UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051103 |
|---|---|
| Receipt number | R000058273 |
| Scientific Title | A prospective study of transcutaneous electrical stimulation and abdominal symptoms |
| Date of disclosure of the study information | 2023/11/26 |
| Last modified on | 2024/11/21 21:51:50 |
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Basic information
Public title
Correlation analysis between transcutaneous electrical stimulation and abdominal symptoms
Acronym
Correlation analysis between transcutaneous electrical stimulation and abdominal symptoms
Scientific Title
A prospective study of transcutaneous electrical stimulation and abdominal symptoms
Scientific Title:Acronym
A prospective study of transcutaneous electrical stimulation and abdominal symptoms
Region
| Japan |
Condition
Condition
constipation
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In developed countries, the prevalence of chronic constipation is estimated to be 12-19% of the general population, and the number of patients is expected to increase with the aging of society. Not only does it cause a decline in quality of life in daily life, but it is also said to increase the risk of cardiovascular events and stroke. At present, diet/exercise therapy and oral therapy are selected as treatments for constipation, but neither of them is always effective. As an alternative therapy, there is a recent report showing the efficacy of transcutaneous electrical stimulation for constipation patients in the pediatric area, but there is still insufficient research on adults. The purpose of this study is to examine the relationship between abdominal symptoms and transcutaneous electrical stimulation in adults with constipation, and to clarify its efficacy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change from baseline observation period in SBM After 4 Weeks
Key secondary outcomes
complete spontaneous bowel movement(CSBM), Bristol Stool Form Scale(BSFS), HR-QOL(SF-8), Constipation scoring system, JPAC-QOL, Change in the drug usage from the baseline observation period, Improvement rate for constipation symptoms after 2 weeks and 4 weeks of transcutaneous electrical stimulation, Relationship between the intensity of electrical stimulation and improvement rate of constipation symptoms
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Duration: 4 weeks
Transcutaneous electrical stimulator: SIXPAD Abs Fit 2(MTW Co., Ltd.)
Administration: Electrical stimulation is performed once a day at an arbitrary time and at an arbitrary intensity.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Subjects aged 18 or more
2. Patients with constipation who have undergone colonoscopy or CT and have ruled out organic diseases
3. Constipation in these studies was defined as a subpopulation of the Rome 3
Key exclusion criteria
1. Patients with organic constipation
2. Patients with a history of intestinal resection
3. Patients using medical electrical equipment
4. Patients who are pregnant or have just given birth
5. Those who started using new products such as food/beverages, supplements and drugs for constipation within 2 weeks from the start of electrical stimulation
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Akihito |
| Middle name | |
| Last name | Nagahara |
Organization
Juntendo University School of Medicine
Division name
Department of Gastroenterology
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
0338133111
s-oki@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Shotaro |
| Middle name | |
| Last name | Oki |
Organization
Juntendo University School of Medicine
Division name
Department of Gastroenterology
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
0338133111
Homepage URL
s-oki@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Juntendo University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University School of Medicine, Clinical Research Judging Committee
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel
03-5802-1584
crbkanri-kyoka@juntendo.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 26 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 05 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 27 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2023 | Year | 05 | Month | 19 | Day |
Last modified on
| 2024 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058273
