Interprofessional Rehabilitation for Adults With Chronic Non-specific Low Back Pain

NCT ID: NCT02056951

Last Updated: 2015-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 536 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2011-03-31

Brief Summary

The primary aim of the study is to analyse the long-term effectiveness of an interprofessional and interdisciplinary rehabilitation program named "PASTOR", with a biopsychosocial approach for participants with chronic non-specific low back pain (CLBP) compared to the standard inpatient multidisciplinary orthopaedic rehabilitation (MOR) in Germany. The investigators hypothesize that in adults with CLBP the rehabilitation program PASTOR would result in a significantly higher increase in functional ability 12 months after completion of the program in comparison to the standard inpatient MOR. The investigators further hypothesize that PASTOR would lead to significantly larger improvements regarding pain-related cognitions, pain coping strategies, physical activity, health-related quality of life, and back pain episodes compared to the standard inpatient MOR.

Conditions

Low Back Pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Multidisciplinary rehabilitation

The central objective of inpatient multidisciplinary orthopedic rehabilitation (MOR) is to improve functional health with the main focus on restoring and improving work ability. A MOR lasts on average 23 days with a total extent of therapy of 48 hours on average. MOR is provided by a multiprofessional team consisting of physicians, psychologists, sport therapists, physiotherapists, occupational therapists, masseurs, social workers, dieticians and nurses. The interventions are carried out mainly in open groups.

Group Type: ACTIVE_COMPARATOR

Multidisciplinary rehabilitation

Intervention Type: PROCEDURE

Multidisciplinary rehabilitation includes interventions from the physical and psychological dimensions:

• health education
• exercise therapy
• back school
• physical treatments
• psychological interventions in groups and individual counselling
• rehabilitation/social counselling.

Interprofessional rehabilitation

The central objective of the interprofessional rehabilitation (PASTOR) is the development of active self-management of chronic non-specific low back pain. PASTOR is matched to the MOR with respect to the total duration and total extent of therapy, the included professions and the interventions dimensions (physical, psychological). The differences between PASTOR and MOR are characterized by, a) an integrative combination of profession related modules within a comprehensive and consistent treatment approach, b) an interprofessional and collaborative teamwork based on profession related modules, c) the use of standardized methods, media and materials by all professions in the therapeutic team d) a highly structured and detailed manual for the entire treatment process. The interventions are carried in fixed groups with eight to twelve participants.

Group Type: EXPERIMENTAL

Interprofessional rehabilitation

Intervention Type: PROCEDURE

Interprofessional rehabilitation includes also interventions from the physical and psychological dimensions:

• education about low back pain
• behavioural exercise therapy
• coping with pain
• relaxation
• work related informations

Interventions

Multidisciplinary rehabilitation

Multidisciplinary rehabilitation includes interventions from the physical and psychological dimensions:

• health education
• exercise therapy
• back school
• physical treatments
• psychological interventions in groups and individual counselling
• rehabilitation/social counselling.

Intervention Type: PROCEDURE

Interprofessional rehabilitation

Interprofessional rehabilitation includes also interventions from the physical and psychological dimensions:

• education about low back pain
• behavioural exercise therapy
• coping with pain
• relaxation
• work related informations

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• M51.2 Other specified intervertebral disc displacement
• M51.3 Other specified intervertebral disc degeneration
• M51.4 Schmorl's nodes
• M51.8 Other specified intervertebral disc disorders
• M51.9 Intervertebral disc disorder, unspecified
• M53.8 Other specified dorsopathies
• M53.9 dorsopathy, unspecified
• M54.4 Lumbago with sciatica
• M54.5 Low back pain
• M54.6 Pain in thoracic spine
• M54.8 Other dorsalgia
• M54.9 Dorsalgia, unspecified

Exclusion Criteria

• age below 18 years or over 65 years
• specific underlying diagnosis of back pain (e. g. radicular symptoms, myelopathy)
• considerably reduced health status (e.g. comorbidity)
• considerably reduced sight and hearing (not corrected)
• severe psychiatric condition as secondary diagnosis
• inability to speak German
• current application for early retirement or invalidity pension (§51 SG V - german law)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Deutsche Rentenversicherung

OTHER

Sponsor Role: collaborator

University of Wuerzburg

OTHER

Sponsor Role: collaborator

University of Erlangen-Nürnberg

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Klaus Pfeifer

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Klaus Pfeifer, Prof. Dr.

Role: STUDY_CHAIR

Friedrich-Alexander-University Erlangen-Nürnberg, Institute of Sport Science and Sport

Locations

Frankenklinik

Bad Kissingen, Bavaria, Germany

Klinik Franken, Reha-Zentrum Bad Steben

Bad Steben, Bavaria, Germany

Asklepios Klinik Schaufling

Schaufling, Bavaria, Germany

University of Würzburg, Department of Medical Psychology, Medical Sociology, and Rehabilitation Sciences

Würzburg, Bavaria, Germany

Countries

Germany

References

Semrau J, Hentschke C, Buchmann J, Meng K, Vogel H, Faller H, Bork H, Pfeifer K. Long-term effects of interprofessional biopsychosocial rehabilitation for adults with chronic non-specific low back pain: a multicentre, quasi-experimental study. PLoS One. 2015 Mar 13;10(3):e0118609. doi: 10.1371/journal.pone.0118609. eCollection 2015.

Reference Type: RESULT

PMID: 25768735 (View on PubMed)

Other Identifiers

0421-FSCP-0529

Identifier Type: -

Identifier Source: org_study_id