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DOI: 10.1055/a-1205-1380
Effects of a Risk-Stratified Treatment in Patients with Chronic Back Pain in Rehabilitation: Results of a Controlled Clinical Trial
Effekte einer risikostratifizierten Behandlung von Patienten mit chronischen Rückenschmerzen: Ergebnisse einer kontrollierten klinischen Studie Funding The manuscript is based on a research project supported by the German Pension Fund Bayern Süd. The funding had no influence on the interpretation of the data and the final conclusions.Trial registration The trial was prospectively registered in the German Clinical Trials Register (DRKS00008831) at the 29/07/2015.
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Abstract
Background and Aim The management of chronic low back pain is a persisting challenge for multidisciplinary biopsychosocial rehabilitation (MBR). A promising approach to improve the effectiveness is better individual tailoring of the therapeutic minutes to the impairment. We designed a questionnaire-based algorithm to identify individual risk profiles, which allows physicians and patients to decide upon the kind and amount of suitable and adequate therapeutic components of MBR. Our aim was to test whether the algorithm leads to a shift in the therapeutic components depending on the impairment, which should significantly increase the functional capacity of the rehabilitants 6 months after the end of rehabilitation.
Methods Between January and November 2016, a controlled clinical trial with a sequential arrangement of study groups and 3 measurement time points (start of rehabilitation, end of rehabilitation and 6-month follow-up) was conducted. The control group (CG) passed through the standard inpatient MBR. In the intervention group (IG)the MBR components were matched to the individual risk-profiles determined via a new algorithm. The shift of therapeutic minutes is displayed via boxplots. The primary outcome was statistically tested by applying an analysis of covariance. All secondary outcomes are presented descriptively.
Results Of 169 patients in total, 85 were assigned to the CG and 84 to the IG. Complete data concerning the primary outcome were available for 76 (89.4%) patients in the CG and 75 (89.3%) patients in the IG. Compared to the CG, the boxplots for the IG show a better fit of therapeutic minutes according to the impairments. For example, in the IG, the mean value of psychological therapies was about 120 min if they were impaired and 44.3 min if not. In contrast, impaired tested patients of the CG shown mean values of those therapies of about 96.6 min and 50.6 min if not. The baseline adjusted mean difference in functional capacity was significantly (p=0.047) improved by 4.4 points (95% CI: 0.063–8.465) in favor of the IG. . Main limitation is lack of randomization. In order to avoid inadequate therapy recommendations, the physician had the decision-making authority over the therapies.
Conclusion The application of the developed algorithm for individual adaptation of the MBR increases the effectiveness of rehabilitation in terms of functional capacity.
Zusammenfassung
Hintergrund und Ziel Die Behandlung chronischer Rückenschmerzen bleibt eine Herausforderung in der multidisziplinären biopsychosozial orientierten Rehabilitation (MBR). Wir haben auf Basis etablierter Instrumente einen Algorithmus entwickelt, der individuelle Risikoprofile identifizieren kann. Diese Profile erlauben es Klinikern und Patienten über die Art und Umfang einzelner Therapiebausteine der MBR zu entscheiden. Unser Ziel war es in einer kontrollierter Studie zu testen, ob der Algorithmus zu einem Verschiebung der Therapien über die Beeinträchtigungen führt und die Funktionskapazität 6 Monate nach der Reha steigert.
Methodik Zwischen Januar und November 2016 wurde ein kontrollierte klinische Studie mit 3 Messzeitpunkten (Reha-Anfang, Reha-Ende und 6-Monats-Katamnese) durchgeführt. Die Kontrollgruppe (KG) durchlief die übliche MBR. In der Interventionsgruppen (IG) wurden die MBR Therapiebausteine auf Grundlage des neu entwickelten Algorithmus empfohlen. Die Verteilung der Therapieminuten wird über Boxplots veranschaulicht. Der primäre Endpunkt wurde mittels Kovarianzanalyse auf statistische Signifikanz getestet. Alle sekundären Outcomes werden deskriptiv präsentiert.
Ergebnisse Von 169 Patienten, wurden 85 in der KG und 84 in der IG rekrutiert. Vollständige Daten bezüglich des primären Endpunkts liegen von 76 (89,4%) Patienten in der KG und 75 (89,3%) in der IG vor. Verglichen mit der KG zeigen die Boxplots der IG eine bessere Verteilung der Therapieminuten nach Beeinträchtigung. Zum Beispiel beträgt der Mittelwert psychologischer Therapien in der IG 120 Min. bei Beeinträchtigung und 44,3 Min. wenn keine vorliegt. Im Gegensatz dazu betragen diese Therapien 96,6 Min. bei Beeinträchtigung und 50,6 Min. bei keiner in der KG. Die um die Eingangswerte adjustierte Differenz der Mittelwerte der Funktionskapazität zeigte eine signifikante (p=0,047) Verbesserung von 4,4 Punkten zu Gunsten der IG. Stärkste Limitation ist die fehlende Randomisierung. Zur Vermeidung inadäquater Therapieempfehlungen hatte der Arzt die Entscheidungshoheit über die Therapien.
Schlussfolgerung Die Anwendung des entwickelten Algorithmus zu individuellen Gestaltung der MBR steigert die Effektivität der Rehabilitation hinsichtlich der Funktionsfähigkeit.
Studienregistrierung Die Studie wurde im Deutschen Register Klinischer Studien (DRKS00008831) am 29.7.2015 registriert.
Key words
chronic low back pain - multidisciplinary biopsychosocial rehabilitation - risk-stratified therapy - inpatient rehabilitation - clinical trialSchlüsselwörter
chronische Rückenschmerzen - multidisziplinäre biopsychosoziale Rehabilitation - risikostratifizierte Therapie - stationäre Rehabilitation - klinische StudiePublication History
Received: 16 January 2020
Accepted: 19 June 2020
Article published online:
15 July 2020
© 2020. Thieme. All rights reserved.
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