Pain Neuroscience Education, Exercise, and Cognitive Training in Individuals With Idiopathic Chronic Low Back Pain: a Three-arm Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Numeric Pain Rating Scale Numeric Pain Rating Scale
研究概览
简要总结
This study aims of to investigate whether combining cognitive training to exercise and Pain Neuroscience Education will contribute to reduction of pain and associated symptoms (i.e., catastrophizing, fear of movement, disability) in individuals with low back pain (LBP).
详细描述
This study aims of to investigate whether combining cognitive training to exercise and Pain Neuroscience Education (PNE) will contribute to reduction of pain and associated symptoms (i.e., catastrophizing, fear of movement, disability) in individuals with low back pain (LBP).
It will have three arms of which will receive exercise, PNE and/or cognitive training for 8 weeks (Group I - exercise and PNE; Group II - exercise, PNE and cognitive training; Group III - cognitive training).
Participants will be assessed for pain characteristics, psychological, and cognitive aspects at baseline, post-intervention and at 3 months follow-up.
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
- •have chronic idiopathic LBP
- •report pain intensity of at least 2 out of 10 on the Numeric Pain Rating Scale
- •18 to 64 years old
- •Be able to read, write and speak Portuguese
- •Asses to personal computer and internet for those receiving cognitive training
排除标准
- •individuals receiving any chronic treatment for their pain
- •symptoms of peripheral nervous system pathology (e.g., motor weakness and sensory disturbance);
- •a diagnosis of an ongoing neurological disease with peripheral or central nervous system involvement or relevant sequela;
- •having a diagnosis of ongoing psychiatric disease
- •having relevant cognitive impairment as assessed by Montreal Cognitive Assessment (MoCA).
结局指标
主要结局
Numeric Pain Rating Scale Numeric Pain Rating Scale
时间窗: 3 months follow-up
Measured with a 11-point scale ranging from 0 meaning "no pain" to 10 meaning "the worst pain imaginable".
次要结局
- Central sensitization Inventory(3 months follow-up)
- Pain Catastrophizing Scale(3 months follow-up.)
- Two-point discrimination(3 months follow-up)
- Patient's Global Impression of Change (PGIC)(3 months follow-up.)
- Basic Scale on Insomnia Complaints and Quality of Sleep (BaSIQs)(3 months follow-up.)
- Cognitive Function(3 months follow-up.)
- Roland Morris disability questionnaire(3 months follow-up)
- Hospital Anxiety and Depression Scale (HADS)(3 months follow-up.)
- TAMPA Scale of Kinesiophobia(3 months follow-up.)
研究者
Ellen Hirose Pereira Nery
Principal Investigator
Aveiro University