Low Back Pain
Conditions
Keywords
Rehabilitation, Treatment Outcome, Interprofessional Relations, Interdisciplinary Communication, Behavioural Exercise Therapy, Cognitive Therapy, Health Education, Workplace related information, Multicenter Study
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.
Interventions
PROCEDUREMultidisciplinary 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.
PROCEDUREInterprofessional 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
Sponsors
Deutsche Rentenversicherung
University of Wuerzburg
University of Erlangen-Nürnberg
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Hannover Functional Ability Questionnaire (FFbH-R) at 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numerical rating scale (NRS) | 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) | 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. |
| Health-related Quality of Life (SF-12) | 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. |
| Avoidance-Endurance Questionnaire (AEQ) | 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 | 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. |
| Pain Management Questionnaire (FESV) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time off work for back pain | baseline, one year | Self-reported day of sick leave due to low back pain during the last six month |
| Tampa Scale of Kinesiophobia | 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. |
| Job satisfaction | 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. |
| Health care utilization due to low back pain | baseline, one year | Self-reported health care utilization due to low back pain during the last six months |
| Patient Health Questionnaire (PHQ) | 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) | 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) | 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 | 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 | 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) | 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. |
Countries
Germany
Outcome results
None listed