Dare to Move: Treatment of Movement Phobia in Patient With Low Back Pain A Randomized Controlled Study of Two Methods Comparing the Role of Exposure in Session
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Absenteeism from work
研究概览
简要总结
Unspecific low back pain (LBP) is a major world wide health problem. The purpose of this study is to improve the care of LBP.
Our hypothesis is that Cognitive Behavioural Therapy (CBT) with physical intervention during group sessions focusing on fear and avoidance behaviour will be more effective than physical therapy alone.
The study has two arms. Both will receive education related to LBP and appropriate advice regarding how to react and behave towards their LBP.
The main focus in the intervention group will be:
- Identifying their fear of movements and perform the frightened movements during the group sessions.
- Reassuring that gradually normalizing daily activities will not be harmful but rather reduce their pain.
详细描述
Cognitive-behavioural treatment is the treatment of choice in the treatment of most patients with chronic LBP. Several randomized controlled trials and recent meta-analysis have demonstrated the potent effects of CBT.
The fear and avoidance model developed by Vlaeyen and Linton has been recommended to be applied in the treatment of patients with chronic low back pain. No randomized controlled study has been published comparing the use of a fear and avoidance treatment with a comparison treatment. Such a study is highly warranted to examine if the model actually has a superior effect compared to other CBT-based treatments. In addition, it is of vital importance to examine whether all patients profit better from such a treatment or whether it only will demonstrate superior effect in a subgroup of patients with chronic low back pain.
PROBLEMS OF INTEREST:
Main aims are to improve the treatment of patients with chronic LBP by:
-
- Testing the effect of a treatment assumed by the international scientific community to be the treatment of choice;
-
- To develop a diagnostic screening procedure that at an initial examination can differentiate patients that need special treatment attention in the form of exposure towards feared movements from those who can benefit sufficiently from just receiving appropriate advice.
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- To identify the mechanism of change in the treatment of LBP.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Low Back Pain (LBP) lasting from 3 months to 10 years.
- •Pain of such a severity that life of quality is reduced.
- •The patient's main problem must be LBP, localized from L1 to S
- •The pain must not be caused by nerve root affection (e.g. herniated disc)
- •The patient has to be able to understand instructions given in Norwegian and to take part in a group activity.
- •The patient must be partly or fully on sick leave from work.
- •The patient must have a regular work to return to.
排除标准
- •100 % disability pension, of any reason.
- •LBP that clearly is secondary to other somatic or psychiatric disorders.
- •Alcohol and drug abuse.
- •LBP caused by ankylosing spondylitis and other spondylarthropathies.
- •Patients with "red flags" such as bladder- and anal paresis, impotence or progressing paresis.
- •Ongoing insurance affairs for all types of sickness, injuries and accidents both against insurance companies and NAV (The Norwegian Labour and Welfare Administration)
- •Indication for back surgery or performed back surgery last 12 months
- •On medication known to cause depression or other psychiatric symptoms
研究组 & 干预措施
Arm 1: CBGT
Cognitive Behavioural Group Therapy (CBGT)
干预措施: Arm 1: CBGT (Behavioral)
Arm 2: CBGT-ISE
Cognitive Behavioural Group Therapy, with in-Session Exposure (CBGT-ISE).
干预措施: Arm 2: CBGT-ISE (Behavioral)
结局指标
主要结局
Absenteeism from work
时间窗: Week 52
Registrations of absenteeism will be given by the Norwegian Sick leave Register. This has certainly to be retrospectively (Is already approved)
次要结局
- Pain(Will be done the following weeks: -1., 6., 14., and 52.)
- Physical functioning.(Will be done the following weeks: -1., 6., 14., and 52.)
- Emotional functioning(Will be done the following weeks: -1., 6., 14., and 52.)
- Patient ratings of improvement and satisfaction with treatment(Will be done the following weeks: -1., 6., 14., and 52.)
- Health-related quality of life(Will be done the following weeks: -1., 6., 14., and 52.)
- Coping/catastrophising(One week before intervention starts, then week 2 during the intervention, week 6 after finished intervention, week 14 after the booster and week 52.)
- Side effects(Will be done the following weeks: -1., 6., 14., and 52.)
- Quality of life(Will be done the following weeks: -1., 6., 14., and 52.)