UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037235 |
|---|---|
| Receipt number | 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 | 2022/11/28 09:12:53 |
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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
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
takasaki-hiroshi@spu.ac.jp
Sponsor or person
Institute
Saitama Prefectural University
Institute
Department
Personal name
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
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
Completed
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
| 2022 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042451
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| Registered date | File name |
| Research case data | |
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