JPRN-jRCTs031210314招募中未知
Biomarker development study of pain quantification in patients with chronic pain using AMPA receptor density as an index
Miyazaki Tomoyuki0 个研究点目标入组 60 人开始时间: 2021年9月15日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 65age old（—）
- 性别
- All
入选标准
- •Patients that meet all of the following criteria 1) to 4).
- •1) Patients having sustained pain that lasts for 3 months or longer
- •2) 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
- •3) Patients whose ages are between 20 and 65 at the time of registration
- •4) Patients whose written consent regarding participation in this study can be obtained
排除标准
- •1) Implantation of metal substances and pacemakers
- •2) head, neck and body size not suitable for MRI scanner
- •3) A tattoo larger than one point (including tattoo and art makeup)
- •4) Advanced claustrophobic
- •5) A remarkable variant of brain structure (including congenital and traumatic)
- •6) Patient with renal dysfunction (Serum creatinine 1.5 mg / dl or more)
- •7) Patient with liver dysfunction (AST 150 IU / L or more ALT 150 IU / L or more)
- •8) 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)
- •9) Sensitive to alcohol
- •10) Participating in unapproved nuclear medicine clinical trials and clinical trials within 6 months prior to enrollment
- •11) 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)
- •12) Patients who have difficulty communicating in Japanese
- •13) Patients judged as inappropriate for study by the research investigator
研究者
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