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

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

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Procedure: Multidisciplinary rehabilitation; Procedure: Interprofessional rehabilitation

• Study Type: Interventional
• Enrollment (Actual): 536
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Bad Kissingen, Bavaria, Germany, 97688
      • Frankenklinik
    • Bad Steben, Bavaria, Germany, 95138
      • Klinik Franken, Reha-Zentrum Bad Steben
    • Schaufling, Bavaria, Germany, 94571
      • Asklepios Klinik Schaufling
    • Würzburg, Bavaria, Germany, 97070
      • University of Würzburg, Department of Medical Psychology, Medical Sociology, and Rehabilitation Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tampa Scale of Kinesiophobia	A 17-item self report checklist using a 4-point Likert scale to assess fear of movement/ re-injury. Vlaeyen JWS, Kole-Snijders AMJ, Boeren RGB, & Van Eek H (1995). Fear of movement/(re) injury in chronic low back pain and its relation to behavioral performance. Pain, 62(3), 363-372. Nigbur K, Rusu A, Hallner D & Hasenbring M (2009). Fear of movement/(re)injury in chronic pain: Preliminary validation of a German version of the Tampa Scale for Kinesiophobia. Poster presented at Pain in Europe - 6th Congress of the European Federation of IASP® Chapters (EFIC), Lisbon 2009.	baseline, three weeks, one year
Patient Health Questionnaire (PHQ)	Löwe B, Spitzer RL, Zipfel S & Herzog W (2002). Gesundheitsfragebogen für Patienten (PHQ-D). Manual und Testunterlagen (2. Aufl.). Karlsruhe: Pfizer.	baseline, three weeks, one year
Pain Catastrophizing Scale (PCS)	Meyer K, Sprott H & Mannion AF (2008). Cross-cultural adaptation, reliability, and validity of the German version of the Pain Catastrophizing Scale. J Psychosom Res, 64 (5), 469-478.	baseline, three weeks, one year
Self-control inventory (SSI-L)	Fröhlich S & Kuhl J (2003). Das Selbststeuerungsinventar: Dekomponierung volitionaler Funktionen. In: J. Stiensmeier-Pelster & F. Rheinberg (Hrsg.), Diagnostik von Motivation und Selbstkonzept (S. 221-258). Göttingen [u.a.]: Hogrefe.	baseline, one year
HAPA variables	HAPA variables include sets of items about the risk perception, self-efficacy, outcome expectations, intention, action and coping planning, and action control regarding physical activity. Sniehotta FF, Scholz U & Schwarzer R (2005). Bridging the intention-behaviour gap: Planning, self-efficacy, and action control in the adoption and maintenance of physical exercise. Psychol Health, 20 (2), 143-160. Sniehotta FF, Schwarzer R, Scholz U & Schüz B. (2005). Action planning and coping planning for long-term lifestyle change: Theory and assessment. Eur J Soc Psychol (35), 565-576.	baseline, three weeks, one year
Stage of behavior change	Stage assessment of behaviour change contains the question: Have you performed moderate physical for 30 minutes or longer on a minimum of 3 days per week? (rating: No, and I don't intend to do so - No, but I am currently thinking about that - No, but I strongly intend to do so - Yes, but it is difficult to me - Yes and it is easy to me), and a validation item ("Since when are you regularly active as you are now?") Lippke S, Ziegelmann J, Schwarzer R & Velicer W (2009). Validity of stage assessment in the adoption and maintenance of physical activity and fruit and vegetable consumption. Health Psychology (28), 183-193.	baseline, one year
Graded Chronic Pain Status (GCPS)	Six items to assess the number of days with pain during the last six months, the history of pain and the functional disability due to pain (adapted for 6 months). Korff M von, Ormel J, Keefe FJ & Dworkin SF (1992). Grading the severity of chronic pain. Pain, 50 (2), 133-149.	baseline, one year
Time off work for back pain	Self-reported day of sick leave due to low back pain during the last six month	baseline, one year
Health care utilization due to low back pain	Self-reported health care utilization due to low back pain during the last six months	baseline, one year
Job satisfaction	A 8-item self report checklist of the IRES using a 5-point Likert scale to assess job satisfaction (ranging from 1="complete agreement" to 5="complete disagreement". Bührlen B, Gerdes N & Jäckel WH (2005). Entwicklung und psychometrische Testung eines Patientenfragebogens für die medizinische Rehabilitation (IRES-3). Rehabilitation, 44, 63-74.	baseline, one year

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg
• Collaborators: University of Wuerzburg; Deutsche Rentenversicherung
• Investigators: Study Chair: Klaus Pfeifer, Prof. Dr., Friedrich-Alexander-University Erlangen-Nürnberg, Institute of Sport Science and Sport

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: February 4, 2014
• First Submitted That Met QC Criteria: February 5, 2014
• First Posted (Estimate): February 6, 2014

Study Record Updates

• Last Update Posted (Estimate): September 9, 2015
• Last Update Submitted That Met QC Criteria: September 8, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Rehabilitation; Health Education; Cognitive Therapy; Treatment Outcome; Multicenter Study; Interdisciplinary Communication; Interprofessional Relations; Behavioural Exercise Therapy; Workplace related information
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 0421-FSCP-0529