UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Understanding changes of body-specific attention and spatial attention in patients with complex regional pain syndrome.
Title of the study (Brief title)	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	Shin-Ichi Izumi
Organization	Tohoku University Graduate School of Biomedical Engineering
Division name	Department of Physical Medicine and Rehabilitation
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	Naoki Aizu
Organization	Tohoku University Hospital
Division name	Department of Rehabilitation
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 03 Day
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

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Publication of results	Unpublished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