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
- 已完成
- 发起方
- 入组人数
- 99
- 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
- Single (Outcomes Assessor)
盲法说明
Outcome assessors were masked to group allocation throughout the study. The allocation sequence was kept by a second researcher and the sealed opaque envelope was delivered only after the baseline assessment of each participant had been completed. All baseline assessments were therefore performed before allocation was known. After allocation, participants and the physiotherapist delivering the interventions could not be masked, because the interventions differ in content, setting and mode of delivery.
入排标准
- 年龄范围
- 18 Years 至 64 Years（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).
研究组 & 干预措施
Intervention 1
Participants will receive exercise, PNE and online cognitive training sessions.
干预措施: Experimental (Other)
Intervention 2
Participants will receive exercise and pain neuroscience education (PNE).
干预措施: Exercise and PNE (Other)
Intervention 3
Participants will receive online cognitive training sessions.
干预措施: Cognitive training (Other)
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".
Numeric Pain Rating Scale Numeric Pain Rating Scale
时间窗: baseline
Measured with a 11-point scale ranging from 0 meaning "no pain" to 10 meaning "the worst pain imaginable".
Numeric Pain Rating Scale Numeric Pain Rating Scale
时间窗: post-intervention - 8 weeks
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.)
- Cognitive Function(baseline)
- Cognitive Function(post-intervention - 8 weeks)
- Roland Morris disability questionnaire(baseline)
- Roland Morris disability questionnaire(post-intervention - 8 weeks)
- Central sensitization Inventory(baseline)
- Central sensitization Inventory(post-intervention - 8 weeks)
- Hospital Anxiety and Depression Scale (HADS)(baseline)
- Hospital Anxiety and Depression Scale (HADS)(post-intervention - 8 weeks)
- TAMPA Scale of Kinesiophobia(baseline)
- TAMPA Scale of Kinesiophobia(post-intervention - 8 weeks)
- Pain Catastrophizing Scale(Baseline)
- Pain Catastrophizing Scale(post-intervention - 8 weeks)
- Basic Scale on Insomnia Complaints and Quality of Sleep (BaSIQs)(baseline)
- Basic Scale on Insomnia Complaints and Quality of Sleep (BaSIQs)(post-intervention - 8 weeks)
- Two-point discrimination(baseline)
- Two-point discrimination(post-intervention - 8 weeks)
- Patient's Global Impression of Change (PGIC)(post-intervention - 8 weeks)
研究者
Ellen Hirose Pereira Nery
Principal Investigator
Aveiro University