Clinical trial NCT02056951: Interprofessional Rehabilitation for Adults With Chronic Non-specific Low Back Pain
Official title: Interprofessional Biopsychosocial Rehabilitation to Optimize Inpatient Multidisciplinary Orthopedic Rehabilitation for Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Rehabilitation
Treatment Outcome
Interprofessional Relations
Interdisciplinary Communication
Behavioural Exercise Therapy
Cognitive Therapy
Health Education
Workplace related information
Multicenter Study
Lead sponsor: University of Erlangen-Nürnberg
Sponsor class: OTHER
Collaborators: name: Deutsche Rentenversicherung
name: University of Wuerzburg
First posted: 2014-02-06
Enrollment: 536
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Change from Baseline in Hannover Functional Ability Questionnaire (FFbH-R) at 12 months
timeFrame: baseline, one year
Secondary outcomes:
measure: Health-related Quality of Life (SF-12)
timeFrame: baseline, three weeks, one year
measure: Numerical rating scale (NRS)
timeFrame: baseline, three weeks, one year
measure: Freiburg Questionnaire of physical activity (FFkA)
timeFrame: baseline, one year
measure: Pain Management Questionnaire (FESV)
timeFrame: baseline, three weeks, one year
measure: Avoidance-Endurance Questionnaire (AEQ)
timeFrame: baseline, three weeks, one year
measure: Change from Baseline in Hannover Functional Ability Questionnaire (FFbH-R) at 3 weeks
timeFrame: baseline, three weeks
Other outcomes:
measure: Tampa Scale of Kinesiophobia
timeFrame: baseline, three weeks, one year
measure: Patient Health Questionnaire (PHQ)
timeFrame: baseline, three weeks, one year
measure: Pain Catastrophizing Scale (PCS)
timeFrame: baseline, three weeks, one year
measure: Self-control inventory (SSI-L)
timeFrame: baseline, one year
measure: HAPA variables
timeFrame: baseline, three weeks, one year
measure: Stage of behavior change
timeFrame: baseline, one year
measure: Graded Chronic Pain Status (GCPS)
timeFrame: baseline, one year
measure: Time off work for back pain
timeFrame: baseline, one year
measure: Health care utilization due to low back pain
timeFrame: baseline, one year
measure: Job satisfaction
timeFrame: baseline, one year
Locations:
city: Bad Kissingen
country: Germany
facility: Frankenklinik
state: Bavaria
city: Bad Steben
country: Germany
facility: Klinik Franken, Reha-Zentrum Bad Steben
state: Bavaria
city: Schaufling
country: Germany
facility: Asklepios Klinik Schaufling
state: Bavaria
city: Würzburg
country: Germany
facility: University of Würzburg, Department of Medical Psychology, Medical Sociology, and Rehabilitation Sciences
state: Bavaria
Study officials:
affiliation: Friedrich-Alexander-University Erlangen-Nürnberg, Institute of Sport Science and Sport
name: Klaus Pfeifer, Prof. Dr.
role: STUDY_CHAIR
References:
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.