UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009302
Receipt number 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 21:09:09

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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

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

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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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