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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040367
Receipt No. R000044755
Scientific Title How web-based Intervention impact on cost due to presenteeism among workers with chronic low back pain?
Date of disclosure of the study information 2020/05/15
Last modified on 2020/05/11

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Basic information
Public title How web-based Intervention impact on cost due to presenteeism among workers with chronic low back pain?
Acronym How web-based Intervention impact on cost due to presenteeism among workers with chronic low back pain?
Scientific Title How web-based Intervention impact on cost due to presenteeism among workers with chronic low back pain?
Scientific Title:Acronym How web-based Intervention impact on cost due to presenteeism among workers with chronic low back pain?
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this study is to examine the impact of a Web intervention for individuals with chronic low back pain on health-related cost loss due to presenteeism compared to pain education, which has already been shown to be effective for chronic low back pain.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Presenteeism
Key secondary outcomes Pain intensity

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
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
Behavior,custom
Interventions/Control_1 We use Pocket Therapist(Backtech, Inc.), which is a web service for corporate clients to deal with back pain. Pocket therapists are nationally qualified medical professionals, such as physical and occupational therapists, who provide customized exercise therapy, cognitive behavioral therapy, and occupational management guidance to research subjects through online chat (including the ability to send images and exercise videos). Because it is a chat exchange, the study subjects can use the Pocket Therapist at any time.
Interventions/Control_2 We provide pain education that has already been shown to be effective for musculoskeletal pain. Specifically, we send out an email newsletter with information on the relationship between chronic low back pain and psychosocial factors, the effectiveness of exercise, and work environment management. The frequency of distribution will be once 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
18 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria A person with back pain that has been continuous for more than 3 months
Those who have Internet access
Persons with a smartphone or PC
Key exclusion criteria Those who are pregnant
Those who are currently visiting a medical institution (excluding osteopathic and orthopedic clinics, etc.) for back pain
Target sample size 154

Research contact person
Name of lead principal investigator
1st name Tomoki
Middle name
Last name Aoyama
Organization Kyoto University Graduate School
Division name Department of Human Health Sciences, Graduate School of Medicine
Zip code 6068507
Address 53 Kawabara-cho, Shogoin, Sakyo-ku, Kyoto
TEL 0757513952
Email aoyama.tomoki.4e@kyoto-u.ac.jp

Public contact
Name of contact person
1st name Yu
Middle name
Last name Odake
Organization Kyoto University Graduate School
Division name Department of Human Health Sciences, Graduate School of Medicine
Zip code 6068507
Address 53 Kawabara-cho, Shogoin, Sakyo-ku, Kyoto
TEL 09079749948
Homepage URL
Email yuu.1001.bb@gmail.com

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization Kyoto 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 Kyoto University
Address 53 Kawabara-cho, Shogoin, Sakyo-ku, Kyoto
Tel 09079749948
Email yuu.1001.bb@gmail.com

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
2020 Year 05 Month 15 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
2020 Year 05 Month 11 Day
Date of IRB
Anticipated trial start date
2020 Year 06 Month 01 Day
Last follow-up date
2020 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 05 Month 11 Day
Last modified on
2020 Year 05 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044755

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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