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

Study Overview
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Brief Summary
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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.

Official Title
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Behavioral Exercise Therapy to Optimize Inpatient Behavioral Orthopedic Rehabilitation for Chronic Non-specific Low Back Pain

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Behavioral: Behavioral Medical Rehabilitation plus behavioral exercise therapy
* Behavioral: Usual Behavioral Medical Rehabilitation


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br> | Behavioral: Usual Behavioral Medical Rehabilitation<br>* 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.<br>|
| Experimental: Intervention Group<br> | Behavioral: Behavioral Medical Rehabilitation plus behavioral exercise therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | one year | 
| 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). | one year | 
| 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. | one year | 
| Generalized Anxiety Disorder (GAD-7) (Löwe et al., 2008) |  | one year | 
| 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). | one year | 
| Health-related Quality of Life (SF-12) (Bullinger, Kirchberger, 1998) |  | one year | 
| Depression (PHQ-D) (Löwe et al., 2002) |  | one year | 
| Perceived Stress scale (Cohen, Williamson, 1988) |  | one year | 
| 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. | one year | 
| Questionnaire for the detection of pain coping strategies (FESV) (Geissner, 2001) |  | one year | 
| Tampa Scale of Kinesiophobia (TSK) (Kori et al., 1990) |  | one year | 
| Avoidance-Endurance Questionnaire (AEQ) (Hasenbring et al., 2009) |  | one year |