Predicting Chronic Post TKR Pain by Assessing Central Sensitisation Using Functional Brain MRI
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Brain activity related to temporal summation of pain in healthy individuals and OA patients using a novel fMRI cuff algometer.
研究概览
简要总结
Painful osteoarthritis (OA) is the 4th largest cause of disability in the UK. Preoperative temporal summation, a measure of central pain facilitation, has been shown to predict postoperative pain after total knee replacement surgery (TKR). The assessment of the brain's response to noxious stimuli using non-invasive functional MRI (fMRI) may be key in identifying imaging biomarkers within the brain that map central sensitization changes seen in OA. fMRI may help explain why up to 20% of patients undergoing TKR surgery develop persistent post-operative pain. To test these concepts the study aims to functionally characterise the brain activity related to temporal summation of pain in healthy individuals and OA patients using a novel fMRI cuff algometer. Assessment of outcomes in terms of pain and function will be performed 6 months post TKR surgery
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Unilateral Knee OA No previous knee surgery Able to give informed consent Age > 40 years
- •Healthy Volunteers Group
- •No OA or knee pain Able to give informed consent Age > 40 years
排除标准
- •Major medical, psychiatric, neurological Cx Other chronic pain condition (fibromyalgia) Contraindications to MRI Active Cancer Neuropathic drug treatment
- •Healthy Volunteers Group
- •Pregnancy Lower limb pain or previous knee surgery Contraindications to MRI Active Cancer Major medical, psychiatric, neurological condition
结局指标
主要结局
Brain activity related to temporal summation of pain in healthy individuals and OA patients using a novel fMRI cuff algometer.
时间窗: 6 months post total knee replacement surgery
Using BOLD fMRI we aim to assess the difference in neural brain activity between patients with chronic knee OA pain and a group of healthy volunteers and to assess the reversal of this activity pattern 6 months post TKR surgery
次要结局
- Assessment of knee pain using the Visual Analogue Scale for Pain (0-10)(6 months post total knee replacement surgery)
- Assessment of improvement in the Oxford Knee Score(6 months post total knee replacement surgery)
- Assessment of change in healthy related quality of life measure using the EQ5D-5L questionnaire(6 months post total knee replacement)