UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035406 |
|---|---|
| Receipt number | R000040343 |
| Scientific Title | Efeects of acupuncture therapy on fibromyalgia patients with with drug resistance |
| Date of disclosure of the study information | 2019/05/01 |
| Last modified on | 2020/06/30 10:29:38 |
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Basic information
Public title
Efeects of acupuncture therapy on fibromyalgia patients with with drug resistance
Acronym
Efeects of acupuncture therapy on fibromyalgia patients
Scientific Title
Efeects of acupuncture therapy on fibromyalgia patients with with drug resistance
Scientific Title:Acronym
Efeects of acupuncture therapy on fibromyalgia patients
Region
| Japan |
Condition
Condition
fibromyalgia patients
Classification by specialty
| Medicine in general | Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this research is to construct a protocol to analyze the effects of acupuncture on the patients with fibromyalgia (FM) who do not respond to the prescription drugs.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
drugs
pain
Key secondary outcomes
QOL
PCS
Base
Study type
Interventional
Study design
Basic design
expanded access
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
acupuncture
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.agreement in this study
2.more than 20 years
3.fibromyalgia patients
4.more than 3 months during pain
5.more thna VAS 50mm
6.more than JFIQ 50scores
7.more than 3 months using drug
Key exclusion criteria
1.no more other disorders
2.no more other pain disorders
3.no chang the drug during study
Target sample size
20
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
hiyoshi, Nantan, Kyoto
TEL
+8177711181
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
Hiyoshi, Nantan, Kyoto
TEL
+8177711181
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
Other
Nationality of Funding Organization
JP
Other related organizations
Co-sponsor
no
Name of secondary funder(s)
IRB Contact (For public release)
Organization
MEiji University of Integrative Medicine
Address
Hiyoshi-cyo
Tel
+8177711181
@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
明治国際医療大学
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 01 | 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
| 2018 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2021 | 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
| 2018 | Year | 12 | Month | 29 | Day |
Last modified on
| 2020 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040343
