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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000011125
Receipt No. 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 2018/01/09

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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
Last name of lead principal investigator
1st name
Middle name
Last name Hiroshi Maeoka
Organization Kio University
Division name Department of physical therapy, faculty of health science
Zip code
Address 4-2-2 Umami-naka Koryo-cho, Kitakatsuragi-gun, Nara, Japan
TEL 0745-54-1601
Email h.maeoka@kio.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Hiroshi Maeoka
Organization Kio University
Division name Department of physical therapy, faculty of health science
Zip code
Address 4-2-2 Umami-naka Koryo-cho, Kitakatsuragi-gun, Nara, Japan
TEL 0745-54-1601
Homepage URL
Email h.maeoka@kio.ac.jp

Sponsor
Institute Kio University
Institute
Department

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
Address
Tel
Email

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
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
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 No longer recruiting
Date of protocol fixation
2013 Year 07 Month 31 Day
Date of IRB
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
2018 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013037

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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