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

Phase 2

Completed

• Conditions: Low Back Pain
• Interventions: Other: educational booklet; Other: IRENA; Other: RÜCKGEWINN

• Registration Number: NCT01070849
• Lead Sponsor: University of Erlangen-Nürnberg

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.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-02-17
• Study First Submitted QC: 2010-02-17
• Study First Posted: 2010-02-18
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-17
• Last Update Posted: 2012-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 299

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
a) educational booklet	educational booklet	-
b) IRENA	IRENA	-
c) RÜCKGEWINN	RÜCKGEWINN	-

Primary Outcome Measures

Name	Time	Method
Perceived pain-related functional disability as measured with the Hanover Functional Ability Questionnaire (Kohlmann & Raspe, Rehabilitation. 1996;35:I-VIII.)	one year

Secondary Outcome Measures

Name	Time	Method
Graded chronic pain (GCPS, Von Korff et al. 1992)	one year
Catastrophizing (KPI-AE KRSS, Hasenbring 1994)	one year
Fear avoidance Beliefs (TSK-DE, Schaub et al. 2004)	one year
Physical activity (Freiburger FB, Frey et al. 1999)	one year

Trial Locations

Locations (6)

Rehabilitationsklinik Dübener Heide; 🇩🇪 Bad Schmiedeberg, Brandenburg, Germany

Zentrum für ambulante Rehabilitation (ZaR) Abt. I BO; 🇩🇪 Berlin, Germany

MEDIAN Klinik Hoppegarten; 🇩🇪 Hoppegarten (Mark), Brandenburg, Germany

Rehabilitationsklinik Lautergrund; 🇩🇪 Bad Staffelstein, Bavaria, Germany

REHA-Tagesklinik im Forum Pankow; 🇩🇪 Berlin, Germany

Vivantes Rehabilitation Abt. I BO; 🇩🇪 Berlin, Germany