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

Low Back Pain Clinical Trial

— PASTOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02056951
• Other study ID #: 0421-FSCP-0529
• Status: Completed
• Phase: N/A
• First received: February 4, 2014
• Last updated: September 8, 2015
• Start date: January 2008
• Est. completion date: March 2011

Study information

• Verified date: September 2015
• Source: University of Erlangen-Nürnberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 536
• Est. completion date: March 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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.
• 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

Locations

Country	Name	City	State
Germany	Frankenklinik	Bad Kissingen	Bavaria
Germany	Klinik Franken, Reha-Zentrum Bad Steben	Bad Steben	Bavaria
Germany	Asklepios Klinik Schaufling	Schaufling	Bavaria
Germany	University of Würzburg, Department of Medical Psychology, Medical Sociology, and Rehabilitation Sciences	Würzburg	Bavaria

Sponsors (3)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg	Deutsche Rentenversicherung, University of Wuerzburg

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

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