UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035505 |
|---|---|
| Receipt number | R000040451 |
| Scientific Title | Effect of exercise by Virtual Reality in patients with chronic low back pain |
| Date of disclosure of the study information | 2019/01/10 |
| Last modified on | 2022/07/14 09:51:44 |
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Basic information
Public title
Effect of exercise by Virtual Reality in patients with chronic low back pain
Acronym
Effect of exercise by Virtual Reality
Scientific Title
Effect of exercise by Virtual Reality in patients with chronic low back pain
Scientific Title:Acronym
Effect of exercise by Virtual Reality
Region
| Japan |
Condition
Condition
patients with chronic low back pain
Classification by specialty
| Orthopedics | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the evidence for the effectiveness of Virtual Reality exercise for disability in patients with chronic low back pain
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Pain intensity and Roland-Morris Disability Questionnaire
Key secondary outcomes
Pain Catastrophizing Scale (PCS), Tampa Scale of Kinesiophobia (TSK), Fremantle Back Awareness Questionnaire (FreBAQ) and Pain Self-Efficacy Questionnaire(PSEQ)
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
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
VR exercise
Interventions/Control_2
VR
Interventions/Control_3
exercise
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria in this study were: age between 20 and 85, low back pain duration greater than 3 month , and average low back pain intensity rating >3 on a 0-10 numeric rating scale
Key exclusion criteria
Patients with cLBP were excluded if: (1) back pain manifested with one or more specific causes (e.g., cancer, fracture, infection), (2)stroke or other CNS disorders , (3) back problems were complicated (e.g., medicolegal issues), (4) they had undergone prior back surgery,
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ryota |
| Middle name | |
| Last name | Imai |
Organization
Osaka Kawasaki Rehabilitation University
Division name
Department of Rehabilitation
Zip code
597-0104
Address
158 Mizuma, Kaizuka-City, Osaka
TEL
072-446-6700
ryo7891@gmail.com
Public contact
Name of contact person
| 1st name | Tomohiko |
| Middle name | |
| Last name | Nishigami |
Organization
Konan Woman University
Division name
Department of Nursing and Physical Therapy
Zip code
658-0001
Address
6-2-23, Morikita-machi, Higashinada-ku, Kobe
TEL
0784133648
Homepage URL
ryo7891@gmail.com
Sponsor or person
Institute
Konan Woman University
Institute
Department
Personal name
Funding Source
Organization
No
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
Konan Woman University
Address
6-2-23, Morikita-machi, Higashinada-ku, Kobe
Tel
0784133648
t-nishi@konan-wu.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
| 2019 | Year | 01 | 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
Terminated
Date of protocol fixation
| 2019 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2019 | Year | 01 | Month | 10 | Day |
Last modified on
| 2022 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040451
| 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 |
