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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00015463
Enrollment
600
Registered
2018-09-04
Start date
2015-04-22
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M54

Interventions

Group 1: IG-participants are invited to be attended by networks of physicians (general practitioners, orthopedic specialists, pain therapists). Their interdisciplinary and multimodal treatment of back

Sponsors

Central Krankenversicherung AG
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Germany

Contacts

Public ContactAngelika Hüppe

Institut für Sozialmedizin und Epidemiologie der Universität Lübeck

angelika.hueppe@uksh.de0451 500 51217

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 1, 2026