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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02056951
Recruitment Status : Completed
First Posted : February 6, 2014
Last Update Posted : September 9, 2015
Sponsor:
Collaborators:
Deutsche Rentenversicherung
University of Wuerzburg
Information provided by (Responsible Party):
Prof. Dr. Klaus Pfeifer, University of Erlangen-Nürnberg

Tracking Information
First Submitted Date  ICMJE February 4, 2014
First Posted Date  ICMJE February 6, 2014
Last Update Posted Date September 9, 2015
Study Start Date  ICMJE January 2008
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2014)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 5, 2014)
  • Tampa Scale of Kinesiophobia [ Time Frame: baseline, three weeks, one year ]
    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.
  • Patient Health Questionnaire (PHQ) [ Time Frame: baseline, three weeks, one year ]
    Löwe B, Spitzer RL, Zipfel S & Herzog W (2002). Gesundheitsfragebogen für Patienten (PHQ-D). Manual und Testunterlagen (2. Aufl.). Karlsruhe: Pfizer.
  • Pain Catastrophizing Scale (PCS) [ Time Frame: baseline, three weeks, one year ]
    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.
  • Self-control inventory (SSI-L) [ Time Frame: baseline, one year ]
    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.
  • HAPA variables [ Time Frame: baseline, three weeks, one year ]
    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.
  • Stage of behavior change [ Time Frame: baseline, one year ]
    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.
  • Graded Chronic Pain Status (GCPS) [ Time Frame: baseline, one year ]
    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.
  • Time off work for back pain [ Time Frame: baseline, one year ]
    Self-reported day of sick leave due to low back pain during the last six month
  • Health care utilization due to low back pain [ Time Frame: baseline, one year ]
    Self-reported health care utilization due to low back pain during the last six months
  • Job satisfaction [ Time Frame: baseline, one year ]
    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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Interprofessional Rehabilitation for Adults With Chronic Non-specific Low Back Pain
Official Title  ICMJE Interprofessional Biopsychosocial Rehabilitation to Optimize Inpatient Multidisciplinary Orthopedic Rehabilitation for Chronic Low Back Pain
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Low Back Pain
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Multidisciplinary rehabilitation
  • 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.
    Intervention: Procedure: Interprofessional rehabilitation
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 5, 2014)
536
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02056951
Other Study ID Numbers  ICMJE 0421-FSCP-0529
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Dr. Klaus Pfeifer, University of Erlangen-Nürnberg
Study Sponsor  ICMJE University of Erlangen-Nürnberg
Collaborators  ICMJE
  • Deutsche Rentenversicherung
  • University of Wuerzburg
Investigators  ICMJE
Study Chair: Klaus Pfeifer, Prof. Dr. Friedrich-Alexander-University Erlangen-Nürnberg, Institute of Sport Science and Sport
PRS Account University of Erlangen-Nürnberg
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP