UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051154 |
|---|---|
| Receipt number | R000058337 |
| Scientific Title | Chronic pain and intestinal microflora, and the relation with PGC1-alpha in the blood, and the efficacy of a multidisciplinary approach: A multicenter study |
| Date of disclosure of the study information | 2023/06/01 |
| Last modified on | 2023/05/24 14:26:48 |
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Basic information
Public title
Chronic pain and intestinal microflora, and the relation with PGC1-alpha in the blood, and the efficacy of a multidisciplinary approach: A multicenter study
Acronym
Chronic pain and intestinal microflora
Scientific Title
Chronic pain and intestinal microflora, and the relation with PGC1-alpha in the blood, and the efficacy of a multidisciplinary approach: A multicenter study
Scientific Title:Acronym
Chronic pain and intestinal microflora
Region
| Japan |
Condition
Condition
Chronic pain
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is 1) to clarify the relationship between physical and mental status in patients with chronic pain and intestinal bacterial flora, and 2) to clarify the efficacy of a multidisciplinary approach to the changes of chronic pain and intestinal bacterial flora. The changes of PGC1-alpha in the blood are also analyzed.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain state and diversity of intestinal microflora at pre-treatment, 3 months and 6 months after treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
A multidisciplinary approach for chronic pain for 6 months
Interventions/Control_2
comparison with a control group
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
| 16 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Chronic pain (3 months or more), 2)if surgery was performed, over 6 months passed, 3)Understanding the purpose of the study and answering questionnaires, 4)first visit patients to a Pain center, and 5)clear past treatment
Key exclusion criteria
1)apparent organic diseases such as fracture, infection, and malignant tumors, 2)cognitive functional disorders impossible to answer questionnaires
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Shoji |
| Middle name | |
| Last name | Yabuki |
Organization
Fukushima Medical University
Division name
Department of Pain Medicine
Zip code
960-8516
Address
10-6 Sakae-machi, Fukushima City, Fukushima
TEL
024-581-5503
toutsuu3@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Shoji |
| Middle name | |
| Last name | Yabuki |
Organization
Fukushima Medical University
Division name
Department of Pain Medicine
Zip code
960-8516
Address
10-6 Sakae-machi, Fukushima City, Fukushima
TEL
024-581-5503
Homepage URL
toutsuu3@fmu.ac.jp
Sponsor or person
Institute
Ministry of Health, Labour and Welfare of Japan
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare of Japan
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
Ethical Committee of Fukushima Medical University
Address
1 Hikarigaoka, Fukushima City, Fukushima
Tel
024- 547-1825
rs@fmu.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
福島県立医科大学附属病院（福島県）、星総合病院（福島県）、札幌医科大学附属病院(北海道）、千葉大学医学部附属病院（千葉県）、富山大学（富山県）、名古屋市立大学（愛知県）、愛知医科大学病院（愛知県）、三重大学医学部附属病院（三重県）、京都府立医科大学（京都府）、兵庫医科大学病院（兵庫県）、奈良県立医科大学（奈良県）、徳島大学病院（徳島県）、四国こどもとおとなの医療センター（香川県）、佐賀大学（佐賀県）、順天堂東京江東高齢者医療センター（東京都）、善衆会病院（群馬県）、富永病院（大阪府）、豊見城中央病院（沖縄県）、中部国際医療センター（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 24 | Day |
Last modified on
| 2023 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058337
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/11/23 | 06_研究計画書20231123.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2023/11/27 | 研究症例データ仕様書.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
| 2023/11/27 | 症例データ.xlsx |
