UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of motor imagery therapy for neuropathic pain after spinal cord injury
Title of the study (Brief title)	The effect of motor imagery therapy for neuropathic pain after spinal cord injury
Region	Japan

Condition
Condition	spinal cord injury
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To study the findings of the motor imagery therapy for neuropathic pain after spinal cord injury
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visual analog scale
Key secondary outcomes	Pain detect Short-Form McGill Pain Questionnaire(SF-MPQ-2)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	1)Use of Head Mounted Display 2)Image training 3)Use of Head Mounted Display 4)Image training
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Inpatients with spinal cord injury 2) Patients with neuropathic pain, over 2 months after injury 3) Patients who received sufficient explanation, understood it and gave written consent based on their free will, before participating in this study
Key exclusion criteria	1) Patients who are emotionally unstable 2) Patients who have difficulty of understanding 3)Patients who were judged inappropriate by the principal investigator
Target sample size	10

Research contact person
Name of lead principal investigator	Hiroshi Shioya
Organization	Osaka General Medical Center
Division name	Department of Rehabilitation
Address	3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka
TEL	06-6692-1201
Email	kenkyusien@gh.opho.jp

Public contact
Name of contact person	Hiroshi Shioya
Organization	Osaka General Medical Center
Division name	Department of Rehabilitation
Address	3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka
TEL	06-6692-1201
Homepage URL
Email	kenkyusien@gh.opho.jp

Sponsor
Institute	Osaka General Medical Center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Osaka Prefecute University
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	大阪府立急性期・総合医療センター（大阪府）

Other administrative information
Date of disclosure of the study information	2015 Year 02 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 01 Month 01 Day
Anticipated trial start date	2014 Year 01 Month 01 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry	2016 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded	2016 Year 03 Month 31 Day

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

Management information
Registered date	2015 Year 02 Month 27 Day
Last modified on	2016 Year 09 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019336