UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040367 |
|---|---|
| Receipt number | 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 17:32:26 |
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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
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
yuu.1001.bb@gmail.com
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044755
