UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015645 |
|---|---|
| Receipt number | R000018186 |
| Scientific Title | Randomized controlled trial of acupuncture treatment on fibromyalgia |
| Date of disclosure of the study information | 2015/01/31 |
| Last modified on | 2016/11/08 12:58:57 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Randomized controlled trial of acupuncture treatment on fibromyalgia
Acronym
Effects of acupuncture on fibromyalgia
Scientific Title
Randomized controlled trial of acupuncture treatment on fibromyalgia
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Kazunori Itoh |
Organization
Meiji University of Integrative Medicine
Division name
Clinical Acupuncture and Moxibustion
Zip code
Address
Hiyoshi-cho, Nantan, Kyoto
TEL
0771-72-1181
k_itoh@meiji-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazunori Itoh |
Organization
Meiji University of Integrative Medicine
Division name
Clinical Acupuncture and Moxibustion
Zip code
Address
Hiyoshi-cho, Nantan, Kyoto
TEL
080-3130-5771
Homepage URL
http://selfmanagement.jp/
k_itoh@meiji-u.ac.jp
Sponsor or person
Institute
Meiji University of Integrative Medicine
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Completed
Date of protocol fixation
| 2014 | Year | 11 | Month | 10 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018186
