UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038144 |
|---|---|
| Receipt number | R000043436 |
| Scientific Title | Effectiveness of Self-management App for low back pain - Randomized controlled trial |
| Date of disclosure of the study information | 2019/09/29 |
| Last modified on | 2019/09/28 08:58:17 |
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Basic information
Public title
Effectiveness of Self-management App for low back pain - Randomized controlled trial
Acronym
Effectiveness of Self-management App for low back pain
Scientific Title
Effectiveness of Self-management App for low back pain - Randomized controlled trial
Scientific Title:Acronym
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 investigate the effectiveness the self-management App for low back pain with a randomized controlled trial (RCT).
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)
Brief Pain Inventory
Baseline, 3 month, 6 month
Key secondary outcomes
Disability due to low back pain (Roland Morris Disability Questionnaire)
Presenteeism (QQ-method)
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 -but assessor(s) are blinded
Control
Active
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
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
E-mail news about low back pain (Once in a week)
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
102
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
654-0142
Address
7-10-2, Tomogaoka, Suma, Kobe
TEL
078-796-4515
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
654-0142
Address
7-10-2, Tomogaoka, Suma, Kobe
TEL
078-796-4515
Homepage URL
yt.green1@gmail.com
Sponsor or person
Institute
Kobe University Graduate School of Health Sciences
Institute
Department
Personal name
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
the Ethics Committee of Kobe University Graduate School of Health Sciences
Address
7-10-2, Tomogaoka, Suma, Kobe
Tel
078-796-4502
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
| 2019 | Year | 09 | Month | 29 | 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
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
Preinitiation
Date of protocol fixation
| 2019 | Year | 09 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 14 | 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 | 09 | Month | 28 | Day |
Last modified on
| 2019 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043436
