UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031628 |
|---|---|
| Receipt number | R000036096 |
| Scientific Title | The association between constipation or stool consistency and pain severity in patients with chronic pain |
| Date of disclosure of the study information | 2018/03/31 |
| Last modified on | 2018/03/07 16:39:04 |
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Basic information
Public title
The association between constipation or stool consistency and pain severity in patients with chronic pain
Acronym
constipation and chronic pain
Scientific Title
The association between constipation or stool consistency and pain severity in patients with chronic pain
Scientific Title:Acronym
constipation and chronic pain
Region
| Japan |
Condition
Condition
chronic pain
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to investigate the association between stool consistency or constipation and pain severity in patients with chronic pain.
Basic objectives2
Others
Basic objectives -Others
relation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pain severity (numerical rating scale)
Key secondary outcomes
stool form (he Bristol Stool Form Scale)
constipation (the Cleveland Clinic Constipation score)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 10 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All chronic pain patients who consulted Multidisciplinary Pain Center, Aichi Medical University.
Key exclusion criteria
The exclusion criteria included serious conditions such as neurological disease (e.g., hereditary disease) or cognitive disease.
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Young-Chang Arai |
Organization
Aichi medical university
Division name
Multidisciplinary Pain Center
Zip code
Address
1-1 Karimata Nagakute city, Aichigun, Aichi, 480-1195
TEL
0561-62-3311
arainon@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Young-Chang Arai |
Organization
Aichi medical university
Division name
Multidisciplinary Pain Center
Zip code
Address
1-1 Karimata Nagakute city, Aichigun, Aichi, 480-1195
TEL
0561-32-3311
Homepage URL
arainon@aichi-med-u.ac.jp
Sponsor or person
Institute
Multidisciplinary Pain Center, Aichi Medical University, 1-1 Karimata
Nagakutecho, Aichigun, Aichi, 480-1195, Japan
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | 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
| 2017 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 09 | Month | 30 | Day |
Other
Other related information
none
Management information
Registered date
| 2018 | Year | 03 | Month | 07 | Day |
Last modified on
| 2018 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036096
