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

Low Back Pain Clinical Trial

— RÜCKGEWINN  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01070849
• Other study ID #: 8011 - 106 - 31/31.87
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 17, 2010
• Last updated: August 17, 2012
• Start date: November 2009
• Est. completion date: October 2011

Study information

• Verified date: August 2012
• Source: University of Erlangen-Nürnberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 299
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Germany	Rehabilitationsklinik Dübener Heide	Bad Schmiedeberg	Brandenburg
Germany	Rehabilitationsklinik Lautergrund	Bad Staffelstein	Bavaria
Germany	REHA-Tagesklinik im Forum Pankow	Berlin
Germany	Vivantes Rehabilitation Abt. I BO	Berlin
Germany	Zentrum für ambulante Rehabilitation (ZaR) Abt. I BO	Berlin
Germany	MEDIAN Klinik Hoppegarten	Hoppegarten (Mark)	Brandenburg

Sponsors (2)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg	Deutsche Rentenversicherung

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived pain-related functional disability as measured with the Hanover Functional Ability Questionnaire (Kohlmann & Raspe, Rehabilitation. 1996;35:I-VIII.)		one year	Yes
Secondary	Graded chronic pain (GCPS, Von Korff et al. 1992)		one year	No
Secondary	Catastrophizing (KPI-AE KRSS, Hasenbring 1994)		one year	No
Secondary	Fear avoidance Beliefs (TSK-DE, Schaub et al. 2004)		one year	No
Secondary	Physical activity (Freiburger FB, Frey et al. 1999)		one year	No