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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031210314
Enrollment
60
Registered
2021-09-15
Start date
2021-12-06
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic pain Chronic pain

Interventions

Sponsors

Miyazaki Tomoyuki
Lead Sponsor
Takahashi Takuya
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Identification of areas of common variation in AMPA receptor density in the brains of patients with chronic pain with different causative disorders

Secondary

MeasureTime frame
-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 - Comparison of AMPA receptor density in the brain by 4 groups including the healthy subject group - Comparison between the signal source region estimated by high-precision EEG and the brain region with changes in AMPA receptor density - 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

Contacts

Public ContactYuu Sakai

Yokohama City University, School of Medicine

ysakai61@yokohama-cu.ac.jp+81-45-787-2918

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026