UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011125 |
|---|---|
| Receipt number | R000013037 |
| Scientific Title | Effect of Repeated pain on pain intensity and emotion |
| Date of disclosure of the study information | 2013/07/31 |
| Last modified on | 2023/01/11 09:30:04 |
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Basic information
Public title
Effect of Repeated pain on pain intensity and emotion
Acronym
Effect of Repeated pain on pain intensity and emotion
Scientific Title
Effect of Repeated pain on pain intensity and emotion
Scientific Title:Acronym
Effect of Repeated pain on pain intensity and emotion
Region
| Japan |
Condition
Condition
Healthy Subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the effects of repeated pain on pain intensity and emotion in healthy controls.
Basic objectives2
Others
Basic objectives -Others
To elucidate the effects of repeated pain on pain intensity and emotion in healthy controls.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Pain threshold and pain tolerance
Algometer using thermal stimulation
2. Pain intensity
Visual analogue scale
3. unpleasant
Visual analogue scale
4. anxiety
State-Trait Anxiety Inventory Form X
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
These stimulation sessions consisted of 10 blocks of thermode stimuli with each block containing a series of six stimuli, resulting in a total number of 60 thermal stimuli. Healthy subjects were stimulated daily with same pain paradigm for 3 consecutive days.
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
| 23 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healthy young adults.
2. Those whose informed consent can be obtained.
3. All subjects had normal pain thresholds at the site of stimulus application.
4. No history of neurological or psychiatric disease.
Key exclusion criteria
Those who do not meet the above criteria.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Maeoka |
Organization
Kio University
Division name
Department of physical therapy, faculty of health science
Zip code
635-0832
Address
4-2-2 Umami-naka Koryo-cho, Kitakatsuragi-gun, Nara, Japan
TEL
0745-54-1601
h.maeoka@kio.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Maeoka |
Organization
Kio University
Division name
Department of physical therapy, faculty of health science
Zip code
635-0832
Address
4-2-2 Umami-naka Koryo-cho, Kitakatsuragi-gun, Nara, Japan
TEL
0745-54-1601
Homepage URL
h.maeoka@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kio University
Address
4-2-2 Umami-naka Koryo-cho, Kitakatsuragi-gun, Nara, Japan
Tel
0745-54-1601
h.maeoka@kio.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
| 2013 | Year | 07 | Month | 31 | 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
8
Results
Eight subjects received 60 administrations of painful stimulation (each lasting 6 s) per day for 3 consecutive days on the medial side of the forearm of the non-dominant hand.Pain intensities were reduced significantly over the experimental period. Although there was no great change in unpleasantness during the 3-day period, anxiety was increased significantly after the painful stimulation compared to that felt normally and before day 1 of the stimulation.
Results date posted
| 2023 | Year | 01 | Month | 11 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
For paper writing
Date of the first journal publication of results
Baseline Characteristics
Eight university students (6 females, 2 males) volunteered to participate in this study. The mean age of the subjects was 20.4 years. All subjects had no history of neurological or psychiatric disease or drug abuse, no history of chronic or acute pain, and were not taking any form of analgesic, antidepressant, anti-anxiety or antihypertensive medication.
Participant flow
inclusion criteria: All subjects have no history of neurological or psychiatric disease or drug abuse, no history of chronic or acute pain, and were not taking any form of analgesic, antidepressant, anti-anxiety or antihypertensive medication. We confirmed that our subjects were not suffering from depression and only included volunteers with a normal score on the Beck-Depression Scale.
Adverse events
not in particular
Outcome measures
We took measurements of the following items to evaluate changes of responses to painful stimulation: pain thresholds, pain tolerance level, pain intensities, unpleasantness and anxiety.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2013 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2013 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2014 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2015 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 05 | Day |
Last modified on
| 2023 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013037
