Patient-oriented training practice in orthopaedic rehabilitation through dissemination of an evaluated training program

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00004835
• Date of registration: 19/03/2013
• Prospective Registration: No
• Primary sponsor: Universität Würzburg, Abteilung für Medizinische Psychologie und Psychotherapie, Medizinische Soziologie und Rehabilitationswissenschaften
• Public title: Patient-oriented training practice in orthopaedic rehabilitation through dissemination of an evaluated training program
• Scientific title: Patient-oriented training practice in orthopaedic rehabilitation through dissemination of an evaluated training program - none
• Date of first enrolment: 02/05/2011
• Target sample size: 540
• Recruitment status: Complete
• URL: http://drks.de/search/en/trial/DRKS00004835
• Study type: interventional
• Study design: Allocation: Non-randomized controlled study; Masking: Blinded (masking used); Control: active; Assignment: other; Study design purpose: treatment
• Phase: N/A

Countries of recruitment

Germany

Contacts

• Name: Karin Meng
• Affiliation: Universität Würzburg, Abteilung für Medizinische Psychologie und Psychotherapie, Medizinische Soziologie und Rehabilitationswissenschaften

• Name: Karin Meng
• Affiliation: Universität Würzburg, Arbeitsbereich Rehabilitationswissenschaften

Key inclusion & exclusion criteria

Inclusion criteria: chronic low back pain patients (main diagnosis: M51, M53, M54) in inpatient orthopedic rehabilitation clinics
Exclusion criteria: (a) age below 18 or above 65 years, (b) inadequate German language ability, (c) severe visual or hearing impairment

Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Other intervertebral disc disorders

Dorsalgia

Other dorsopathies, not elsewhere classified

M51
M53
M54

Intervention(s)

Group 1: Intervention patients receive the new standardized back school "Curriculum Rückenschule" (Meng et al., 2009; 2011) after implementation into routine-use. The back school program consists of 7 patient-oriented, interactive sessions of 55 minutes, which are held in small groups of a closed format (15 participants or less). The program is manual-based and interdisciplinary with sessions led by a physiotherapist (five sessions), an orthopedist (one session) and a psychologist (one session). In each session, patients are actively involved in the educational process by the trainers using a combination of methods (short lectures, group discussion, small group work, practice, and individual work). Didactic materials included PowerPoint presentations, flipcharts, handouts and work sheets. To promote physical activity, a theory-based intervention is applied. Contents of the lessons included basic knowledge about back pain (e.g. epidemiology, risk factors, development, disorders, therapy) with regard to physical, psychological (fear-avoidance-endurance model, coping behavior) and social aspects. Spine-related exercises (muscle training and active stabilization) and techniques to promote physical activity (e.g. motivation, self-regulation) are also part of the lessons. All sessions followed a common bio-psycho-social model.
The back school program has been developed by an interdisciplinary group of health professionals and scientists. The superior effectiveness of the back school as compared to a traditional one has been demonstrated with regard to illness knowledge and self-management behaviors in short-, intermediate- and long-term (Meng et al., 2009, 2011).
Internet ressource: http://www.psychotherapie.uni-wuerzburg.de/forschung/projekte-koop_12.html
Group 2: Con

Primary Outcome(s)

1) Illness knowledge about back pain and its treatment (short-term/discharge); Questionnaire "Illness knowledge" (Meng et al., 2009; 2011); Time frame: admission, discharge, after 6 and 12 months
2) Back exercises (long-term/12 months after discharge from rehabilitation); Questionnaire "Back exercises" (Göhner, 2003); Time frame: admission, after 6 and 12 months

Secondary Outcome(s)

1) Physical activity; The Freiburger questionnaire on physical activity (Frey et al., 1999); Time frame: admission, after 6 and 12 months.
2) Motivational and volitional determinants of physical activity; HAPA-Questionnaires (Schwarzer et al., 2007; Sniehotta et al., 2005); Time frame: admission, discharge, after 6 and 12 months.
3) Fear-Avoidance-Beliefs; Fear-Avoidance Beliefs Questionnaire FABQ-D (Pfingsten et al., 1997); Time frame: admission, discharge, after 6 and 12 months.
4) Avoidance behavior; German version of the Pain Anxiety Symptoms Scale PASS (McCracken et al., 1992; Quint, 2007); Time frame: admission, discharge, after 6 and 12 months.
5) Pain coping strategies; German Pain Management Questionnaire FESV (Geissner, 2006); Time frame: admission, discharge, after 6 and 12 months.
6) Pain intensity; Numeric Rating Scale NRS (Pfingsten et al., 2007); Time frame: admission, discharge, after 6 and 12 months.
7) Funktional ability; Hannover Functional Ability Questionnaire FFbH-R (Kohlmann & Raspe, 1996); Time frame: admission, discharge, after 6 and 12 months.
8) Health related quality of live; German SF-12, a shortened version of the SF-36 Health Survey (Bullinger & Kirch-berger, 1998); Time frame: admission, discharge, after 6 and 12 months.
9) treatment satisfaction with the back school; Questionnaire (Meng et al., 2009); Time frame: discharge.

Source(s) of Monetary Support

BMBF - Projektträger im DLR

Ethics review

Status: Approved
Approval date: 25/03/2011
Contact:

[e-mail]

Ethik-Kommission der Universität Würzburg, Institut für Pharmakologie und Toxikologie

[phone]

[e-mail]

Results

• Results available: Yes
• Date Posted: 11/03/2016
• Date Completed: 30/06/2014
• URL: http://drks.de/search/en/trial/DRKS00004835#studyResults