UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036777 |
|---|---|
| Receipt number | R000041910 |
| Scientific Title | Investigation on the effectiveness of abdominal hollowing home-exercises using a portable ultrasound: randomized controlled trial |
| Date of disclosure of the study information | 2019/07/01 |
| Last modified on | 2021/05/17 09:48:50 |
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Basic information
Public title
Investigation on the effectiveness of abdominal hollowing home-exercises using a portable ultrasound: randomized controlled trial
Acronym
Investigation on the effectiveness of abdominal hollowing home-exercises using a portable ultrasound: randomized controlled trial
Scientific Title
Investigation on the effectiveness of abdominal hollowing home-exercises using a portable ultrasound: randomized controlled trial
Scientific Title:Acronym
Investigation on the effectiveness of abdominal hollowing home-exercises using a portable ultrasound: randomized controlled trial
Region
| Japan |
Condition
Condition
People with low back pain
Classification by specialty
| Orthopedics | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate if there is any difference in the magnitude of learning the abdominal Hollowing (AH) exercise between the groups, where one group undertakes AH home-exercise using palpation after instructions of the AH exercise and the other group undertakes AH home-exercise using a portable ultrasound after instructions of the AH exercise
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change rate in the thickness of the transverse abdominal muscle during the Abdominal Hollowing (baseline and 1 and 2 weeks after the baseline)
Key secondary outcomes
Subjective difficulty of the Abdominal Hollowing (The Rating Scale Mental Effort)(baseline and 1 and 2 weeks after the baseline)
Pain intensity (The P4) (baseline and 1 and 2 weeks after the baseline)
Disability (The Oswestry Disability index)(baseline and 1 and 2 weeks after the baseline)
Quality of life (The EQ-5D) (baseline and 1 and 2 weeks after the baseline)
Exercise adherence (1 week after the baseline)
Effect of intervention (The Global rating recovery scale) (1 and 2 weeks after the baseline)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
One-week Abdominal Hollowing home-exercise (10 s contraction x 10 reps x 3 sets x 2/day) using a portable ultrasound then no intervention for a week
Interventions/Control_2
One-week Abdominal Hollowing home-exercise (10 s contraction x 10 reps x 3 sets x 2/day) using palpation then no intervention for a week
Interventions/Control_3
No intervention for 2 weeks
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
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
At least one episode of low back pain for at least 2 successive days with the intensity of 2 or greater in the 11-point numerical rating scale during one month
Students in the Saitama Prefectural university
Oswestry Disability Index of 13% or more
Key exclusion criteria
Undertaking treatment for the low back pain during the study period in the hospital
Congenital disorders
Diagnosed neurological disorders
Diagnosed mental disorders
Pregnancy
Diagnosed spinal deformity
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Takasaki |
Organization
Saitama Prefectural University
Division name
Physical Therapy
Zip code
3438540
Address
Sannomiya 820, Koshigaya
TEL
0489734706
takasaki-hiroshi@spu.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Takasaki |
Organization
Saitama Prefectural University
Division name
Physical Therapy
Zip code
3438540
Address
Sannomiya 820, Koshigaya
TEL
0489734706
Homepage URL
takasaki-hiroshi@spu.ac.jp
Sponsor or person
Institute
Saitama Prefectural University
Institute
Department
Personal name
Funding Source
Organization
Saitama Prefectural University
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
Saitama Prefectural University
Address
Sannnomiya 820, Koshigaya
Tel
0489710500
rinri@spu.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 | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
60
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
| 2019 | Year | 05 | Month | 23 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 05 | Day |
Last follow-up date
| 2020 | 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 | 05 | Month | 16 | Day |
Last modified on
| 2021 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041910
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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