Evaluation of a novel technology-supported fall prevention intervention - study protocol of a multi-centre randomised controlled trial in older adults at increased risk of falls.

BACKGROUND: Increasing number of falls and fall-related injuries in an aging society give rise to the need for effective fall prevention and rehabilitation strategies. Besides traditional exercise approaches, new technologies show promising options for fall prevention in older adults. As a new technology-based approach, the hunova robot can support fall prevention in older adults. The objective of this study is to implement and evaluate a novel technology-supported fall prevention intervention using the hunova robot compared to an inactive control group. The presented protocol aims at introducing a two-armed, multi-centre (four sites) randomised controlled trial, evaluating the effects of this new approach on the number of falls and number of fallers as primary outcomes. METHODS: The full clinical trial incorporates community-dwelling older adults at risk of falls with a minimum age of 65 years. Including a one-year follow-up measurement, all participants are tested four times. The training programme for the intervention group comprises 24-32 weeks in which training sessions are scheduled mostly twice a week; the first 24 training sessions use the hunova robot, these are followed by a home-based programme of 24 training sessions. Fall-related risk factors as secondary endpoints are measured using the hunova robot. For this purpose, the hunova robot measures the participants' performance in several dimensions. The test outcomes are input for the calculation of an overall score which indicates the fall risk. The hunova-based measurements are accompanied by the timed-up-and-go test as a standard test within fall prevention studies. DISCUSSION: This study is expected to lead to new insights which may help establish a new approach to fall prevention training for older adults at risk of falls. First positive results on risk factors can be expected after the first 24 training sessions using the hunova robot. As primary outcomes, the number of falls and fallers within the study (including the one-year follow-up period) are the most relevant parameters that should be positively influenced by our new approach to fall prevention. After the study completion, approaches to examine the cost-effectiveness and develop an implementation plan are relevant aspects for further steps. TRIAL REGISTRATION: German Clinical Trial Register (DRKS), ID: DRKS00025897. Prospectively registered 16 August 2021, https://drks.de/search/de/trial/DRKS00025897 .

The effectiveness of low-dosed outpatient biopsychosocial interventions compared to active physical interventions on pain and disability in adults with nonspecific chronic low back pain: A systematic review with meta-analysis.

OBJECTIVE: To evaluate the effectiveness of low-dosed outpatient biopsychosocial interventions versus active physical interventions on pain intensity and disability in adults with nonspecific chronic low back pain. INTRODUCTION: Research has shown that primary care biopsychosocial interventions (PCBI) can reduce pain intensity and disability. While scattered studies support low-dosed (≤ 15 treatment hours) PCBI, no systematic review exists comparing the effectiveness of low-dosed PCBI treatment with traditional physical activity interventions in adults with nonspecific chronic low back pain (CLBP). INCLUSION CRITERIA: Randomized controlled trials that evaluate low-dosed PCBI compared to physical treatment with an active component such as exercise, physical activity or usual physiotherapy treatment for adult participants (18 years or older), who suffer from CLBP were included. Not recommended interventions that feature only passive therapies, spinal surgery or pharmacological treatment, and studies with inpatient multidisciplinary-based rehabilitation (MBR) were excluded. METHODS: Databases were searched from inception to December 31, 2021. Language was restricted to English or German. Keywords and derivatives of "chronic back pain", "exercise intervention", "cognitive-behavioral therapy", "primary care" and "randomized controlled trials" were used. Sources were CINAHL, Cochrane Central Register of Controlled Trials (CENTRAL), Ovid Medline, Physiotherapy Evidence Database (PEDro), PubMed and Web of Science. Search was finished on March 08, 2022. Data appraisal, extraction and synthesis followed JBI guidance for systematic reviews of effectiveness. Risk of Bias was assessed using JBI 13-item checklist for randomized controlled trials. The GRADE approach for grading the certainty of evidence was followed. SYSTEMATIC REVIEW REGISTRATION NUMBER: PROSPERO 2022 CRD42022302771. RESULTS: Eighteen RCTs were found eligible and 15 trials comprising a total of 1531 participants suffering from CLBP were entered in the meta-analyses. Risk of Bias was low. Overall evidence was moderate. Significant effects in favor of PCBI were found for pain intensity post-treatment (standardized mean difference (SMD) = -1.09, 95% confidence interval (CI) = -1.84 to -0.34, I2  = 97%, p = 0.004) as well as at short-term (SMD = -0.23, 95% CI = -0.39 to -0.08, I2  = 0%, p = 0.004), long term (SMD = -0.79, 95% CI = -1.42 to -0.17, I2  = 96%, p = 0.01) and very long-term (SMD = -1.13, 95% CI = -1.93 to -0.33, I2  = 94%, p = 0.005) follow-up. Significant effects in favor of PCBI for physical function were found post-treatment (SMD = -1.33, 95% CI = -2.17 to -0.49, I2  = 97%, p = 0.002) at short-term (SMD = -0.20, 95% CI = -0.36 to -0.04, I2  = 0%, p = 0.01) and at long-term follow-up (SMD = -1.17, 95% CI = -2.06 to -0.28, I2  = 98%, p = 0.01). The results were characterized by high heterogeneity due to different types (cognitive behavioral therapy, pain-neuroscience education, mindfulness, and motivation), delivery modes (individual and/or group), durations (3-12 weeks) and contact times (2-15 h) of PCBI. In sensitivity analysis outliers were removed to reduce heterogeneity. The results remained significant for pain intensity at short-term (SMD = -0.23, 95% CI = -0.39 to -0.08, I2  = 0%, p = 0.004) and long-term follow-up (SMD = -0.22, 95% CI = -0.41 to -0.03, I2  = 39%, p = 0.02). CONCLUSIONS: This meta-analysis suggests that low-dosed PCBI has favorable effects in terms of disability and pain intensity compared to active physical treatments alone. All conducted meta-analyses indicate that biopsychosocial interventions produce better outcomes than active physical treatment alone. Therefore, we strongly recommend decision makers and clinical practitioners to analyze how psychosocial elements can be introduced into outpatient (low-dosed) CLBP interventions.

The effectiveness of low-dosed outpatient biopsychosocial interventions compared to active physical interventions on pain and disability in adults with nonspecific chronic low back pain: A protocol for a systematic review with meta-analysis.

BACKGROUND: Best outpatient treatment of nonspecific chronic low back pain is high-dosed exercise that is maintained after therapy. Primary care biopsychosocial intervention (PCBI) is an outpatient multicomponent intervention that includes an active component (exercise, physical activity, or physiotherapy) and at least one psychological, social, or occupational component. Research has shown that PCBI can reduce pain intensity and disability. While scattered studies support low-dosed (<15 treatment hours) PCBI, there is no systematic review comparing the effectiveness of low-dosed PCBI treatment with traditional physical activity interventions in adults with nonspecific chronic low back pain (CLBP). INCLUSION CRITERIA: Randomised controlled trials that evaluate low-dosed outpatient biopsychosocial interventions compared to physical treatment with an active component such as exercise, physical activity or usual physiotherapy treatment for adult participants (18 years or older) who suffer from nonspecific CLBP will be included. METHODS: A comprehensive search of multiple databases will be used to find relevant studies. The databases will be searched from inception to December 2021, with English or German language restrictions imposed. Keywords and derivatives of "chronic back pain", "exercise intervention", "cognitive-behavioral therapy", "primary care" and "randomized controlled trials" will be used. Sources will include CINAHL, Cochrane Central Register of Controlled Trials (CENTRAL), Ovid Medline, Physiotherapy Evidence Database (PEDro), PubMed and Web of Science. DISCUSSION: To our knowledge, this will be the first systematic review and meta-analysis of narrowly defined low- dosed PCBI across populations with nonspecific chronic low back pain. The objective of this review is to evaluate the effectiveness of low-dosed outpatient biopsychosocial interventions versus physical active interventions on pain intensity and disability in adults with CLBP. This study will provide evidence that could improve treatment options for patients with nonspecific CLBP. TRAIL REGISTRATION: Systematic review registration number: PROSPERO 2022 CRD42022302771. https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022302771.

Prognostic ability of the German version of the STarT Back tool: analysis of 12-month follow-up data from a randomized controlled trial.

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.

[Evaluation of a Proactive Health Programme for Insured Persons with Persistent Back Pain: One-year Follow-up of a Randomised Controlled Trial]. / Evaluation eines proaktiv angebotenen Gesundheitsprogramms für Versicherte mit anhaltenden Rückenschmerzen ­ Ein-Jahres-Follow-up einer randomisierten, kontrollierten Studie.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.