UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043486 |
|---|---|
| Receipt number | R000049649 |
| Scientific Title | Effect of the presence of low back pain on lumbar motor control and proprioceptive sensation of the lumbar region in sedentary office workers |
| Date of disclosure of the study information | 2021/03/01 |
| Last modified on | 2021/07/22 17:14:45 |
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Basic information
Public title
Effect of the presence of low back pain on lumbar motor control and proprioceptive sensation of the lumbar region in sedentary office workers
Acronym
Effect of the presence of low back pain on lumbar motor control and proprioceptive sensation of the lumbar region in sedentary office workers
Scientific Title
Effect of the presence of low back pain on lumbar motor control and proprioceptive sensation of the lumbar region in sedentary office workers
Scientific Title:Acronym
Effect of the presence of low back pain on lumbar motor control and proprioceptive sensation of the lumbar region in sedentary office workers
Region
| Japan |
Condition
Condition
low back pain
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the characteristics of lumbar motor control and lumbar proprioception in sedentary office workers with low back pain
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Motor control ability of the lumbar.
Lumbar flexion angle (tilt angle of lumbosacral transition - tilt angle of thoracolumbar transition), hip flexion angle (tilt angle of lumbosacral transition - tilt angle of thigh) for each trunk forward bending angles (tilt angle of thoracolumbar transition).
The error of the active joint repositioning sense
Intensity of low back pain (Visual Analogue Scale).
Effects of low back pain in activities of daily living (Oswestry Disability Index).
Key secondary outcomes
Hip flexion and extension muscle strength
Right and left hip flexion and extension angles
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
Participants were required to have chronic low back pain (more than 3 months), non-specific low back pain (back pain without organic factors), and to spend at least 80% of their daily work time in a seated position.
Key exclusion criteria
Exclusion criteria were those with a disease that causes low back pain, acute low back pain, or less than 80% of work time per day in a sitting position.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Takaaki |
| Middle name | |
| Last name | Nishimura |
Organization
Nanto City Home-Visit Nursing Station
Division name
Rehabilitation Department
Zip code
932-0211
Address
938 Inami, Nanto-shi, Toyama 932-0211, Japan
TEL
0763-82-7775
takaaki07_nishimura05@yahooco.jp
Public contact
Name of contact person
| 1st name | Takaaki |
| Middle name | |
| Last name | Nishimura |
Organization
Nanto City Home-Visit Nursing Station
Division name
Rehabilitation Department
Zip code
932-0211
Address
938 Inami, Nanto-shi, Toyama 932-0211, Japan
TEL
0763-82-7775
Homepage URL
takaaki07_nishimura05@yahoo.co.jp
Sponsor or person
Institute
Nanto City Home-Visit Nursing Station
Institute
Department
Personal name
Funding Source
Organization
Nanto City Home-Visit Nursing Station
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nanto City Home-Visit Nursing Station
Address
938 Inami, Nanto-shi, Toyama 932-0211, Japan
Tel
0763-82-7775
iryoka@city.nanto.lg.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
| 2021 | Year | 03 | Month | 01 | 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
65
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
| 2020 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
cross-sectional study
Management information
Registered date
| 2021 | Year | 03 | Month | 01 | Day |
Last modified on
| 2021 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049649
