Exposure Therapy in Chronic Low Back Pain Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Change from baseline in pain severity at 3 and 6 months after admission
研究概览
简要总结
Chronic low back pain often results in psychosocial and physical disability. A subgroup of these patients shows fear of (re)injury and avoidance behaviour leading to higher disability. The purpose of this study is to determine whether exposure in vivo is more effective in the treatment of fear avoidant chronic back pain patients than psychological treatment as usual (cognitive behavioural psychotherapy).
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
- 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
- •Having at least 3 months back pain
- •Sufficient level on fear avoidance scores (TSK, Phoda)
- •Being German-speaking
- •Agreeing to participate, verified by completion of informed consent
排除标准
- •Red flags
- •Pregnancy
- •Illiteracy
- •Psychoses
- •Alcohol addiction
- •surgeries during the last 6 months or planed surgeries
- •Specific medical disorders or cardiovascular diseases preventing participation in physical exercise
- •Participating in another psychotherapy
研究组 & 干预措施
A Exposure long
Exposure in vivo for fear avoidant chronic low back pain patients. This treatment means that the individual is exposed to movements and tasks that have been avoided due to fear of (re)injury. The treatment begins after three educational lessons including the rational and developing a fear hierarchy. Exposure phase includes 10 exposures sessions which are highly individualized. Behavioral experiments can be included to correct catastrophic misinterpretations. The main purpose of this intervention type is to reduce pain related disability via diminishing fear avoidance.
干预措施: Exposure in vivo (Behavioral)
B Exposure short
See above exposure long. This treatment comprises 5 exposure sessions.
干预措施: Exposure in vivo (Behavioral)
C Cognitive behavioural psychotherapy
Cognitive behavioural psychotherapy for fear avoidant chronic low back patients. The therapy is modularized in three main parts. The educational lesson is followed by the module graded activity which represents the behavioral part of the program. The second module comprises relaxation. And the last part contains cognitive interventions. Cognitive behavioural intervention techniques are employed to support the patient in the process of coping with chronic pain: i.e. reduction of disability and improving functional ability.
干预措施: Cognitive Behavioural Psychotherapy (Behavioral)
结局指标
主要结局
Change from baseline in pain severity at 3 and 6 months after admission
时间窗: from Pretest (admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission)
Numeric Rating Scale (NRS)
Change from baseline in pain disability at 3 and 6 months after admission
时间窗: from Pretest (admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission)
Pain Disability Index (PDI) Quebec Back Pain Disability Scale (QBPDS)
次要结局
- Change in physical activity from Pretest to two in-between timepoints to Posttest to Follow-up Time(from Pretest (admission) to one in-between timepoint (an expected 10 weeks after admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission))
- Change in pain catastrophizing from Pretest to two in-between timepoints to Posttest to Follow-up(from Pretest (admission) to one in-between timepoint (an expected 10 weeks after admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission))
- Change in quality of life from Pretest to two in-between timepoints to Posttest to Follow-up(from Pretest (admission) to one in-between timepoint (an expected 10 weeks after admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission))
- Change in fear avoidance from Pretest to two in-between time points to Posttest(from Pretest (admission) to one in-between timepoint (an expected 10 weeks after admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission))
- Change in emotional distress from Pretest to two in-between timepoints to Posttest to Follow-up(from Pretest (admission) to one in-between timepoint (an expected 10 weeks after admission) to Posttest (an expected average of 3 months after admission) to Follow-up (an expected average of 6 months after admission))
研究者
Julia Anna Glombiewski
Ph.D, Licensed Psychologist, Principal Investigator
Philipps University Marburg Medical Center