Behavioral Exercise Therapy and Multidisciplinary Rehabilitation for Chronic Non-specific Low Back Pain (VBT)
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|ClinicalTrials.gov Identifier: NCT01666639|
Recruitment Status : Completed
First Posted : August 16, 2012
Last Update Posted : January 28, 2014
|Condition or disease||Intervention/treatment||Phase|
|Chronic Low Back Pain||Behavioral: Behavioral Medical Rehabilitation plus behavioral exercise therapy Behavioral: Usual Behavioral Medical Rehabilitation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||351 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Behavioral Exercise Therapy to Optimize Inpatient Behavioral Orthopedic Rehabilitation for Chronic Non-specific Low Back Pain|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
|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.
- 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).
- 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.
- Numeric Rating Scale (NRS) to assess pain intensity (Farrar et al., 2001) [ Time Frame: one year ]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 ]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 ]
- HAPA variables (Fleig et al., 2011; Sniehotta et al., 2005; Schwarzer et al., 2011) [ Time Frame: one year ]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 ]
- Depression (PHQ-D) (Löwe et al., 2002) [ Time Frame: one year ]
- Perceived Stress scale (Cohen, Williamson, 1988) [ Time Frame: one year ]
- Attitudes towards performing sports (Brand, 2006) [ Time Frame: one year ]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 ]
- Tampa Scale of Kinesiophobia (TSK) (Kori et al., 1990) [ Time Frame: one year ]
- Avoidance-Endurance Questionnaire (AEQ) (Hasenbring et al., 2009) [ Time Frame: one year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01666639
|Institute of Sport Science and Sport|
|Erlangen, Bavaria, Germany, 91058|
|Paracelsus-Klinik an der Gande|
|Bad Gandersheim, Lower Saxony, Germany, 37581|
|Bad Pyrmont, Lower Saxony, Germany, 31812|