UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048852 |
|---|---|
| Receipt number | R000055625 |
| Scientific Title | Development of a biomarker of fibromyalgia on neuroinflammation. |
| Date of disclosure of the study information | 2022/09/12 |
| Last modified on | 2026/03/09 11:17:48 |
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Basic information
Public title
Development of a biomarker of fibromyalgia on neuroinflammation.
Acronym
Development of a biomarker of fibromyalgia on neuroinflammation.
Scientific Title
Development of a biomarker of fibromyalgia on neuroinflammation.
Scientific Title:Acronym
Development of a biomarker of fibromyalgia on neuroinflammation.
Region
| Japan |
Condition
Condition
Fibromyalgia, chronic pain
Classification by specialty
| Neurology | Clinical immunology | Psychosomatic Internal Medicine |
| Psychiatry | Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between fibromyalgia and complement.
Basic objectives2
Others
Basic objectives -Others
Validation as biomarkers
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concentration of complement (C3a, C5a, sC5b-9) in peripheral blood.
Key secondary outcomes
The relationship between the concentration of complement and clinical features such as psychological and physiological measurements.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
[Fibromyalgia]
(1) Patients diagnosed with fibromyalgia.
(2) Patients who fully understand this research plan and can give their consent.
(3) Patients who are at least 18 years of age at the time consent is obtained.
[Chronic pain]
(1) Patients who have pain that lasts more than 3 months but do not meet the diagnostic criteria for fibromyalgia.
(2) Patients who fully understand this research plan and can give their consent.
(3) Patients who are at least 18 years of age at the time consent is obtained.
[Healthy control]
(1) Healthy subjects who do not have pain lasting more than 3 months.
(2) Persons who fully understand this research plan and can give their consent.
(3) Persons who are at least 18 years of age at the time consent is obtained.
Key exclusion criteria
[Fibromyalgia]
(1) Patients with symptoms of anemia (hemoglobin 8 g/dl or less)
(2) Patients with poor general condition (PS value >3)
(3) Patients diagnosed with autoimmune disease, chronic infectious disease, demyelinating disease, complement-related disease (PNH, NMO, MS), malignant disease
(4) Other patients deemed by the investigator to be inappropriate as research subjects.
[Chronic pain]
(1) Patients with symptoms of anemia (hemoglobin of 8 g/dl or less)
(2) Patients with poor general condition (numerical value: PS value 3 or higher)
(3) Those diagnosed with autoimmune disease, chronic infectious disease, demyelinating disease, complement-related disease (PNH, NMO, MS), or malignant disease
(4) Other subjects deemed by the investigator to be inappropriate as research subjects.
[Healthy control]
(1) Those with symptoms of anemia (hemoglobin 8 g/dl or less)
(2) Patients with poor general condition (PS value of 3 or higher)
(3) Patients receiving treatment for pain
(4) Those diagnosed with autoimmune disease, chronic infectious disease, demyelinating disease, complement-related disease (PNH, NMO, MS), or malignant disease
(5) Any other person whom the investigator deems inappropriate as a research subject.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Masako |
| Middle name | |
| Last name | HOSOI |
Organization
Kyushu University
Division name
Department of Psychosomatic Medicine, Graduate School of Medical Sciences.
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka City
TEL
092-642-5320
hosoi.masako.642@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | FUJIMOTO |
Organization
Kyushu University
Division name
Department of Psychosomatic Medicine, Graduate School of Medical Sciences.
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka City
TEL
092-642-5320
Homepage URL
fujimoto.koji.059@m.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Psychosomatic Medicine, Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu University Institutional Review Board for Clinical Research
Address
3-1-1, Maidashi Higashi-ku, Fukuoka, 812-8582, Japan
Tel
092-642-6254
ijkseimei@jimu.kyushu-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 12 | Day |
Related information
URL releasing protocol
https://doi.org/10.1038/s41598-025-01347-x
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1038/s41598-025-01347-x
Number of participants that the trial has enrolled
59
Results
The mean (standard deviation) peripheral blood C5a concentrations of fibromyalgia and healthy control were 12.7 (6.48) ng/ml and 8.82 (4.79) ng/ml, respectively (p = 0.0114).
Results date posted
| 2026 | Year | 03 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The age distribution was similar between the two groups, with a mean age of 46.6 +/- 13.75 years for the fibromyalgia group and 49.97 +/- 13.00 years for the healthy control group.
Participant flow
The final analysis of this study included 30 female patients with fibromyalgia (FM) and 29 female healthy controls (HCs), all aged 18 years or older. Although four male patients were initially recruited, they were excluded from the study due to their small number, resulting in an all-female participant cohort.
Adverse events
None.
Outcome measures
The primary evaluation items for this study are the concentration of the complement component C5a in peripheral blood plasma and pain sensitivity, which is measured via quantitative sensory testing (QST) to assess both the cold pain threshold (CPT) and warm pain threshold (WPT). In addition, the average pain intensity over the past week is evaluated as a clinical measure using a visual analog scale (VAS) ranging from 0 to 100 mm. Other blood markers measured in the study include white blood cell count (WBC), C-reactive protein (CRP), and additional complement proteins such as C3, and C4. These measurements are utilized to evaluate the correlation between C5a concentrations and clinical features, particularly pain thresholds and pain intensity.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 12 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2024 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2024 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 08 | Month | 31 | Day |
Other
Other related information
This study will clarify the relationship between fibromyalgia and complemental system. We will examine whether peripheral complement levels are elevated in patients with fibromyalgia compared to controls, as well as the validity of complement as a biomarker for diagnosis and severity by examining clinical features.
Management information
Registered date
| 2022 | Year | 09 | Month | 05 | Day |
Last modified on
| 2026 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055625
