UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046955 |
|---|---|
| Receipt number | R000053559 |
| Scientific Title | Examination of acupuncture points in the iliacus muscle using an ultrasound imaging system |
| Date of disclosure of the study information | 2022/02/21 |
| Last modified on | 2025/03/17 14:35:44 |
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Basic information
Public title
Examination of acupuncture points in the iliacus muscle using an ultrasound imaging system
Acronym
Examination of acupuncture points in the iliacus muscle using an ultrasound imaging system
Scientific Title
Examination of acupuncture points in the iliacus muscle using an ultrasound imaging system
Scientific Title:Acronym
Examination of acupuncture points in the iliacus muscle using an ultrasound imaging system
Region
| Japan |
Condition
Condition
healthy body
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the safe depth and angle of acupuncture in the medial part of the superior anterior iliac spine using an ultrasound imaging system.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ultrasound images (still and moving images on the superior anterior iliac spine)
Key secondary outcomes
Distance of needles from bony landmarks, depth and angle from skin surface
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
After the location of the iliacus muscle is identified by ultrasound imaging, the area is stimulated with acupuncture needles and electro-acupuncture needles as electrodes to see if hip flexion occurs.
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy body.
Key exclusion criteria
Patients with a history of hip or gastrointestinal disease
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | hirosi |
| Middle name | |
| Last name | taniguti |
Organization
Tokyo Ariake University of Medical Science
Division name
Department of Acupuncture and Moxibustion, Faculty of Health and Medical Care
Zip code
1350063
Address
2-9-1 Ariake, Koto-ku, Tokyo
TEL
03-6703-7000
satoruodagi@gmail.com
Public contact
Name of contact person
| 1st name | satoru |
| Middle name | |
| Last name | odagi |
Organization
Tokyo Ariake University of Medical Science
Division name
Tokyo Ariake University of Medical Science Acupuncture Center
Zip code
1350063
Address
2-9-1 Ariake, Koto-ku, Tokyo
TEL
09055602713
Homepage URL
satoruodagi@gmail.com
Sponsor or person
Institute
Tokyo Ariake University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Tokyo Ariake University of Medical Science
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
Tokyo Ariake University of Medical Science
Address
2-9-1 Ariake, Koto-ku, Tokyo
Tel
09055602713
akiyama@gmail.com
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
| 2022 | Year | 02 | Month | 21 | 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
60
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
| 2021 | Year | 11 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 24 | 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
Other related information
The title at the time of the ethical review was "Examination of acupuncture points in the psoas muscle using ultrasound imaging equipment," which is different from the title at the time of this registration.
Management information
Registered date
| 2022 | Year | 02 | Month | 20 | Day |
Last modified on
| 2025 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053559
