UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041318 |
|---|---|
| Receipt number | R000047147 |
| Scientific Title | Development of a new low back pain prevention program focusing on lumbar motor control for sedentary office workers |
| Date of disclosure of the study information | 2020/08/06 |
| Last modified on | 2021/05/19 00:45:44 |
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Basic information
Public title
Development of a new low back pain prevention program focusing on lumbar motor control for sedentary office workers
Acronym
A new low back pain prevention exercise program for sedentary office workers
Scientific Title
Development of a new low back pain prevention program focusing on lumbar motor control for sedentary office workers
Scientific Title:Acronym
A new low back pain prevention exercise program for 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 develop a new low back pain prevention program that focuses on lumbar motor control for sedentary office workers
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).
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
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Exercise group without trunk movement (NTE group)
Abdominal bracing in supine, sitting, and standing positions are performed 50 times a day each, 3 days a week for 8 weeks.
Interventions/Control_2
dynamic motor control exercise group (DMCE group)
squat, Rocking backward in quadruped, and hip joint extension in the prone are performed 30 times a day each, 3 days a week for 8 weeks.
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
30
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@yahoo.co.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
Japanese Physical Therapy Association
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
| 2020 | Year | 08 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
19
Results
The DMCE group showed a significant decrease in lumbar flexion angle at 10 degree of trunk forward flexion and a significant increase in hip flexion angle compared to the NTE group; VAS and ODI, as well as hip range of motion, were also significantly decreased. There was no significant difference in muscle strength.
Results date posted
| 2021 | Year | 02 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
NTE group: 9 participants (male: 2 participants, Female: 7 participants)
DMCE group: 10 participants (male: 3 participants, Female: 7 participants)
Participant flow
Application for volunteer, Submission of consent forms, Determination of volunteer, Schedule adjustment, Measurements before and after intervention
Adverse events
Outcome measures
Motor control ability of the lumbar region.
VAS
ODI
Hip flexion, extension muscle strength, joint range of motion
Plan to share IPD
None
IPD sharing Plan description
None
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 05 | Day |
Last follow-up date
| 2021 | Year | 03 | 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
| 2020 | Year | 08 | Month | 05 | Day |
Last modified on
| 2021 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047147
