UMIN-CTR Clinical Trial

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
Last 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
Email	k_itoh@meiji-u.ac.jp

Public contact
1st 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
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	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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041453