Clinical trial NCT06782633: Deep Core Muscles and Biopsychosocial in Asymptomatic Adults and NSCLBP
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Spesific Chronic Low Back Pain
Aged
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council
name: National Taiwan University, Taiwan
First posted: 2025-01-20
Enrollment: 57
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Taiwanese people

Brief 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); (3) study the correlations between biopsychosocial factors in people with NSCLBP.

The main questions it aims to answer :

1. Are the core muscles, lumbar propriocpetion, and psychological measures altered as age increases?
2. Do the core muscles, lumbar propriocpetion, functional performance, psychological measures, disability, and quality of life affected by NSCLBP?
3. 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

1. 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;
2. ungergo MRI examination to acquire image of deep core muscles;
3. perform lumbar repositioning test which quantifies the lumbar proprioception;
4. perform Timed Up-and-Go Test and Five-Times Sit-to-Stand test, which are used as a measurement of physically functional performance;
5. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Deep core muscles thickness by USI
timeFrame: On the 1 day of data collection for all parameters.
measure: Deep core muscles thickness by MRI
timeFrame: On the 1 day of data collection for all parameters or the day arranged specifically for MRI.
measure: Deep core muscles cross-sectional area
timeFrame: On the 1 day of data collection for all parameters or the day arranged specifically for MRI.
measure: Lumbar proprioception
timeFrame: On the 1 day of data collection for all parameters.
measure: Functional performance-Timed Up-and-Go
timeFrame: On the 1 day of data collection for all parameters.
measure: Functional performance-Five-Times Sit-to-Stnad
timeFrame: On the 1 day of data collection for all parameters.
measure: Psychological Distress
timeFrame: On the 1 day of data collection for all parameters.
measure: Sleep Quality
timeFrame: On the 1 day of data collection for all parameters.
measure: Cognition toward pain
timeFrame: On the 1 day of data collection for all parameters.
measure: Disability
timeFrame: On the 1 day of data collection for all parameters.
measure: Quality of life
timeFrame: On the 1 day of data collection for all parameters.
Secondary outcomes:
measure: VAS
timeFrame: On the 1 day of data collection for all parameters.
measure: Hip range of motion
timeFrame: On the 1 day of data collection for all parameters.
measure: Stability test
timeFrame: On the day of data collection for all parameters.
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: School and Graduate Institute of Physical Therapy, National Taiwan University
Study officials:
References: