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) who do not respond to the prescription drugs
Scientific Title:Acronym	The effects of acupuncture on the patients with fibromyalgia (FM)
Region	Japan

Condition
Condition	fibromyalgia
Classification by specialty	Medicine in general Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	he 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	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase I,II

Assessment
Primary outcomes	the dose of drug
Key secondary outcomes	AS HADS PCS JFIQ

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	Active
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) Participants who have provided with a written agreement 2) Participants who are 20 years of age or older at the time of agreement 3) Participants who have been diagnosed with fibromyalgia 4) Participants who have pain on the half side or more of the body for more than 3 months 5) Participants who have the score of 50 mm or more on VAS 6) Participants who have the score of 50 points or more on JFIQ 7) Participants who have not exhibited improvement in pain after taking Pregabalin 8) Participants who are able to receive outpatient treatment once a week
Key exclusion criteria	1) Participants who are newly diagnosed with a connective tissue disease or a thyroid disease 2) If the evaluation of pain is difficult due to diseases such as diabetic neuropathy 3) If the evaluation of pain is difficult due to the presence of multiple causes of pain 4) If other treatment is commenced during the clinical trial 5) If the amount of or content of the prescription is modified 6) If outpatient treatment is not achievable 7) If fever over 38 degrees Celsius is measured on registration 8) Participants who are pregnant or have the possibility of pregnancy 9) If psychiatric diseases or psychiatric symptoms which interfere with the participants' daily life are present 10) Participants who are unable to perform the self-evaluation 11) Participants who are judged as unsuitable by the researcher in charge
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Kazunori Middle name Last name Itoh
Organization	Meiji University od Interative Medicine
Division name	Acupuncture and Moxibustion
Zip code	6290392
Address	Nantan, Kyoto
TEL	+8177711181
Email	k_itoh@meiji-u.ac.jp

Public contact
Name of contact person	1st name Kazunori Middle name Last name Itoh
Organization	Meiji University od Interative Medicine
Division name	Acupuncture and Moxibustion
Zip code	629-0392
Address	Nantan, Kyoto
TEL	+8177711181
Homepage URL	http://www.meiji-u.ac.jp/
Email	k_itoh@meiji-u.ac.jp

Sponsor
Institute	Meiji University od Interative 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	MEiji University of Integrative Medicine
Address	Nantan, Hiyoshi
Tel	+8177711181
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	明治国際医療大学

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	2018 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date	2019 Year 07 Month 01 Day
Last follow-up date	2020 Year 08 Month 31 Day
Date of closure to data entry	2021 Year 03 Month 31 Day
Date trial data considered complete	2021 Year 03 Month 31 Day
Date analysis concluded	2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2019 Year 02 Month 14 Day
Last modified on	2019 Year 09 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040873