search
Back to results

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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Multidisciplinary rehabilitation
Interprofessional rehabilitation
Sponsored by
University of Erlangen-Nürnberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Rehabilitation, Treatment Outcome, Interprofessional Relations, Interdisciplinary Communication, Behavioural Exercise Therapy, Cognitive Therapy, Health Education, Workplace related information, Multicenter Study

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Frankenklinik
  • Klinik Franken, Reha-Zentrum Bad Steben
  • Asklepios Klinik Schaufling
  • University of Würzburg, Department of Medical Psychology, Medical Sociology, and Rehabilitation Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Multidisciplinary rehabilitation

Interprofessional rehabilitation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
February 4, 2014
Last Updated
September 8, 2015
Sponsor
University of Erlangen-Nürnberg
Collaborators
Deutsche Rentenversicherung, University of Wuerzburg
search

1. Study Identification

Unique Protocol Identification Number
NCT02056951
Brief Title
Interprofessional Rehabilitation for Adults With Chronic Non-specific Low Back Pain
Acronym
PASTOR
Official Title
Interprofessional Biopsychosocial Rehabilitation to Optimize Inpatient Multidisciplinary Orthopedic Rehabilitation for Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Erlangen-Nürnberg
Collaborators
Deutsche Rentenversicherung, University of Wuerzburg

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Rehabilitation, Treatment Outcome, Interprofessional Relations, Interdisciplinary Communication, Behavioural Exercise Therapy, Cognitive Therapy, Health Education, Workplace related information, Multicenter Study

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
536 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multidisciplinary rehabilitation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Interprofessional rehabilitation
Arm Type
Experimental
Arm Description
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 Type
Procedure
Intervention Name(s)
Multidisciplinary rehabilitation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Interprofessional rehabilitation
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from Baseline in Hannover Functional Ability Questionnaire (FFbH-R) at 12 months
Description
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
Secondary Outcome Measure Information:
Title
Health-related Quality of Life (SF-12)
Description
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
Title
Numerical rating scale (NRS)
Description
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
Title
Freiburg Questionnaire of physical activity (FFkA)
Description
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
Title
Pain Management Questionnaire (FESV)
Description
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
Title
Avoidance-Endurance Questionnaire (AEQ)
Description
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
Title
Change from Baseline in Hannover Functional Ability Questionnaire (FFbH-R) at 3 weeks
Description
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
Other Pre-specified Outcome Measures:
Title
Tampa Scale of Kinesiophobia
Description
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
Title
Patient Health Questionnaire (PHQ)
Description
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
Title
Pain Catastrophizing Scale (PCS)
Description
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
Title
Self-control inventory (SSI-L)
Description
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
Title
HAPA variables
Description
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
Title
Stage of behavior change
Description
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
Title
Graded Chronic Pain Status (GCPS)
Description
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
Title
Time off work for back pain
Description
Self-reported day of sick leave due to low back pain during the last six month
Time Frame
baseline, one year
Title
Health care utilization due to low back pain
Description
Self-reported health care utilization due to low back pain during the last six months
Time Frame
baseline, one year
Title
Job satisfaction
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Pfeifer, Prof. Dr.
Organizational Affiliation
Friedrich-Alexander-University Erlangen-Nürnberg, Institute of Sport Science and Sport
Official's Role
Study Chair
Facility Information:
Facility Name
Frankenklinik
City
Bad Kissingen
State/Province
Bavaria
ZIP/Postal Code
97688
Country
Germany
Facility Name
Klinik Franken, Reha-Zentrum Bad Steben
City
Bad Steben
State/Province
Bavaria
ZIP/Postal Code
95138
Country
Germany
Facility Name
Asklepios Klinik Schaufling
City
Schaufling
State/Province
Bavaria
ZIP/Postal Code
94571
Country
Germany
Facility Name
University of Würzburg, Department of Medical Psychology, Medical Sociology, and Rehabilitation Sciences
City
Würzburg
State/Province
Bavaria
ZIP/Postal Code
97070
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
25768735
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs