UMIN-CTR Clinical Trial

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
Email	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
Email	tnomura@tamateyama.ac.jp

Sponsor
Institute	Kansai University of Welfare Sciences
Institute
Department

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
Email

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
URL(English)	https://upload.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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