UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008044 |
|---|---|
| Receipt number | R000009473 |
| Scientific Title | Effects of transcutaneous electrical nerve stimulation in abdominal postoperative patients: A prospective randomized single-blind study |
| Date of disclosure of the study information | 2012/05/28 |
| Last modified on | 2013/05/30 22:39:26 |
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Basic information
Public title
Effects of transcutaneous electrical nerve stimulation in abdominal postoperative patients: A prospective randomized single-blind study
Acronym
Effects of transcutaneous electrical nerve stimulation in abdominal postoperative patients
Scientific Title
Effects of transcutaneous electrical nerve stimulation in abdominal postoperative patients: A prospective randomized single-blind study
Scientific Title:Acronym
Effects of transcutaneous electrical nerve stimulation in abdominal postoperative patients
Region
| Japan |
Condition
Condition
The patients who receive elective abdominal surgery.
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine effects of transcutaneous electrical nerve stimulation in abdominal postoperative patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
Visula analog scale(rest pain, sit up pain, cough pain), vital capacity, cough peak flow
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Electrical stimulation 60min/day for 3days.
Interventions/Control_2
Sham electrical stimulation 60min/day for 3days.
Interventions/Control_3
No treatment.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who receive elective abdominal surgery.
Key exclusion criteria
Contraindications for electrical stimulation (e.g.,a pacemaker),inability to give informed consent form.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsunori Tokuda |
Organization
Heisei Memorial Hospital
Division name
Department of Rehabilitation
Zip code
Address
827 Shijyo-cho, Kashihara-city, Nara
TEL
0744-29-3300
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsunori Tokuda |
Organization
Heisei Memorial Hospital
Division name
Department of Rehabilitation
Zip code
Address
827 Shijyo-cho, Kashihara-city, Nara
TEL
0744-29-3300
Homepage URL
H1081006@kio.ac.jp
Sponsor or person
Institute
Heisei Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
Kio University
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
| 2012 | Year | 05 | Month | 28 | 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
| 2010 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 05 | Month | 28 | Day |
Last modified on
| 2013 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009473
| 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 |
