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

NCT02056951 | Completed

• 1 other identifier: 0421-FSCP-0529
• Study Type: interventional
• Target: 536
• Locations: 1 country
• Sites: 4

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.

Conditions

Low Back Pain

Keywords

Rehabilitation; Treatment Outcome; Interprofessional Relations; Interdisciplinary Communication; Behavioural Exercise Therapy; Cognitive Therapy; Health Education; Workplace related information; Multicenter Study

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Health-related Quality of Life (SF-12)

  baseline, three weeks, one year

• Numerical rating scale (NRS)

  baseline, three weeks, one year

• Freiburg Questionnaire of physical activity (FFkA)

  baseline, one year

• Pain Management Questionnaire (FESV)

  baseline, three weeks, one year

• Avoidance-Endurance Questionnaire (AEQ)

  baseline, three weeks, one year

Other Outcomes (10)

• Tampa Scale of Kinesiophobia

  baseline, three weeks, one year

• Patient Health Questionnaire (PHQ)

  baseline, three weeks, one year

• Pain Catastrophizing Scale (PCS)

  baseline, three weeks, one year

Study Arms (2)

Multidisciplinary rehabilitation

ACTIVE COMPARATOR

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

Interprofessional rehabilitation

EXPERIMENTAL

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

Interventions

Multidisciplinary rehabilitation PROCEDURE

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.

Multidisciplinary rehabilitation

Interprofessional rehabilitation PROCEDURE

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

Interprofessional rehabilitation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Erlangen-Nürnberg: lead
• Deutsche Rentenversicherung: collaborator
• University of Wuerzburg: collaborator

Study Sites (4)

Frankenklinik

Bad Kissingen, Bavaria, 97688, Germany

Location

Klinik Franken, Reha-Zentrum Bad Steben

Bad Steben, Bavaria, 95138, Germany

Location

Asklepios Klinik Schaufling

Schaufling, Bavaria, 94571, Germany

Location

University of Würzburg, Department of Medical Psychology, Medical Sociology, and Rehabilitation Sciences

Würzburg, Bavaria, 97070, Germany

Location

Related 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. 2015 Mar 13;10(3):e0118609. doi: 10.1371/journal.pone.0118609. eCollection 2015.

  PMID: 25768735 RESULT

Related Links

• Homepage: Research funding for care-oriented research "Chronic diseases and patient orientation"

MeSH Terms

Conditions

Low Back Pain; Health Education

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Klaus Pfeifer, Prof. Dr.

  Friedrich-Alexander-University Erlangen-Nürnberg, Institute of Sport Science and Sport

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: February 4, 2014
• First Posted: February 6, 2014
• Study Start: January 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: March 1, 2011
• Last Updated: September 9, 2015

Record last verified: 2015-09

Locations

DE (4)