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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 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
研究组 & 干预措施
Pain education
The patient education provides a basic set of information that includes the explanation of possible pathophysiological mechanisms involved in the development of chronic pain. The main objective is to reduce pain threatening and alarmist interpretation. The patient must understand that the pain is not necessarily a sign of injury, but the consequence of a maladaptive central sensitization. One element of this therapeutic strategy is to help the patient to perform physical activities that involve a gradual exposition to stimuli associated with their pain and promote physical recovery exposure. Pain education also aims to reduce fear-avoidance behavior and the patient's disability.
干预措施: Pain education (Other)
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
Study Functional Magnetic Resonance Image (fMRI)
时间窗: At day 1
Fractional anisotropy maps Functional MRI Voxel voxel orientation maps Maps diffusivity Functional study RestingState
Study Functional Magnetic Resonance Image (fMRI)
时间窗: Between 7 and 31 days later randomly
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)
- Multidimensional Pain Inventory (MPI) - Interference Scale(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)
- 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