UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized controlled trial of the effect of coaching for low back pain over the Internet
Title of the study (Brief title)	A randomized controlled trial of the effect of coaching for low back pain over the Internet
Region	Japan

Condition
Condition	Low back pain
Classification by specialty	Psychosomatic Internal Medicine Orthopedics Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To reveal the effectiveness of coaching for low back pain with a smartphone or personal computer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	degree of low back pain
Key secondary outcomes	health related productivity (presenteeism) quality of life fear avoidance beliefs

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	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom Maneuver
Interventions/Control_1	coaching by physical therapist(twice a month/3 months) educate how to stretch training by movies record the degree of pain(daily)
Interventions/Control_2	Nothing
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	20 years-old <=
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	the persons who have low back pain
Key exclusion criteria	the persons who visit the hospital regularly for low back pain the persons who have a history of surgery for low back pain the persons who is pregnant
Target sample size	60

Research contact person
Name of lead principal investigator	Tomohisa Nagata
Organization	University of Occupational and Environmental Health
Division name	Institute of Industrial Ecological Sciences
Address	1-1 Iseigaoka, yahatanishi-ku, Kitakyushu, 807-8555 Fukuoka, Japan
TEL	+81-93-603-1611
Email	tomohisa@med.uoeh-u.ac.jp

Public contact
Name of contact person	Tomohisa Nagata
Organization	University of Occupational and Environmental Health
Division name	Institute of Industrial Ecological Sciences
Address	1-1 Iseigaoka, yahatanishi-ku, Kitakyushu, 807-8555 Fukuoka, Japan
TEL	+81-93-603-1611
Homepage URL
Email	tomohisa@med.uoeh-u.ac.jp

Sponsor
Institute	University of Occupational and Environmental Health
Institute
Department

Funding Source
Organization	Collabo-Health Study Group
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 12 Month 12 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 06 Month 30 Day
Anticipated trial start date	2017 Year 09 Month 01 Day
Last follow-up date	2018 Year 09 Month 01 Day
Date of closure to data entry	2018 Year 10 Month 01 Day
Date trial data considered complete	2018 Year 11 Month 01 Day
Date analysis concluded	2018 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 12 Month 12 Day
Last modified on	2017 Year 12 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034663