Efficacy of Classification Based 'Cognitive Functional Therapy' in Patients With Non Specific Chronic Low Back Pain (NSCLBP) - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 2
- 主要终点
- Disability
研究概览
简要总结
A randomized controlled trial of the efficacy of classification based cognitive functional physiotherapy according to the system proposed by Peter O'Sullivan as compared to manual therapy and exercise in patients with non specific chronic low back pain.
The investigators hypothesis was that treatment targeted at the mechanism behind the problem from a multidimensional perspective would be superior to traditional treatment.
详细描述
NSCLBP is widely viewed as a multifactorial biopsychosocial pain syndrome. It has been proposed by several authors that NSCLBP represents a vicious cycle associated with different combinations of maladaptive; cognitive (negative beliefs, fear avoidance behaviours, catastrophising, depression, stress, lack of pacing and coping), physical (pain provocative postures, movement patterns and pain behaviours) and lifestyle (inactivity, rest) behaviours that act to promote pain and disability. However a recent systematic review suggests that this change in paradigm and our new understanding of NSCLBP has not resulted in clinical trials utilizing multidimensional classification systems or targeted interventions based on the underlying mechanisms. line with this shift in paradigm a novel multidimensional classification system has been developed incorporating the biopsychosocial model, which subgroups patients based on their presentation of. with matched interventions directed at the maladaptive cognitive, physical and lifestyle behaviours associated with the disorder.
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 (Outcomes Assessor)
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
- 是
入选标准
- •all patients with non-specific LBP for more that 8 weeks duration
- •mechanical provocation of pain with postures, movement and activities
- •localised pain in the area from T12 to gluteal folds
- •moderate ongoing LBP with a VAS > 2/10
- •disability had to be higher than 14% on Oswestry Disability Index
排除标准
- •sick listed for more than 4 months continuous duration
- •acute exacerbation of LBP
- •radicular pain with positive neural tissue provocation test
- •any low limb surgery on the last 3 months
- •surgery involving the lumbar spine (fusion)
- •pregnancy
- •psychiatric disorders - somatisation
- •dominant psycho-social problems
- •widespread non-specific pain disorder (no primary LBP focus)
- •specific diagnoses: active rheumatologic disease, progressive neurological disease, serious cardiac or other internal medical condition, malignant basic diseases, acute traumas, infections, or acute vascular catastrophies
结局指标
主要结局
Disability
时间窗: 12 months
Disability measured by Oswestry Disability Index.
Pain
时间窗: 12 months
Pain was assessed using a pain numerical rating scale from 0 to 10
次要结局
- Well being(12 months)
- Beliefs(12 months)
- Screening questionnaire(12 months)
- Patient satisfaction(12 months)