UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized controlled trial of acupuncture treatment on fibromyalgia
Title of the study (Brief title)	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	Kazunori Itoh
Organization	Meiji University of Integrative Medicine
Division name	Clinical Acupuncture and Moxibustion
Address	Hiyoshi-cho, Nantan, Kyoto
TEL	0771-72-1181
Email	k_itoh@meiji-u.ac.jp

Public contact
Name of contact person	Kazunori Itoh
Organization	Meiji University of Integrative Medicine
Division name	Clinical Acupuncture and Moxibustion
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000018186