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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000046142
Receipt No. R000042733
Scientific Title Development of effective physical therapy for sensitivity improvement effect of chronic low back pain-Combined effect of aerobic exercise and electrical stimulation-
Date of disclosure of the study information 2021/11/24
Last modified on 2021/11/22

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Basic information
Public title Development of effective physical therapy for sensitivity improvement effect of chronic low back pain-Combined effect of aerobic exercise and electrical stimulation-
Acronym Physical therapy for chronic low back pain
Scientific Title Development of effective physical therapy for sensitivity improvement effect of chronic low back pain-Combined effect of aerobic exercise and electrical stimulation-
Scientific Title:Acronym Development of effective physical therapy for sensitivity improvement effect of chronic low back pain-Combined effect of aerobic exercise and electrical stimulation-
Region
Japan

Condition
Condition low back pain
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Development of physical therapy combining electrical stimulation and exercise for chronic low back pain
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pain threshold
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 aerobic exercise
Interventions/Control_2 Electrical stimulation
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
60 years-old >=
Gender Male and Female
Key inclusion criteria Low back pain person
Key exclusion criteria Someone who is prohibited from exercising
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Yoshio
Middle name
Last name Takano
Organization International University of Health and Welfare
Division name School of Health Science at Department Fukuoka Physical Therapy
Zip code 8318501
Address 137-1 Enokizu Okawa Fukuoka
TEL 0944892000
Email y-takano@iuhw.ac.jp

Public contact
Name of contact person
1st name Yoshio
Middle name
Last name Takano
Organization International University of Health and Welfare
Division name School of Health Science at Department Fukuoka Physical Therapy
Zip code 8318501
Address 137-1 Enokizu Okawa Fukuoka
TEL 0944892000
Homepage URL
Email y-takano@iuhw.ac.jp

Sponsor
Institute International University of Health and Welfare
Institute
Department

Funding Source
Organization JST
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization International University of Health and welfare
Address 137-1 Enokizu Okawa Fukuoka
Tel 0944892000
Email y-takano@iuhw.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 11 Month 24 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 20
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 Suspended
Date of protocol fixation
2019 Year 12 Month 01 Day
Date of IRB
2020 Year 02 Month 01 Day
Anticipated trial start date
2020 Year 03 Month 01 Day
Last follow-up date
2024 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 11 Month 22 Day
Last modified on
2021 Year 11 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042733

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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