Clinical trial NCT01666639: Behavioral Exercise Therapy and Multidisciplinary Rehabilitation for Chronic Non-specific Low Back Pain
Official title: Behavioral Exercise Therapy to Optimize Inpatient Behavioral Orthopedic Rehabilitation for Chronic Non-specific Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Lead sponsor: University of Erlangen-Nürnberg
Sponsor class: OTHER
Collaborators: name: Deutsche Rentenversicherung
First posted: 2012-08-16
Enrollment: 351
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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)

Primary outcomes:
measure: Hannover Functional Ability Questionnaire (HFAQ) (Kohlmann, Raspe, 1996)
timeFrame: one year
Secondary outcomes:
measure: Freiburger Questionnaire on Physical Activity (FQPA) (Frey et al., 1999)
timeFrame: one year
measure: Numeric Rating Scale (NRS) to assess pain intensity (Farrar et al., 2001)
timeFrame: one year
measure: Graded Chronic Pain Status (GCPS)(von Korff et al., 1992)(adapted for 6 months)
timeFrame: one year
measure: Generalized Anxiety Disorder (GAD-7) (Löwe et al., 2008)
timeFrame: one year
measure: HAPA variables (Fleig et al., 2011; Sniehotta et al., 2005; Schwarzer et al., 2011)
timeFrame: one year
measure: Health-related Quality of Life (SF-12) (Bullinger, Kirchberger, 1998)
timeFrame: one year
measure: Depression (PHQ-D) (Löwe et al., 2002)
timeFrame: one year
measure: Perceived Stress scale (Cohen, Williamson, 1988)
timeFrame: one year
measure: Attitudes towards performing sports (Brand, 2006)
timeFrame: one year
measure: Questionnaire for the detection of pain coping strategies (FESV) (Geissner, 2001)
timeFrame: one year
measure: Tampa Scale of Kinesiophobia (TSK) (Kori et al., 1990)
timeFrame: one year
measure: Avoidance-Endurance Questionnaire (AEQ) (Hasenbring et al., 2009)
timeFrame: one year
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Institute of Sport Science and Sport
state: Bavaria
city: Bad Gandersheim
country: Germany
facility: Paracelsus-Klinik an der Gande
state: Lower Saxony
city: Bad Pyrmont
country: Germany
facility: Klinik Weser
state: Lower Saxony
Study officials:
References:
citation: Hofmann J, Peters S, Geidl W, Hentschke C, Pfeifer K. Effects of behavioural exercise therapy on the effectiveness of a multidisciplinary rehabilitation for chronic non-specific low back pain: study protocol for a randomised controlled trial. BMC Musculoskelet Disord. 2013 Mar 11;14:89. doi: 10.1186/1471-2474-14-89.
citation: Semrau J, Hentschke C, Peters S, Pfeifer K. Effects of behavioural exercise therapy on the effectiveness of multidisciplinary rehabilitation for chronic non-specific low back pain: a randomised controlled trial. BMC Musculoskelet Disord. 2021 May 29;22(1):500. doi: 10.1186/s12891-021-04353-y.