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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044488
Receipt No. R000050826
Scientific Title Effects of Virtual Reality Training on Intractable Pain in the Upper Extremity
Date of disclosure of the study information 2021/06/10
Last modified on 2021/06/10

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Basic information
Public title Effects of Virtual Reality Training on Intractable Pain in the Upper Extremity
Acronym Effects of Virtual Reality Training on Intractable Pain in the Upper Extremity
Scientific Title Effects of Virtual Reality Training on Intractable Pain in the Upper Extremity
Scientific Title:Acronym Effects of Virtual Reality Training on Intractable Pain in the Upper Extremity
Region
Japan

Condition
Condition Patients with intractable pain in the upper extremities
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of the study is to clarify the effects of VR Training (Multi-sensory Feedback) on pain intensity and upper limb activity for intractable upper limb pain.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Short-Form McGill pain questionnaire2 (SF-MPQ2)
Key secondary outcomes Pain intensity: Visual Analog Scale (VAS)
Pain Catastrophizing Scale (PCS)
Hospital anxiety and depression scale (HADS)
Immersion: Visual Analog Scale (VAS)
Motivation / enjoyment
Sense of Agency (SoA)
Upper limb activity
Disability of the Arm, Shoulder and Hand (DASH)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 VR Visual-Feedback
Interventions/Control_2 VR Sensory-Feedback
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 Patients whose pain intensity is less than the average VAS40 in the past week.
The duration of pain is less than 3 months.
Key exclusion criteria Those under 20 years of age.
Those who are over 80 years old and have cognitive problems (MMSE less than 24 points).
Target sample size 52

Research contact person
Name of lead principal investigator
1st name Manabu
Middle name
Last name Yohimura
Organization Kawasaki Medical school Hospital
Division name Rehabilitation center
Zip code 701-0192
Address Okayama, Japan, 577 Matsushima, Kurashiki, Okayama
TEL 0864621111
Email mnb328@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name Manabu
Middle name
Last name Yohimura
Organization Kawasaki Medical school Hospital
Division name Rehabilitation center
Zip code 701-0192
Address Okayama, Japan, 577 Matsushima, Kurashiki, Okayama
TEL 0864621111
Homepage URL
Email mnb328@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization Kawasaki Medical School
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 Kawasaki Medical school Hospital
Address Okayama, Japan, 577 Matsushima, Kurashiki, Okayama
Tel 0864321111
Email mnb328@med.kawasaki-m.ac.jp

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
2021 Year 06 Month 10 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
2021 Year 06 Month 10 Day
Date of IRB
Anticipated trial start date
2021 Year 07 Month 10 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 06 Month 10 Day
Last modified on
2021 Year 06 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050826

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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