Low Back Pain Clinical Trial
Official title:
Effect and Sustainability of a Bio-psycho-social Exercise Program (RÜCKGEWINN) for Chronic Low Back Pain in Rehabilitation Aftercare - a Randomised Controlled Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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