TY  - GEN
A1  - Puerto Valencia, Laura Maria
A1  - Arampatzis, Adamantios
A1  - Beck, Heidrun
A1  - Dreinhöfer, Karsten E.
A1  - Drießlein, Drießlein
A1  - Mau, Wilfried
A1  - Zimmer, Julia-Marie
A1  - Schäfer, Michael
A1  - Steinfeldt, Friedemann
A1  - Wippert, Pia-Maria
T1  - RENaBack: Low back pain patients in rehabilitation: Study Protocol for a Multicenter, Randomized Controlled Trial
T2  - Zweitveröffentlichungen der Universität Potsdam : Humanwissenschaftliche Reihe
N2  - 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
T3  - Zweitveröffentlichungen der Universität Potsdam : Humanwissenschaftliche Reihe - 772 
KW  - Chronic low back pain
KW  - Aftercare
KW  - Individualized therapy
KW  - Randomized controlled trial
KW  - Rehabilitation
Y1  - 2022
UR  - https://publishup.uni-potsdam.de/frontdoor/index/index/docId/55468
UR  - https://nbn-resolving.org/urn:nbn:de:kobv:517-opus4-554683
SN  - 1866-8364
SP  - 1
EP  - 18
PB  - Universitätsverlag Potsdam
CY  - Potsdam
ER  -