UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027348 |
|---|---|
| Receipt number | R000031290 |
| Scientific Title | Understanding changes of body-specific attention and spatial attention in patients with complex regional pain syndrome. |
| Date of disclosure of the study information | 2017/05/16 |
| Last modified on | 2018/08/15 19:10:38 |
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Basic information
Public title
Understanding changes of body-specific attention and spatial attention in patients with complex regional pain syndrome.
Acronym
Changes of body-specific attention and spatial attention in CRPS.
Scientific Title
Understanding changes of body-specific attention and spatial attention in patients with complex regional pain syndrome.
Scientific Title:Acronym
Changes of body-specific attention and spatial attention in CRPS.
Region
| Japan |
Condition
Condition
Complex regional pain syndrome
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between changes of body-specific and spatial attention and change of the pain in CRPS by using psychophysiological methods.
Basic objectives2
Others
Basic objectives -Others
Complex Regional Pain Syndrome (CRPS), characterized by severe pain and swelling, and changes in the skin on affected limb, is intractable pain for long-term after injury. Because the diagnostic criterias of CRPS are very broad , it is difficult to select effective treatments for CRPS in clinical. Previous reports showed that patients with CRPS neglect affected limb (decline of body-specific attention) and hyperattention is directed to the space where the affected limb is placed. However, there is no report that both body-specific attention to affected limb and spatial attention to the affected space were measured at the same time. Other studies showed that mental rotation and prism adaptation tasks reduced pain of CRPS probably due to modulating body-specific attention and spatial attention. Therefore, in this research, we investigate the relationship between changes of body-specific and spatial attention and change of the pain in CRPS by using psychophysiological methods.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
reaction time to a visual target
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
In mental rotation task, the patient sits on the chair in front of PC on the table and watch image of either left or right hand rotated at 0-360 degrees on the PC display. The patients perform will be asked to judge of either left or right hand against the hand picture diplayed, and then to push the button of either left or right by unaffected finger. The patients perform 4 sessions (96 trials in a session) and it takes about 16 minutes to complete this intervention.
The patients perform the mental rotation task first for two weeks (five times a week, ten times in total). After two weeks, they perform prism adaptation task for two weeks.
Interventions/Control_2
In prism adaptation task, the patients wear the prism glasses which change visual angle from left to right or right to left. The patients who wear the glasses sit on the chair in front of PC with touch-panel display on the table. When visual stimulus appears on the display at random location in the monitor, they directly push the visual stimulus by unaffected finger. One set of this task take about four minutes and they perform four sets.
The patients perform the prism adaptation task first for two weeks (five times a week, ten times in total). After two weeks, they perform mental rotation task for two weeks.
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 with complex regional pain syndrome (CRPS)
(2) Acute and chronic phase
(3) Type 1(without nerve injury) and 2(with nerve injury)
(4) Over 20 years old
(5) Agree to participate our research
Key exclusion criteria
(1) Patients with neurological history
(2) Patients with dementia
(3) Patients with visual field defect
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shin-Ichi Izumi |
Organization
Tohoku University Graduate School of Biomedical Engineering
Division name
Department of Physical Medicine and Rehabilitation
Zip code
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7338
izumis@bme.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Aizu |
Organization
Tohoku University Hospital
Division name
Department of Rehabilitation
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7677
Homepage URL
aizu.naoki.0628@gmail.com
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Department of Physical Medicine and Rehabilitation
Institute
Department
Personal name
Funding Source
Organization
Tohoku University Graduate School of Medicine
Department of Physical Medicine and Rehabilitation
Organization
Division
Category of Funding Organization
Other
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
| 2017 | Year | 05 | Month | 16 | 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
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 16 | 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
| 2017 | Year | 05 | Month | 15 | Day |
Last modified on
| 2018 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031290
