Biomarker development study of pain quantification in patients with chronic pain using AMPA receptor density as an index
Recruiting
- Conditions
- Chronic pain
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Patients that meet all of the following criteria 1) to 4).
- Patients having sustained pain that lasts for 3 months or longer
- Patients who meet any of each following (1) to (3) without any overlap with each other
(1) Patients having postoperative pain that was developed after surgery: Patients must meet the following (A) and (B)
(A) Pain that is observed around surgical sites and developed after surgery
(B) Pain that onset was within 3 months after surgery
(2) Patients having pain caused by psychosocial factors: Patients must meet each criterion (A) or (B) and also meet the conditions of (C) and (D).
(A) Pain that followed Neurotic symptoms (psychiatric symptoms) such as anxiety and depressive symptoms
(B) Those corresponding to "F45.4 Persistent somatic symptom pain disorder" in ICD-10 or "Physical symptom pain is the main symptom" in DSM-5
(C) Does not meet the following diagnostic criteria;
Psychiatric disorders other than anxiety and depressive symptoms (e.g. panic disorder, general anxiety, mood disorders, illness anxiety, conversion disorder, delusion disorder, dysmorphophobia, obsessive-compulsive disorder, schizophrenia)
- Patients who had anxiety and mood disorder in the past and recovered currently can be participated in this study.
(D) There are no organic factors that cause pain
(3) Patients having pain caused by fibromyalgia: Patients must meet each criterion (A) or (B) and also meet (C) at the same time
(A) Those corresponding to either ACR1990 or ACR2010
(B) Those corresponding to "M79.7 fibromyalgia" in ICD-10
(C) Pain that did not appear prior to neurotic symptoms (psychiatric symptoms) such as anxiety and depressive symptoms
- Patients whose ages are between 20 and 65 at the time of registration
- Patients whose written consent regarding participation in this study can be obtained
Exclusion Criteria
- Implantation of metal substances and pacemakers
- head, neck and body size not suitable for MRI scanner
- A tattoo larger than one point (including tattoo and art makeup)
- Advanced claustrophobic
- A remarkable variant of brain structure (including congenital and traumatic)
- Patient with renal dysfunction (Serum creatinine 1.5 mg / dl or more)
- Patient with liver dysfunction (AST 150 IU / L or more ALT 150 IU / L or more)
- Combination of serious neurologic diseases (neurodegenerative diseases, cases of cerebral hemorrhage and cerebral infarction which are not slight in the image before this study participation)
- Sensitive to alcohol
- Participating in unapproved nuclear medicine clinical trials and clinical trials within 6 months prior to enrollment
- During pregnancy, nursing or wishing to be pregnant(For premenopausal women,blood hCG is measured by blood sampling and confirmed to be less than 6 mIU / ml)
- Patients who have difficulty communicating in Japanese
- Patients judged as inappropriate for study by the research investigator
Study & Design
- Study Type
- Interventional
- Study Design
- single assignment
- Primary Outcome Measures
Name Time Method Identification of areas of common variation in AMPA receptor density Identification of areas of common variation in AMPA receptor density in the brains of patients with chronic pain with different causative disorders
- Secondary Outcome Measures
Name Time Method Differences in brain AMPA receptor density from healthy subjects in patients with chronic pain 比较慢性疼痛患者与健康受试者之间脑AMPA受体密度的差异
Correlation between AMPA receptor density in the brain and the chronic pain rating scale 脑AMPA受体密度与慢性疼痛评分量表之间的相关性（使用第一次PET检查方案的结果）
Correlation between changes in AMPA receptor density in the brain and changes in the evaluation scale for chronic pain 脑AMPA受体密度的变化与慢性疼痛评估量表变化之间的相关性（使用第一次和第二次PET检查方案的结果）
Difference in AMPA receptor density in the brain between pain with clear injury mechanism and unclear pain 明确损伤机制的疼痛（术后长期疼痛组）与不明确疼痛（其他2个疾病组）之间脑AMPA受体密度的差异
Comparison of AMPA receptor density in the brain between the above and 3 groups including the healthy subject group 上述组别与包括健康受试者组在内的3组之间脑AMPA受体密度的比较
Comparison of AMPA receptor density in the brain by 4 groups including the healthy subject group 包括健康受试者组在内的4组之间脑AMPA受体密度的比较
Comparison between the signal source region estimated by high-precision EEG and the brain region with changes in AMPA receptor density 高精度EEG估计的信号源区域与AMPA受体密度变化的脑区域之间的比较
Calculation of binding or association strength between brain regions obtained by resting fMRI, DTI, and EEG analysis using brain regions with changes in AMPA receptor density when comparing all patients with chronic pain and healthy subjects as seeds 使用静息态fMRI、DTI和EEG分析获得的脑区域之间的结合或关联强度计算，以AMPA受体密度变化的脑区域作为种子，比较所有慢性疼痛患者和健康受试者