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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000009302
Receipt No. R000010923
Scientific Title Analysis of function of the trunk and the lower limb in patients with low back pain history, and immediate changes following training of the lumbar paraspinal muscles.
Date of disclosure of the study information 2012/11/10
Last modified on 2012/11/09

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Basic information
Public title Analysis of function of the trunk and the lower limb in patients with low back pain history, and immediate changes following training of the lumbar paraspinal muscles.
Acronym Analysis of function of the trunk and the lower limb in patients with low back pain history, and immediate changes following training of the lumbar paraspinal muscles.
Scientific Title Analysis of function of the trunk and the lower limb in patients with low back pain history, and immediate changes following training of the lumbar paraspinal muscles.
Scientific Title:Acronym Analysis of function of the trunk and the lower limb in patients with low back pain history, and immediate changes following training of the lumbar paraspinal muscles.
Region
Japan

Condition
Condition Patients with low back pain history
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examine immediate changes in the muscle activity of the trunk and the lower limb, the spinal movement and pelvic motion during standing position movement in patients with low back pain history following quadruped upper and lower extremity lifts to selectively strengthen the multifidus muscle or extension training to strengthen all paraspinal muscles.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in the muscle activity of the trunk muscles and the lower limb muscles, onset of trunk muscles, the spinal movement and pelvic motion during standing position movement in patients with low back pain history following training interventions.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 The subjects perform quadruped upper and lower extremity lifts for 10 seconds. The exercise is performed 1set of 10 repetitions.
Interventions/Control_2 The subjects perform trunk extension training in the prone for 10 seconds. The exercise is performed 1set of 10 repetitions.
Interventions/Control_3 The subjects don't perform any exercises.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria People with low back pain history.
Key exclusion criteria 1. Patient having any orthopedic, neurological, respiratory or circulatory disorders.
2. Patient had motor signs of nerve root compression when low back pain was experienced.
3. Patient having a history of spinal canal stenosis, spondylolisthesis, spondylolysis, vertebral fracture, lumbosacral strain.
4. Patient having previous spinal or abdominal surgery.
5. Pregnant woman

Target sample size 39

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Noriaki Ichihashi
Organization Human Health Sciences, Graduate School of Medicine, Kyoto University
Division name Department of Development and Rehabilitation of Motor Function
Zip code
Address 606-8507 53 Kawahara-cho Shogoin, Sakyo-ku, Kyoto
TEL
Email

Public contact
1st name of contact person
1st name
Middle name
Last name Mitsuhiro Masaki
Organization Human Health Sciences, Graduate School of Medicine, Kyoto University
Division name Department of Development and Rehabilitation of Motor Function
Zip code
Address 606-8507 53 Kawahara-cho Shogoin,Sakyo-ku, Kyoto
TEL 075-751-3935
Homepage URL
Email so588-masaki@edu.city.kyoto.jp

Sponsor
Institute Department of Development and Rehabilitation of Motor Function,
Human Health Sciences, Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2012 Year 11 Month 10 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
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 Preinitiation
Date of protocol fixation
2012 Year 11 Month 05 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 11 Month 09 Day
Last modified on
2012 Year 11 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010923

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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