Interprofessional Biopsychosocial Rehabilitation to Optimize Inpatient Multidisciplinary Orthopedic Rehabilitation for Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 536
- 试验地点
- 8
- 主要终点
- Change from Baseline in Hannover Functional Ability Questionnaire (FFbH-R) at 12 months
研究概览
简要总结
The primary aim of the study is to analyse the long-term effectiveness of an interprofessional and interdisciplinary rehabilitation program named "PASTOR", with a biopsychosocial approach for participants with chronic non-specific low back pain (CLBP) compared to the standard inpatient multidisciplinary orthopaedic rehabilitation (MOR) in Germany. The investigators hypothesize that in adults with CLBP the rehabilitation program PASTOR would result in a significantly higher increase in functional ability 12 months after completion of the program in comparison to the standard inpatient MOR. The investigators further hypothesize that PASTOR would lead to significantly larger improvements regarding pain-related cognitions, pain coping strategies, physical activity, health-related quality of life, and back pain episodes compared to the standard inpatient MOR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •M51.2 Other specified intervertebral disc displacement
- •M51.3 Other specified intervertebral disc degeneration
- •M51.4 Schmorl's nodes
- •M51.8 Other specified intervertebral disc disorders
- •M51.9 Intervertebral disc disorder, unspecified
- •M53.8 Other specified dorsopathies
- •M53.9 dorsopathy, unspecified
- •M54.4 Lumbago with sciatica
- •M54.5 Low back pain
- •M54.6 Pain in thoracic spine
- •M54.8 Other dorsalgia
- •M54.9 Dorsalgia, unspecified
排除标准
- •age below 18 years or over 65 years
- •specific underlying diagnosis of back pain (e. g. radicular symptoms, myelopathy)
- •considerably reduced health status (e.g. comorbidity)
- •considerably reduced sight and hearing (not corrected)
- •severe psychiatric condition as secondary diagnosis
- •inability to speak German
- •current application for early retirement or invalidity pension (§51 SG V - german law)
结局指标
主要结局
Change from Baseline in Hannover Functional Ability Questionnaire (FFbH-R) at 12 months
时间窗: baseline, one year
The FFbH-R consists of twelve items with a three-stage answering scale (2=yes; 1=yes, but with difficulty; 0=no, or only with assistance). The summary score describes the low back pain associated functional ability in activities of daily living (e.g. "Can you wash and dry yourself from head to toe?") in adults on a scale of 0% (minimum functional ability) to 100% (maximum functional ability). Kohlmann Th \& Raspe H (1996). Der Funktionsfragebogen Hannover zur alltagsnahen Diagnostik der Funktionsbeeinträchtigung durch Rückenschmerzen (FFbH-R). Die Rehabilitation, 34, I-VIII.
次要结局
- Pain Management Questionnaire (FESV)(baseline, three weeks, one year)
- Freiburg Questionnaire of physical activity (FFkA)(baseline, one year)
- Health-related Quality of Life (SF-12)(baseline, three weeks, one year)
- Numerical rating scale (NRS)(baseline, three weeks, one year)
- Change from Baseline in Hannover Functional Ability Questionnaire (FFbH-R) at 3 weeks(baseline, three weeks)
- Avoidance-Endurance Questionnaire (AEQ)(baseline, three weeks, one year)
研究者
Prof. Dr. Klaus Pfeifer
Prof. Dr.
University of Erlangen-Nürnberg