Trial document




This trial has been registered retrospectively.
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  DRKS00015463

Trial Description

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Title

a randomized controlled trial investigating the efficacy and benefit of the health program "initiative.rücken" in members of a private health insurance with persistent unspecific low back pain

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

A German private medical insurance offers participation in a health program called initiative.rücken to their members with persistent back pain. The out-patient treatment occurs through a net of physicians (general practitioners, orthopedic specialists, pain therapists) following evidence based guidelines. The health program aims to reduce the severity of back pain and to increase the health related quality of life. To evaluate the success insured persons with presumed persistent back pain are allocated by chance to one of two study groups. One study group is invited to participate in the health program, the other is invited to participate in a back pain survey. The severity of back pain and the health related quality of life of both groups are assessed by online questionnaire for two years and compared against one another.

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Brief Summary in Scientific Language

A German private medical insurance wants to facilitate access to evidence-based care for members with persistent back pain and therefore proactively offers a complex integrative out-patient health care concept called initiative.rücken. Long term efficacy and benefit of this approach is evaluated by a randomized controlled trial using Zelen´s design. Insured persons with presumed persistent backache with regard to settlement data are identified and randomized to the intervention (IG) or the control group (CG) prior to giving consent. After allocation the IG is invited to participate in the health program, an evidence-based interdisciplinary care of back pain through special networks of physicians including medical exercise therapy and life style coaching. The CG is invited to participate in a longitudinal back pain survey. Primary outcomes are back pain severity (Korff´s Chronic Pain Grading Scale) as well as health-related quality of life (SF-12) assessed by online questionnaires at baseline, 6, 12 and 24 months follow up.

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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

  •   DRKS00015463
  •   2018/09/04
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  •   no
  •   Approved
  •   14-249, Ethik-Kommission Universität zu Lübeck Medizinische Fakultät des Universitätsklinikums Schleswig-Holstein
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Secondary IDs

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Health Condition or Problem studied

  •   M54 -  Dorsalgia
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Interventions/Observational Groups

  •   IG-participants are invited to be attended by networks of physicians (general practitioners, orthopedic specialists, pain therapists). Their interdisciplinary and multimodal treatment of back pain complies with the recommendations of the German Clinical Practice Guideline Non-Specific Low Back Pain. In the context of medical exercise therapy up to 24 hours equipment based training sessions (1-2 hours per week) are administered to IG-participants in specialized back center (in detail see https://www.fpz.de). In addition a personal coach accompanies the IG participants during and post medical treatment to facilitate the transfer of new knowledge into everyday life and to encourage life style changes (coaching by phone).
  •   The back pain treatment of the CG members is not influenced. They receive “usual care”. That means the care follows the instructions of their health care providers (e.g. family doctors and/or medical specialists).
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Back pain severity assessed by the Chronic Pain Grading Scale (CPGS). We analyzed the characteristic back pain intensity and the back pain related disability.
Health related quality of life was another primary outcome assessed with the Short Form 12 (physical and mental health composite scores). These outcomes are assessed at baseline and 6, 12 and 24 months later.

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Secondary Outcome

psychological distress assessed with the Patient Health Questionnaire-4 (PHQ-4); the risk of back pain chronification measured by the Keele STarT Back Screening Tool, German version (STarT-G); physical activity measured with two questions (“On how many days a week are you physically active on average in a way that you start to sweat or get out of breath?” “How long are you physically active on average on these days?”). These outcomes are assessed at baseline and 6, 12 and 24 months later.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2015/04/22
  •   600
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- at least 18 years
- at least 2 cases of settlement data due to ICD codes M40-M54 (dorsopathies)
- at least one of the following three:
• one or more cases of temporary work disability in the past 12 months due to ICD codes M40-M54 or
• two or more opioid prescriptions or
• one or more settlement data from this list of ICD-10 codes: F32 depressive episode; F33 recurrent depressive disorder; F34 persistent mood [affective] disorders; F38 other mood [affective] disorders; F41.2 mixed anxiety and depressive disorder; F43.2 adjustment disorders; F45.4 persistent somatoform pain disorder; F48.0 neurasthenia; F54 psychological and behavioural factors associated with disorders or diseases classified elsewhere; F62.8 chronic pain personality syndrome
- appropriately signed informed consent document is available

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Exclusion Criteria

- Care level II or III (long-term care insurance act, SGBXI)
- in the past 12 month more than one settlement data due to the same diagnosis or due
to 5 or more different diagnosis from the following list of ICD-10 codes:
B16 acute hepatitis B; B17.1 acute hepatitis C; B20-24 human immunodeficiency virus; D00-D09.9 in situ neoplasms; F00-F09 organic, including symptomatic, mental disorders; F10-F19 mental and behavioral disorders due to psychoactive substance use without F17 mental and behavioral disorders due to use of tobacco; F20-F29 Schizophrenia, schizotypal and delusional disorders; F30 manic episode; F31 bipolar affective disorder; F42 obsessive-compulsive disorder; F60 specific personality disorders; G00-09 Inflammatory diseases of the central nervous system; G10 Huntington disease; G13 systemic atrophies primarily affecting central nervous system in diseases classified elsewhere; G23 other degenerative diseases of basal ganglia; G30-32 other degenerative diseases of the nervous system; G36 Other acute disseminated demyelination; G37.9 demyelinating disease of central nervous system, unspecified; G92 toxic encephalopathy; G93 other disorders of brain; H54.0 Blindness, binocular; H91.3 Deaf mutism, not elsewhere classified; I64 Stroke, not specified as haemorrhage or infarction; K74 fibrosis and cirrhosis of liver; N18 chronic kidney disease; R54 Senility

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Addresses

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    • Central Krankenversicherung AG
    • Mr.  Dr.  Max  Wunderlich 
    • Hansaring 40-50
    • 50670  Köln
    • Germany
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    • Institut für Sozialmedizin und Epidemiologie der Universität zu Lübeck
    • Ms.  Dr. phil.  Angelika  Hüppe 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    • Institut für Sozialmedizin und Epidemiologie der Universität Lübeck
    • Ms.  Dr. phil.  Angelika  Hüppe 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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Sources of Monetary or Material Support

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    • Central Krankenversicherung AG
    • Hansaring 40-50
    • 50670  Köln
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/08/31
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Trial Publications, Results and other Documents

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