UMIN-ICDS Clinical Trial

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

constipation

Classification by specialty

Medicine in general

Gastroenterology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Subjects aged 40 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

30

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

Email

s-oki@juntendo.ac.jp

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

Email

s-oki@juntendo.ac.jp

Institute

Juntendo University School of Medicine

Institute

Department

Personal name

Organization

Juntendo University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Juntendo University School of Medicine, Clinical Research Judging Committee

Address

3-1-3 Hongo, Bunkyo-ku, Tokyo

Tel

03-5802-1584

Email

crbkanri-kyoka@juntendo.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

11

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

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

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

2024

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

05

Month

19

Day

Last modified on

2023

Year

11

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058273