UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033210
Receipt No. 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 2019/10/04

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 (Numerical Rating Scale, NRS)
Once in a week
Key secondary outcomes Roland-Morris Disability Questionnaire, STarT Back Screening tool, Medication history, Consultation history, Work Limitations Questionnaire, Sleep quality (One part of Pittsburgh Sleep Quality Index), Other musculoskeletal pain (NRS)

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
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, Japan
TEL 078-796-4515
Homepage URL
Email yt.green1@gmail.com

Sponsor
Institute Kobe University Graduate School of Health Sciences, Department of Public Health
Institute
Department

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
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 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
2019 Year 10 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037348

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.