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

NCT01070849 | Completed Phase 2

• 1 other identifier: 8011 - 106 - 31/31.87
• Study Type: interventional
• Target: 299
• Locations: 1 country
• Sites: 6

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.

Conditions

Low Back Pain

Keywords

exercise; physical activity

Outcome Measures

Primary Outcomes (1)

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

  one year

Secondary Outcomes (4)

• 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

Study Arms (3)

a) educational booklet

ACTIVE COMPARATOR

Other: educational booklet

b) IRENA

ACTIVE COMPARATOR

Other: IRENA

c) RÜCKGEWINN

EXPERIMENTAL

Other: RÜCKGEWINN

Interventions

educational booklet OTHER

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.

a) educational booklet

IRENA OTHER

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.

b) IRENA

RÜCKGEWINN OTHER

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.

c) RÜCKGEWINN

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg: lead
• Deutsche Rentenversicherung: collaborator

Study Sites (6)

Rehabilitationsklinik Lautergrund

Bad Staffelstein, Bavaria, 96231, Germany

Location

Rehabilitationsklinik Dübener Heide

Bad Schmiedeberg, Brandenburg, 6905, Germany

Location

MEDIAN Klinik Hoppegarten

Hoppegarten (Mark), Brandenburg, 15366, Germany

Location

Zentrum für ambulante Rehabilitation (ZaR) Abt. I BO

Berlin, State of Berlin, 10115, Germany

Location

Vivantes Rehabilitation Abt. I BO

Berlin, State of Berlin, 12157, Germany

Location

REHA-Tagesklinik im Forum Pankow

Berlin, State of Berlin, 13187, Germany

Location

Related Publications (1)

• 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.

  PMID: 21083918 DERIVED

MeSH Terms

Conditions

Low Back Pain; Motor Activity

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Klaus Pfeifer, Prof. Dr.

  Institute of Sport Science and Sport / University of Erlangen-Nürnberg

  PRINCIPAL INVESTIGATOR

• Christian Hentschke, Dipl. Sportwiss.

  Institute of Sport Science and Sport / University of Erlangen-Nürnberg

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair for Exercise and Health

Study Record Dates

• First Submitted: February 17, 2010
• First Posted: February 18, 2010
• Study Start: November 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: August 20, 2012

Record last verified: 2012-08

Locations

DE (6)