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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015645
Receipt No. R000018186
Scientific Title Randomized controlled trial of acupuncture treatment on fibromyalgia
Date of disclosure of the study information 2015/01/31
Last modified on 2016/11/08

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Basic information
Public title Randomized controlled trial of acupuncture treatment on fibromyalgia
Acronym Effects of acupuncture on fibromyalgia
Scientific Title Randomized controlled trial of acupuncture treatment on fibromyalgia
Scientific Title:Acronym Effects of acupuncture on fibromyalgia
Region
Japan

Condition
Condition fibromyalgia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We compared the effect of acupuncture with that of sham acupucture on pain and QOL in patients with fibromyalgia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes VAS
fibromyalgia impact questionnaire
Key secondary outcomes McGill Pain Questionnaire
HADS
Pain Vision


Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 acupuncture
Interventions/Control_2 electro-acupuncture
Interventions/Control_3 sham acupuncture
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 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 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazunori Itoh
Organization Meiji University of Integrative Medicine
Division name Clinical Acupuncture and Moxibustion
Zip code
Address Hiyoshi-cho, Nantan, Kyoto
TEL 0771-72-1181
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 Clinical Acupuncture and Moxibustion
Zip code
Address Hiyoshi-cho, Nantan, Kyoto
TEL 080-3130-5771
Homepage URL http://selfmanagement.jp/
Email k_itoh@meiji-u.ac.jp

Sponsor
Institute Meiji University of Integrative Medicine
Institute
Department

Funding Source
Organization Health Labour Sciences Research Grant
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization JAPAN

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 平成医療学園専門学校

Other administrative information
Date of disclosure of the study information
2015 Year 01 Month 31 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 Completed
Date of protocol fixation
2014 Year 11 Month 10 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 15 Day
Last follow-up date
2015 Year 12 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
2014 Year 11 Month 10 Day
Last modified on
2016 Year 11 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018186

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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