/severity differences. Shoulder and neck symptoms within the past 3 months were reported by 63 and 67% respectively, with 51% reporting shoulder symptoms within the past week. Among those with symptoms, 61% had experienced shoulder symptoms and 56% neck symptoms, for more than 30 days during the previous 3 months. Symptoms often prevented participants from performing their usual activities (due to shoulder symptoms 46%, neck symptoms 41%). CONCLUSIONS: A high prevalence of self-reported shoulder and neck symptoms was found, which may limit physical function and social activities. We succeeded in generating the Danish Spinal Cord Injury Shoulder (DanSCIS) dataset, which comprised a substantial proportion of Danish adults with SCI. Future studies using data from this cohort will investigate patterns and associations between shoulder/neck symptoms, use of assistive mobility devices, LTPA and QoL.

Adherence and characteristics of participants enrolled in a standardised programme of patient education and exercises for low back pain, GLA:D® Back - a prospective observational study.

BACKGROUND: Low back pain is often long-lasting, and implementation of low-cost interventions to improve care and minimise its burden is needed. GLA:D® Back is an evidence-based programme consisting of patient education and supervised exercises for people with low back pain, which was implemented nationwide in primary care clinics in Denmark. To assess how the intervention was received and factors influencing adherence to the program, we aimed to evaluate participants' adherence to the intervention and identified characteristics related to the completion of GLA:D® Back. Specifically, we investigated: 1) level of attendance of participants enrolled in the programme, and 2) participant-related factors associated with low attendance. METHODS: Primary care clinicians delivered GLA:D® Back, a standardised 10-week programme of 2 educational and 16 supervised exercise sessions, to patients with low back pain. Attendance was defined as low, medium or high based on self-reported number of attended sessions. Additional participant-reported data included demographic characteristics, pain, prognostic risk profiles, self-efficacy, illness-beliefs, function and clinician-reported physical performance tests. Results for high, medium, low, and unknown attendance were reported descriptively. Odds ratios for low attendance compared to medium/high attendance were calculated by including all baseline factors in a mixed-model logistic regression model. RESULTS: Of 1730 participants, 52% had high, 23% medium, and 25% low levels of attendance. Level of attendance was not strongly associated with participants' individual factors, but in combination, prediction of low attendance was fair (AUC 0.77; 95% CI 0.74-0.79). The strongest indicator of low attendance was not completing the baseline questionnaire. CONCLUSIONS: Most participants of a 10-week low back pain programme attended almost all session. Non-response to the baseline questionnaire was strongly associated with low attendance, whereas individual patient characteristics were weakly related to attendance. Not completing baseline questionnaires might be an early indicator of poor adherence in programs for people with persistent low back pain. TRIAL REGISTRATION: The Health Research Ethics for Southern Denmark decided there was no need for ethical approval (S-20172000-93). The Danish data collection has obtained authorisation from the Danish Data Protection Agency as part of the University of Southern Denmark's institutional authorisation (DPA no. 2015-57-0008 SDU no. 17/30591). The trial was registred at ClinicalTrials.gov NCT03570463 .

Distribution and prevalence of musculoskeletal pain co-occurring with persistent low back pain: a systematic review.

BACKGROUND: Co-occurring musculoskeletal pain is common among people with persistent low back pain (LBP) and associated with more negative consequences than LBP alone. The distribution and prevalence of musculoskeletal pain co-occurring with persistent LBP has not been systematically described, which hence was the aim of this review. METHODS: Literature searches were performed in MEDLINE, Embase, CINAHL and Scopus. We considered observational studies from clinical settings or based on cohorts of the general or working populations involving adults 18 years or older with persistent LBP (≥4 wks) and co-occurring musculoskeletal pain for eligibility. Study selection, data extraction and risk of bias assessment were carried out by independent reviewers. Results are presented according to study population, distribution and location(s) of co-occurring pain. RESULTS: Nineteen studies out of 5744 unique records met the inclusion criteria. Studies were from high-income countries in Europe, USA and Japan. A total of 34,492 people with persistent LBP were included in our evidence synthesis. Methods for assessing and categorizing co-occurring pain varied considerably between studies, but based on the available data from observational studies, we identified three main categories of co-occurring pain - these were axial pain (18 to 58%), extremity pain (6 to 50%), and multi-site musculoskeletal pain (10 to 89%). Persistent LBP with co-occurring pain was reported more often by females than males, and co-occurring pain was reported more often in patients with more disability. CONCLUSIONS: People with persistent LBP often report co-occurring neck pain, extremity pain or multi-site pain. Assessment of co-occurring pain alongside persistent LBP vary considerable between studies and there is a need for harmonisation of measurement methods to advance our understanding of how pain in different body regions occur alongside persistent LBP. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42017068807 .