Evaluation eines proaktiv angebotenen Gesundheitsprogramms für Versicherte mit anhaltenden Rückenschmerzen – Ein-Jahres-Follow-up einer randomisierten, kontrollierten Studie

Hüppe, Angelika; Wunderlich, M; Hochheim, Martin; Mirbach, Andrea; Zeuner, C.; Raspe, Heiner

doi:10.1055/s-0043-121696

Cited by 6 publications

(4 citation statements)

References 19 publications

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“…Since 2014, Generali Deutschland has been operating a German-wide primary care intervention using a biopsychosocial approach that is offered proactively to clients suffering from CLBP. The intervention consists of a 12-month programme of spine muscle stabilising training, behavioural change telephone coaching, and patient education [42,43]. Whereas training was conducted exclusively on-site at specific treatment centres before the pandemic, it had to be performed primarily with the Kaia mobile app [44][45][46] during pandemic lockdowns, when access to local training facilities was tightly restricted or closed [47].…”

Section: Settingmentioning

confidence: 99%

Association between chronic low back pain and regular exercise, sedentary behaviour and mental health before and during COVID-19 pandemic: insights from a large-scale cross-sectional study in Germany

Hochheim

Ramm

Wunderlich

et al. 2022

BMC Musculoskelet Disord

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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.

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Section: Settingmentioning

confidence: 99%

Association between chronic low back pain and regular exercise, sedentary behaviour and mental health before and during COVID-19 pandemic: insights from a large-scale cross-sectional study in Germany

Hochheim

Ramm

Wunderlich

et al. 2022

BMC Musculoskelet Disord

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“…The intervention was accompanied by a controlled trial in Zelen's -Design, registered at the German Clinical Trials Register under DRKS00015463. Results showed medical effectiveness in the 12-month follow-up [31,32]. To nd out whether the intervention is also cost-effective, inpatient as well as outpatient costs, the development of sick days due to BP and the overall health status of the participants enrolled in the aforementioned study were collected and analysed in detail.…”

Section: This Paper Addresses the Gap And Ful Ls The Consolidated Health Economic Evaluation Reportingmentioning

confidence: 99%

“…The present economic evaluation reuses data from a two-arm randomised controlled evaluation study in parallel-group Zelen's design for which recruitment took place between April and October 2015 [31,32] and amends it with administrative direct health costs data. Searches in the database of the PHI identi ed adults with administrative indications of CLBP.…”

Section: Target Population and Subgroupsmentioning

confidence: 99%

Cost-Utility Analysis of a Chronic Back Pain Multidisciplinary Biopsychosocial Rehabilitation (MBR) compared to Standard Care for Privately Insured in Germany

Hochheim

Ramm

Wunderlich

et al. 2021

Preprint

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Introduction: Multidisciplinary biopsychosocial rehabilitation (MBR) is highly recommended to treat chronic lower back pain (CLBP). However, its economic benefit remains to be clearly demonstrated. Objective: To analyse the effect of a 12-month MBR with behaviour-change coaching and device-supported exercise on direct medical costs, sick leave and health-related quality of life (HRQOL) at 24 months. Methods: A cohort of privately insured in Germany was evaluated using administrative and trial data. After removing dissimilarities in characteristics between MBR and control via propensity score matching, treatment effects were calculated with a Difference-in-Difference approach.Results: The base-case analysis comprised 112 MBR participants and 111 members in the standard care group. With an incremental cost-effectiveness ratio (ICER) of €8,428 per quality-adjusted life year (QALY) gained, the intervention was classified as cost-effective. Economically unaccounted sick leave due to back pain (BP) in the last six months was reduced by 17.5 days (p = 0.001) in the MBR group. Development of HRQOL was positive for the MBR (0.046, p= 0.026). Subgroup analysis with major impaired participants demonstrated the possibility of a dominant intervention with an ICER of - €6,861 per QALY. Savings were driven by a reduction in BP specific costs by - €1,733 (p= 0.035). Difference in sick leave was 27 days (p = 0.006) in favour of the MBR group.Conclusion: This is the first cost-utility study with combined data from a private health insurer and a controlled trial to demonstrate that long term MBR is cost-effective in the treatment of CLBP. Subgroups with major impairment benefit more from the intervention than participants with minor impairment. MBR significantly reduces sick leave in all participants making it a profitable intervention from society’s point of view.

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“…Besides feasibility and acceptance, efficacy, benefit and cost analyses were additional objectives of this study. First follow-up data collected shortly after the end of the program gave reason to suppose that this approach had beneficial effects [17]. In this study, we analyze the long-term effects on outcomes as reported by patients and discuss ways to improve the effectiveness of this approach to treatment of BP.…”

Section: Introductionmentioning

confidence: 99%

Feasibility and long-term efficacy of a proactive health program in the treatment of chronic back pain: a randomized controlled trial

Hüppe

Zeuner

Karstens

et al. 2019

BMC Health Serv Res

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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).

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Evaluation eines proaktiv angebotenen Gesundheitsprogramms für Versicherte mit anhaltenden Rückenschmerzen – Ein-Jahres-Follow-up einer randomisierten, kontrollierten Studie

Cited by 6 publications

References 19 publications

Association between chronic low back pain and regular exercise, sedentary behaviour and mental health before and during COVID-19 pandemic: insights from a large-scale cross-sectional study in Germany

Association between chronic low back pain and regular exercise, sedentary behaviour and mental health before and during COVID-19 pandemic: insights from a large-scale cross-sectional study in Germany

Cost-Utility Analysis of a Chronic Back Pain Multidisciplinary Biopsychosocial Rehabilitation (MBR) compared to Standard Care for Privately Insured in Germany

Feasibility and long-term efficacy of a proactive health program in the treatment of chronic back pain: a randomized controlled trial

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