UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000036385 |
|---|---|
| Receipt number | R000041453 |
| Scientific Title | The effects of acupuncture on the patients with fibromyalgia (FM) |
| Date of disclosure of the study information | 2019/04/15 |
| Last modified on | 2019/04/02 19:33:55 |
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Basic information
Public title
The effects of acupuncture on the patients with fibromyalgia (FM) who do not respond to the prescription drugs
Acronym
The effects of acupuncture on the patients with fibromyalgia (FM)
Scientific Title
The effects of acupuncture on the patients with fibromyalgia (FM)
Scientific Title:Acronym
The effects of acupuncture on the patients with fibromyalgia (FM)
Region
| Japan |
Condition
Condition
fibromyalgia (FM)
Classification by specialty
| Medicine in general | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this research is to investigate the effectiveness of trans-scalp electroacupuncture in addition to pharmacotherapy in reducing pain and the dose of drugs, and consequently, improving the scores on pain catastrophizing scale and the quality of life for the gabapentin-resistant FM patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
The dose of drug
Key secondary outcomes
VAS
HADS
JFIQ
AIS
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
electroacupuncture
Interventions/Control_2
drug
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
1 fibromyalgia patients
2 pain lasting for six months or longer
3 no osteoarthritis of systemic bone and joint disorder
4 normal neurological examination findings
Key exclusion criteria
1) major trauma
2) systemic disease
3) other conflicting or on-going treatments
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kazunori |
| Middle name | |
| Last name | Itoh |
Organization
MEiji University of Integrative Medicine
Division name
Acupuncture and Moxibustion
Zip code
629-0392
Address
Nantan, Kyoto
TEL
0771721181
k_itoh@meiji-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazunori |
| Middle name | |
| Last name | Itoh |
Organization
MEiji University of Integrative Medicine
Division name
Acupuncture and Moxibustion
Zip code
629-0392
Address
Nantan, Kyoto
TEL
0771721181
Homepage URL
k_itoh@meiji-u.ac.jp
Sponsor or person
Institute
MEiji University of Integrative Medicine
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
JP
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
MEiji University of Integrative Medicine
Address
Natan, Hiyoshi
Tel
0771721181
k_itoh@meiji-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
| 2019 | Year | 04 | Month | 15 | 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
| 2019 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 02 | Day |
Last modified on
| 2019 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041453
| 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 |
