Trial document





This trial has been registered retrospectively.
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  DRKS00004310

Trial Description

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Title

Behavioral exercise therapy (BET) to optimize inpatient behavioral orthopedic rehabilitation for chronic low back pain

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Trial Acronym

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URL of the Trial

http://www.sport.uni-erlangen.de/lehrstuehle-und-fachgebiete/bewegung-und-gesundheit/forschungsprojekte/rehabilitationsforschung/vbt-bei-rueckenschmerz.shtml

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Brief Summary in Lay Language

The so called „behavioral medical inpatient rehabilitation (VMO) is a program, which is mainly delivered to patients suffering from chronic low back pain und eventually a mental health impairment such as depression and/or anxiety disorder. The VMO is part of their treatment of three to four weeks in a rehabilitation facility. Within the VMO, patients are being treated by multiple health professionals (e.g. physicians, physio- and exercise therapists and psychologists). There is scientific evidence at least for the short-term effectiveness of the VMO in patients with chronic low back pain.
Exercise therapy to improve physical fitness plays a large role in the VMO. There is a remaining potential for development regarding the integration of aspects such as “Empowerment in coping with pain” and in terms of strategies, which foster the long-term adherence of the patients to a physically active lifestyle. Furthermore, the role of exercise therapy as one of many treatments regarding the effectiveness of the VMO is not yet clear.
The center piece of this study is a standardized “behavioral” exercise therapy (BET). The BET is called “behavioral”, because it contains elements, which target behavior in coping with pain on the one hand, and the behavior “physical activity” on the other hand.
It is the goal of the study, to implement this BET into existing VMOs in two rehabilitation facilities. It will then be evaluated, how effective the BET is, by randomizing back pain patients to either the VMO with “normal” exercise therapy or to a VMO with BET. For this evaluation, 214 patients on four occasions are being asked. They answer questions in areas such as the disability due to back pain, the pain intensity and how physically active they are, etc.

The hypothesis of this study: The behavioral exercise therapy leads to a sustainable improvement of the rehabilitation outcome in patients with chronic low back pain in comparison to the usual VMO in terms of physical functional disability (The reduction of disability is significantly lower in usual care).

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Brief Summary in Scientific Language

Multidisciplinary behavioral-medical inpatient rehabilitation is an effective treatment for chronic low back pain in the short term. Exercise therapy for the improvement of physical fitness is a central component. There is a potential of development in exercise therapy regarding the goal-oriented integration of behavioral aspects such as the teaching of self-management competencies in coping with back pain and of strategies to foster a long-term adherence to physical activity. A differentiated workup of the mechanisms of action regarding a successful and sustainable rehabilitation has not been delivered yet. Goal of this project is the implementation of a standardized behavioral exercise therapy into existing behavioral-medical rehabilitation in patients with chronic low back pain. In a prospective randomized-controlled multicenter study specific effects of the optimized exercise therapy in a behavioral-medical inpatient rehabilitation are evaluated in comparison to usual care. For the evaluation of a sustainable effectiveness, relevant variables are being captured in 214 patients at four points of measurement (Outcome-variables are e.g. pain-related disability, pain intensity, and physical activity).

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00004310
  •   2012/11/08
  •   2012/06/18
  •   yes
  •   Approved
  •   4510, Ethik-Kommission der Friedrich-Alexander-Universität Erlangen-Nürnberg
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Secondary IDs

  •   NCT01666639  (www.clinicaltrials.gov)
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Health Condition or Problem studied

  •   F45.4 -  Persistent somatoform pain disorder
  •   F45.41 -  [generalization F45.4: Persistent somatoform pain disorder]
  •   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 -  Dorsopathy, 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
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Interventions/Observational Groups

  •   The behavioral-medical inpatient rehabilitation (VMO), as it is delivered in both of the rehabilitation facilities participating in this study, takes into account the biopsychosocial mechanisms for chronicity, which are relevant for the maintenance of non-specific low back pain following international and national research (Hildebrandt et al., 2004; Waddell, 2004). The emphasis is on activation and strengthening of the self-responsibility of the patient while using principles of learning theory. Multiprofessional interventions are used such as interactive lectures with health information, physiotherapy or exercise therapy (ET), back school (with a rather biomedical orientation), psychological work in groups (or after individual counseling as required), social counseling and occupational therapy as required with a high amount of 120 hours on average in both facilities. Concretely, the movement- (or exercise-) related interventions in the “Paracelus-Klinik an der Gande” include water-based ET (18 x 60min) and the so called “Bewegungskompetenztraining” (Training of movement competencies) (14 x 60 min), which are delivered in closed groups with ten to twelve participants, as well as sports therapy (walking, medical training therapy, both with an amount of 16 x 60 min; swimming, freely plannable, with an amount of approximately 10 x 60 min) and individual-based and group-based physiotherapy (app. 10 x 30 min for individual-based therapy).
    At the “Klinik Weser”, the movement- (or exercise-) related interventions include physiotherapy (11 x 60 min), water-based gymnastics (8 x 60min), medical training therapy (10 x 60 min), indoor gymnastics (10 x 60 min), back school (14 x 60 min) and freely plannable dates for doing swimming, fitness-gymnastics or walking in open groups ( 21 x 60 min). The medical training therapy and a physiotherapy group (5 x 30 min) are delivered in closed groups with 8 to 12 participants and the same therapist for each session. The above-mentioned movement- (or exercise-) related interventions being used in the VMO are mainly based on a somatic-functional approach without systematic or unified application of principles of learning theory. The focus is on decreasing physical deconditioning via relaxation and strengthening of muscles and improvement of endurance, reduction of pain via posture-education and teaching of postures, which are supposed to be a relief for the spine/back, the teaching of (patho-)physiological nexuses as well as the improvement of well-being by schooling coenesthesia.
  •   For the second arm in this study, the treatment is also the VMO, but the exercise therapy, delivered as part of the VMO is being modified. The temporal amount of the exercise therapy is being held changeless. The attributes of the “optimized”, behavioral exercise therapy (BET) are being described below.
    BET is mainly characterized by a goal-oriented and systematic assignment of knowledge-, behavior- and exercise-related elements. In doing so, the individual self-management competencies in coping with low back pain and a sustainable adherence to physical activity are strengthened gradually. The program is taught in closed groups on 15 therapy-days during the stay in the rehabilitation facilities of three to four weeks by specifically trained exercise-therapists (and physiotherapists respectively). Coceptionally, the program consists of specific modules and collections of exercises, which can be categorized in the target areas (I) setup of self-management competencies in coping with back pain, (II) introduction to physical activity and enhancement of long-term adherence thereof and (III) improvement of health-related fitness. Every module includes a detailed description of the actual goal, of intervention content respectively and of the didactical methodological approach (methods, hints for execution), of the length of time, of the use of materials and media and of the relation to other modules. Altogether, there is additional value of the program of BET by the following aspects: goal-oriented and systematic didactical-methodological mediation of knowledge-, behavior- and exercise-related interventional elements; combined use of motivational-volitional intervention strategies to foster a self-reliant long-term adherence to physical activity; integrative linkage with interventions delivered by physicians and psychologists by picking up and enforcing important messages and competencies; specific patient-oriented media and materials with a high stimulative nature; manual for trainers with explicit description of content and methodological-didactical approach for a unified communication of knowledge-, behavior- and exercise-related elements as well as the use of media and materials to reach multidimensional target levels.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Single blind
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  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Back pain conditioned functional ability, measured by the Hannover Functional Ability Questionnaire for Back pain (Kohlmann, Raspe, 1996); The comparison is between intervention group and control group, M1 vs. M4 (time span 1 year); M1 = point of measurement immediately prior to treatment (prior to the stay at the rehabilitation facility); M4 = point of measurement 1 year after M1; in between, there are M2 (immediately after the end of the three- to four week treatment) and M3 (6 months after M2)

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Secondary Outcome

Physical activity: M1, M3, M4 (time span M1-M3 7 months, M1-M4 13 months), “Freiburger questionnaire on physical activity (Frey et al., 1999);
Pain intensity: M1, M2, M3, M4 (time span M1-M2 four weeks, M1-M3 7 months, M1-M4 13 months), numeric rating scale (Farrar et al., 2001);
Various pain parameters (e.g. course, amount of days in pain): M1, M2, M3, M4, Graded Chronic Pain Status (GCPS) (von Korff et al., 1992) (adapted for six months).
Coping with pain: M1, M2, M3, M4, Questionnaire for the detection of pain coping strategies (FESV) (Geissner, 2001);
Generalized anxiety disorder: M1, M2, M3, M4, GAD-7 (Löwe et al., 2008);

Depression: M1, M2, M3, M4, PHQ-D (Löwe et al., 2002);

Perceived Stress: M1, M2, M3, M4, Perceived Stress Scale (Cohen, Williamson, 1988);

Fear-avoidance behavior: M1, M2, M3, M4, Tampa Scale of Kinesiophobia (TSK) (Kori et al., 1990);

Fear-avoidance and endurance-behavior: M1, M2, M3, M4, Avoidance-Endurance Questionnaire (AEQ) (Hasenbring et al., 2009);

Affective and cognitive attitudes towards physical activity: M1, M2, M3, M4, four items measure the cognitive component (e.g. If I think about it, I regard physical activity as: not healthy – very healthy), four items measure the affective component (e.g. If I think about being physically active, I feel: not satisfied – very satisfied);
HAPA variables: The HAPA variables include a stage-assessment regarding the stage of behavior change (cf. Did you perform physical activity recently: “No, and I don’t intend to do so” to “Yes, and it is easy for me). There is an item for validity attached to that (Since when are regularly as physically active, as you are right now?) Furthermore, questions are asked concerning the Intention, self-efficacy, action and coping planning as well as risk perception, outcome expectancies regarding physical activity, action control respectively as well as the experiences with physical activity. For a detailed description, see further Schwarzer et al., 2011 (Rehabilitation psychology, 56(3), 161-170) and Fleig et al., 2011 for experiences.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2012/02/01
  •   214
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

main diagnoses (ICD-10 codes as described above)

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Exclusion Criteria

Specific underlying diagnosis of back pain (e.g. radicular symptoms, myelopathy; considerably reduced health status (comorbidities); considerable reduction of sight and hearing; severe psychiatric condition as secondary diagnosis; age below 18 or above 65 respectively; lacking ability to speak German; ongoing application for retirement in the sense of §51 SGB V

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Addresses

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    • Deutsche Rentenversicherung Bund, Geschäftsbereich Sozialmedizin und Rehabilitation, Bereich Reha-Wissenschaften/R 4003
    • 10704  Berlin
    • Germany
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    • Paracelsus-Klinik an der Gande, Bad Gandersheim
    • Ms.  Dr.  Désirée  Herbold 
    • Dr.-Heinrich-Jasper-Str. 2a
    • 37581  Bad Gandersheim
    • Germany
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    • Rehazentrum Bad Pyrmont, Klinik Weser
    • Mr.  Dr.  Martin  Holme 
    • Schulstraße 2
    • 31812  Bad Pyrmont
    • Germany
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    • Universität Erlangen-Nürnberg, Institut für Sportwissenschaft und Sport
    • Mr.  Prof. Dr.  Klaus  Pfeifer 
    • Gebbertstr. 123b
    • 91058  Erlangen
    • Germany
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    • Universität Erlangen-Nürnberg, Institut für Sportwissenschaft und Sport
    • Ms.  Jana  Hofmann 
    • Gebbertstr. 123b
    • 91058  Erlangen
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Rentenversicherung Bund in der zweiten Förderphase des Förderschwerpunktes "Chronische Krankheiten und Patientenorientierung"
    • 10704   Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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