UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027348
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email aizu.naoki.0628@gmail.com

Sponsor
Institute Tohoku University Graduate School of Medicine
Department of Physical Medicine and Rehabilitation
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031290

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.