Effect and Sustainability of a Bio-psycho-social Exercise Program (RÜCKGEWINN) for Chronic Low Back Pain in Rehabilitation Aftercare - a Randomised Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 299
- 试验地点
- 12
- 主要终点
- Perceived pain-related functional disability as measured with the Hanover Functional Ability Questionnaire (Kohlmann & Raspe, Rehabilitation. 1996;35:I-VIII.)
研究概览
简要总结
Background:
In chronic back pain, rehabilitation specific aftercare programs, needed for a long-term improvement of pain and functional ability, are absent. Purposeful and differentiated aftercare treatments offer the possibility, in particular in the rehabilitation of chronic back pain, to increase the sustainability of positive effects of a mostly three weeks taking rehabilitation or to intensify them.
Hypothesis:
The implementation of a developed bio-psycho-social aftercare intervention program for CLBP (RÜCKGEWINN) leeds to a better rehabilitation outcome in comparison to current usual aftercare (IRENA) and a control group in view of pain-conditioned functional ability and back pain episodes.
Methods/Design:
A multicenter prospective 3-armed randomised controlled trial is conducted. 456 participants will be consecutively enrolled in inpatient and outpatient rehabilitation and assigned to either one of the three study arms. Outcomes are measured before and after rehabilitation and twelve month after dismissal form rehabilitation into the aftercare program.
详细描述
Background:
There is strong internationally confirmed evidence for short-term effectiveness of multimodal interdisciplinary specific treatment programmes for chronic back pain. Indeed, the proof of a lasting protection of achieved effects is missing so far. For a long-term improvement of pain and functional ability high intervention intensity or high extent seems to be necessary (> 100 therapy hours). Especially in chronic back pain rehabilitation specific aftercare programs are absent. Purposeful and differentiated aftercare treatments offer the possibility, in particular in the rehabilitation of chronic back pain, to increase the sustainability of positive effects of a mostly three weeks taking rehabilitation or to intensify them.
Hypothesis:
The implementation of a bio-psycho-social exercise based aftercare intervention program, specifically structured for the needs of chronic low back pain (CLBP) patients, leeds to a better rehabilitation outcome in comparison to current usual aftercare (IRENA) and a control group that is given an educational booklet in view of pain-conditioned functional ability and back pain episodes.
Methods/Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 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
- •ICD-10 is used:
- •M51.2 - M51.4
- •M51.8 - M51.9
- •M53.8 - M53.9
- •M54.5, M54.8 - M54.9
- •M54.4 (if radicular symptoms are not dominating)
排除标准
- •specific reason for back pain, based on a clear cause or diagnosis, which could sufficiently explain its extent (e.g. radicular symptomatic, myelopathesis, inflammatory changes in the spinal column etc.)
- •already carried out operation on the spine within the last year
- •additional serious psychic diagnosis
- •uncorrected serious visual and acoustic disability
- •seriously reduced health status (other diseases) with considerable reduction of dexterity
- •application for retirement
- •low German language skills (to fulfill the questionnaires)
- •age lower than 18 or over 65
- •residential area out of Berlin
结局指标
主要结局
Perceived pain-related functional disability as measured with the Hanover Functional Ability Questionnaire (Kohlmann & Raspe, Rehabilitation. 1996;35:I-VIII.)
时间窗: one year
次要结局
- Graded chronic pain (GCPS, Von Korff et al. 1992)(one year)
- Catastrophizing (KPI-AE KRSS, Hasenbring 1994)(one year)
- Fear avoidance Beliefs (TSK-DE, Schaub et al. 2004)(one year)
- Physical activity (Freiburger FB, Frey et al. 1999)(one year)
研究者
Prof. Dr. Klaus Pfeifer
Chair for Exercise and Health
University of Erlangen-Nürnberg