A bio-psycho-social exercise program (RÜCKGEWINN) for chronic low back pain in rehabilitation aftercare - Study protocol for a randomised controlled trial

Abstract

BackgroundThere is strong, internationally confirmed evidence for the short-term effectiveness of multimodal interdisciplinary specific treatment programs for chronic back pain. However, the verification of long-term sustainability of achieved effects is missing so far. For long-term improvement of pain and functional ability high intervention intensity or high volume seems to be necessary (> 100 therapy hours). Especially in chronic back pain rehabilitation, purposefully refined aftercare treatments offer the possibility to intensify positive effects or to increase their sustainability. However, quality assured goal-conscious specific aftercare programs for the rehabilitation of chronic back pain are absent.Methods/DesignThis study aims to examine the efficacy of a specially developed bio-psycho-social chronic back pain specific aftercare intervention (RÜCKGEWINN) in comparison to the current usual aftercare (IRENA) and a control group that is given an educational booklet addressing pain-conditioned functional ability and back pain episodes. Overall rehabilitation effects as well as predictors for compliance to the aftercare programs are analysed. Therefore, a multicenter prospective 3-armed randomised controlled trial is conducted. 456 participants will be consecutively enrolled in inpatient and outpatient rehabilitation and assigned to either one of the three study arms. Outcomes are measured before and after rehabilitation. Aftercare programs are assessed at ten month follow up after dismissal form rehabilitation.DiscussionSpecial methodological and logistic challenges are to be mastered in this trial, which accrue from the interconnection of aftercare interventions to their residential district and the fact that the proportion of patients who take part in aftercare programs is low. The usability of the aftercare program is based on the transference into the routine care and is also reinforced by developed manuals with structured contents, media and material for organisation assistance as well as training manuals for therapists in the aftercare.Trial RegistrationTrial Registration number: NCT01070849

Efficacy of perceptive rehabilitation in the treatment of chronic nonspecific low back pain through a new tool: a randomized clinical study

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Effects of behavioural exercise therapy on the effectiveness of multidisciplinary rehabilitation for chronic non-specific low back pain: a randomised controlled trial

“…After registration, the online-based randomisation automatically carried out the allocation to one of the treatment groups. This system has been developed in a prior study [ 63 ] and incorporates the existing national data protection regulations. Clear advantages of this procedure are a prompt randomisation and a concealment of the sequence of allocation.…”

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“…Vale ressaltar que a implementação de um programa de pós-tratamento promove o fortalecimento e o desenvolvimento de competências de autogestão para a manutenção de resultados, como apresentado em estudos recentes que comparavam os métodos IRENA e RÜCKEGEWINN, os quais incluem componentes de fisioterapia, exercícios recreacionais e Escola de Postura (16).…”