UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057993 |
|---|---|
| Receipt number | R000066297 |
| Scientific Title | An Analysis of the Clinical Aspects of Fibromyalgia Patients |
| Date of disclosure of the study information | 2025/05/28 |
| Last modified on | 2025/05/28 09:50:29 |
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Basic information
Public title
An Analysis of the Clinical Aspects of Fibromyalgia Patients
Acronym
An Analysis of the Clinical Aspects of Fibromyalgia Patients
Scientific Title
An Analysis of the Clinical Aspects of Fibromyalgia Patients
Scientific Title:Acronym
An Analysis of the Clinical Aspects of Fibromyalgia Patients
Region
| Japan |
Condition
Condition
Fibromyalgia
Classification by specialty
| Neurology | Psychosomatic Internal Medicine | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the clinical features of fibromyalgia by evaluating a range of factors in approximately 400 patients. The findings are expected to contribute to a further understanding of the clinical pathology of the disorder and to inform appropriate management strategies.
Basic objectives2
Others
Basic objectives -Others
This study aims to clarify the clinical features of fibromyalgia by evaluating a range of factors in approximately 400 patients. The findings are expected to contribute to a further understanding of the clinical pathology of the disorder and to inform appropriate management strategies.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Pain intensity and distribution were assessed using the Numerical Rating Scale (NRS), Widespread Pain Index (WPI), Symptom Severity Scale (SS), the Short-Form McGill Pain Questionnaire (SF-MPQ), and the Brief Pain Inventory (BPI). These assessments were conducted at the initial visit and at each subsequent outpatient visit. If the initial consultation occurred at another institution, and relevant pain scale data were included in the referral documents, those data were utilized. The baseline values were defined as those recorded at the initial visit, and the final values were defined as those recorded as of March 2025. In cases where no data were available in March 2025, the most recent available data prior to that date were used as the final values. For patients who discontinued follow-up, the last recorded values at the time of discontinuation were considered the final values. The rate of change was calculated based on these baseline and final values.
Key secondary outcomes
For approximately 40 hospitalized patients, changes in pain intensity during hospitalization were evaluated. In patients with comorbid migraine, headache severity was assessed using the Headache Impact Test-6 (HIT-6) and the Migraine Disability Assessment Scale (MIBS-4). In addition, relevant clinical data were collected, including laboratory tests, computed tomography (CT), magnetic resonance imaging (MRI), radionuclide imaging (RI), and electrophysiological studies.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The data collection period spanned from April 1, 2022, to March 31, 2025. Patient records were extracted from the hospital's electronic medical record system. Cases with a documented insurance diagnosis of 'fibromyalgia' were initially identified. To account for potential omissions, additional cases were manually reviewed and identified based on outpatient records maintained by the attending physicians.
Key exclusion criteria
none
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Kenya |
| Middle name | |
| Last name | Nishioka |
Organization
Juntendo Tokyo Koto Geriatric Medical Center
Division name
Department of Neurology
Zip code
136-0075
Address
3-3-20 Shinsuna, Koto-ku, Tokyo
TEL
03-5632-3111
nishioka@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Maya |
| Middle name | |
| Last name | Ando |
Organization
Juntendo Tokyo Koto Geriatric Medical Center
Division name
Department of Neurology
Zip code
136-0075
Address
3-3-20 Shinsuna, Koto-ku, Tokyo
TEL
03-5632-3111
Homepage URL
my-ando@juntendo.ac.jp
Sponsor or person
Institute
Juntendo Tokyo Koto Geriatric Medical Center
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University
Address
3-1-1 Hongo Bunkyo-ku, Tokyo, Japan
Tel
03-3813-3111
igakubu.rinri1@juntendo.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
| 2025 | Year | 05 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 05 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 05 | Month | 28 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2025 | Year | 05 | Month | 28 | Day |
Last modified on
| 2025 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066297
