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

Not Applicable

Completed

• Conditions: Low Back Pain

• Registration Number: NCT02056951
• Lead Sponsor: University of Erlangen-Nürnberg

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2010-12
• Study Completion: 2011-03
• Study First Submitted: 2014-02-04
• Study First Submitted QC: 2014-02-05
• Study First Posted: 2014-02-06
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-08
• Last Update Posted: 2015-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 536

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Hannover Functional Ability Questionnaire (FFbH-R) at 12 months	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 Outcome Measures

Name	Time	Method
Pain Management Questionnaire (FESV)	baseline, three weeks, one year	Questionnaire to assess cognitive and behavioral pain coping strategies.; Geissner E (2001). Fragebogen zur Erfassung der Schmerzverarbeitung (FESV). Manual. Göttingen: Hogrefe.
Freiburg Questionnaire of physical activity (FFkA)	baseline, one year	The FQPA measures the amount of physical activity in different contexts performed by the participants: occupational setting (rating: intensive movement, moderate movement, mostly sitting) as well as leisure time physical activity (e.g. gardening, stair-climbing, habitual walking and cycling, sports). It consists of eight items.; Frey I, Berg A, Grathwohl D \& Keul J (1999). Freiburger Fragebogen zur körperlichen Aktivität - Entwicklung, Prüfung und Anwendung. Sozial- und Präventivmedizin, 44, 55-64.
Health-related Quality of Life (SF-12)	baseline, three weeks, one year	To assess mental and physical health status during the past four weeks.; Bullinger M \& Kirchberger I (1998). SF-36, Fragebogen zum Gesundheitszustand. Göttingen: Hogrefe.
Numerical rating scale (NRS)	baseline, three weeks, one year	Three items to assess the pain intensity reported by participants at the moment, as well as during the last six months (mean and maximum pain).; Nagel B, Gerbershagen HU, Lindena G \& Pfingsten M (2002). Entwicklung und empirische Überprüfung des Deutschen Schmerzfragebogens der DGSS. Schmerz, 16 (4), 263-270.
Change from Baseline in Hannover Functional Ability Questionnaire (FFbH-R) at 3 weeks	baseline, three weeks	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.
Avoidance-Endurance Questionnaire (AEQ)	baseline, three weeks, one year	Questionnaire to assess fear-avoidance response pattern and avoidance-endurance response pattern to pain.; Hasenbring MI, Hallner D \& Rusu AC (2009). Fear-avoidance- and endurance-related responses to pain: development and validation of the Avoidance-Endurance Questionnaire (AEQ). Eur J Pain, 13 (6), 620-628.

Trial Locations

Locations (4)

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