UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of assistive system for recording symptoms of chronic pain and investigation of pain exacerbation factors
Title of the study (Brief title)	Development of assistive system for recording symptoms of chronic pain and investigation of pain exacerbation factors
Region	Japan

Condition
Condition	Chronic pain
Classification by specialty	Anesthesiology Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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.

Base
Study type	Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Akio Gofuku
Organization	Okayama University
Division name	Graduate School of Natural Science and Technology
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

Public contact
Name of contact person	Kenji Sato
Organization	Okayama University
Division name	Graduate School of Medicine Dentistry and Pharmaceutical Sciences
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

Sponsor
Institute	Okayama 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)

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	2016 Year 08 Month 15 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 07 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 05 Month 30 Day
Last modified on	2016 Year 08 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025979