RENaBack: low back pain patients in rehabilitation-study protocol for a multicenter, randomized controlled trial.

Autor: Puerto Valencia L; Medical Sociology and Psychobiology, University of Potsdam, Potsdam, Germany., Arampatzis D; Department of Training and Movement Sciences, Humboldt-Universität zu Berlin, Berlin, Germany., Beck H; University Center for Orthopaedics and Trauma Surgery, Hospital Carl Gustav Carus at Technical University Dresden, Dresden, Germany., Dreinhöfer K; Statistical Consulting Unit StaBLab, Ludwig-Maximilians-Universität München, Munich, Germany., Drießlein D; Department of Orthopaedics and Trauma Surgery, Medical Park Berlin Humboldtmühle, Charité Berlin, Germany., Mau W; Institute for Rehabilitation Medicine, Interdisciplinary Center for Health Sciences, Medical Faculty, Martin-Luther-University (MLU) Halle-Wittenberg, Halle, Germany., Zimmer JM; Institute for Rehabilitation Medicine, Interdisciplinary Center for Health Sciences, Medical Faculty, Martin-Luther-University (MLU) Halle-Wittenberg, Halle, Germany., Schäfer M; Department of Orthopedics, German Pension Insurance Berlin-Brandenburg, Rehabilitation Clinic Hohenelse, Rheinsberg, Germany., Steinfeldt F; Johannesbad Specialist Clinic & Health Center Raupennest, Orthopedic Clinic in Altenberg, Altenberg, Germany., Wippert PM; Medical Sociology and Psychobiology, University of Potsdam, Potsdam, Germany. wippert@uni-potsdam.de.; Faculty of Health Sciences Brandenburg, University of Potsdam, Am Neuen Palais 10, 14469, Potsdam, Germany. wippert@uni-potsdam.de.
Jazyk: angličtina
Zdroj: Trials [Trials] 2021 Dec 18; Vol. 22 (1), pp. 932. Date of Electronic Publication: 2021 Dec 18.
DOI: 10.1186/s13063-021-05823-3
Abstrakt: Background: Millions of people in Germany suffer from chronic pain, in which course and intensity are multifactorial. Besides physical injuries, certain psychosocial risk factors are involved in the disease process. The national health care guidelines for the diagnosis and treatment of non-specific low back pain recommend the screening of psychosocial risk factors as early as possible, to be able to adapt the therapy to patient needs (e.g., unimodal or multimodal). However, such a procedure has been difficult to implement in practice and has not yet been integrated into the rehabilitation care structures across the country.
Methods: The aim of this study is to implement an individualized therapy and aftercare program within the rehabilitation offer of the German Pension Insurance in the area of orthopedics and to examine its success and sustainability in comparison to the previous standard aftercare program. The study is a multicenter randomized controlled trial including 1204 patients from six orthopedic rehabilitation clinics. A 2:1 allocation ratio to intervention (individualized and home-based rehabilitation aftercare) versus the control group (regular outpatient rehabilitation aftercare) is set. Upon admission to the rehabilitation clinic, participants in the intervention group will be screened according to their psychosocial risk profile. They could then receive either unimodal or multimodal, together with an individualized training program. The program is instructed in the clinic (approximately 3 weeks) and will continue independently at home afterwards for 3 months. The success of the program is examined by means of a total of four surveys. The co-primary outcomes are the Characteristic Pain Intensity and Disability Score assessed by the German version of the Chronic Pain Grade questionnaire (CPG).
Discussion: An improvement in terms of pain, work ability, patient compliance, and acceptance in our intervention program compared to the standard aftercare is expected. The study contributes to provide individualized care also to patients living far away from clinical centers.
Trial Registration: DRKS, DRKS00020373 . Registered on 15 April 2020.
(© 2021. The Author(s).)
Databáze: MEDLINE
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