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Clinical Trials/NCT02056951
NCT02056951
Completed
Not Applicable

Interprofessional Biopsychosocial Rehabilitation to Optimize Inpatient Multidisciplinary Orthopedic Rehabilitation for Chronic Low Back Pain

University of Erlangen-Nürnberg4 sites in 1 country536 target enrollmentJanuary 2008
ConditionsLow Back Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Low Back Pain
Sponsor
University of Erlangen-Nürnberg
Enrollment
536
Locations
4
Primary Endpoint
Change from Baseline in Hannover Functional Ability Questionnaire (FFbH-R) at 12 months
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2008
End Date
March 2011
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Erlangen-Nürnberg
Responsible Party
Principal Investigator
Principal Investigator

Prof. Dr. Klaus Pfeifer

Prof. Dr.

University of Erlangen-Nürnberg

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

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)

Outcomes

Primary Outcomes

Change from Baseline in Hannover Functional Ability Questionnaire (FFbH-R) at 12 months

Time Frame: baseline, one year

The FFbH-R consists of twelve items with a three-stage answering scale (2=yes; 1=yes, but with difficulty; 0=no, or only with assistance). The summary score describes the low back pain associated functional ability in activities of daily living (e.g. "Can you wash and dry yourself from head to toe?") in adults on a scale of 0% (minimum functional ability) to 100% (maximum functional ability). Kohlmann Th \& Raspe H (1996). Der Funktionsfragebogen Hannover zur alltagsnahen Diagnostik der Funktionsbeeinträchtigung durch Rückenschmerzen (FFbH-R). Die Rehabilitation, 34, I-VIII.

Secondary Outcomes

  • Pain Management Questionnaire (FESV)(baseline, three weeks, one year)
  • Freiburg Questionnaire of physical activity (FFkA)(baseline, one year)
  • Health-related Quality of Life (SF-12)(baseline, three weeks, one year)
  • Numerical rating scale (NRS)(baseline, three weeks, one year)
  • Change from Baseline in Hannover Functional Ability Questionnaire (FFbH-R) at 3 weeks(baseline, three weeks)
  • Avoidance-Endurance Questionnaire (AEQ)(baseline, three weeks, one year)

Study Sites (4)

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