UMIN-CTR Clinical Trial

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