Back to resultsBehavioral Exercise Therapy and Multidisciplinary Rehabilitation for Chronic Non-specific Low Back Pain (VBT)
Primary Purpose
Chronic Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Behavioral Medical Rehabilitation plus behavioral exercise therapy
Usual Behavioral Medical Rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low Back Pain
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)
Sites / Locations
- Institute of Sport Science and Sport
- Paracelsus-Klinik an der Gande
- Klinik Weser
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control Group
Intervention Group
Arm Description
Outcomes
Primary Outcome Measures
Hannover Functional Ability Questionnaire (HFAQ) (Kohlmann, Raspe, 1996)
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)
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)
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)
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)
HAPA variables (Fleig et al., 2011; Sniehotta et al., 2005; Schwarzer et al., 2011)
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)
Depression (PHQ-D) (Löwe et al., 2002)
Perceived Stress scale (Cohen, Williamson, 1988)
Attitudes towards performing sports (Brand, 2006)
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)
Tampa Scale of Kinesiophobia (TSK) (Kori et al., 1990)
Avoidance-Endurance Questionnaire (AEQ) (Hasenbring et al., 2009)
Full Information
NCT ID
NCT01666639
First Posted
June 18, 2012
Last Updated
January 26, 2014
Sponsor
University of Erlangen-Nürnberg
Collaborators
Deutsche Rentenversicherung
1. Study Identification
Unique Protocol Identification Number
NCT01666639
Brief Title
Behavioral Exercise Therapy and Multidisciplinary Rehabilitation for Chronic Non-specific Low Back Pain
Acronym
VBT
Official Title
Behavioral Exercise Therapy to Optimize Inpatient Behavioral Orthopedic Rehabilitation for Chronic Non-specific Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Erlangen-Nürnberg
Collaborators
Deutsche Rentenversicherung
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
351 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Active Comparator
Arm Title
Intervention Group
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Medical Rehabilitation plus behavioral exercise therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual Behavioral Medical Rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hannover Functional Ability Questionnaire (HFAQ) (Kohlmann, Raspe, 1996)
Description
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).
Time Frame
one year
Secondary Outcome Measure Information:
Title
Freiburger Questionnaire on Physical Activity (FQPA) (Frey et al., 1999)
Description
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.
Time Frame
one year
Title
Numeric Rating Scale (NRS) to assess pain intensity (Farrar et al., 2001)
Description
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).
Time Frame
one year
Title
Graded Chronic Pain Status (GCPS)(von Korff et al., 1992)(adapted for 6 months)
Description
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.
Time Frame
one year
Title
Generalized Anxiety Disorder (GAD-7) (Löwe et al., 2008)
Time Frame
one year
Title
HAPA variables (Fleig et al., 2011; Sniehotta et al., 2005; Schwarzer et al., 2011)
Description
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).
Time Frame
one year
Title
Health-related Quality of Life (SF-12) (Bullinger, Kirchberger, 1998)
Time Frame
one year
Title
Depression (PHQ-D) (Löwe et al., 2002)
Time Frame
one year
Title
Perceived Stress scale (Cohen, Williamson, 1988)
Time Frame
one year
Title
Attitudes towards performing sports (Brand, 2006)
Description
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.
Time Frame
one year
Title
Questionnaire for the detection of pain coping strategies (FESV) (Geissner, 2001)
Time Frame
one year
Title
Tampa Scale of Kinesiophobia (TSK) (Kori et al., 1990)
Time Frame
one year
Title
Avoidance-Endurance Questionnaire (AEQ) (Hasenbring et al., 2009)
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Institute of Sport Science and Sport
City
Erlangen
State/Province
Bavaria
ZIP/Postal Code
91058
Country
Germany
Facility Name
Paracelsus-Klinik an der Gande
City
Bad Gandersheim
State/Province
Lower Saxony
ZIP/Postal Code
37581
Country
Germany
Facility Name
Klinik Weser
City
Bad Pyrmont
State/Province
Lower Saxony
ZIP/Postal Code
31812
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
23496822
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.
Results Reference
background
PubMed Identifier
34051780
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.
Results Reference
derived
Links:
URL
http://www.forschung-patientenorientierung.de/index.php/projekte/zweite-foerderphase/modul-zwei-phase-2/vmo-vbt-pfeifer.html
Description
Homepage: Research funding for care-oriented research "Chronic diseases and patient orientation"
Learn more about this trial
Behavioral Exercise Therapy and Multidisciplinary Rehabilitation for Chronic Non-specific Low Back Pain
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