UMIN-CTR Clinical Trial

Basic information
Public title	Development and Effectiveness of Self-management App for low back pain - Randomized controlled trial
Acronym	Development and Effectiveness of Self-management App for low back pain
Scientific Title	Development and Effectiveness of Self-management App for low back pain - Randomized controlled trial
Scientific Title:Acronym	Development and Effectiveness of Self-management App for low back pain
Region	Japan

Condition
Condition	Chronic low back pain
Classification by specialty	Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To develop the Self-management App for low back pain and preliminary investigate its effectiveness.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Low back pain intensity (Numerical Rating Scale) Baseline, 3 month, 6 month
Key secondary outcomes	Disability due to low back pain (Roland Morris Disability Questionnaire) Presenteeism (Work Limitations Questionnaire) Seeking care / Medicine intake Kinesiophobia (Tampa Scale for Kinesiophobia 11) Depresiive symptom (Center for Epidemiologic Studies Depression Scale 10) Lifestyle factors (Self-reported) Baseline, 3 month, 6 month Adherence: Data from App Other: Satisfaction and opinions about App (6 month follow-up)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom Other
Interventions/Control_1	Under support from physical therapists, participants set the long-term and short-term goal, monitor their own pain and physical activity, and execute the solution of low back pain. Participants receive chat support from physical therapists. The duration of intervention is 6 month. Physical therapists give participants solutions of low back pain such as back pain education , exercise, cognitive behavioral therapy, stress coping, and ergonomic intervention. Physical therapists have 3 or more years clinical experience and abundant experience of chat support.
Interventions/Control_2	No intervention (Waiting list) The duration of intervention is 6 month.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	eldercare worker chronic low back pain lasting 3 month or more NRS: 4 or more own smartphones or tablets
Key exclusion criteria	fracture, trauma, Infectious spondylitis, cancer, back pain due to internal disorder difficult to join the study due to diseases pregnant
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Rei Middle name Last name Ono
Organization	Kobe University Graduate School of Health Sciences
Division name	Department of Public Health
Zip code	6540012
Address	7-10-2, Tomogaoka, Suma, Kobe
TEL	078-796-4515
Email	ono@phoenix.kobe-u.ac.jp

Public contact
Name of contact person	1st name Yamato Middle name Last name Tsuboi
Organization	Kobe University Graduate School of Health Sciences
Division name	Department of Community Health Sciences
Zip code	6540012
Address	7-10-2, Tomogaoka, Suma, Kobe
TEL	078-796-4515
Homepage URL
Email	yt.green1@gmail.com

Sponsor
Institute	Kobe University Graduate School of Health Sciences
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology, The Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Kobe University Graduate School of Health Sciences
Address	7-10-2, Tomogaoka, Suma, Kobe
Tel	078-796-4502
Email	syomu2@ams.kobe-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 11 Month 16 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	19
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 11 Month 01 Day
Date of IRB	2018 Year 11 Month 02 Day
Anticipated trial start date	2018 Year 11 Month 03 Day
Last follow-up date	2019 Year 05 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	2018 Year 11 Month 15 Day
Last modified on	2019 Year 11 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039769