A combined pain competence and depression prevention training in inpatient multidisciplinary rehabilitation for chronic low back pain (Debora I)

Phase 2

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

• Registration Number: DRKS00015465
• Lead Sponsor: Deutsche Rentenversicherung Bund

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2018-02-28
• Study Start: 2018-09-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 1306

Inclusion Criteria

A diagnosis of CLBP lasting at least 6 months (ICD-10: M51, M53, M54), informed consent for participation, and German language skills.

Exclusion Criteria

Patients were excluded if they underwent surgery or had an accident in the last 6 months before rehabilitation, had somatic diseases inducing back pain (radicular symptoms, tumors, osteoporosis, inflammation, fibromyalgia), were pregnant, had infections, had cardiovascular or metabolic diseases affecting rehabilitation, or had a serious psychiatric disorder (severe anxiety disorder, depression, or psychotic symptoms, posttraumatic stress disorder).

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the primary outcome and the secondary outcome measures as well as the sociodemographic parameters, standardized questionnaires were used at the beginning of rehabilitation (t0), immediate after rehabilitation (t1), 6 (t2), 12 (t3) and 24 months after rehabilitation (t4).<br><br>Primary target size:<br>- Depression (German version of the Center for Epidemiological Studies Depression Scale (CES-D)<br>- anxiety (anxiety scale of the Hospital Anxiety and Depression Scale; HADS)<br>- Somatization (Brief Symptom Inventory; BSI-18)<br>- Symptoms of anxiety and depression in addition with Patient Health Questionnaire (PHQ-4)<br>- Short version of the short-form health survey (SF-12)<br>

Secondary Outcome Measures

Name	Time	Method
Other essential parameters relate inter alia. on:<br>- Pain-related parameters (e.g., DGSS pain questionnaire),<br>- pain-related self-efficacy (FESS)<br>- pain coping (FESV-BW),<br>- pain cognitions (AEQ),<br>- General and occupational-related strain (TICS and SPE)<br>- Subjective work ability (WAI).<br>