Medical App Treatment of Non-Specific Low Back Pain in the 12-month Cluster-Randomized Controlled Trial Rise-uP: Where Clinical Superiority Meets Cost Savings.

Purpose: Non-specific low back pain (NLBP) exerts a profound impact on global health and economics. In the era of Web 3.0, digital therapeutics offer the potential to improve NLBP management. The Rise-uP trial introduces a digitally anchored, general practitioner (GP)-focused back pain management approach with the Kaia back pain app as the key intervention. Here, we present the 12-months evaluation of the Rise-uP trial including clinical and economic outcomes, patient satisfaction and behavioral tracking analysis. Methods: The cluster-randomized controlled study (registration number: DRKS00015048) enrolled 1237 patients, with 930 receiving treatment according to the Rise-uP approach and 307 subjected to standard of care treatment. Assessments of pain, psychological state, functional capacity, and well-being (patient-reported outcome measures; PROMs) were collected at baseline, and at 3-, 6-, and 12-months follow-up intervals. Health insurance partners AOK, DAK, and BARMER provided individual healthcare cost data. An artificial intelligence (AI)-driven behavioral tracking analysis identified distinct app usage clusters that presented all with about the same clinical outcome. Patient satisfaction (patient-reported experience measures; PREMs) was captured at the end of the trial. Results: Intention-to-treat (ITT) analysis demonstrated that the Rise-uP group experienced significantly greater pain reduction at 12 months compared to the control group (IG: -46% vs CG: -24%; p < 0.001) with only the Rise-uP group achieving a pain reduction that was clinically meaningful. Improvements in all other PROMs were notably superior in patients of the Rise-uP group. The AI analysis of app usage discerned four usage clusters. Short- to long-term usage, all produced about the same level of pain reduction. Cost-effectiveness analysis indicated a substantial economic benefit for Rise-uP. Conclusion: The Rise-uP approach with a medical multimodal back pain app as the central element of digital treatment demonstrates both, clinical and economic superiority compared to standard of care in the management of NLBP.

Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain.

Aim: The availability of long-term (>2 years) safety outcomes of spinal cord stimulation (SCS) remains limited. We evaluated safety in a global SCS registry for chronic pain. Methods: Participants were prospectively enrolled globally at 79 implanting centers and followed out to 3 years after device implantation. Results: Of 1881 participants enrolled, 1289 received a permanent SCS implant (1776 completed trial). The annualized rate of device explant was 3.5% (all causes), and 1.1% due to inadequate pain relief. Total incidence of device explantation >3 years was 7.6% (n = 98). Of these, 32 subjects (2.5%) indicated inadequate pain relief as cause for removal. Implant site infection (11 events) was the most common device-related serious adverse event (<1%). Conclusion: This prospective, global, real-world study demonstrates a high-level of safety for SCS with low rate of explant/serious adverse events. Clinical Trial Registration: NCT01719055 (ClinicalTrials.gov).

Digital Treatment of Back Pain versus Standard of Care: The Cluster-Randomized Controlled Trial, Rise-uP.

PURPOSE: Non-specific low back pain (NLBP) causes an enormous burden to patients and tremendous costs for health care systems worldwide. Frequently, treatments are not oriented to existing guidelines. In the future, digital elements may be promising tools to support guideline-oriented treatment in a broader range of patients. The cluster-randomized controlled "Rise-uP" trial aims to support a General Practitioner (GP)-centered back pain treatment (Registration No: DRKS00015048) and includes the following digital elements: 1) electronic case report form (eCRF), 2) a treatment algorithm for guideline-based clinical decision making of GPs, 3) teleconsultation between GPs and pain specialists for patients at risk for development of chronic back pain, and 4) a multidisciplinary mobile back pain app for all patients (Kaia App). METHODS: In the Rise-uP trial, 111 GPs throughout Bavaria (southern Germany) were randomized either to the Rise-uP intervention group (IG) or the control group (CG). Rise-uP patients were treated according to the guideline-oriented Rise-uP treatment algorithm. Standard of care was applied to the CG patients with consideration given to the "National guideline for the treatment of non-specific back pain". Pain rating on the numeric rating scale was the primary outcome measure. Psychological measures (anxiety, depression, stress), functional ability, as well as physical and mental wellbeing, served as secondary outcomes. All values were assessed at the beginning of the treatment and at 3-month follow-ups. RESULTS: In total, 1245 patients (IG: 933; CG: 312) with NLBP were included in the study. The Rise-uP group showed a significantly stronger pain reduction compared to the control group after 3 months (IG: M=-33.3% vs CG: M=-14.3%). The Rise-uP group was also superior in secondary outcomes. Furthermore, high-risk patients who received a teleconsultation showed a larger decrease in pain intensity (-43.5%) than CG patients (-14.3%). ANCOVA analysis showed that the impact of teleconsultation was mediated by an increased training activity in the Kaia App. CONCLUSION: Our results show the superiority of the innovative digital treatment algorithm realized in Rise-uP, even though the CG also received relevant active treatment by their GPs. This provides clear evidence that digital treatment may be a promising tool to improve the quality of treatment of non-specific back pain. In 2021, analyses of routine data from statutory health insurances will enable us to investigate the cost-effectiveness of digital treatment.

Subgroups in chronic low back pain patients - a step toward cluster-based, tailored treatment in inpatient standard care: On the need for precise targeting of treatment for chronic low back pain.

Objective: The purpose of this study was to find applicable clusters for the development of different treatment pathways in an inpatient multimodal pain-therapy setting based on the multifaceted nature of CLBP. Methods: Based on data of questionnaires (Hospital Anxiety and Depression Scale (HADS), Marburg Questionnaire on Habitual Health Findings (MFHW), quality of life assessment using the Short-Form 12 (SF 12)), a retrospective two-step cluster analysis involving a sample of chronic low back pain (CLBP) patients (N=320) was calculated. Subsequently, the clusters were precisely described and compared on the basis of further data collected during the patients' standard care: pain characteristics, socio-demographic data and the general state of health, psychological variables, therapy intensity, and Diagnosis Related Groups (DRG) data. Results: We found a three-cluster solution: little psychological interference but marginal physical and mental quality of life (Cluster 1); poor well-being, low physical quality of life, and marginal mental quality of life (Cluster 2); and heavy mental strain and marginal physical quality of life (Cluster 3). Conclusions: Similar to previous studies, our results suggest that patients suffering from CLBP differ with regard to the magnitude of mental burden and the presence of physical impairment. These differences ascertain the need for precise targeting of treatment for CLBP. Inpatient pain centers therefore should offer different multimodal therapy pathways and integrate a meaningful triage, taking into account the multifaceted nature of CLBP based on sophisticated knowledge about forms, differences, and relationships among the biopsychosocial components of CLBP.

Patient-related predictors of treatment satisfaction of patients with fibromyalgia syndrome: results of a cross-sectional survey.

OBJECTIVES: This study aimed to determine patient-related predictors of treatment satisfaction in fibromyalgia syndrome (FMS)-patients. METHODS: In a cross-sectional survey, participants with self-reported diagnosis of FMS were recruited by FMS-self help organisations and clinical institutions. The patients answered demographic and medical questionnaires, the Fibromyalgia Survey Questionnaire (FSQ) including the Somatic Severity Score (SSS) and Widespread Pain Index (WPI), the Patient Health Questionnaire (PHQ-4), and rated their treatment satisfaction on an 11-point Likert scale. The impact of patient-related variables (age, gender, partnership, educational level, time since onset of pain, time since FMS-diagnosis, health status since diagnosis, membership in FMS self-help organisations, polysymptomatic distress, anxiety and depression) and types of treatment on treatment satisfaction were tested by a multiple regression analysis. RESULTS: The study sample (n=1651 patients) was composed mainly of middle-aged women with a long disease history, and 83.9% fulfilled the American College of Rheumatology diagnostic criteria of 2010. There was considerate variety regarding treatment satisfaction in FMS-patients, 14.8% reported no, 31.7% low, 40.8% moderate and 12.7% high satisfaction. Higher satisfaction was predicted by longer time since FMS diagnosis (p=0.03), improved health status since FMS-diagnosis (p<0.0001), lower depression score (p=0.005) and higher amount of active therapies (p<0.0001). Other sociodemographic (age, gender etc.) and disease-related variables (polysymptomatic distress intensity) did not influence treatment satisfaction. CONCLUSIONS: The results of the study illustrate the influence of patient-related factors on treatment satisfaction. Treating comorbid depression and enabling patients to actively cope with the disease might prove successful in improving treatment satisfaction of FMS-patients.

The German fibromyalgia consumer reports - a cross-sectional survey.

BACKGROUND: Consumer surveys provide information on effectiveness and side effects of medical interventions in routine clinical care. A report of fibromyalgia syndrome (FMS) consumers has not been carried out in Europe. METHODS: The study was carried out from November 2010 to April 2011. Participants diagnosed with FMS rated the effectiveness and side effects of pharmacological and non-pharmacological FMS interventions on a 0 to 10 scale, with 10 being most efficacious (harmful). The questionnaire was distributed by the German League for people with Arthritis and Rheumatism and the German Fibromyalgia Association to their members and to all consecutive FMS patients of nine clinical centers of different levels of care. RESULTS: 1661 questionnaires (95% women, mean age 54 years, mean duration since FMS diagnosis 6.8 years) were analysed. The most frequently used therapies were self-management strategies, prescription pain medication and aerobic exercise. The highest average effectiveness was attributed to whole body and local warmth therapies, thermal bathes, FMS education and resting. The highest average side effects were attributed to strong opioids, local cold therapy, gamma-amino-butyric acid analogues (pregabalin and gabapentin), tramadol and opioid transdermal systems. CONCLUSION: The German fibromyalgia consumer reports highlight the importance of non-pharmcological therapies in the long-term management of FMS, and challenges the strong recommendations for drug therapies given by FMS-guidelines.