UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058753 |
|---|---|
| Receipt number | R000067181 |
| Scientific Title | The influence of amygdala function on pain threshold and acupuncture analgesia |
| Date of disclosure of the study information | 2025/08/15 |
| Last modified on | 2025/08/10 17:30:26 |
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Basic information
Public title
Influence of Pain Catastrophizing and Trait Anxiety on Electroacupuncture-Induced Change in Pain Threshold
Acronym
Influence of Pain Catastrophizing and Trait Anxiety on Electroacupuncture-Induced Change in Pain Threshold
Scientific Title
The influence of amygdala function on pain threshold and acupuncture analgesia
Scientific Title:Acronym
The influence of amygdala function on pain threshold and acupuncture analgesia
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to examine how the function of the amygdala affects pain perception and acupuncture analgesia, we will examine how it affects each questionnaire indicating brain function, CPM indicating the descending pain inhibitory system, and changes in pain thresholds.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CPM and pain threshold
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
As an input, perform 30 minutes of electroacupuncture at 4 Hz on both lower limbs (Zusanli-Yanglingquan) and the dominant upper limb (He Gu-Shou San Li) (LFP-4000 Ohm Pulsar/All Medical Devices).
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The purpose of the study was explained, and informed consent was obtained from adult students enrolled at our university.
Key exclusion criteria
Those with chronic pain or taking medication that could affect this study were excluded.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | kazunori |
| Middle name | |
| Last name | Itoh |
Organization
Meiji University of Integrative Medicine
Division name
Graduate School of Acupuncture and Moxibustion
Zip code
629-0301
Address
6-1 Hino-tani, Hiyoshi-cho, Nantan-shi, Kyoto 629-0301, Japan
TEL
0771-72-1181
k_itoh@meiji-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Oi |
Organization
Meiji University of Integrative Medicine
Division name
graduate school
Zip code
629-0301
Address
6-1 Hino-tani, Hiyoshi-cho, Nantan-shi, Kyoto 629-0301, Japan
TEL
0771-72-1181
Homepage URL
8asuhi60@gmail.com
Sponsor or person
Institute
Meiji University of Integrative Medicine
Institute
Department
Personal name
Funding Source
Organization
Meiji University of Integrative Medicine
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
Meiji University of Integrative Medicine
Address
6-1 Hino-tani, Hiyoshi-cho, Nantan-shi, Kyoto 629-0301, Japan
Tel
0771-72-1181
k_itoh@meiji-u.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
| 2025 | Year | 08 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
29
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
Terminated
Date of protocol fixation
| 2024 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 08 | Month | 10 | Day |
Last modified on
| 2025 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067181
