A combined pain competence and depression prevention training in inpatient multidisciplinary orthopaedic rehabilitation (Debora II)

Phase 2

• Conditions: M51; M54; M53; Other intervertebral disc disorders; Dorsalgia; Other dorsopathies, not elsewhere classified

• Registration Number: DRKS00011302
• Lead Sponsor: Deutsche Rentenversicherung Berlin/Brandenburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-27
• Study Completion: 2019-10-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 171

Inclusion Criteria

Men and women aged between 20 and 65 years; main diagnosis: chronic low back pain (ICD-10: M 51, M 53, M 54; = 6 months); voluntary participation with a written declaration of consent; knowledge of german language (the ability to read and write)

Exclusion Criteria

surgical operations in the musculoskeletal system; accidents within the last six months before the beginning of rehabilitation; somatic illnesses, which could be responsible for chronic low back pain (radicular symptoms, tumor, osteoporosis, inflammation, fibromyalgia); pregnancy, infections, cardiovascular diseases or metabolic diseases, which could complicate the rehabilitation; psychiatric diseases (anxiety disorder or depression, psychoses, post-traumatic stress disorder)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Standardised questionnaires are used to measure the primary and secondary outcome as well as sociodemographic data at the beginning of rehabilitation (t0), at the end of rehabilitation (t1) and 6 (t2) and 12 months (t3) after rehabilitation. <br>primary outcome:<br>- depressive symptoms (ADS)<br>- anxiety (HADS)<br>- somatisation (BSI-18)<br>- symptoms of depression and anxiety (PHQ-4)<br>- health-related quality of life (SF-12)<br>

Secondary Outcome Measures

Name	Time	Method
Other important target parameters are: <br>- pain-related parameters (e.g. pain-related questionnaire DGSS),<br>- pain coping (FESV-BW),<br>- pain-related cognition (AEQ),<br>- generally and work-related load values (TICS and SPE), <br>- subjective work ability (WAI).