UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044620 |
|---|---|
| Receipt number | R000050054 |
| Scientific Title | An exploratory study investigating the effectiveness of the Quasi-particle accelerator (QPA) for fibromyalgia |
| Date of disclosure of the study information | 2021/06/22 |
| Last modified on | 2024/03/29 15:56:36 |
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Basic information
Public title
Examination of the effectiveness of Quasi-particle accelerator (QPA) for fibromyalgia
Acronym
Examination of the effectiveness of Quasi-particle accelerator (QPA) for fibromyalgia
Scientific Title
An exploratory study investigating the effectiveness of the Quasi-particle accelerator (QPA) for fibromyalgia
Scientific Title:Acronym
An exploratory study investigating the effectiveness of the Quasi-particle accelerator (QPA) for fibromyalgia
Region
| Japan |
Condition
Condition
fibromyalgia
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Patients with fibromyalgia will be treated with QPA to evaluate efficacy (pain relief) and safety to determine if it could be a promising trial treatment for randomized controlled trials.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total score of the Japanese version of the Revised Fibromyalgia Impact Questionnaire (JFIQR) before and 4 weeks after the start of QPA treatment
Key secondary outcomes
The changes in JFIQR domain (1), (2), (3) and each item before and 4 weeks after the start of QPA treatment
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Treatment with QPA (2.5 hours once, once a week, 5 times in total)
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with fibromyalgia according to the American College of Rheumatology (ACR) Fibromyalgia Preliminary Diagnostic Criteria (2010)
Prevalence period 6 months or more
Key exclusion criteria
Patients with implantable electronic devices (such as pacemakers)
Patients with serious heart disease, kidney disease, liver disease
Patients with arterial oxygen saturation <94% without oxygen
Patients with severe peripheral neuropathy
Persons who have lost temperature sensitivity
Patients who cannot express their intention
Patients with hypersensitivity, injury or lesions on the skin of the pad area (upper back and lower back)
Pregnancy
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Tani |
Organization
Tokushima University Hospital
Division name
Department of General Medicine and Primary Care
Zip code
770-8503
Address
3-18-15 Kuramoto-cho, Tokushima 770-8503, Japan
TEL
088-633-9614
taniken@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Harutaka |
| Middle name | |
| Last name | Yamaguchi |
Organization
Tokushima University Graduate School of Biomedical Sciences
Division name
Department of General Medicine
Zip code
770-8503
Address
3-18-15 Kuramoto-cho, Tokushima 770-8503, Japan
TEL
088-633-9656
Homepage URL
yharutaka@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
Asias Corp
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Center for Developmental Therapeutics, Tokushima University Hospital
Address
2-50-1 Kuramoto-cho, Tokushima 770-8503, Japan
Tel
088-633-9294
awachiken@tokushima-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
徳島大学（徳島県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 22 | 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
3
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
Terminated
Date of protocol fixation
| 2021 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 22 | Day |
Last modified on
| 2024 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050054
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
