- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01666639
Behavioral Exercise Therapy and Multidisciplinary Rehabilitation for Chronic Non-specific Low Back Pain (VBT)
January 26, 2014 updated by: Prof. Dr. Klaus Pfeifer, University of Erlangen-Nürnberg
Behavioral Exercise Therapy to Optimize Inpatient Behavioral Orthopedic Rehabilitation for Chronic Non-specific Low Back Pain
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
351
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bavaria
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Erlangen, Bavaria, Germany, 91058
- Institute of Sport Science and Sport
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Lower Saxony
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Bad Gandersheim, Lower Saxony, Germany, 37581
- Paracelsus-Klinik an der Gande
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Bad Pyrmont, Lower Saxony, Germany, 31812
- Klinik Weser
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Group
|
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.
|
Active Comparator: Control Group
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hannover Functional Ability Questionnaire (HFAQ) (Kohlmann, Raspe, 1996)
Time Frame: one year
|
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).
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Freiburger Questionnaire on Physical Activity (FQPA) (Frey et al., 1999)
Time Frame: one year
|
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.
|
one year
|
Numeric Rating Scale (NRS) to assess pain intensity (Farrar et al., 2001)
Time Frame: one year
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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).
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one year
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Graded Chronic Pain Status (GCPS)(von Korff et al., 1992)(adapted for 6 months)
Time Frame: one year
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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.
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one year
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Generalized Anxiety Disorder (GAD-7) (Löwe et al., 2008)
Time Frame: one year
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one year
|
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HAPA variables (Fleig et al., 2011; Sniehotta et al., 2005; Schwarzer et al., 2011)
Time Frame: one year
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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).
|
one year
|
Health-related Quality of Life (SF-12) (Bullinger, Kirchberger, 1998)
Time Frame: one year
|
one year
|
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Depression (PHQ-D) (Löwe et al., 2002)
Time Frame: one year
|
one year
|
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Perceived Stress scale (Cohen, Williamson, 1988)
Time Frame: one year
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one year
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Attitudes towards performing sports (Brand, 2006)
Time Frame: one year
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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.
|
one year
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Questionnaire for the detection of pain coping strategies (FESV) (Geissner, 2001)
Time Frame: one year
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one year
|
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Tampa Scale of Kinesiophobia (TSK) (Kori et al., 1990)
Time Frame: one year
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one year
|
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Avoidance-Endurance Questionnaire (AEQ) (Hasenbring et al., 2009)
Time Frame: one year
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one year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
June 18, 2012
First Submitted That Met QC Criteria
August 10, 2012
First Posted (Estimate)
August 16, 2012
Study Record Updates
Last Update Posted (Estimate)
January 28, 2014
Last Update Submitted That Met QC Criteria
January 26, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0421-FSCP-Z256
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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