BackgroundTo facilitate access to evidence-based care for back pain, a German private medical insurance offered a health program proactively to their members. Feasibility and long-term efficacy of this approach were evaluated.MethodsUsing Zelen’s design, adult members of the health insurance with chronic back pain according to billing data were randomized to the intervention (IG) or the control group (CG). Participants allocated to the IG were invited to participate in the comprehensive health program comprising medical exercise therapy and life style coaching, and those allocated to the CG to a longitudinal back pain survey. Primary outcomes were back pain severity (Korff’s Chronic Pain Grade Questionnaire) as well as health-related quality of life (SF-12) assessed by identical online questionnaires at baseline and 2-year follow-up in both study arms. In addition to analyses of covariance, a subgroup analysis explored the heterogeneity of treatment effects among different risks of back pain chronification (STarT Back Tool).ResultsOut of 3462 persons selected, randomized and thereafter contacted, 552 agreed to participate. At the 24-month follow-up, data on 189 of 258 (73.3%) of the IG were available, in the CG on 255 of 294 (86.7%). Significant, small beneficial effects were seen in primary outcomes: Compared to the CG, the IG reported less disability (1.6 vs 2.0; p = 0.025; d = 0.24) and scored better at the SF-12 physical health scale (43.3 vs 41.0; p < 0.007; d = 0.26). No effect was seen in back pain intensity and in the SF-12 mental health scale. Persons with medium or high risk of back pain chronification at baseline responded better to the health program in all primary outcomes than the subgroup with low risk at baseline.ConclusionsAfter 2 years, the proactive health program resulted in small positive long-term improvements. Using risk screening prior to inclusion in the health program might increase the percentage of participants deriving benefits from it.Trial registrationThe trial was registered at the German Clinical Trials Register under DRKS00015463 retrospectively (dated 4 Sept 2018).

Background Stratified care is an up-to-date treatment approach suggested for patients with back pain in several guidelines. A comprehensively studied stratification instrument is the STarT Back Tool (SBT). It was developed to stratify patients with back pain into three subgroups, according to their risk of persistent disabling symptoms. The primary aim was to analyse the disability differences in patients with back pain 12 months after inclusion according to the subgroups determined at baseline using the German version of the SBT (STarT-G). Moreover, the potential to improve prognosis for disability by adding further predictor variables, an analysis for differences in pain intensity according to the STarT-Classification, and discriminative ability were investigated. Methods Data from the control group of a randomized controlled trial were analysed. Trial participants were members of a private medical insurance with a minimum age of 18 and indicated as having persistent back pain. Measurements were made for the risk of back pain chronification using the STarT-G, disability (as primary outcome) and back pain intensity with the Chronic Pain Grade Scale (CPGS), health-related quality of life with the SF-12, psychological distress with the Patient Health Questionnaire-4 (PHQ-4) and physical activity. Analysis of variance (ANOVA), multiple linear regression, and area under the curve (AUC) analysis were conducted. Results The mean age of the 294 participants was 53.5 (SD 8.7) years, and 38% were female. The ANOVA for disability and pain showed significant differences ( p < 0.01) among the risk groups at 12 months. Post hoc Tukey tests revealed significant differences among all three risk groups for every comparison for both outcomes. AUC for STarT-G’s ability to discriminate reference standard ‘cases’ for chronic pain status at 12 months was 0.79. A prognostic model including the STarT-Classification, the variables global health, and disability at baseline explained 45% of the variance in disability at 12 months. Conclusions Disability differences in patients with back pain after a period of 12 months are in accordance with the subgroups determined using the STarT-G at baseline. Results should be confirmed in a study developed with the primary aim to investigate those differences.

Background Nonspecific chronic low back pain (CLBP) is a complex symptom with numerous possible causes and influencing factors. Understanding how modifiable factors affect the course of CLBP is important for preventing progression. As the COVID-19 pandemic has changed the lifestyle of many people, this study paper assessed whether it also changed the influence of modifiable lifestyle factors (regular exercise and sedentary behaviour) and mental health factors (anxiety and depression) on CLBP pain intensity and disability by comparing the strength of these associations before and during the pandemic. We hypothesised that the importance of regular physical activity and good mental health for CLBP patients would increase during the pandemic. Methods These questions were investigated in a cross-sectional study of insurance claims data and self-reported data from various questionnaires from 3,478 participants in a German CLBP health intervention (2014–2021) by calculating pre- and intra-pandemic odds ratios (OR) and 95% confidence intervals (CI) for each variable of interest and outcome. Potential confounders were also considered. Pandemic status was treated as an effect modifier. Based on the date of enrolment, participants were classified as “pre-pandemic” or “pandemic”. Results Regularly exercising ≥ 4 h/week significantly reduced the odds of high disability for men (OR 0.49, 95% CI 0.31 – 0.79, p = 0.003) and women (OR 0.30, 95% CI 0.14 – 0.563, p = 0.002) and reduced the probability of severe pain in women (OR 0.37, 95% CI 0.21 – 0.65, p < 0.001). Each one-point increase in PHQ-4 score for anxiety and depression increased the OR of high pain intensity by 1.25 points (95% CI 1.18 – 1.34, p < 0.001). A clear impact of COVID-19 lockdowns was observed. In individuals who exercised ≥ 4 h/week the OR of high disability was 0.57 (95% CI 0.36 – 0.92, p = 0.021) in the pre-pandemic group compared to 0.29 (95% CI 0.12 – 0.56, p = 0.002) in the pandemic group. The probability of high disability increased from an OR of 1.42 (95% CI 1.33 – 1.52, p < 0.001) per marginal increase in the PHQ-4 scale before the pandemic, to an OR of 1.73 (95% CI 1.58 – 1.89, p < 0.001) during the pandemic. Conclusions The magnitude of association of the factors that influenced high pain intensity and disability increased during the pandemic. On the one hand, the protective effect of regular exercising was greater in participants surveyed during lockdown. On the other hand, a higher risk through anxiety or depression during the lockdown was identified. An additional study with objective measures of sedentary behaviour and physical activity is needed to validate these results. More in-depth investigation of lockdown-induced associations between reduced daily physical activity, increased levels of anxiety and depression, and their effects on CLPB could also be worthwhile. Trial registration This study used routinely collected data from a CLBP intervention that was previously evaluated and registered in the German Registry of Clinical Trials under DRKS00015463 (04/09/2018). The original ethics approval, informed consent and self-reported questionnaire have remained unchanged and are still valid.