UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046142 |
|---|---|
| Receipt number | 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 | 2024/06/07 19:20:01 |
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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
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
y-takano@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
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
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
Data. Analysis is underway.
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
| 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
| 2023 | 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
| 2021 | Year | 11 | Month | 22 | Day |
Last modified on
| 2024 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042733
