NCT04179708已完成不适用
Effectiveness of Pain Neuroscience Education Compared to a Conventional Education for Patients With Chronic Low Back Pain : A Randomized Monocentric Trial.
University Hospital, Lille2 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2020年1月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Functional disability level (Rolland Morris questionnaire).
研究概览
简要总结
The hypothesis is that pain biology education, combined with a rehabilitation program, reduces disability to 3 months, compared to conventional spinal physiology education.
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
- •Low Back Pain since more than 1 year
- •Affiliated to Social Security Scheme
- •Rolland Moris ≥ 8
- •Start Back ≥ 4
排除标准
- •Suspicion or proven case of serious pathology such as recent vertebral fracture (less than 6 months), infection, malignant tumors and / or radiculopathy.
- •Have a history of rheumatic inflammatory disease
- •Have a true radiculalgia (with or without radiculopathy)
- •Have a scoliosis > 30° (if it is considered as a predominant contributor of pain's persistence).
- •Rating of pain > 8/10
- •Have had lumbar surgery in the past 12 months
- •Have had an injection in the past 3 months
- •Patients under legal protection (guardianship, curatorship)
- •Pregnant patients
- •Patients who are not able to understand, read or speak french
- •Inability to receive informed information
结局指标
主要结局
Functional disability level (Rolland Morris questionnaire).
时间窗: At 3 months
次要结局
- Functional disability level (Rolland Morris questionnaire)(at baseline (pre intervention), at 5 days (post intervention) and at 1 year)
- semi-conductive interview(At 3 months)
- Functional disability level (Dallas questionnaire)(at baseline (pre intervention), at 5 days (post intervention), at 3 months and at 1 year)
- Negatives believes level (Fear Avoidance and Belief Questionnaire)(at baseline (pre intervention), at 5 days (post intervention), at 3 months and at 1 year)
- Anxiety and Depression level (Hospital Anxiety and Depression scale)(at baseline (pre intervention), at 5 days (post intervention), at 3 months and at 1 year)
- Catastrophism level (Pain Catastrophizing Questionnaire)(at baseline (pre intervention), at 5 days (post intervention), at 3 months and at 1 year)
- Pain rating (Numeric scale)(at baseline (pre intervention), at 5 days (post intervention), at 3 months and at 1 year)
- Kinesiophobia level (Tampa Scale of Kinesiophobia)(at baseline (pre intervention), at 5 days (post intervention), at 3 months and at 1 year)
- Satisfaction level (18-item of Patient Satisfaction Questionnaire)(At one year)
研究者
研究点 (2)
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