NCT03929952已完成不适用
Descriptive Pilot Study of the Effects of a Standardized Neuromodulation Program on Cortical Brain Function in Chronic Low Back Pain Patients
Centre Hospitalier Universitaire de Nīmes2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2022年1月19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
- 15
- 试验地点
- 2
- 主要终点
- Description of the cortical zone activated by neurofeedback
研究概览
简要总结
This study aims to evaluate neurofeedback-induced changes in brain function and the correlations between these changes and clinical scores by functional magnetic resonance imaging and electroencephalography in patients with low back pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with a wifi connexion at home
- •Patient with the ability to modulate the height of the candle by thinking in the alpha synchrony test.
- •Patient with chronic low back pain for more than six months with a visual analogue pain scale greater than 5 impacting activities of daily living, hobbies and work
- •Patient having given free and informed consent and signed consent.
- •Affected patient or beneficiary of a health insurance plan.
- •Patient who is at least 18 years old (≥) and younger than 75 years old (<).
排除标准
- •Pregnant or breastfeeding patient
- •Patient with a contraindication to performing a fMRI scan: ferromagnetic implant in the body, piercing, claustrophobia, unable to remain in the scanner stationary for 40 minutes
- •Patient already included in another study
- •Patient in a exclusion period determined by a previous study
- •The subject is under the protection of justice, guardianship or curatorship.
- •The subject refuses to sign the consent.
- •It is not possible to give the subject informed information.
结局指标
主要结局
Description of the cortical zone activated by neurofeedback
时间窗: Day 20
Measure taken by electroencephalography
次要结局
- Fear Avoidance Beliefs Questionnaire (FABQ)(Day 20)
- Back Beliefs Questionnaire (BBQ)(Day 20)
- Oswestry Disability Index (ODI)(Day 20)
- Coping Strategies Questionnaire (CSQ)(Day 20)
- Scale of lumbar pain in Quebec(Day 20)
- Tampa scale(Day 20)
- Hospital Anxiety and Depression Scale (HADS)(Day 20)
研究者
研究点 (2)
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