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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000041318
Receipt No. 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

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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
Email 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
Email takaaki07_nishimura05@yahoo.co.jp

Sponsor
Institute Nanto City Home-Visit Nursing Station
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047147

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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