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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036777
Receipt No. 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 2019/12/13

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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
Email 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
Email takasaki-hiroshi@spu.ac.jp

Sponsor
Institute Saitama Prefectural University
Institute
Department

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
Email 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 Unpublished

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 No longer recruiting
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
2019 Year 12 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041910

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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