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Behavioral Exercise Therapy (BET) to Optimize Inpatient Behavioral Orthopedic Rehabilitation for Chronic Low Back Pain (VBT)

This study is currently recruiting participants.
Verified December 2012 by University of Erlangen-Nürnberg
Sponsor:
Collaborators:
Klinik Weser, Bad Pyrmont
Paracelsus-Klinik an der Gande, Bad Gandersheim
Information provided by (Responsible Party):
Prof. Dr. Klaus Pfeifer, University of Erlangen-Nürnberg
ClinicalTrials.gov Identifier:
NCT01666639
First received: June 18, 2012
Last updated: December 14, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Chronic Low Back Pain
 Behavioral: Behavioral Medical Rehabilitation plus behavioral exercise therapy
Behavioral: Usual Behavioral Medical Rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Behavioral Exercise Therapy (BET) to Optimize Inpatient Behavioral Orthopedic Rehabilitation for Chronic Low Back Pain

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Erlangen-Nürnberg:

Primary Outcome Measures:
  • Hannover Functional Ability Questionnaire (HFAQ) (Kohlmann, Raspe, 1996) [ Time Frame: one year ] [ Designated as safety issue: No ]
    The Hannover Functional Ability Questionnaire surveys the subjective estimate of a person of his or her functional ability in the context of physical activities of daily living. The Questionnaire has 12 Items. The participant is asked whether he or she is able to perform activities (e.g. to put on and pull off one's socks) and rates each on a 3-point scale (1=yes, 2=yes, but with trouble), 3=no, or only with help).


Secondary Outcome Measures:
  • Freiburger Questionnaire on Physical Activity (FQPA) (Frey et al., 1999) [ Time Frame: one year ] [ Designated as safety issue: No ]
    The FQPA measures the amount of physical activity in different contexts performed by the participants: occupational setting (rating: intensive movement, moderate movement, mostly sitting) as well as leisure time physical activity (e.g. gardening, stair-climbing, habitual walking and cycling, sports). It consists of eight items.

  • Numeric Rating Scale (NRS) to assess pain intensity (Farrar et al., 2001) [ Time Frame: one year ] [ Designated as safety issue: No ]
    Three items to assess the pain intensity felt by participants at the moment, as well as during the last six months (mean and maximum pain).

  • Graded Chronic Pain Status (GCPS)(von Korff et al., 1992)(adapted for 6 months) [ Time Frame: one year ] [ Designated as safety issue: No ]
    Six items to assess the number of days with pain during the last six months, the history of pain and the functional disability due to pain.

  • Generalized Anxiety Disorder (GAD-7) (Löwe et al., 2008) [ Time Frame: one year ] [ Designated as safety issue: No ]
  • HAPA variables (Fleig et al., 2011; Sniehotta et al., 2005; Schwarzer et al., 2011) [ Time Frame: one year ] [ Designated as safety issue: No ]
    The HAPA variables include a stage assessment of behaviour change: Have you performed moderate physical for 30 minutes or longer on a minimum of 3 days per week? (rating: No, and I don't intend to do so - No, but I am currently thinking about that - No, but I strongly intend to do so - Yes, but it is difficult to me - Yes and it is easy to me) Further more, the HAPA variables include a validation item ("Since when are you regularly active as you are now?") and sets of items about the participants' intention, self-efficacy, action and coping planning, risk perception, expectations of consequences of physical activity behaviour and action control regarding physical activity. See Schwarzer et al., 2011 (Rehabilitation psychology 56(3), 161-170) for more details. Furthermore, experiences with physical activity are included (Fleig et al., 2011).

  • Health-related Quality of Life (SF-12) (Bullinger, Kirchberger, 1998) [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Depression (PHQ-D) (Löwe et al., 2002) [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Perceived Stress scale (Cohen, Williamson, 1988) [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Attitudes towards performing sports (Brand, 2006) [ Time Frame: one year ] [ Designated as safety issue: No ]
    Four items assess the attitudes towards performing physical activity which are based on cognitions (e.g. "When I think about it, I regard physical activity as: not healthy -- very healthy"). Four items assess the attitudes based on affective judgement (e.g. "When I think about bein physically active, I feel not satisfied -- very satisfied"). Each of the eight items is rated on a 7-point scale in between the two poles.

  • Questionnaire for the detection of pain coping strategies (FESV) (Geissner, 2001) [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Tampa Scale of Kinesiophobia (TSK) (Kori et al., 1990) [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Avoidance-Endurance Questionnaire (AEQ) (Hasenbring et al., 2009) [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 214
Study Start Date: March 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control Group Behavioral: Usual Behavioral Medical Rehabilitation
The Behavioral Medical Rehabilitation (BMR), which is in this case the control group (usual care), consists of usual orthopedic medical care, exercise therapy, individual physiotherapy, psychological treatment elements (e.g. a pain management group), occupational therapy and back school. Pain medication is given if necessary. For the most part, the psychological elements draw a distinction between more "traditional" concepts or orthopedic rehabilitation and the BMR. The pain management group with its cognitive-behavioral principles comprises 9 sessions of 90 minutes each.
Experimental: Intervention Group Behavioral: Behavioral Medical Rehabilitation plus behavioral exercise therapy
The Intervention Group is characterized by the same treatment as in the control group, plus a modification of the exercise therapy. An "Behavioral Exercise Therapy" (BET) is implemented in the usual care. The Behavioral Exercise Therapy is based on a goal-oriented and systematic combination of knowledge-, behavior-, and exercise-related elements. It had been developed prior as part of a multidisciplinary treatment and was adapted for this study. The Aims of BET are gradual improvements of individual coping competencies and self-management regarding back pain as well as long-term adherence to physical activity.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01666639

Contacts
Contact: Jana Hofmann, M.A. +499131-8528171 Jana.Hofmann@sport.uni-erlangen.de
Contact: Stefan G. Peters, Dipl.-Sportwiss. +499131/85-28175 Stefan.Peters@sport.uni-erlangen.de

Locations
Germany
Institute of Sport Science and Sport Recruiting
Erlangen, Bavaria, Germany, 91058
Contact: Jana Hofmann, M.A.     +499131-8528171     Jana.Hofmann@sport.uni-erlangen.de    
Contact: Klaus Pfeifer, Prof.Dr.     +49913185-28106     klaus.pfeifer@sport.uni-erlangen.de    
Sub-Investigator: Jana Hofmann, M.A.            
Sponsors and Collaborators
University of Erlangen-Nürnberg
Klinik Weser, Bad Pyrmont
Paracelsus-Klinik an der Gande, Bad Gandersheim
  More Information

No publications provided by University of Erlangen-Nürnberg

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Prof. Dr. Klaus Pfeifer, Prof. Dr., University of Erlangen-Nürnberg
ClinicalTrials.gov Identifier: NCT01666639     History of Changes
Other Study ID Numbers: 0421-FSCP-Z256
Study First Received: June 18, 2012
Last Updated: December 14, 2012
Health Authority: Germany: German Pension Insurance

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013