UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049808 |
|---|---|
| Receipt number | R000056720 |
| Scientific Title | Effects of virtual reality training and pain neuroscience plus motor control on pain, disability, and quality of life of women with non-specific chronic back pain, A Randomized controlled study |
| Date of disclosure of the study information | 2022/12/19 |
| Last modified on | 2022/12/16 15:51:54 |
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Basic information
Public title
Effects of virtual reality training and pain neuroscience plus motor control on pain, disability, and quality of life of women with non-specific chronic back pain, A Randomized controlled study
Acronym
Effects of virtual reality training and pain neuroscience plus motor control on pain, disability, and quality of life of women with non-specific chronic back pain, A Randomized controlled study
Scientific Title
Effects of virtual reality training and pain neuroscience plus motor control on pain, disability, and quality of life of women with non-specific chronic back pain, A Randomized controlled study
Scientific Title:Acronym
Effects of virtual reality training and pain neuroscience plus motor control on pain, disability, and quality of life of women with non-specific chronic back pain, A Randomized controlled study
Region
| Asia(except Japan) |
Condition
Condition
pretesr-posttest
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effects of Virtual reality training and pain neuroscience plus motor control on pain, disability, and quality of life of women with non-specific chronic back pain
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual Analog Scale (VAS)
Oswestry Disability Index (ODI)
Key secondary outcomes
General Health Questionnaire (GHQ-28)
Quality of life (QOL- WHO)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Virtual reality training
Interventions/Control_2
Pain neuroscience plus motor control training
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
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
(1) women age range between 20-45 years; (2) average pain level lower than 4 on a 10-cm visual analog scale during SLR test and (3) reporting pain in the last six months.
Key exclusion criteria
(1) any history of back surgery; (2) orthopedic and neurological injuries; (4) report of pain in the buttock to back during training, and (5) medication as part of treatment
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Ensiye |
| Middle name | |
| Last name | Reza |
Organization
South Branch Payam Noor University
Division name
Sport medicine
Zip code
6634569
Address
Tehran
TEL
989198986365
rezaensiye@gmail.com
Public contact
Name of contact person
| 1st name | Ensiye |
| Middle name | |
| Last name | Reza |
Organization
South Branch Payam Noor University
Division name
Sport medicine
Zip code
6634569
Address
Tehran
TEL
989198986365
Homepage URL
rezaensiye@gmail.com
Sponsor or person
Institute
self funding
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Ethics Committee of the Polytechnic Institute of Santarem, Portugal (29-2022ESDRM).
Address
Portugal
Tel
23227250
rafaeloliveira@esdrm.ipsantarem.pt
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
| 2022 | Year | 12 | Month | 19 | 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
36
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
| 2022 | Year | 12 | Month | 09 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 03 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 02 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 07 | Day |
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 03 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 16 | Day |
Last modified on
| 2022 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056720
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
