UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048851 |
|---|---|
| Receipt number | R000055644 |
| Scientific Title | The examination of local and segmental thermal pain threshold increases by high-frequency acupuncture energization stimulation |
| Date of disclosure of the study information | 2022/09/05 |
| Last modified on | 2022/09/05 11:38:16 |
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Basic information
Public title
The examination of local and segmental thermal pain threshold increases by high-frequency acupuncture energization stimulation
Acronym
The examination of local and segmental thermal pain threshold increases by high-frequency acupuncture energization stimulation
Scientific Title
The examination of local and segmental thermal pain threshold increases by high-frequency acupuncture energization stimulation
Scientific Title:Acronym
The examination of local and segmental thermal pain threshold increases by high-frequency acupuncture energization stimulation
Region
| Japan |
Condition
Condition
nothing
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aims of this study are check the thermal pain threshold using a pain thermometer to see if acupuncture anesthesia by acupuncture energization stimulation acts locally or segmentally. also checks to see if there is a gender difference in acupuncture analgesic effects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The thermal pain threshold is measured using a pain thermometer (manufactured by Unique Medical) to confirm the temperature threshold (temperature at which the temperature was felt), the thermal pain threshold (the temperature that turned into hot pain), and the pain resistance threshold (the temperature at which the temperature at which the temperature can no longer withstand the hot pain). The probe uses a pen type, and the probe temperature starts at 32 degree and reaches a maximum of 50 degree. The temperature rise shall be 0.25 degree/sec. The measurement site is the proximal and distal part of the C 6 region of the right forearm lateral (position 2 cm outside from the height of the proximal quarter of the palm side striated center of the hand joint palmar strident and the proximal quarter of the elbow joint striated) and the opposite side thereof.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Control group (untreated group): Subjects rested in a reclining position for 20 minutes, followed by 9 experiments, 3 times in the proximal part of the right forearm, 3 times in the distal part, and 3 times in the opposite side. The thermal threshold measurement is recorded by having a signal given at the timing when the sensation explained in advance is obtained and at the pain resistance threshold, the switch can be held by the examinee themselves to stop temperature from rising. Each measurement is spaced 1 minute. The average value of each site and three measurements is adopted.
Interventions/Control_2
Acupuncture energization group: Subjects rested in a reclining position for 20 minutes, followed by 9 experiments, 3 times in the proximal part of the right forearm, 3 times in the distal part, and 3 times in the opposite side. The thermal threshold measurement is recorded by having a signal given at the timing when the sensation explained in advance is obtained and at the pain resistance threshold, the switch can be held by the examinee themselves to stop temperature from rising. Each measurement is spaced 1 minute. The average value of each site and three measurements is adopted. Acupuncture energization is performed at 100Hz in the C6 area of the lateral right forearm (2 cm outside from the center of the palm striatum of the hand joint and the proximal to the proximal of the elbow joint striated) and the amount of current is increased to the point before the pain caused by acupuncture energization is felt.
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Eligibility criteria for subjects are healthy right-handed persons between the ages of 18 and 30
Key exclusion criteria
The exclusion criteria are: (1) those who were to the hospital and on medication due to underlying medical conditions, (2) those who were unwell due to sleep disorders,
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Imai |
Organization
Teikyo Heisei University
Division name
Graduate School of Health Sciences
Zip code
170-8445
Address
2-51-4 Higashi-ikebukuro, Toshimaku, Tokyo
TEL
080-1527-1617
k.imai@thu.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Takahashi |
Organization
Teikyo Heisei University
Division name
Graduate School of Health Sciences
Zip code
170-8445
Address
2-51-4 Higashi-ikebukuro, Toshimaku, Tokyo
TEL
090-9295-9588
Homepage URL
r.takahashi.acp@gmail.com
Sponsor or person
Institute
Teikyo Heisei University
Institute
Department
Personal name
Funding Source
Organization
Teikyo Heisei 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
Ethical commitie, Teikyo Heisei University
Address
2-51-4 Higashi-ikebukuro, Toshimaku, Tokyo
Tel
03-5843-3111
rec@thu.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
| 2022 | Year | 09 | Month | 05 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 05 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 12 | Day |
Last follow-up date
| 2023 | 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
| 2022 | Year | 09 | Month | 05 | Day |
Last modified on
| 2022 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055644
