UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031168 |
|---|---|
| Receipt number | R000035586 |
| Scientific Title | The effectiveness of the abdominal trunk muscles exercise for chronic low back pain |
| Date of disclosure of the study information | 2018/02/06 |
| Last modified on | 2020/03/19 18:28:03 |
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Basic information
Public title
The effectiveness of the abdominal trunk muscles exercise for chronic low back pain
Acronym
The effectiveness of the abdominal trunk muscles exercise for chronic low back pain
Scientific Title
The effectiveness of the abdominal trunk muscles exercise for chronic low back pain
Scientific Title:Acronym
The effectiveness of the abdominal trunk muscles exercise for chronic low back pain
Region
| Japan |
Condition
Condition
chronic low back pain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of the abdominal trunk muscles exercise for improving chronic low back pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
improvement of Numerical Rating Scale (NRS) for low back pain after 12 weeks of abdominal trunk muscles exercise
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
everyday stretching, and abdominal trunk muscles exercise using our device, twice or three times a week
Interventions/Control_2
everyday stretching
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients who have chronic low back pain for more than three months
Key exclusion criteria
patients who have severe complications of cardiovascular disease, renal disease, respiratory disease, hematological disease or other diseases
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Kato |
Organization
Kanazawa University Hospital
Division name
Orthopedic surgery
Zip code
920-8640
Address
13-1, Takara-machi, Kanazawa-shi, Ishikawa-ken
TEL
076-265-2374
seikei@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Kitagawa |
Organization
Kanazawa University Hospital
Division name
Orthopedic surgery
Zip code
920-8640
Address
13-1, Takara-machi, Kanazawa-shi, Ishikawa-ken
TEL
076-265-2374
Homepage URL
seikei@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Kanazawa University Hospital
Address
13-1, Takara-machi, Kanazawa-shi, Ishikawa-ken
Tel
076-265-2374
seikei@med.kanazawa-u.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
| 2018 | Year | 02 | Month | 06 | 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
44
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
| 2018 | Year | 01 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 06 | Day |
Last modified on
| 2020 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035586
| 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 |
