NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs031210314

Registered date:15/09/2021

Biomarker development study of pain quantification in patients with chronic pain using AMPA receptor density as an index

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedChronic pain
Date of first enrollment15/09/2021
Target sample size60
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Administration unapproved drug

Outcome(s)

Primary OutcomeIdentification of areas of common variation in AMPA receptor density in the brains of patients with chronic pain with different causative disorders
Secondary Outcome-Differences in brain AMPA receptor density from healthy subjects in patients with chronic pain -Correlation between AMPA receptor density in the brain and the chronic pain rating scale (using the results of the first PET examination protocol) -Correlation between changes in AMPA receptor density in the brain and changes in the evaluation scale for chronic pain (using the results of the first and second PET examination protocols) -Difference in AMPA receptor density in the brain between pain with clear injury mechanism (postoperative prolonged pain group) and unclear pain (other 2 disease groups) -Comparison of AMPA receptor density in the brain between the above and 3 groups including the healthy subject group

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum< 65age old
GenderBoth
Include criteriaPatients 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
Exclude criteria1) 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

Related Information

Contact

Public contact
Name Yuu Sakai
Address 3-9 Fukuura,Kanazawa-ku,Yokohama,Kanagawa,Japan Kanagawa Japan 236-0004
Telephone +81-45-787-2918
E-mail ysakai61@yokohama-cu.ac.jp
Affiliation Yokohama City University, School of Medicine
Scientific contact
Name Tomoyuki Miyazaki
Address 3-9 Fukuura,Kanazawa-ku,Yokohama,Kanagawa,Japan Kanagawa Japan 236-0004
Telephone +81-457872579
E-mail johney@yokohama-cu.ac.jp
Affiliation Yokohama City University Hospital