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.

Stressful life events and low back pain in older men: A cross-sectional and prospective analysis using data from the MrOS study.

BACKGROUND: Stressful life events, such as loss of a partner, loss of a pet or financial problems, are more common with increasing age and may impact the experience of pain. The aim of the current study is to determine the cross-sectional and prospective association between stressful life events and low back pain reporting in the Osteoporotic Fracture in Men Study, a cohort of older men aged ≥65 years. METHODS: At a study visit (March 2005-May 2006), 5149 men reported whether they had experienced a stressful life event or low back pain in the prior 12 months. Following that visit, data on low back pain patients were gathered through triannual questionnaires every 4 months for 1 year. Multivariable logistic regression analyses estimated the association of stressful life events with recent past low back pain or future low back pain. RESULTS: N = 2930, (57%) men reported at least one stressful life event. The presence of a stressful life event was associated with greater odds of any low back pain (OR = 1.42 [1.26-1.59]) and activity-limiting low back pain (OR = 1.74 [1.50-2.01]) in the same period and of any low back pain (OR = 1.56 [1.39-1.74]) and frequent low back pain (OR = 1.80 [1.55-2.08]) in the following year. CONCLUSION: In this cohort of men, the presence of stressful life events increased the likelihood of reporting past and future low back pain. SIGNIFICANCE: Stressful life events such as accident or illness to a partner are common in later life and may impact the experience of pain. We present cross-sectional and prospective data highlighting a consistent association between stressful life events and low back pain in older men. Further, there is evidence to suggest that this relationship is upregulated by an individual's living situation. This information may be used to strengthen a biopsychosocial perspective of an individual's pain experience.

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/ ).

Patient and provider characteristics associated with therapeutic intervention selection in a chiropractic clinical encounter: a cross-sectional analysis of the COAST and O-COAST study data.

BACKGROUND: Chiropractors use a variety of therapeutic interventions in clinical practice. How the selection of interventions differs across musculoskeletal regions or with different patient and provider characteristics is currently unclear. This study aimed to describe how frequently different interventions are used for patients presenting for chiropractic care, and patient and provider characteristics associated with intervention selection. METHODS: Data were obtained from the Chiropractic Observation and Analysis STudy (COAST) and Ontario (O-COAST) studies: practice-based, cross-sectional studies in Victoria, Australia (2010-2012) and Ontario, Canada (2014-2015). Chiropractors recorded data on patient diagnosis and intervention selection from up to 100 consecutive patient visits. The frequency of interventions selected overall and for each diagnostic category (e.g., different musculoskeletal regions) were descriptively analysed. Univariable multi-level logistic regression (provider and patient as grouping factors), stratified by diagnostic category, was used to assess the association between patient/provider variables and intervention selection. RESULTS: Ninety-four chiropractors, representative of chiropractors in Victoria and Ontario for age, sex, and years in practice, participated. Data were collected on 7,966 patient visits (6419 unique patients), including 10,731 individual diagnoses (mean age: 43.7 (SD: 20.7), 57.8% female). Differences in patient characteristics and intervention selection were observed between chiropractors practicing in Australia and Canada. Overall, manipulation was the most common intervention, selected in 63% (95%CI:62-63) of encounters. However, for musculoskeletal conditions presenting in the extremities only, soft tissue therapies were more commonly used (65%, 95%CI:62-68). Manipulation was less likely to be performed if the patient was female (OR:0.74, 95%CI:0.65-0.84), older (OR:0.79, 95%CI:0.77-0.82), presenting for an initial visit (OR:0.73, 95%CI:0.56-0.95) or new complaint (OR:0.82, 95%CI:0.71-0.95), had one or more comorbidities (OR:0.63, 95%CI:0.54-0.72), or was underweight (OR:0.47, 95%CI:0.35-0.63), or obese (OR:0.69, 95%CI:0.58-0.81). Chiropractors with more than five years clinical experience were less likely to provide advice/education (OR:0.37, 95%CI:0.16-0.87) and exercises (OR:0.17, 95%CI:0.06-0.44). CONCLUSION: In more than 10,000 diagnostic encounters, manipulation was the most common therapeutic intervention for spine-related problems, whereas soft tissue therapies were more common for extremity problems. Different patient and provider characteristics were associated with intervention selection. These data may be used to support further research on appropriate selection of interventions for common musculoskeletal complaints.

Presenters at chiropractic research conferences 2010-2019: is there a gender equity problem?

BACKGROUND: Presenting at professional and scientific conferences can be an important part of an individual's career advancement, especially for researchers communicating scientific findings, and can signal expertise and leadership. Generally, women presenting at conferences are underrepresented in various science disciplines. We aimed to evaluate the gender of presenters at research-oriented chiropractic conferences from 2010 to 2019. METHODS: We investigated the gender of presenters at conferences hosted by chiropractic organisations from 2010 to 2019 that utilised an abstract submission process. Gender classification was performed by two independent reviewers. The gender distribution of presenters over the ten-year period was analysed with linear regression. The association of conference factors with the gender distribution of presenters was also assessed with linear regression, including the gender of organising committees and abstract peer reviewers, and the geographic region where the conference was hosted. RESULTS: From 39 conferences, we identified 4,340 unique presentations. Women gave 1,528 (35%) of the presentations. No presenters were classified as gender diverse. Overall, the proportion of women presenters was 30% in 2010 and 42% in 2019, with linear regression demonstrating a 1% increase in women presenting per year (95% CI = 0.4-1.6%). Invited/keynote speakers had the lowest proportion of women (21%) and the most stagnant trajectory over time. The gender of conference organisers and abstract peer reviewers were not significantly associated with the gender of presenters. Oceanic conferences had a lower proportion of women presenting compared to North America (27% vs. 36%). CONCLUSIONS: Overall, women gave approximately one-third of presentations at the included conferences, which gradually increased from 2010 to 2019. However, the disparity widens for the most prestigious class of keynote/invited presenters. We make several recommendations to support the goal of gender equity, including monitoring and reporting on gender diversity at future conferences.

Temporal stability in the prevalence and pattern of co-occurring musculoskeletal pain among people with persistent low back pain: population-based data from the Norwegian HUNT Study, 1995 to 2019.

ABSTRACT: People with persistent low back pain (LBP) often report co-occurring persistent musculoskeletal (MSK) pain in other body regions that may influence prognosis as well as treatment approaches and outcomes. This study describes the prevalence and patterns of co-occurring persistent MSK pain among people with persistent LBP based on consecutive cross-sectional studies over 3 decades in the population-based HUNT Study, Norway. The analyses comprised 15,375 participants in HUNT2 (1995-1997), 10,024 in HUNT3 (2006-2008), and 10,647 in HUNT4 (2017-2019) who reported persistent LBP. Overall, ∼90% of participants in each of the HUNT surveys with persistent LBP reported persistent co-occurring MSK pain in other body sites. The age-standardized prevalence of the most common co-occurring MSK pain sites was consistent across the 3 surveys: 64% to 65% report co-occurring neck pain, 62% to 67% report shoulder pain, and 53% to 57% report hip or thigh pain. Using latent class analysis (LCA), we identified 4 distinct patterns of persistent LBP phenotypes that were consistent across the 3 surveys: (1) "LBP only," (2) "LBP with neck or shoulder pain," (3) "LBP with lower extremity or wrist or hand pain," and (4) "LBP with multisite pain," with conditional item response probabilities of 34% to 36%, 30% to 34%, 13% to 17%, and 16% to 20%, respectively. In conclusion, 9 of 10 adults in this Norwegian population with persistent LBP report co-occurring persistent MSK pain, most commonly in the neck, shoulders, and hips or thighs. We identified 4 LCA-derived LBP phenotypes of distinct MSK pain site patterns. In the population, both the prevalence and pattern of co-occurring MSK pain and the distinct phenotypic MSK pain patterns seem stable over decades.

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.

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.

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 .

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.

Association between objectively measured physical behaviour and neck- and/or low back pain: A systematic review.

BACKGROUND AND OBJECTIVE: Clinical guidelines recommend physical activity to manage neck pain (NP) and low back pain (LBP). However, studies used to support these guidelines are based on self-reports of physical behaviour, which are prone to bias and misclassification. This systematic review aimed to investigate associations between objectively measured physical behaviour and the risk or prognosis of NP and/or LBP. DATABASES AND DATA TREATMENT: Literature searches were performed in MEDLINE, Embase and Scopus from their inception until 18 January 2019. We considered prospective cohort studies for eligibility. Article selection, data extraction and critical appraisal were carried out by independent reviewers. Results were stratified on activity/sedentariness. RESULTS: Ten articles out of 897 unique records identified met the inclusion criteria, of which eight studied working populations with mainly blue-collar workers. The overall results indicate that increased sitting time at work reduces the risk of NP and LBP while increased physical activity during work and/or leisure increases the risk of these conditions among blue-collar workers; however, associations were weak. Physical activity was not associated with prognosis of LBP (no studies investigated prognosis of NP). Most of the included articles have methodological shortcomings. CONCLUSIONS: This review indicates that, among blue-collar workers, increased sitting at work may protect against NP and LBP while increased physical activity during work and/or leisure may increase this risk. There was no evidence supporting physical activity as a prognostic factor for LBP. Findings should be interpreted with caution due to the weak associations and few available studies with methodological shortcomings. SIGNIFICANCE: Based on prospective cohort studies with objectively measured physical behaviour, this review questions the common notion that increased physical activity is associated with reduced risk or better prognosis of NP and/or LBP. We found that, among blue-collar workers, increased sitting time at work reduces the risk of NP and LBP, whereas physical activity somewhat increases the risk. Despite methodological shortcomings, there was consistency in the direction of the results, although high-quality articles reported the weakest associations. Systematic review registration: PROSPERO CRD42018100765.

Novel approach towards musculoskeletal phenotypes.

BACKGROUND: The multidimensional array of clinical features and prognostic factors makes it difficult to optimize management within the heterogeneity of patients with common musculoskeletal pain. This study aimed to identify phenotypes across prognostic factors and musculoskeletal complaints. Concurrent and external validity were assessed against an established instrument and a new sample, respectively, and treatment outcome was described. METHODS: We conducted a longitudinal observational study of 435 patients (aged 18-67 years) seeking treatment for nonspecific complaints in the neck, shoulder, low back or multisite/complex pain in primary health care physiotherapy in Norway. Latent class analysis was used to identify phenotypes based on 11 common prognostic factors within four biopsychosocial domains; pain, beliefs and thoughts, psychological and activity and lifestyle. RESULTS: Five distinct phenotypes were identified. Phenotype 1 (n = 77, 17.7%) and 2 (n = 142, 32.6%) were characterized by the lowest scores across all biopsychosocial domains. Phenotype 2 showed somewhat higher levels of symptoms across the biopsychosocial domains. Phenotype 3 (n = 89, 20.5%) and 4 (n = 78, 17.9%) were more affected across all domains, but phenotype 3 and 4 had opposite patterns in the psychological and pain domains. Phenotype 5 (n = 49, 11.3%) were characterized by worse symptoms across all domains, indicating a complex phenotype. The identified phenotypes had good external and concurrent validity, also differentiating for the phenotypes in function and health-related quality of life outcome at 3-month follow-up. CONCLUSION: The phenotypes may inform the development of targeted interventions aimed at improving the treatment efficiency in patients with common musculoskeletal disorders. SIGNIFICANCE: This observational prospective study identified five distinct and clinically meaningful phenotypes based on biopsychosocial prognostic factors across common musculoskeletal pain. These phenotypes were independent of primary pain location, showed good external validity, and clear variation in treatment outcome. The findings are particularly valuable as they describe the heterogeneity of patients with musculoskeletal pain and points to a need for more targeted interventions in common musculoskeletal disorders to improve treatment outcome.

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.