UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000035877
Receipt number 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 15:11:05

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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 or person

Institute

Meiji University od Interative Medicine

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_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