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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000043387
Receipt No. R000049538
Scientific Title Effects of dynamic lumbar motor control training on lumbar proprioception in Participants with Low Back Pain: a randomized trial
Date of disclosure of the study information 2021/02/19
Last modified on 2021/02/19

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Basic information
Public title Effects of Dynamic Lumbar Motor Control Training on Lumbar Sensation in Participants with Low Back Pain
Acronym Effects of Dynamic Lumbar Motor Control Training on Lumbar Sensation
Scientific Title Effects of dynamic lumbar motor control training on lumbar proprioception in Participants with Low Back Pain: a randomized trial
Scientific Title:Acronym Effects of dynamic lumbar motor control training on lumbar proprioception
Region
Japan

Condition
Condition chronic low back pain
Classification by specialty
Orthopedics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of lumbar motor control training on lumbar spine proprioception to help identify the appropriate training for patients with low back pain.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II,III

Assessment
Primary outcomes Proprioception in the lumbar region( Fremantle Back Awareness Questionnaire score, the error of the active joint repositioning sense (After 8 weeks of intervention))
Key secondary outcomes LBP intensity based on a numerical rating scale, the motion angles of the lumbar spine and hip joint during trunk forward bending movement(After 8 weeks of intervention)

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 YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Dynamic lumbar motor control training ( squats, quadruped rock back, and hip extension in the prone position). Training was conducted 3 days a week for 8 weeks/Interventions
Interventions/Control_2 normal trunk training (supine, sitting, and standing positions with abdominal bracing). Training was conducted 3 days a week for 8 weeks / Control
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
20 years-old <=
Age-upper limit
60 years-old >
Gender Male and Female
Key inclusion criteria Chronic non-specific low back pain patients with no specific diagnosis and with low back pain for more than 3 months
Key exclusion criteria 1) those with specific diagnoses, such as disc herniation, spinal stenosis, or compression fracture; 2) those with typical physical dysfunction, such as paralysis or arthropathy; 3) those with pain in areas other than the lower back that interferes with activities of daily living; 4) those who have had previous spinal or hip surgery; 5) those with significant spinal deformities; 6) those with difficulty in understanding the study due to cognitive decline or other reasons
Target sample size 32

Research contact person
Name of lead principal investigator
1st name Ryo
Middle name Miyachi
Last name Miyachi
Organization Kyoto Tachibana University
Division name Department of Physical Therapy Faculty of Health Science
Zip code 607-8175
Address 34 Oyakeyamada-machi, Yamashina-ku, Kyoto-shi, Kyoto-fu
TEL 075-574-4313
Email ryomiyati@yahoo.co.jp

Public contact
Name of contact person
1st name Ryo
Middle name
Last name Miyachi
Organization Kyoto Tachibana University
Division name Department of Physical Therapy Faculty of Health Science
Zip code 607-8175
Address 34 Oyakeyamada-machi, Yamashina-ku, Kyoto-shi, Kyoto-fu
TEL 075-574-4313
Homepage URL
Email ryomiyati@yahoo.co.jp

Sponsor
Institute Kyoto Tachibana University
Department of Physical Therapy Faculty of Health Science
Institute
Department

Funding Source
Organization JSPS KAKENHI
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 Nanto City Home-Visit Nursing Station
Address 938 Inami, Nanto-shi, Toyama-ken
Tel 0763827775
Email yoshizawa.tamaki@city.nanto.jg.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 02 Month 19 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 19
Results In the pre- and post- intervention comparisons, Fremantle Back Awareness Questionnaire score, numerical rating scale value, and lumbar spine motion angle decreased whereas hip motion angle and hip- lumbar spine motion angle difference increased in the dynamic lumbar motor control training group only, and no difference in the error of the active joint repositioning sense was found between the two groups.
Results date posted
2021 Year 02 Month 19 Day
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 06 Month 01 Day
Date of IRB
2020 Year 07 Month 01 Day
Anticipated trial start date
2020 Year 09 Month 04 Day
Last follow-up date
2020 Year 11 Month 20 Day
Date of closure to data entry
2021 Year 02 Month 19 Day
Date trial data considered complete
2021 Year 02 Month 19 Day
Date analysis concluded
2021 Year 02 Month 19 Day

Other
Other related information

Management information
Registered date
2021 Year 02 Month 19 Day
Last modified on
2021 Year 02 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049538

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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