Non-Spesific Chronic Low Back PainNCT06782633

Deep Core Muscles and Biopsychosocial in Asymptomatic Adults and NSCLBP

An observational study of Non-Spesific Chronic Low Back Pain and Aged, run by National Taiwan University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goal of this observational study is to (1) investigate age effects on core muscles, sensorimotor system, psychosocial factors in asymptomatic adults across years of age; (2) explore the differences in biopsychosocial factors between asymptomatic adults and people with non-specific chronic low back pain (NSCLBP)… Read more about this study

Who is it for?: Ages 20 years and olderHealthy volunteers can take part
Conditions the study is for: Non-Spesific Chronic Low Back Pain, Aged
How many people: 57 participants
Where: 1 siteTaiwan
Study dates: 1 Aug 2022to 30 Aug 2024
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Taiwanese people

Who may be able to join

aged above 20 years old
Non-specific chronic low back defined as discomfort in the low back area, which persisted over a day during the past three months and was diagnosed as non-specific low back pain.

Who cannot join

history of surgery at the low back or lower extremity
neurological symptoms, such as numbness or tingling
not able to walk or stand independently
cancer
systemic inflammation, such as ankylosing spondylitis, rheumatoid arthritis, and systemic lupus erythematosus
in pregnancy

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

School and Graduate Institute of Physical Therapy, National Taiwan University
Taipei, 110

Other trials in Taiwan

About this study

Official title: Assessment of Deep Core Muscles, Postural Analysis, Functional and Mental Performance in Different Age Group of Asymptomatic Participants and Patients With Non-specific Low Back Pain

The main questions it aims to answer :

Are the core muscles, lumbar propriocpetion, and psychological measures altered as age increases?
Do the core muscles, lumbar propriocpetion, functional performance, psychological measures, disability, and quality of life affected by NSCLBP?
following (2), if so, are there correlations between the measured biopsychosocial factors, disability, and quality of life in people with NSCLBP?

Researchers will compare between people with NSCLBP and age-matched asymptomatic participants across years of age to see if the effect of age and effect of NSCLBP existed in biopsychosocial factors.

Participants will

be observed by ultrasound image at the low back and abdominal areas to collect parameters related to trunk deep core muscles, such as changes in muscle thickness from resting state to contraction;
ungergo MRI examination to acquire image of deep core muscles;
perform lumbar repositioning test which quantifies the lumbar proprioception;
perform Timed Up-and-Go Test and Five-Times Sit-to-Stand test, which are used as a measurement of physically functional performance;
fill out the psychosocial questionnaires including: Patient-Reported Outcomes Measurement Information System Short Form Depression 4a and Anxiety 4a, Pittsburgh Sleep Quality Index, Pain Catastrophizing Scale, Fear-Avoidance Belief Questionnaire, Oswestry Disability Index, and Heath Survey Short Form-36.

Conditions: Non-Spesific Chronic Low Back Pain, Aged

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06782633
Study group	Role	What they receive
non-specific chronic low back pain		Participants with non-specific chronic low back pain (CLBP) aged 20-65 years old were recruited from the community by posters. Non-specific chronic low back was defined as discomfort in the low back area, which persisted over a day during the past three months and was diagnosed as non-specific low back pain. Participants who 1) had gone through surgery at the low back or lower extremity; 2) presented neurological symptoms, such as numbness or tingling; 3) could not walk or stand independently; 4) had cancer; 5) had systemic inflammation, such as ankylosing spondylitis, rheumatoid arthritis, and systemic lupus erythematosus; 6) were in pregnancy were excluded from the study.
Asymptomatic		Asymptomatic participants aged 20-65 years old were recruited from the community by posters. Participants who 1) had gone through surgery at the low back or lower extremity; 2) presented neurological symptoms, such as numbness or tingling; 3) could not walk or stand independently; 4) had cancer; 5) had systemic inflammation, such as ankylosing spondylitis, rheumatoid arthritis, and systemic lupus erythematosus; 6) were in pregnancy were excluded from the study.

What is being measured

The primary outcome is the main question the study is designed to answer.

Deep core muscles thickness by USI
The deep core muscles, including transversus abdominis, psoas major, and multifidus, are observed by USI. During USI measurements, participants are instructed to perform specific movement within normal range of motion to activate muscles.
Measured: On the 1 day of data collection for all parameters.
Deep core muscles thickness by MRI
The deep core muscles, including transversus abdominis, psoas major, and multifidus, are observed by MRI. Data collected by MRI is analyzed through ImageJ.
Measured: On the 1 day of data collection for all parameters or the day arranged specifically for MRI.
Deep core muscles cross-sectional area
The deep core muscles, including transversus abdominis, psoas major, and multifidus, are observed by MRI. Data collected by MRI is analyzed through ImageJ with threshold method, to acquire funcitonal cross-sectional area of core muscles.
Measured: On the 1 day of data collection for all parameters or the day arranged specifically for MRI.
Lumbar proprioception
Proprioception was evaluated by lumbar repositioning error with the Zebris motion analysis system (Zebris Medizintechnik GmbH, Isny, Germany). The smaller the error suggests the better proprioception. Repositioning test was performed in a standing position. Participants were first instructed and practiced anterior and posterior pelvic tilting with minimal paraspinal muscle activation, and the neutral position of the lumbar spine was identified. Then, anterior and posterior pelvis tilting to the half and maximal range were practiced with eyes closed. For the actual tests, participants performed 5 repetitions of half range of anterior tilt, back to neutral spine, half range of posterior tilt, and back to neutral spine position. The performance of the first repetition served as the reference for the repositioning test. The error between the reference and the following 4 repetitions indicated the proprioception of the lumbar spine.
Measured: On the 1 day of data collection for all parameters.
Functional performance-Timed Up-and-Go
Timed-Up-and-Go (TUG) was adopted to test functional performance. A 10-foot walkway was set with a chair at one end and a mark on the other. Trunk muscle activation for stabilization, lower limb strength, and mobility were required to complete the test.
Measured: On the 1 day of data collection for all parameters.
Functional performance-Five-Times Sit-to-Stnad
Five-Times Sit-To-Stand (5-STS) was adopted to test functional performance. Participants were asked to perform sit to stand for consecutive 5 repetitions as fast as possible. Trunk muscle activation for stabilization, lower limb strength, and mobility were required to complete 5-STS.
Measured: On the 1 day of data collection for all parameters.
Psychological Distress
Psychological distress were evaluated with the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Depression 4a and Anxiety 4a, which included 4 questions for each domain. Raw scores of PROMIS Short Form Depression 4a and Anxiety 4a were transformed into T scores according to the scoring manual (HealthMeasures; HealthMeasures). Higher scores of PROMIS indicated a higher degree of depression or anxiety.
Measured: On the 1 day of data collection for all parameters.
Sleep Quality
Sleep quality was examined with the Pittsburgh Sleep Quality Index (PSQI), a self-report questionnaire that assesses sleep quality over a 1-month time interval.
Measured: On the 1 day of data collection for all parameters.
Cognition toward pain
Fear-Avoidance Beliefs Questionnaire (FABQ) and Pain Catastrophizing Scale (PCS) were filled out to quantify the cognition and behaviors toward pain. Higher scores on both questionnaires indicated greater fear or tendency to catastrophize.
Measured: On the 1 day of data collection for all parameters.
Disability
Oswestry Disability Index (ODI) was used to measure the disability, which included 10 questions. The total scores of ODI ranged from 0 to 50 and higher scores indicated a higher extent of disability.
Measured: On the 1 day of data collection for all parameters.
Quality of life
Short Form-36 (SF-36) questionnaire was used to assess physical, psychological, and social factors, whose dimensions include physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social function (SF), role emotional (RE), and mental health (MH). Standardized scores of each domain in SF-36 ranged from 0 to 100 and higher scores referred to higher satisfaction. Raw scores of each domain in SF-36 were standardized according to the SF-36 Health Survey Manual.
Measured: On the 1 day of data collection for all parameters.

Secondary outcomes (3)

VAS
Pain intensity is measured by Visual Analog Scale in which the 10 indicates the most severe pain participants can imagine.
Measured: On the 1 day of data collection for all parameters.
Hip range of motion
Hip joint range of motion was measured, including extension, internal rotation, and external rotation.
Measured: On the 1 day of data collection for all parameters.
Stability test
Stability was examined by Shraman's test. There were five levels of movement tasks. Completing the tasks meanwhile maintaining spine stability was the required. The higher level completed indicates better stability.
Measured: On the day of data collection for all parameters.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 202230 Aug 2024

First posted20 Jan 2025
Study start1 Aug 2022
Primary completion30 Aug 2024
Study completion30 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Non-Spesific Chronic 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: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06782633
Sponsor's protocol ID: 202012268RIND
Other IDs: MOST 111-2221-E-002-059, MOST 112-2221-E-002-092
Status last verified: Jan 2025
First submitted: 10 Jan 2025
Last updated: 20 Jan 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Study at a glance

From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of Deep Core Muscles, Postural Analysis, Functional and Mental Performance in Different Age Group of Asymptomatic Participants and Patients With Non-specific Low Back Pain
ClinicalTrials.gov ID: NCT06782633
Acronym / sponsor ID: 202012268RIND
Conditions: Non-Spesific Chronic Low Back Pain, Aged
Study type: Observational
Recruitment status: Completed
Enrolment: 57 participants (actual)
Lead sponsor: National Taiwan University HospitalUniversity, hospital or other
Collaborators: National Science and Technology Council, National Taiwan University
Study start: 1 Aug 2022 (actual)
Primary completion: 30 Aug 2024 (actual)
Study completion: 30 Aug 2024 (actual)
First posted: 20 Jan 2025 (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 main questions it aims to answer :

Are the core muscles, lumbar propriocpetion, and psychological measures altered as age increases?
Do the core muscles, lumbar propriocpetion, functional performance, psychological measures, disability, and quality of life affected by NSCLBP?
following (2), if so, are there correlations between the measured biopsychosocial factors, disability, and quality of life in people with NSCLBP?

Researchers will compare between people with NSCLBP and age-matched asymptomatic participants across years of age to see if the effect of age and effect of NSCLBP existed in biopsychosocial factors.

Participants will

be observed by ultrasound image at the low back and abdominal areas to collect parameters related to trunk deep core muscles, such as changes in muscle thickness from resting state to contraction;
ungergo MRI examination to acquire image of deep core muscles;
perform lumbar repositioning test which quantifies the lumbar proprioception;
perform Timed Up-and-Go Test and Five-Times Sit-to-Stand test, which are used as a measurement of physically functional performance;
fill out the psychosocial questionnaires including: Patient-Reported Outcomes Measurement Information System Short Form Depression 4a and Anxiety 4a, Pittsburgh Sleep Quality Index, Pain Catastrophizing Scale, Fear-Avoidance Belief Questionnaire, Oswestry Disability Index, and Heath Survey Short Form-36.

Study design

Observational model: Case-control
Time perspective: Cross-sectional
Number of arms: 2

Arm	Type	Receives
non-specific chronic low back pain	–	–Participants with non-specific chronic low back pain (CLBP) aged 20-65 years old were recruited from the community by posters. Non-specific chronic low back was defined as discomfort in the low back area, which persisted over a day during the past three months and was diagnosed as non-specific low back pain. Participants who 1) had gone through surgery at the low back or lower extremity; 2) presented neurological symptoms, such as numbness or tingling; 3) could not walk or stand independently; 4) had cancer; 5) had systemic inflammation, such as ankylosing spondylitis, rheumatoid arthritis, and systemic lupus erythematosus; 6) were in pregnancy were excluded from the study.
Asymptomatic	–	–Asymptomatic participants aged 20-65 years old were recruited from the community by posters. Participants who 1) had gone through surgery at the low back or lower extremity; 2) presented neurological symptoms, such as numbness or tingling; 3) could not walk or stand independently; 4) had cancer; 5) had systemic inflammation, such as ankylosing spondylitis, rheumatoid arthritis, and systemic lupus erythematosus; 6) were in pregnancy were excluded from the study.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Taiwanese people

Key inclusion criteria (2 listed)

aged above 20 years old
Non-specific chronic low back defined as discomfort in the low back area, which persisted over a day during the past three months and was diagnosed as non-specific low back pain.

Key exclusion criteria (6 listed)

history of surgery at the low back or lower extremity
neurological symptoms, such as numbness or tingling
not able to walk or stand independently
cancer
systemic inflammation, such as ankylosing spondylitis, rheumatoid arthritis, and 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

Deep core muscles thickness by USI
Time frame: On the 1 day of data collection for all parameters.
The deep core muscles, including transversus abdominis, psoas major, and multifidus, are observed by USI. During USI measurements, participants are instructed to perform specific movement within normal range of motion to activate muscles.
Deep core muscles thickness by MRI
Time frame: On the 1 day of data collection for all parameters or the day arranged specifically for MRI.
The deep core muscles, including transversus abdominis, psoas major, and multifidus, are observed by MRI. Data collected by MRI is analyzed through ImageJ.
Deep core muscles cross-sectional area
Time frame: On the 1 day of data collection for all parameters or the day arranged specifically for MRI.
The deep core muscles, including transversus abdominis, psoas major, and multifidus, are observed by MRI. Data collected by MRI is analyzed through ImageJ with threshold method, to acquire funcitonal cross-sectional area of core muscles.
Lumbar proprioception
Time frame: On the 1 day of data collection for all parameters.
Proprioception was evaluated by lumbar repositioning error with the Zebris motion analysis system (Zebris Medizintechnik GmbH, Isny, Germany). The smaller the error suggests the better proprioception. Repositioning test was performed in a standing position. Participants were first instructed and practiced anterior and posterior pelvic tilting with minimal paraspinal muscle activation, and the neutral position of the lumbar spine was identified. Then, anterior and posterior pelvis tilting to the half and maximal range were practiced with eyes closed. For the actual tests, participants performed 5 repetitions of half range of anterior tilt, back to neutral spine, half range of posterior tilt, and back to neutral spine position. The performance of the first repetition served as the reference for the repositioning test. The error between the reference and the following 4 repetitions indicated the proprioception of the lumbar spine.
Functional performance-Timed Up-and-Go
Time frame: On the 1 day of data collection for all parameters.
Timed-Up-and-Go (TUG) was adopted to test functional performance. A 10-foot walkway was set with a chair at one end and a mark on the other. Trunk muscle activation for stabilization, lower limb strength, and mobility were required to complete the test.
Functional performance-Five-Times Sit-to-Stnad
Time frame: On the 1 day of data collection for all parameters.
Five-Times Sit-To-Stand (5-STS) was adopted to test functional performance. Participants were asked to perform sit to stand for consecutive 5 repetitions as fast as possible. Trunk muscle activation for stabilization, lower limb strength, and mobility were required to complete 5-STS.
Psychological Distress
Time frame: On the 1 day of data collection for all parameters.
Psychological distress were evaluated with the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Depression 4a and Anxiety 4a, which included 4 questions for each domain. Raw scores of PROMIS Short Form Depression 4a and Anxiety 4a were transformed into T scores according to the scoring manual (HealthMeasures; HealthMeasures). Higher scores of PROMIS indicated a higher degree of depression or anxiety.
Sleep Quality
Time frame: On the 1 day of data collection for all parameters.
Sleep quality was examined with the Pittsburgh Sleep Quality Index (PSQI), a self-report questionnaire that assesses sleep quality over a 1-month time interval.
Cognition toward pain
Time frame: On the 1 day of data collection for all parameters.
Fear-Avoidance Beliefs Questionnaire (FABQ) and Pain Catastrophizing Scale (PCS) were filled out to quantify the cognition and behaviors toward pain. Higher scores on both questionnaires indicated greater fear or tendency to catastrophize.
Disability
Time frame: On the 1 day of data collection for all parameters.
Oswestry Disability Index (ODI) was used to measure the disability, which included 10 questions. The total scores of ODI ranged from 0 to 50 and higher scores indicated a higher extent of disability.
Quality of life
Time frame: On the 1 day of data collection for all parameters.
Short Form-36 (SF-36) questionnaire was used to assess physical, psychological, and social factors, whose dimensions include physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social function (SF), role emotional (RE), and mental health (MH). Standardized scores of each domain in SF-36 ranged from 0 to 100 and higher scores referred to higher satisfaction. Raw scores of each domain in SF-36 were standardized according to the SF-36 Health Survey Manual.

3 secondary outcomes

VAS
Time frame: On the 1 day of data collection for all parameters.
Hip range of motion
Time frame: On the 1 day of data collection for all parameters.
Stability test
Time frame: On the day of data collection for all parameters.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
Individual participant dataSharing planned: Undecided

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.

The record lists no contact. Use the official record to reach the sponsor.

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 Non-Spesific Chronic Low Back Pain and Aged, 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 2 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: finished, as of the sponsor's last update on 20 Jan 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Deep core muscles thickness by USI (time frame: On the 1 day of data collection for all parameters.). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06782633.

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 20 Jan 2025.