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

Overview

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.

Full Title of Study: “Interprofessional Biopsychosocial Rehabilitation to Optimize Inpatient Multidisciplinary Orthopedic Rehabilitation for Chronic Low Back Pain”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2010

Interventions

  • Procedure: 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.
  • 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

Arms, Groups and Cohorts

  • Active Comparator: 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.
  • Experimental: 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Health-related Quality of Life (SF-12)
    • Time Frame: 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)
    • Time Frame: 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.
  • Freiburg Questionnaire of physical activity (FFkA)
    • Time Frame: 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.
  • Pain Management Questionnaire (FESV)
    • Time Frame: 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.
  • Avoidance-Endurance Questionnaire (AEQ)
    • Time Frame: 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.
  • Change from Baseline in Hannover Functional Ability Questionnaire (FFbH-R) at 3 weeks
    • Time Frame: 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.

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Erlangen-Nürnberg
  • Collaborator
    • Deutsche Rentenversicherung
  • Provider of Information About this Clinical Study
    • Principal Investigator: Prof. Dr. Klaus Pfeifer, Prof. Dr. – University of Erlangen-Nürnberg
  • Overall Official(s)
    • Klaus Pfeifer, Prof. Dr., Study Chair, Friedrich-Alexander-University Erlangen-Nürnberg, Institute of Sport Science and Sport

Citations Reporting on Results

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.

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