Behavioral Exercise Therapy and Multidisciplinary Rehabilitation for Chronic Non-specific Low Back Pain (VBT)

University of Erlangen-Nürnberg

Status: Completed

Conditions: Chronic Low Back Pain

Treatments: Behavioral: Behavioral Medical Rehabilitation plus behavioral exercise therapy; Behavioral: Usual Behavioral Medical Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT01666639

0421-FSCP-Z256

Details and patient eligibility

About

Multidisciplinary behavioral-orthopedic rehabilitation in the treatment of chronic back pain has proven its short-term effectiveness. Exercise therapy plays a major role in such a combination of treatments. There is a considerable need to develop theory-based exercise interventions which foster a long-term adherence to physical activity. Furthermore, an integration of behavioral elements such as coping competencies regarding back pain is needed. It is not yet clear, which specific part of multidisciplinary rehabilitation causes its effects. The role of exercise therapy has yet to be investigated. Aim of this study is the implementation of a standardized behavioral exercise therapy into an existing behavioral-medical rehabilitation for patients with chronic back pain. The main hypothesis is that the participation in the behavioral exercise therapy leads to greater short- and long-term improvements in functional capacity compared to the usual care.

Enrollment: 351 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (ICD-10):

• F45.4 Persistent somatoform pain disorder
• F45.41 Chronic pain disorder with somatic and psychological factors
• F54 Psychological and behavioural factors associated with disorders or diseases classified elsewhere
• 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 dorsophathy, 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
• R52.2 Other chronic pain

Exclusion Criteria:

• distinct specific diagnosis for back pain (e.g. radicular symptoms, myelopathy)
• severely limited health status (comorbidity)
• serious impairment of vision and hearing (not corrected)
• serious psychiatric codiagnosis (exkl. see inclusion criteria)
• inability to speak german
• pension claim (§51 SGB V - german law)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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351 participants in 2 patient groups

Control Group

Active Comparator group

Treatment:

Behavioral: Usual Behavioral Medical Rehabilitation

Intervention Group

Experimental group

Treatment:

Behavioral: Behavioral Medical Rehabilitation plus behavioral exercise therapy