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 pai

Not Applicable

• Conditions: M54; Dorsalgia

• Registration Number: DRKS00015463
• Lead Sponsor: Central Krankenversicherung AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2017-08-31
• Study Start: 2018-09-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 552

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

- 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Back pain severity assessed by the Chronic Pain Grading Scale (CPGS). We analyzed the characteristic back pain intensity and the back pain related disability. <br>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.<br>

Secondary Outcome Measures

Name	Time	Method
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.