UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044488 |
|---|---|
| Receipt number | 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 | 2021/12/14 14:24:30 |
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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
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
mnb328@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
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
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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 28 | Day |
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 | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050826
