Trial document




This trial has been registered retrospectively.
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  DRKS00016404

Trial Description

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Title

Evaluation of behavioral medical rehabilitation in patients with musculoskeletal disorders

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Trial Acronym

EVA-BMR

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URL of the Trial

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Brief Summary in Lay Language

Behavioral medical rehabilitation (BMR) is a strategy of the German Pension Insurance (GPI) developed for patients with physical diseases that follows a multidisciplinary and behavioral approach and involves psychological single and group interventions. These programs were developed for patients with mental comorbidity and problems in coping with their disease. Studies that tested the efficacy of BMR under ideal study conditions have shown effects on various outcomes (e.g. depression or pain). However, an evaluation of its effectiveness (i.e. effects under conditions of daily routine) is still lacking. The study therefore analyses the effects of BMR under conditions of daily routine. The study also examines if BMR is implemented as intended.

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Brief Summary in Scientific Language

Mental comorbidity is a risk factor for the chronicity of back pain and is associated with an increased risk of receiving a disability pension. In Germany, medical rehabilitation programs focus on improving and restoring work ability. In case of mental comorbidity early identification and treatment of mental impairments are necessary to achieve these aims. BMR programs therefore follow a multidisciplinary and behavioral approach and integrate psychological single and group interventions. Controlled and randomized controlled trials have compared BMR programs and conventional medical rehabilitation programs and have shown effects on depression, pain-related coping strategies, pain and the self-reported health (efficacy). However, it is unclear if BMR also yields better results than conventional medical rehabilitation under real-life conditions (effectiveness) and if BMR is implemented as intended. We include patients with approved medical rehabilitation due to musculoskeletal disorders. Data are assessed by questionnaires before rehabilitation and 3 and 10 months after rehabilitation. Additionally, administrative data from the GPI accounts is used. Effectiveness of BMR will be tested by a propensity score matched comparison of BMR and medical rehabilitation patients. Additionally, individual and institutional moderators on effectiveness will be examined.

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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

  •   DRKS00016404
  •   2019/02/08
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  •   yes
  •   Approved
  •   18-154A, Ethik-Kommission Universität zu Lübeck Medizinische Fakultät des Universitätsklinikums Schleswig-Holstein
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Secondary IDs

  •   U1111-1192-3052 
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Health Condition or Problem studied

  •   M00-M99 -  Diseases of the musculoskeletal system and connective tissue
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Interventions/Observational Groups

  •   People in study arm 1 (intervention) will receive a behavioral medical rehabilitation (BMR) in a rehabilitation center approved by the Federal German Pension Insurance. BMR involves a psychological core group, an exercise group, psychological one-on-one consultations, a relaxation training and exercise diagnostics at the beginning and end of the rehabilitation. Goals and contents as well as frequency and duration of these core interventions are described in the BMR guideline of the Federal German Pension Insurance.
  •   People in study arm 2 (control condition) receive a conventional medical rehabilitation according to the guideline for musculoskeletal rehabilitation in a rehabilitation center approved by the Federal German Pension Insurance.
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

stable return to work (at least 4 weeks employed without sick leave), including the time until it was achieved

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Secondary Outcome

- sick leave duration
- self-reported work ability (Ilmarinen 2007)
- duration of and income from regular employment (administrative data)
- subjective prognosis of return to work (Mittag et al. 2006)
- pain (Klasen et al. 2004; Schmitz et al. 2000)
- somatization (Schmitz et al. 2000)
- pain generalization
- pain medication
- physical functioning (Wirtz et al. 2005)
- depression (Löwe and Rose 2010)
- anxiety (Löwe and Rose 2010)
- fear-avoidance beliefs (Pfingsten et al. 2000)
- self-management skills (Osborne et al. 2007)
- self-reported health (Nübling and Hasselhorn 2006)
- physical activity (Godin und Shephard 1985)
- treatment satisfaction (Attkisson and Zwick 1982)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2016/03/07
  •   7700
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

We include patients with musculoskeletal disorders receiving a rehabilitation which was approved by the Federal German Pension Insurance.

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Exclusion Criteria

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Addresses

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    • Universität zu Lübeck; Institut für Sozialmedizin und Epidemiologie
    • Mr.  Prof. Dr.   Matthias  Bethge 
    • Ratzeburger Allee 160
    • 23562  Lübeck
    • Germany
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    • Universität zu Lübeck; Institut für Sozialmedizin und Epidemiologie
    • Mr.  Prof. Dr.  Matthias  Bethge 
    • Ratzeburger Allee 160
    • 23562  Lübeck
    • Germany
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    • Universität zu Lübeck; Institut für Sozialmedizin und Epidemiologie
    • Ms.  Miriam  Markus 
    • Ratzeburger Allee 160
    • 23562  Lübeck
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Rentenversicherung Bund
    • Ruhrstraße 2
    • 10709  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/07/12
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Trial Publications, Results and other Documents

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