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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04772950
Other study ID # 202012034RINB
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 8, 2021
Est. completion date July 31, 2021

Study information

Verified date February 2021
Source National Taiwan University Hospital
Contact Shing-Tian Chiang
Phone 097531458
Email tian090808@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The first propose of the study is to understand the contraction of deep and superficial multifidus in patients with non-specific low back pain and the elderly. The second purpose of the study is to understand the relationship between the multifidus and the functional performance in patients with non-specific low back pain and the elderly. The hypothesis is that the patients with non-specific low back pain and the elderly have less ability to contract the deep multifidus then asymptomatic adults and younger adults. Besides, the multifidus is correlated to the functional performance.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date July 31, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 90 Years
Eligibility Inclusion Criteria: - age 20-90 - have lumbar region discomfort in the past three months, and the discomfort is more than one day - have diagnosis of non-specific low back pain Exclusion Criteria: - have received surgery of lumbar or lower extremities - neurological symptom (eg. numbness of lower extremities) - have no ability to stand and walking independently - cancer - systemic disease (eg. ankylosing spondylitis, rheumatoid arthritis, Systemic lupus erythematosus) - pregnancy

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan Shing-Tian, Chiang Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of superficial multifidus change of superficial multifidus during contraction by using ultrasound image 10 minutes
Primary Change of deep multifidus change of deep multifidus during contraction by using ultrasound image 10 minutes
Primary Disability index use Oswestry Disability Index 5 minutes
Primary Timed up and go test Examiner will record the seconds the subjects spend in the test including standing up, walking, turn around and sit down. 3 minutes
Primary Sit to stand test Subjects will repeat 5 times sit to stand and the seconds subjects spend will be recorded. 3 minutes
Primary Countermovement jump test The subjects start from an upright standing position, makes a preliminary downward movement by flexing at the knees and hips, then immediately extends the knees and hips again to jump vertically up off the ground. The distance which the subjects jump for will be recorded. 3 minutes
Primary Sahrmann five-level core stability test Examiner will use stabilizer pressure biofeedback unit to detect whether there is lumbar motion during different levels of lower extremities movement. 5 minutes
Primary Rotatory stability test Rotatory stability test is one of the test from functional movement screen. Subjects will start in quadruped position and move the extremities to maintain the spine in neutral position. 3 minutes
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