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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035877
Receipt No. R000040873
Scientific Title The effects of acupuncture on the patients with fibromyalgia (FM) who do not respond to the prescription drugs
Date of disclosure of the study information 2019/04/15
Last modified on 2019/09/02

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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

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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