UMIN-CTR 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
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/
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
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/ctr_e/ctr_view.cgi?recptno=R000040873
