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

Not Applicable

Recruiting

• Conditions: Chronic pain; D059350

• Registration Number: JPRN-jRCTs031210314
• Lead Sponsor: Miyazaki Tomoyuki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identification of areas of common variation in AMPA receptor density in the brains of patients with chronic pain with different causative disorders