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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000037235
Receipt No. R000042451
Scientific Title Identifying factors including a secondary preventative strategies influencing attendance at work and medical costs in people with low back pain.
Date of disclosure of the study information 2019/07/31
Last modified on 2020/02/12

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Basic information
Public title Identifying factors including a secondary preventative strategies influencing attendance at work and medical costs in people with low back pain.
Acronym Identifying factors including a secondary preventative strategies influencing attendance at work and medical costs in people with low back pain.
Scientific Title Identifying factors including a secondary preventative strategies influencing attendance at work and medical costs in people with low back pain.
Scientific Title:Acronym Identifying factors including a secondary preventative strategies influencing attendance at work and medical costs in people with low back pain.
Region
Japan

Condition
Condition Low back pain
Classification by specialty
Orthopedics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate combinations of factors influencing attendance at work and medical costs in workers with low back pain, which include clinician's level in the the Mechanical Diagnosis and Therapy and other bio-psycho-social factors
Basic objectives2 Others
Basic objectives -Others Investigation of relevant factors
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Attendance at work (1, 3, 6, and 12 months after the initial MDT session)
Key secondary outcomes Medical costs (1, 3, 6, and 12 months after the initial MDT session)
Clinician's level in the MDT (baseline)
Intervention sessions and time (1, 3, 6, and 12 months after the initial MDT session)
Exercise adherence (1, 3, 6, and 12 months after the initial MDT session)
A Japanese version of the Patient Attitudes and Beliefs Scale (1, 3, 6, and 12 months after the initial MDT session)
Health Education Impact Questionnaire (baseline and 1, 3, 6, and 12 months after the initial MDT session)
Working Alliance Inventory-Short Form Japanese version (1, 3, 6, and 12 months after the initial MDT session)
Tampa Scale for Kinesiophobia (1, 3, 6, and 12 months after the initial MDT session)
Japanese Version of the Pain Self-Efficacy Questionnaire (baseline and 1, 3, 6, and 12 months after the initial MDT session)
Japanese version of the 12-item Orebro Musculoskeletal Screening Questionnaire and KeeleSTarT Back screening tool (baseline and 1, 3, 6, and 12 months after the initial MDT session)
Oswestry Disability Index (baseline and 1, 3, 6, and 12 months after the initial MDT session)
Symptom location (baseline and 1, 3, 6, and 12 months after the initial MDT session)
Pain intensity: P4 (baseline and 1, 3, 6, and 12 months after the initial MDT session)
Pain Catastrophizing Scale (baseline and 1, 3, 6, and 12 months after the initial MDT session)
Central Sensitization Inventory (baseline and 1, 3, 6, and 12 months after the initial MDT session)
Global rating recovery scale (1, 3, 6, and 12 months after the initial MDT session)
Work content (baseline)
Work satisfaction (baseline and 1, 3, 6, and 12 months after the initial MDT session)
Previous history of low back pain (baseline)
MDT classification (12 months after the initial MDT session)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Interventions by the credential therapists in the Mechanical Diagnosis and Therapy
Interventions/Control_2 Interventions by the diploma therapists in the Mechanical Diagnosis and Therapy
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 Full time workers with primary complaint of low back pain, who undertake interventions by the Mechanical Diagnosis and Therapy therapists
Key exclusion criteria Hospitalization due to unrelated reasons for the low back pain
Target sample size 170

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Takasaki
Organization Saitama Prefectural University
Division name Physical Therapy
Zip code 3438540
Address Sannomiya 820, Koshigaya, Saitama
TEL +81489734706
Email takasaki-hiroshi@spu.ac.jp

Public contact
Name of contact person
1st name Hiroshi
Middle name
Last name Takasaki
Organization Saitama Prefectural University
Division name Physical Therapy
Zip code 3438540
Address Sannomiya 820, Koshigaya, Saitama
TEL +81489734706
Homepage URL
Email takasaki-hiroshi@spu.ac.jp

Sponsor
Institute Saitama Prefectural University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Saitama Prefectural University
Address Sannomiya 820, Koshigaya, Saitama
Tel +81489710500
Email rinri@spu.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
2019 Year 07 Month 31 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 0
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 Enrolling by invitation
Date of protocol fixation
2019 Year 07 Month 02 Day
Date of IRB
2019 Year 05 Month 29 Day
Anticipated trial start date
2019 Year 08 Month 01 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 07 Month 02 Day
Last modified on
2020 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042451

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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