Behavioral Exercise Therapy to Optimize Inpatient Behavioral Orthopedic Rehabilitation for Chronic Non-specific Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 351
- 试验地点
- 6
- 主要终点
- Hannover Functional Ability Questionnaire (HFAQ) (Kohlmann, Raspe, 1996)
研究概览
简要总结
Multidisciplinary behavioral-orthopedic rehabilitation in the treatment of chronic back pain has proven its short-term effectiveness. Exercise therapy plays a major role in such a combination of treatments. There is a considerable need to develop theory-based exercise interventions which foster a long-term adherence to physical activity. Furthermore, an integration of behavioral elements such as coping competencies regarding back pain is needed. It is not yet clear, which specific part of multidisciplinary rehabilitation causes its effects. The role of exercise therapy has yet to be investigated. Aim of this study is the implementation of a standardized behavioral exercise therapy into an existing behavioral-medical rehabilitation for patients with chronic back pain. The main hypothesis is that the participation in the behavioral exercise therapy leads to greater short- and long-term improvements in functional capacity compared to the usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •F45.4 Persistent somatoform pain disorder
- •F45.41 Chronic pain disorder with somatic and psychological factors
- •F54 Psychological and behavioural factors associated with disorders or diseases classified elsewhere
- •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 dorsophathy, 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
- •R52.2 Other chronic pain
排除标准
- •distinct specific diagnosis for back pain (e.g. radicular symptoms, myelopathy)
- •severely limited health status (comorbidity)
- •serious impairment of vision and hearing (not corrected)
- •serious psychiatric codiagnosis (exkl. see inclusion criteria)
- •inability to speak german
- •pension claim (§51 SGB V - german law)
结局指标
主要结局
Hannover Functional Ability Questionnaire (HFAQ) (Kohlmann, Raspe, 1996)
时间窗: one year
The Hannover Functional Ability Questionnaire surveys the subjective estimate of a person of his or her functional ability in the context of physical activities of daily living. The Questionnaire has 12 Items. The participant is asked whether he or she is able to perform activities (e.g. to put on and pull off one's socks) and rates each on a 3-point scale (1=yes, 2=yes, but with trouble), 3=no, or only with help).
次要结局
- Numeric Rating Scale (NRS) to assess pain intensity (Farrar et al., 2001)(one year)
- Graded Chronic Pain Status (GCPS)(von Korff et al., 1992)(adapted for 6 months)(one year)
- Freiburger Questionnaire on Physical Activity (FQPA) (Frey et al., 1999)(one year)
- Generalized Anxiety Disorder (GAD-7) (Löwe et al., 2008)(one year)
- HAPA variables (Fleig et al., 2011; Sniehotta et al., 2005; Schwarzer et al., 2011)(one year)
- Health-related Quality of Life (SF-12) (Bullinger, Kirchberger, 1998)(one year)
- Depression (PHQ-D) (Löwe et al., 2002)(one year)
- Perceived Stress scale (Cohen, Williamson, 1988)(one year)
- Attitudes towards performing sports (Brand, 2006)(one year)
- Questionnaire for the detection of pain coping strategies (FESV) (Geissner, 2001)(one year)
- Tampa Scale of Kinesiophobia (TSK) (Kori et al., 1990)(one year)
- Avoidance-Endurance Questionnaire (AEQ) (Hasenbring et al., 2009)(one year)
研究者
Prof. Dr. Klaus Pfeifer
Prof. Dr.
University of Erlangen-Nürnberg