UMIN-CTR Clinical Trial

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

Healthy Subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

h.maeoka@kio.ac.jp

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

Email

h.maeoka@kio.ac.jp

Institute

Kio University

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Kio University

Address

4-2-2 Umami-naka Koryo-cho, Kitakatsuragi-gun, Nara, Japan

Tel

0745-54-1601

Email

h.maeoka@kio.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

07

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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