- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04772950
Measuring Deep and Superficial Multifidus and the Activation Pattern During Dynamic Task Correlating With Trunk Stability Ability and Functional Performance in Different Ages Asymptomatic and Unspecific Low Back Pain Adult
May 20, 2021 updated by: National Taiwan University Hospital
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.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taipei, Taiwan, 100
- Recruiting
- Shing-Tian, Chiang
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Contact:
- Shing-Tian Chiang
- Phone Number: 0975314583
- Email: tian090808@gmail.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patients with non-specific low back pain
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Healthy adults
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Patients with non-specific low back pain
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change of superficial multifidus
Time Frame: 10 minutes
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change of superficial multifidus during contraction by using ultrasound image
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10 minutes
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Change of deep multifidus
Time Frame: 10 minutes
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change of deep multifidus during contraction by using ultrasound image
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10 minutes
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Disability index
Time Frame: 5 minutes
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use Oswestry Disability Index
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5 minutes
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Timed up and go test
Time Frame: 3 minutes
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Examiner will record the seconds the subjects spend in the test including standing up, walking, turn around and sit down.
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3 minutes
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Sit to stand test
Time Frame: 3 minutes
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Subjects will repeat 5 times sit to stand and the seconds subjects spend will be recorded.
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3 minutes
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Countermovement jump test
Time Frame: 3 minutes
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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.
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3 minutes
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Sahrmann five-level core stability test
Time Frame: 5 minutes
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Examiner will use stabilizer pressure biofeedback unit to detect whether there is lumbar motion during different levels of lower extremities movement.
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5 minutes
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Rotatory stability test
Time Frame: 3 minutes
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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.
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3 minutes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 8, 2021
Primary Completion (Anticipated)
June 30, 2021
Study Completion (Anticipated)
July 31, 2021
Study Registration Dates
First Submitted
February 23, 2021
First Submitted That Met QC Criteria
February 25, 2021
First Posted (Actual)
February 26, 2021
Study Record Updates
Last Update Posted (Actual)
May 25, 2021
Last Update Submitted That Met QC Criteria
May 20, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202012034RINB
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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