UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022543 |
|---|---|
| Receipt number | R000025979 |
| Scientific Title | Development of assistive system for recording symptoms of chronic pain and investigation of pain exacerbation factors |
| Date of disclosure of the study information | 2016/08/15 |
| Last modified on | 2016/08/08 11:29:20 |
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Basic information
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
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
| 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
fukuchan@sys.okayama-u.ac.jp
Public contact
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
tento@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama 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
Address
Tel
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 |
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
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025979
