UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033210 |
|---|---|
| Receipt number | R000037348 |
| Scientific Title | Effectiveness of Workplace Active Rest Program on low back pain among office workers |
| Date of disclosure of the study information | 2018/07/02 |
| Last modified on | 2021/05/08 19:59:13 |
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Basic information
Public title
Effectiveness of Workplace Active Rest Program on low back pain among office workers
Acronym
Effectiveness of Active Rest on low back pain
Scientific Title
Effectiveness of Workplace Active Rest Program on low back pain among office workers
Scientific Title:Acronym
Effectiveness of Active Rest on low back pain
Region
| Japan |
Condition
Condition
Chronic low back pain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Chronic low back pain (CLBP) is prevalent problem among office workers. CLBP should be resolved because it causes work productivity loss, sick absence, and medical cost. Prolonged sitting is closely related to LBP among office workers. Although previous studies have tried to investigate the effectiveness of ergonomic intervention and back support, these are shown ineffective. Recent study showed that standing desk improved LBP. However, standing desk has some limitations such as application to workplaces in terms of spaces and cost. Thus, easy-to-use solutions are needed.
We focus on how office workers take a rest. We hypothesized that frequent standing and brief exercise during work could improve LBP and develop the Workplace Active Rest Program (WARP). WARP consists of frequent standing and brief exercise focused on LBP, which can decrease burden on lower back due to prolonged sitting and improve LBP.
The objective of the present study is to show the effectiveness of WARP on chronic low back pain among office workers.
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 (subscale of Brief Pain Inventory; BPI)
Once in 4 weeks
Key secondary outcomes
Roland-Morris Disability Questionnaire, STarT Back Screening tool, Work Limitations Questionnaire, Physical Activity in work (Accelerometer)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
1. Workplace active rest program composes of frequent rest and brief exercise (1-2 minutes) led by physical therapist at the seminar.
2. The seminar is held when the group will move from control phase to intervention phase.
3. The contents of seminar composes of cause of low back pain (LBP), sedentary and LBP, sedentary and health, orientation of intervention, development of exercise program.
4. Researchers who is specialized in LBP and sedentary hold a seminar and evaluate the condition of participants, prescribe a brief and effective office exercise.
5. Exercise focuses on spine and hip stretch and training which improve their mobility and stability (trunk extension exercise, stretching of Iliopsoas and hamstrings, abdominal oblique, erector spinae muscles, thoracolumbar fascia).
6. We disseminate leaflets of exercise.
7. Timing of active rest is start time of work, AM break, lunch break, PM break, finishing time of work. During these five timing, reminder music turns on, and then all workers (study participants as well as the rest of workers in the same office) take an active rest (stand up and exercise) under supervisors' instruction.
8. Researchers visit the office once in a week to check if any problems happen or not.
Interventions/Control_2
Usual work (music of general exercise before starting job, AM and PM break)
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
Chronic low back pain lasting more that 3 months (12th rib to gluteal fold)
Office workers (more than 4 hours/day for desk work)
Key exclusion criteria
Low back pain due to fracture and trauma injury, infectious disease, internal organ disorder
Difficult to participate in the study due to medical or surgical disease
Target sample size
30
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, Japan
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
6540012
Address
7-10-2, Tomogaoka ,Suma, Kobe, Japan
TEL
078-796-4515
Homepage URL
yt.green1@gmail.com
Sponsor or person
Institute
Kobe University Graduate School of Health Sciences, Department of Public Health
Institute
Department
Personal name
Funding Source
Organization
Meiji Yasuda Life Foundation of Health and Welfare
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
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, Japan
Tel
0787922555
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 | 07 | Month | 02 | 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
29
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 | 06 | Month | 23 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 02 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 09 | 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 | 06 | Month | 30 | Day |
Last modified on
| 2021 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037348
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