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

Trials

David Drießlein¹  Michael Schäfer²  Diamantes Arampatzis³  Wilfried Mau⁴  Julia-Marie Zimmer⁴  Friedemann Steinfeldt⁵  Laura Puerto Valencia⁶  Pia-Maria Wippert⁷  Karsten Dreinhöfer⁸  Heidrun Beck⁹ 

[1] Department of Orthopaedics and Trauma Surgery, Medical Park Berlin Humboldtmühle, Charité Berlin, Germany;Department of Orthopedics, German Pension Insurance Berlin-Brandenburg, Rehabilitation Clinic Hohenelse, Rheinsberg, Germany;Department of Training and Movement Sciences, Humboldt-Universität zu Berlin, Berlin, Germany;Institute for Rehabilitation Medicine, Interdisciplinary Center for Health Sciences, Medical Faculty, Martin-Luther-University (MLU) Halle-Wittenberg, Halle, Germany;Johannesbad Specialist Clinic & Health Center Raupennest, Orthopedic Clinic in Altenberg, Altenberg, Germany;Medical Sociology and Psychobiology, University of Potsdam, Potsdam, Germany;Medical Sociology and Psychobiology, University of Potsdam, Potsdam, Germany;Faculty of Health Sciences Brandenburg, University of Potsdam, Am Neuen Palais 10, 14469, Potsdam, Germany;Statistical Consulting Unit StaBLab, Ludwig-Maximilians-Universität München, Munich, Germany;University Center for Orthopaedics and Trauma Surgery, Hospital Carl Gustav Carus at Technical University Dresden, Dresden, Germany;

关键词: Chronic low back pain;    Aftercare;    Individualized therapy;    Randomized controlled trial;    Rehabilitation;   

DOI  :  10.1186/s13063-021-05823-3

来源: Springer

【 摘 要 】

BackgroundMillions 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.MethodsThe 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).DiscussionAn 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 registrationDRKS, DRKS00020373. Registered on 15 April 2020

【 授权许可】

CC BY