Clinical trial NCT01070849: A Bio-psycho-social Exercise Program (RÜCKGEWINN) for Chronic Low Back Pain in Rehabilitation Aftercare
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Low Back Pain
Keywords: exercise
physical activity
Lead sponsor: University of Erlangen-Nürnberg
Sponsor class: OTHER
Collaborators: name: Deutsche Rentenversicherung
First posted: 2010-02-18
Enrollment: 299
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

ICD-10 is used:

* M51.2 - M51.4
* M51.8 - M51.9
* M53.8 - M53.9
* M54.5, M54.8 - M54.9
* M54.4 (if radicular symptoms are not dominating)

Exclusion Criteria:

* specific reason for back pain, based on a clear cause or diagnosis, which could sufficiently explain its extent (e.g. radicular symptomatic, myelopathesis, inflammatory changes in the spinal column etc.)
* already carried out operation on the spine within the last year
* additional serious psychic diagnosis
* uncorrected serious visual and acoustic disability
* seriously reduced health status (other diseases) with considerable reduction of dexterity
* application for retirement
* low German language skills (to fulfill the questionnaires)
* age lower than 18 or over 65
* residential area out of Berlin

Primary outcomes:
measure: Perceived pain-related functional disability as measured with the Hanover Functional Ability Questionnaire (Kohlmann & Raspe, Rehabilitation. 1996;35:I-VIII.)
timeFrame: one year
Secondary outcomes:
measure: Graded chronic pain (GCPS, Von Korff et al. 1992)
timeFrame: one year
measure: Catastrophizing (KPI-AE KRSS, Hasenbring 1994)
timeFrame: one year
measure: Fear avoidance Beliefs (TSK-DE, Schaub et al. 2004)
timeFrame: one year
measure: Physical activity (Freiburger FB, Frey et al. 1999)
timeFrame: one year
Other outcomes:
Locations:
city: Bad Staffelstein
country: Germany
facility: Rehabilitationsklinik Lautergrund
state: Bavaria
city: Bad Schmiedeberg
country: Germany
facility: Rehabilitationsklinik Dübener Heide
state: Brandenburg
city: Hoppegarten (Mark)
country: Germany
facility: MEDIAN Klinik Hoppegarten
state: Brandenburg
city: Berlin
country: Germany
facility: Zentrum für ambulante Rehabilitation (ZaR) Abt. I BO
city: Berlin
country: Germany
facility: Vivantes Rehabilitation Abt. I BO
city: Berlin
country: Germany
facility: REHA-Tagesklinik im Forum Pankow
Study officials:
affiliation: Institute of Sport Science and Sport / University of Erlangen-Nürnberg
name: Klaus Pfeifer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Sport Science and Sport / University of Erlangen-Nürnberg
name: Christian Hentschke, Dipl. Sportwiss.
role: STUDY_DIRECTOR
References:
citation: Hentschke C, Hofmann J, Pfeifer K. A bio-psycho-social exercise program (RUCKGEWINN) for chronic low back pain in rehabilitation aftercare--study protocol for a randomised controlled trial. BMC Musculoskelet Disord. 2010 Nov 17;11:266. doi: 10.1186/1471-2474-11-266.