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).

To facilitate access to evidence-based care for persisting back pain, a private medical insurance developed a health programme and offered it proactively to their members. The aim of this study was to evaluate the feasibility and efficacy of this procedure. The design of the study was a Zelen randomized controlled trial. Adult insured persons with persistent back pain were randomized to the control (CG) or intervention group (IG) prior to giving consent. The IG was invited to participate in the health programme, the CG in a survey. Primary outcomes were back pain intensity and disability (according to von Korff) and health-related quality of life (SF-12). At baseline, 12- and 24-month follow-up, outcomes were documented by identical online questionnaires. 552 of 3462 randomized insured persons agreed to participate in the study; 132 of 258 (51.2%) from the IG and 243 of 294 (82.7%) from the CG completed the questionnaires at the 12-month follow-up. Small beneficial effects were seen for 3 of 4 primary outcomes. Compared to the CG, the IG reported less severe pain intensity (38.6 vs 44.5; p=0.001; d=0.36) and less disability (1.6 vs 2.2; p=0.002; d=0.41). The IG scored better at the SF-12 physical health scale (43.6 vs 39.0; p<0.001; d=0.54); no beneficial effect was seen in the SF-12 mental health scale. The pro-active health programme seems to be feasible and effective as determined by patient-reported outcomes. Final evaluation awaits cost analysis and the results of the 24-month follow-up.