An interventional study of Multidisciplinary rehabilitation and Interprofessional rehabilitation in Low Back Pain, sponsored by University of Erlangen-Nürnberg. Completed at 4 sites in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-09-09.
Sponsored by University of Erlangen-Nürnberg · Not applicable, Interventional, and Treatment
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.
2,875 studies on the registry are indexed under Low Back Pain; 484 are open to participants now.
This study's enrollment of 536 is above the median of 60 across 2,315 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →University of Erlangen-Nürnberg is the lead sponsor of 22 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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
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
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.
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
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.
Time frame: baseline, one year
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline, three weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: baseline, one year
The record gives a start of Jan 2008, a primary completion of Dec 2010 and a completion of Mar 2011. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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University of Erlangen-Nürnberg