Evidence map›Paper›PMID 34922613›Full record

ArticleTrials2021

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

Laura Puerto Valencia, Diamantes Arampatzis, Heidrun Beck, Karsten Dreinhöfer, David Drießlein, Wilfried Mau, Julia-Marie Zimmer, Michael Schäfer, Friedemann Steinfeldt, Pia-Maria Wippert

Abstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Laura Puerto ValenciaMedical Sociology and Psychobiology, University of Potsdam, Potsdam, Germany.
Diamantes ArampatzisDepartment of Training and Movement Sciences, Humboldt-Universität zu Berlin, Berlin, Germany.
Heidrun BeckUniversity Center for Orthopaedics and Trauma Surgery, Hospital Carl Gustav Carus at Technical University Dresden, Dresden, Germany.
Karsten DreinhöferStatistical Consulting Unit StaBLab, Ludwig-Maximilians-Universität München, Munich, Germany.
David DrießleinDepartment of Orthopaedics and Trauma Surgery, Medical Park Berlin Humboldtmühle, Charité Berlin, Germany.
Wilfried MauInstitute for Rehabilitation Medicine, Interdisciplinary Center for Health Sciences, Medical Faculty, Martin-Luther-University (MLU) Halle-Wittenberg, Halle, Germany.
Julia-Marie ZimmerInstitute for Rehabilitation Medicine, Interdisciplinary Center for Health Sciences, Medical Faculty, Martin-Luther-University (MLU) Halle-Wittenberg, Halle, Germany.
Michael SchäferDepartment of Orthopedics, German Pension Insurance Berlin-Brandenburg, Rehabilitation Clinic Hohenelse, Rheinsberg, Germany.
Friedemann SteinfeldtJohannesbad Specialist Clinic & Health Center Raupennest, Orthopedic Clinic in Altenberg, Altenberg, Germany.
Pia-Maria WippertMedical Sociology and Psychobiology, University of Potsdam, Potsdam, Germany. wippert@uni-potsdam.de.ORCID http://orcid.org/0000-0001-7221-4073

Funding

German Pension Insurance Berlin-Brandenburg and Central Germany 10-R-40.07.05.07.022; 10-R-40.07.05.07.019
6 · The paper itself

Abstract

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). 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 registrationDRKS, DRKS00020373 . Registered on 15 April 2020.

Indexed as

Low Back PainGermanyHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicAftercareChronic low back painIndividualized therapyRandomized controlled trialRehabilitation

Identifiers

PMID34922613
PMCPMC8684145

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.