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

Study Overview
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Brief Summary
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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.

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

Conditions
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Low Back Pain

Intervention / Treatment
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* Procedure: Multidisciplinary rehabilitation
* Procedure: Interprofessional rehabilitation


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Multidisciplinary rehabilitation<br>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. | Procedure: Multidisciplinary rehabilitation<br>* 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.<br>|
| Experimental: Interprofessional rehabilitation<br>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. | Procedure: Interprofessional rehabilitation<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Hannover Functional Ability Questionnaire (FFbH-R) at 12 months | 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. | baseline, one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related Quality of Life (SF-12) | To assess mental and physical health status during the past four weeks. Bullinger M & Kirchberger I (1998). SF-36, Fragebogen zum Gesundheitszustand. Göttingen: Hogrefe. | baseline, three weeks, one year | 
| Numerical rating scale (NRS) | 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. | baseline, three weeks, one year | 
| Freiburg Questionnaire of physical activity (FFkA) | 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. | baseline, one year | 
| Pain Management Questionnaire (FESV) | Questionnaire to assess cognitive and behavioral pain coping strategies. Geissner E (2001). Fragebogen zur Erfassung der Schmerzverarbeitung (FESV). Manual. Göttingen: Hogrefe. | baseline, three weeks, one year | 
| Avoidance-Endurance Questionnaire (AEQ) | 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. | baseline, three weeks, one year | 
| Change from Baseline in Hannover Functional Ability Questionnaire (FFbH-R) at 3 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. | baseline, three weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation, Treatment Outcome, Interprofessional Relations, Interdisciplinary Communication, Behavioural Exercise Therapy, Cognitive Therapy, Health Education, Workplace related information, Multicenter Study