Low Back PainNCT04772950
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
An observational study of Low Back Pain, run by National Taiwan University Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Mar 2021to 31 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with non-specific low back pain
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Shing-Tian, Chiang
Taipei, 100
Shing-Tian Chiang, 0975314583, tian090808@gmail.com
About this study
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.
- Conditions
- Low Back Pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy adults | Not described | |
| Patients with non-specific low back pain | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of superficial multifidus
change of superficial multifidus during contraction by using ultrasound image
Measured: 10 minutes
Change of deep multifidus
change of deep multifidus during contraction by using ultrasound image
Measured: 10 minutes
Disability index
use Oswestry Disability Index
Measured: 5 minutes
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.
Measured: 3 minutes
Sit to stand test
Subjects will repeat 5 times sit to stand and the seconds subjects spend will be recorded.
Measured: 3 minutes
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.
Measured: 3 minutes
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.
Measured: 5 minutes
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.
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start8 Mar 2021
- Primary completion30 Jun 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772950
- Sponsor's protocol ID
- 202012034RINB
- Status last verified
- Feb 2021
- First submitted
- 23 Feb 2021
- Last updated
- 25 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04772950
- Acronym / sponsor ID
- 202012034RINB
- Conditions
- Low Back Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 26 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy adults | – | – |
| Patients with non-specific low back pain | – | – |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with non-specific low back pain
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of superficial multifidus
Time frame: 10 minutes
change of superficial multifidus during contraction by using ultrasound image
Change of deep multifidus
Time frame: 10 minutes
change of deep multifidus during contraction by using ultrasound image
Disability index
Time frame: 5 minutes
use Oswestry Disability Index
Timed up and go test
Time frame: 3 minutes
Examiner will record the seconds the subjects spend in the test including standing up, walking, turn around and sit down.
Sit to stand test
Time frame: 3 minutes
Subjects will repeat 5 times sit to stand and the seconds subjects spend will be recorded.
Countermovement jump test
Time frame: 3 minutes
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.
Sahrmann five-level core stability test
Time frame: 5 minutes
Examiner will use stabilizer pressure biofeedback unit to detect whether there is lumbar motion during different levels of lower extremities movement.
Rotatory stability test
Time frame: 3 minutes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shing-Tian Chiang (097531458, tian090808@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of superficial multifidus (time frame: 10 minutes). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2021; AzTrials last refreshed its copy on 29 Oct 2026.