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

This study has been completed.
Sponsor:
Collaborator:
German Pension Insurance
Information provided by (Responsible Party):
Prof. Dr. Klaus Pfeifer, University of Erlangen-Nürnberg
ClinicalTrials.gov Identifier:
NCT01070849
First received: February 17, 2010
Last updated: August 17, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Low Back Pain
Other: educational booklet
Other: IRENA
Other: RÜCKGEWINN
Phase 2
Phase 3

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

Resource links provided by NLM:


Further study details as provided by University of Erlangen-Nürnberg:

Primary Outcome Measures:
  • Perceived pain-related functional disability as measured with the Hanover Functional Ability Questionnaire (Kohlmann & Raspe, Rehabilitation. 1996;35:I-VIII.) [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Graded chronic pain (GCPS, Von Korff et al. 1992) [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Catastrophizing (KPI-AE KRSS, Hasenbring 1994) [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Fear avoidance Beliefs (TSK-DE, Schaub et al. 2004) [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Physical activity (Freiburger FB, Frey et al. 1999) [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 299
Study Start Date: November 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: a) educational booklet 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.
Active Comparator: b) IRENA Other: 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.
Experimental: c) RÜCKGEWINN Other: 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.

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01070849

Locations
Germany
Rehabilitationsklinik Lautergrund
Bad Staffelstein, Bavaria, Germany, 96231
Rehabilitationsklinik Dübener Heide
Bad Schmiedeberg, Brandenburg, Germany, 6905
MEDIAN Klinik Hoppegarten
Hoppegarten (Mark), Brandenburg, Germany, 15366
REHA-Tagesklinik im Forum Pankow
Berlin, Germany, 13187
Vivantes Rehabilitation Abt. I BO
Berlin, Germany, 12157
Zentrum für ambulante Rehabilitation (ZaR) Abt. I BO
Berlin, Germany, 10115
Sponsors and Collaborators
University of Erlangen-Nürnberg
German Pension Insurance
Investigators
Principal Investigator: Klaus Pfeifer, Prof. Dr. Institute of Sport Science and Sport / University of Erlangen-Nürnberg
Study Director: Christian Hentschke, Dipl. Sportwiss. Institute of Sport Science and Sport / University of Erlangen-Nürnberg
  More Information

No publications provided by University of Erlangen-Nürnberg

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. Klaus Pfeifer, Chair for Exercise and Health, University of Erlangen-Nürnberg
ClinicalTrials.gov Identifier: NCT01070849     History of Changes
Other Study ID Numbers: 8011 - 106 - 31/31.87
Study First Received: February 17, 2010
Last Updated: August 17, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by University of Erlangen-Nürnberg:
exercise
physical activity

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 22, 2014