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

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          Abstract

          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.

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          Most cited references 35

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          Non-specific low back pain.

          Non-specific low back pain affects people of all ages and is a leading contributor to disease burden worldwide. Management guidelines endorse triage to identify the rare cases of low back pain that are caused by medically serious pathology, and so require diagnostic work-up or specialist referral, or both. Because non-specific low back pain does not have a known pathoanatomical cause, treatment focuses on reducing pain and its consequences. Management consists of education and reassurance, analgesic medicines, non-pharmacological therapies, and timely review. The clinical course of low back pain is often favourable, thus many patients require little if any formal medical care. Two treatment strategies are currently used, a stepped approach beginning with more simple care that is progressed if the patient does not respond, and the use of simple risk prediction methods to individualise the amount and type of care provided. The overuse of imaging, opioids, and surgery remains a widespread problem.
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            Low back pain: what is the long-term course? A review of studies of general patient populations.

            It is often claimed that up to 90% of low back pain (LBP) episodes resolve spontaneously within 1 month. However, the literature in this area is confusing due to considerable variations regarding the exact definitions of LBP as well as recovery. Therefore, the claim--attractive as it might be to some--may not reflect reality. In order to investigate the long-term course of incident and prevalent cases of LBP, a systematic and critical literature review was undertaken. A comprehensive search of the topic was carried out utilizing both Medline and EMBASE databases. The Cochrane Library and the Danish Article Base were also screened. Journal articles following the course of LBP without any known intervention were included, regardless of study type. However, the population had to be representative of the general patient population and a follow-up of at least 12 months was a requirement. Data were extracted independently by two reviewers using a standard check list. The included articles were also independently assessed for quality by the same two reviewers before they were studied in relation to the course of LBP using various definitions of recovery. Thirty-six articles were included. The results of the review showed that the reported proportion of patients who still experienced pain after 12 months was 62% on average (range 42-75%), the percentage of patients sick-listed 6 months after inclusion into the study was 16% (range 3-40%), the percentage who experienced relapses of pain was 60% (range 44-78%), and the percentage who had relapses of work absence was 33% (range 26-37%). The mean reported prevalence of LBP in cases with previous episodes was 56% (range 14-93%), which compared with 22% (range 7-39%) for those without a prior history of LBP. The risk of LBP was consistently about twice as high for those with a history of LBP. The results of the review show that, despite the methodological variations and the lack of comparable definitions, the overall picture is that LBP does not resolve itself when ignored. Future research should include subgroup analyses and strive for a consensus regarding the precise definitions of LBP.
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              Clinical significance of reported changes in pain severity.

              To determine the amount of change in pain severity, as measured by a visual analog scale, that constitutes a minimum clinically significant difference. Patients 18 years of age or older who presented with acute pain resulting from trauma were enrolled in this prospective, descriptive study. The setting was an urban county hospital emergency department with a Level 1 trauma center. In the course of a brief interview, patients were asked to indicate their current pain severity with a single mark through a standard 100-mm visual analog scale. At intervals of 20 minutes for the next 2 hours, patients were asked to repeat this measurement and, in addition, to contrast their present pain severity with that at the time of the previous measurement. They were to indicate whether they had "much less," "a little less," "about the same," "a little more," or "much more" pain. All contrasts were made without reference to prior visual analog scale measurements. A maximum of six measurements of pain change were recorded per patient. Measurements ended when the patient left the ED or when the patient reported a pain score of zero. The minimum clinically significant change in visual analog scale pain score was defined as the mean difference between current and preceding visual analog scale scores when the subject noted a little less or a little more pain. Forty-eight subjects were enrolled, and 248 pain contrasts were recorded. Of these contrasts, 41 were rated as a little less and 39 as a little more pain. The mean difference between current and preceding visual analog scale scores in these 80 contrasts was 13 mm (95% confidence interval, 10 to 17 mm). The minimum clinically significant change in patient pain severity measured with a 100-mm visual analog scale was 13 mm. Studies of pain experience that report less than a 13-mm change in pain severity, although statistically significant, may have no clinical importance.
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                Author and article information

                Journal
                J Pain Res
                J Pain Res
                JPR
                jpainres
                Journal of Pain Research
                Dove
                1178-7090
                17 July 2020
                2020
                : 13
                : 1823-1838
                Affiliations
                [1 ]Center of Interdisciplinary Pain Medicine, Department of Neurology, Klinikum Rechts der Isar, Technical University of Munich , Munich, Germany
                [2 ]Bayerische TelemedAllianz (BTA) , Ingolstadt, Germany
                [3 ]Pain Clinic, Algesiologikum Pain Center , Munich, Germany
                [4 ]Institute for Applied Health Services Research, inav GmbH , Berlin, Germany
                [5 ]StatConsult GmbH Magdeburg , Magdeburg, Germany
                [6 ]Barmer Hauptverwaltung , Wuppertal, Germany
                Author notes
                Correspondence: Thomas R Toelle Center of Interdisciplinary Pain Medicine, Department of Neurology, Klinikum Rechts der Isar, Technische Universität München , Ismaninger Str. 22, Munich81675, GermanyTel +49-89-4140-4613 Email thomas.toelle@tum.de
                Article
                260761
                10.2147/JPR.S260761
                7381830
                © 2020 Priebe et al.

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

                Page count
                Figures: 7, Tables: 3, References: 48, Pages: 16
                Categories
                Clinical Trial Report

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