A Bio-psycho-social Exercise Program (RÜCKGEWINN) for Chronic Low Back Pain in Rehabilitation Aftercare

Summary

Background:

In chronic back pain, rehabilitation specific aftercare programs, needed for a long-term improvement of pain and functional ability, are absent. Purposeful and differentiated aftercare treatments offer the possibility, in particular in the rehabilitation of chronic back pain, to increase the sustainability of positive effects of a mostly three weeks taking rehabilitation or to intensify them.

Hypothesis:

The implementation of a developed bio-psycho-social aftercare intervention program for CLBP (RÜCKGEWINN) leeds to a better rehabilitation outcome in comparison to current usual aftercare (IRENA) and a control group in view of pain-conditioned functional ability and back pain episodes.

Methods/Design:

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 and twelve month after dismissal form rehabilitation into the aftercare program.

Conditions

• Low Back Pain

Interventions

OTHER

educational booklet

Participants will receive an educational booklet and the advice to return to normal activities as soon as possible from their rehabilitation practitioner in their dismissal examination. As educational booklet the German version of the "back book" of Burton et al. was chosen. This booklet provides information about the new approach to back pain, causes of back pain, dealing with an attack of back pain, risk factors for development of chronic back pain and the role of activity. All information that is provided is in accordance with actual scientific knowledge and is based on a bio-psycho-social model of back pain like described in Waddell.

OTHER

IRENA

Participants will be introduced into the normal IRENA program (in German: Intensivierte Rehabilitationsnachsorge), which is usual care in Germany. Every patient will be assigned to a certified aftercare facility near their residential area. Aftercare practitioners and patients can compile an individual therapeutic package from certain appointed therapeutic services. Predominantly resistance training, gymnastics, aquatic exercise, back school and recreation exercises are prescribed by the physicians for aftercare. Most therapies are carried out in open access groups of at least 6 patients without being specific for medical indication. In the IRENA program it is possible to pass the intended 24 exercise sessions with different frequency per week. Usually participants do two or three exercise sessions per week with duration of 90 to 120 minutes per session. Every aftercare facility offers certain therapy combinations at different days in week.

OTHER

RÜCKGEWINN

For long term sustainability and the enhancement of intensity of the rehabilitation process this investigational aftercare intervention shows formal and didactic divergences from standard programmes in rehabilitation aftercare. Three important areas for multidimensional interventions are targeted: attitude and behaviour change concerning back pain, guidance to health enhancing physical activity, improvement of health related physical fitness. Every 90 minutes taking exercise session contains parts for mediation of knowledge, for behavioural modulation and for physical exercises and interlocks them in the mediation process. To take the time into account that is necessary for the process of behavioural change RÜCKGEWINN is planned for duration of six months in one session weekly for 26 weeks.

Sponsors & Collaborators

• Deutsche Rentenversicherung

  collaborator OTHER

• University of Erlangen-Nürnberg

  lead OTHER

Principal Investigators

• Klaus Pfeifer, Prof. Dr. · Institute of Sport Science and Sport / University of Erlangen-Nürnberg

• Christian Hentschke, Dipl. Sportwiss. · Institute of Sport Science and Sport / University of Erlangen-Nürnberg

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-11-30

Primary Completion

2011-10-31

Completion

2011-10-31

Countries

• Germany

Study Locations