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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035406
Receipt No. 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 2018/12/29

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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
Middle name
Last name Kazunori Itoh
Organization Meiji University of Integrative Medicine
Division name Acupuncture and Moxibustion
Zip code
Address hiyoshi, Nantan, Kyoto
TEL +8177711181
Email k_itoh@meiji-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazunori Itoh
Organization Meiji University of Integrative Medicine
Division name Acupuncture and Moxibustion
Zip code
Address Hiyoshi, Nantan, Kyoto
TEL +8177711181
Homepage URL
Email k_itoh@meiji-u.ac.jp

Sponsor
Institute Meiji University of Integrative Medicine
Institute
Department

Funding Source
Organization AMED
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization JP

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
Anticipated trial start date
2019 Year 05 Month 01 Day
Last follow-up date
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
2018 Year 12 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040343

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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