UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009260 |
|---|---|
| Receipt number | R000010872 |
| Scientific Title | Randomized controlled trial of integrative medicine program for self management on fibromyalgia |
| Date of disclosure of the study information | 2012/12/01 |
| Last modified on | 2019/08/13 16:02:14 |
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Basic information
Public title
Randomized controlled trial of integrative medicine program for self management on fibromyalgia
Acronym
Establishment of self management program on chronic pain (fibromyalgia)
Scientific Title
Randomized controlled trial of integrative medicine program for self management on fibromyalgia
Scientific Title:Acronym
Establishment of self management program on chronic pain (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 self management with that of non-treatments on pain and QOL in patients with fibromyalgia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
VAS
FIQ(fibromyalgia impact questionnaire)
Key secondary outcomes
McGill Pain Questionnaire
SF-36
HADS
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
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
teaching of self management (Stretches, exercise, acupressure, moxibustion, massage, cognitive-behavior therapy, yoga, forest therapy)
Interventions/Control_2
control
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
| 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 (e.g. rheumatoid arthritis)
4) normal neurological examination findings including deep tendon reflexes, voluntary muscle action, and sensory function
Key exclusion criteria
1) major trauma
2) systemic disease
Target sample size
200
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 | Sodai Kawashima |
Organization
Hari-kyu Oribe
Division name
Department of acupuncture
Zip code
Address
580-4-204, Myomanji, Shimogyo, Kyoto
TEL
075-366-8199
Homepage URL
http://selfmanagement.jp/
info@selfmanagement.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
森ノ宮医療専門学校（大阪）、東京医療専門学校（東京
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
http://selfmanagement.jp/
Publication of results
Unpublished
Result
URL related to results and publications
http://mhlw-grants.niph.go.jp/niph/search/NIDD00.do?resrchNum=201325025B
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
| 2012 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2012 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 11 | Month | 05 | Day |
Last modified on
| 2019 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010872
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
