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临床试验/NCT01882686
NCT01882686已完成不适用

Efficacy of a Classification Based 'Cognitive Functional Therapy' in Nurses With Non Specific Chronic Low Back Pain - a Series of Case-controls

KU Leuven1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2012年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
KU Leuven
入组人数
41
试验地点
1
主要终点
Change from baseline in pain

研究概览

简要总结

A series of case-studies to explore the efficacy of classification based cognitive functional physiotherapy according to the classification system proposed by Peter O'Sullivan in specific nursing population with non specific chronic low back pain.

The investigators hypothesis was that treatment targeting the mechanisms behind the problem from a multidimensional perspective would be effective to reduce pain, disability and sick-leave.

详细描述

Low back pain (LBP) is a common, recalcitrant and costly health problem, which limits patients' daily activities. In 85% of the cases, LBP is classified as 'non-specific', which means there is no clear underlying patho-anatomical/radiological abnormality. This subgroup often gives rise to a chronic fluctuating problem. Although most cases of LBP resolve within 8 to 12 weeks, it may become chronic in up to 15% of patients. LBP constitutes an enormous and growing medical and socio-economical problem for the modern society. Nursing has been identified amongst the top professions at risk for occupational LBP, with lifetime prevalence between 66%-82%. The impact of LBP for nurses includes time off work, increased risk of chronicity, associated personal and economic costs and reduced nursing workforce efficiency.

Non Specific Chronic Low Back Pain (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 the investigators new understanding of NSCLBP has not resulted in clinical trials utilizing multidimensional classification systems or targeted interventions based on the underlying mechanisms. In line with this paradigm shift a novel multidimensional classification system has been developed incorporating the biopsychosocial model, which subgroups patients based on their underlying pain mechanism. Enabling a classification based interventions targetting the maladaptive cognitive, physical and lifestyle behaviours associated with the disorder.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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
是

入选标准

  • •Low Back Pain (LBP) with/without referred pain in buttock/thigh for > 3 months, including the four weeks prior to testing
  • •LBP is primarily localised from T12 to gluteal folds
  • •mechanical provocation of LBP with postures, movement and activities
  • •average pain intensity in the past week Numerical Rating Scale (NRS) >/= 1/10
  • •Disability (ODI) >/=2%
  • •willingness to sign the informed consent

排除标准

  • •specific spinal pathology
  • •presence of red flags
  • •previous lumbar spinal surgery
  • •pregnancy
  • •diagnosed psychiatric disorder - somatisation
  • •radicular pain with positive neural tissue provocation test
  • •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 catastrophes

研究组 & 干预措施

Classification Based Cognitive Functional Therapy

Experimental

干预措施: Classification Based Cognitive Functional Therapy (Other)

结局指标

主要结局

Change from baseline in pain

时间窗: 3, 6, 9 and 12 months

Pain was assessed using a numerical pain rating scale (NPRS) ranging from 0 (no pain) to 10 (worst imaginable pain)

Change from baseline in disability

时间窗: 3, 6, 9 months, 1 and 3 year

Disability was measured using the Oswestry Disability Index (ODI)

次要结局

  • Change from baseline in Physical activity(3, 6, 9 and 12 months)
  • Change from baseline in Sleep problems(3, 6, 9 and 12 months)
  • Change from baseline in Beliefs about LBP(3, 6, 9 and 12 months)
  • Change from baseline in Self-efficacy, coping(3, 6, 9 and 12 months)
  • Change from baseline in Pain catastrophizing(3, 6, 9 and 12 months)
  • Change from baseline in Category of risk of poor outcome (persistent disabling symptoms)(3, 6, 9 and 12 months)
  • Change from baseline in Chance of long-term disability and failure to return to work(3, 6, 9 and 12 months)
  • Change from baseline in Depression, anxiety and stress(3, 6, 9 and 12 months)
  • Change from baseline in Fear-avoidance / kinesiophobia(3, 6, 9 and 12 months)
  • Change from baseline in Psychosocial aspects of work(3, 6, 9 and 12 months)
  • Change from baseline in Psychosocial job aspects(3, 6, 9 and 12 months)
  • Change from baseline in Lower Lumbar spine Kinematics(3, 6, 9 and 12 months)
  • Patient satisfaction of the intervention(3, 6, 9 and 12 months)

研究者

发起方
KU Leuven
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. dr. Wim Dankaerts

Prof. dr.

KU Leuven

研究点 (1)

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