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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035505
Receipt No. R000040451
Official scientific title of the study 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 2019/01/12

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Basic information
Official scientific title of the study Effect of exercise by Virtual Reality in patients with chronic low back pain
Title of the study (Brief title) 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 pain and 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 Ryota Imai
Organization Kawachi General Hospital
Division name Department of Rehabilitation
Address 1-31 Yokomakura, Higashiosaka-city, Osaka
TEL 0729680731
Email ryo7891@gmail.com

Public contact
Name of contact person Tomohiko Nishigami
Organization Konan Woman University
Division name Department of Nursing and Physical Therapy
Address 6-2-23, Morikita-machi, Higashinada-ku, Kobe
TEL 0784133648
Homepage URL
Email ryo7891@gmail.com

Sponsor
Institute Konan Woman University
Institute
Department

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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2019 Year 01 Month 20 Day
Anticipated trial start date
2019 Year 01 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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Publication of results Unpublished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

Management information
Registered date
2019 Year 01 Month 10 Day
Last modified on
2019 Year 01 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040451

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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