A Bio-psycho-social Exercise Program (RÜCKGEWINN) for Chronic Low Back Pain in Rehabilitation Aftercare
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Detailed description: 
      Background:

      There is strong internationally confirmed evidence for short-term effectiveness of multimodal
      interdisciplinary specific treatment programmes for chronic back pain. Indeed, the proof of a
      lasting protection of achieved effects is missing so far. For a long-term improvement of pain
      and functional ability high intervention intensity or high extent seems to be necessary (>
      100 therapy hours). Especially in chronic back pain rehabilitation specific aftercare
      programs 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 bio-psycho-social exercise based aftercare intervention program,
      specifically structured for the needs of chronic low back pain (CLBP) patients, leeds to a
      better rehabilitation outcome in comparison to current usual aftercare (IRENA) and a control
      group that is given an educational booklet 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.

      Discussion:

      Special methodological and logistic challenges are to be mastered in this trial, which accrue
      from the engagement of aftercare interventions to their residential district and the fact the
      fact that the proportion of patients, who take part in aftercare programs, is low. The
      usability of the aftercare program lies in the transference into the routine care and is also
      given by developed manuals with structured contents, media and material for organisation
      assistance as well as training draughts for practise therapists in the aftercare.
    

Intervention name(s): educational booklet; IRENA; RÜCKGEWINN
Intervention type(s): Other; Other; Other
Intervention description(s): 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.; 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.; 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.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: exercise; physical activity