UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041910