Effect and Sustainability of a Bio-psycho-social Exercise Program (RÜCKGEWINN) for Chronic Low Back Pain in Rehabilitation Aftercare - a Randomised Controlled Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 299
- Locations
- 12
- Primary Endpoint
- Perceived pain-related functional disability as measured with the Hanover Functional Ability Questionnaire (Kohlmann & Raspe, Rehabilitation. 1996;35:I-VIII.)
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Perceived pain-related functional disability as measured with the Hanover Functional Ability Questionnaire (Kohlmann & Raspe, Rehabilitation. 1996;35:I-VIII.)
Time Frame: one year
Secondary Outcomes
- 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)
Investigators
Prof. Dr. Klaus Pfeifer
Chair for Exercise and Health
University of Erlangen-Nürnberg