UMIN-CTR Clinical Trial

Public title

Development of assistive system for recording symptoms of chronic pain and investigation of pain exacerbation factors

Acronym

Development of assistive system for recording symptoms of chronic pain and investigation of pain exacerbation factors

Scientific Title

Development of assistive system for recording symptoms of chronic pain and investigation of pain exacerbation factors

Scientific Title:Acronym

Development of assistive system for recording symptoms of chronic pain and investigation of pain exacerbation factors

Region

Japan

Condition

Chronic pain

Classification by specialty

Anesthesiology	Rehabilitation medicine	Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Some patients with chronic pain report that their pain is fluctuated intermittently in daily living. The exacerbation of pain is caused by various exacerbation factors, which can be classified into environmental, physiological and psychological factors. Conventional studies suggested that association between these factors and pain exacerbation. However, these studies did not pay attention to records for correlating exacerbation factors, time and patient personalities.
The purpose of this study is to develop an assistive system for recording symptoms of chronic pain in order to find the relation regarding exacerbation factors. We analyze data recorded by the system, and then elucidate both the specific exacerbation factors in each patients and the common factors in patients with chronic pain.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

We implement several interfaces as a part of the assistive system for recording symptoms of chronic pain and their related data. These interfaces are composed of smart devices, input devices and wearable devices.
Primary outcome is the usability of these interfaces for integrating into the system. The usability of these interfaces is evaluated by questionnaires and interviews with participants.

Key secondary outcomes

The promising cause of chronic pain exacerbation factors will be analyzed after four to twelve weeks system use, by contrast with the questionnaires and the change in the other related data (e.g. atmospheric pressure). These are correlated by date and time.
Key secondary outcome is results in recording data analysis. The results are associated with the relationship between an exacerbation of pain and its factors, and between the exacerbation and the degree of environmental factor changes.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

We implement several interfaces as a part of the assistive system for recording symptoms of chronic pain and their related data. These interfaces of assistive system are composed of smart devices, input devices and wearable devices. The system will record symptoms of chronic pain and their related data which are correlated by date and time.
As a preliminary test, healthy subjects will use the system for a week and then the usability of these interfaces is evaluated by questionnaires and interviews with participants. After a preliminary test, patients will use the system for four to twelve weeks and then the usability of these interfaces is evaluated by questionnaires and interviews with participants.

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

Not applicable

Gender

Male and Female

Key inclusion criteria

(1)Patients are required to meet the following conditions:
1. consenting to voluntary participation of the study with consent form
2. suffering from refractory chronic pain, such as neuropathic pain
3. receiving medical care in one or more of the following department of Okayama University Hospital:
3.1. Anesthesiology and Resuscitology Department
3.2. Neuropsychiatry Department

(2)Healthy people are required to meet the following conditions:
1. consenting to voluntary participation of the study with consent form
2. having a mid-level educational experience, more than the average high school graduate
3. over 20 year old

Key exclusion criteria

Patients who are unable to operate information input devices from some reasons, such as severe pain or motor disturbance, are excluded.
There is no key exclusion criteria for healthy person.

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Akio Gofuku

Organization

Okayama University

Division name

Graduate School of Natural Science and Technology

Zip code

Address

#408 Studies of Natural Science and Technology,3-1-1,Tsushimanaka,Kita-ku,Okayama-shi, Okayama,700-0082,Japan

TEL

086-251-8022

Email

fukuchan@sys.okayama-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Kenji Sato

Organization

Okayama University

Division name

Graduate School of Medicine Dentistry and Pharmaceutical Sciences

Zip code

Address

2-5-1, Shikatacho, Kita-ku Okayama-shi, Okayama, 700-0914, Japan

TEL

086-235-7778

Homepage URL

Email

tento@cc.okayama-u.ac.jp

Institute

Okayama 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

Address

Tel

Email

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

2016

Year

08

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2016

Year

07

Month

31

Day

Date of IRB

Anticipated trial start date

2016

Year

07

Month

31

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

05

Month

30

Day

Last modified on

2016

Year

08

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025979