UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018450 |
|---|---|
| Receipt number | R000021294 |
| Scientific Title | The effects of the "consulting system for physical therapy in occupational health (compo)" in the prevention of lower back pain among workers |
| Date of disclosure of the study information | 2015/07/29 |
| Last modified on | 2019/01/16 11:12:13 |
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Basic information
Public title
The effects of the "consulting system for physical therapy in occupational health (compo)" in the prevention of lower back pain among workers
Acronym
The effects of the "consulting system for physical therapy in occupational health (compo)" in the prevention of lower back pain among workers
Scientific Title
The effects of the "consulting system for physical therapy in occupational health (compo)" in the prevention of lower back pain among workers
Scientific Title:Acronym
The effects of the "consulting system for physical therapy in occupational health (compo)" in the prevention of lower back pain among workers
Region
| Japan |
Condition
Condition
Low back pain
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to examine the effects of the "consulting system for physical therapy in occupational health (compo)," in the prevention of lower back pain among workers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Risks of chronic low back pain (FABQ and STarT Back)
Key secondary outcomes
State of low back pain, K6 scale, EQ-5D, Work ability
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Email guidance by a physical therapist is provided for half a year.
Interventions/Control_2
Non-intervention. After the observation period, the non-intervention group members receive the same email guidance same as the intervention group members.
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
| 30 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Care workers.
2. Workers who have experienced lower back pain (LBP) in the past and workers who have uneasiness regarding LBP.
3. Workers have (and can use) a cell phone and/or PC.
Key exclusion criteria
1. Workers with acute LBP and those who were receiving medical treatment at the time of the study.
2. Workers with mental illnesses, and who were receiving medical treatment at the time of the study.
3. Workers with severe motor impairment of the upper/lower-extremities.
4. Other conditions that resulted in the workers being considered to be ineligible by the researcher.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuo Nomura |
Organization
Kansai University of Welfare Sciences
Division name
Department of Rehabilitation Sciences, Faculty of Allied Health Sciences
Zip code
Address
1-11, 3-chome, Asahigaoka, Kashiwara, Osaka 582-0026, JAPAN
TEL
072-978-0088
tnomura@tamateyama.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuo Nomura |
Organization
Kansai University of Welfare Sciences
Division name
Department of Rehabilitation Sciences, Faculty of Allied Health Sciences
Zip code
Address
1-11, 3-chome, Asahigaoka, Kashiwara, Osaka 582-0026, JAPAN
TEL
072-978-0088
Homepage URL
tnomura@tamateyama.ac.jp
Sponsor or person
Institute
Kansai University of Welfare Sciences
Institute
Department
Personal name
Funding Source
Organization
Japanese Physical Therapy Association
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Medical Research and Management for Musculoskeletal Pain, 22nd Century Medical and Research Center, The University of Tokyo Hospital
Name of secondary funder(s)
Ministry of Health, Labour and Welfare of Japan
IRB Contact (For public release)
Organization
Address
Tel
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
社会福祉法人友愛園（京都府）、社会福祉法人秀孝会（京都府）、社会福祉法人帝塚山福祉会（大阪府）、社会福祉法人博愛福祉会（兵庫県）、社会福祉法人神愛会（和歌山）、紀南地方老人福祉施設組合（和歌山）、社会福祉法人長岡京市社会福祉協議会（京都府）、社会福祉法人三養福祉会（和歌山）、社会福祉法人鶴林園（兵庫県）、社会福祉法人関西福祉会（大阪府）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.mhlw.go.jp/seisakunitsuite/bunya/koyou_roudou/roudoukijun/rousai/hojokin/0000051129.html
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
Completed
Date of protocol fixation
| 2015 | Year | 07 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 29 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1) Nomura T, Asada F, Takano K, Matsudaira K. The Current State along with Outstanding Issues Related to Email-Based Guidance by Physical Therapists Aiming to Prevent Low Back Pain among Workers. JJOMT 64(2): 113-118, 2016.
2) Oka H, Nomura T, Asada F, Takano K, Nitta Y, Uchima Y, Sato T, Kawase M, Sawada S, Sakamoto K, Yasue M, Arima S, Katsuhira J, Kawamata K, Fujii T, Tanaka S, Konishi H, Okazaki H, Miyoshi K, Watanabe J, Matsudaira K. The effect of the "One Stretch" exercise on the improvement of low back pain in Japanese nurses: a large-scale, randomized, controlled trial. Mod Rheumatol 22: 1-17, 2018.
Management information
Registered date
| 2015 | Year | 07 | Month | 28 | Day |
Last modified on
| 2019 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021294
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
