NCT02957214已完成不适用
Prospective Controlled Study of the Effects of an Intervention Program Based on Pain Education in Pain Activity Patterns and Brain Connectivity in Patients With Chronic Pelvic Pain by Magnetic Resonance Images
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Study Functional Magnetic Resonance Image (fMRI)
研究概览
简要总结
The purpose of this study is to obtain imaging biomarkers based on changes in activity patterns and changes in brain connectivity obtained with the analysis of functional magnetic resonance imaging (fMRI) and tractography that are related to chronic pelvic 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 55 years
- •Chronic pelvic pain diagnosis
- •Pain duration > 6 months
- •Average pain intensity ≥ 6 during the previous week
排除标准
- •Suspected or knowledge of actual organic pathology that requires medical or surgical treatment
- •Psychiatric illness: major depression, bipolar syndrome...
- •Patients with significant cognitive deficits
- •Have pacemaker, metal prostheses or hearing aids incompatible with MRI
- •Severe traumatic brain injury
- •Previous cranial surgeries
- •History of alcoholism
- •Do not sign informed consent
结局指标
主要结局
Study Functional Magnetic Resonance Image (fMRI)
时间窗: At 6 months of completing the education program
Fractional anisotropy maps Functional MRI
次要结局
- Oswestry Disability Index (ODI)(Day 1 and at 6 months of completing the education program)
- Female Sexual Function Index(Day 1 and at 6 months of completing the education program)
- Hospital Anxiety and Depression Scale (HADS)(Day 1 and at 6 months of completing the education program)
- Multidimensional Pain Inventory (MPI) - Interference Scale(Day 1 and at 6 months of completing the education program)
- Pain Catastrophizing Scale(Day 1 and at 6 months of completing the education program)
- numerical rating scale NRS(Day 1 and at 6 months of completing the education program)
- Tampa Scale for Kinesiophobia-11(Day 1 and at 6 months of completing the education program)
研究者
Rafael Torres Cueco
PT
University of Valencia
研究点 (2)
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