UMIN-CTR Clinical Trial

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
Email	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
Email	seikei@med.kanazawa-u.ac.jp

Sponsor
Institute	Kanazawa University Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035586