Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-26 @ 1:35 AM
Study NCT ID:
NCT06782633
Status:
COMPLETED
Last Update Posted:
2025-01-20
First Post:
2025-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Deep Core Muscles and Biopsychosocial in Asymptomatic Adults and NSCLBP
Sponsor:
National Taiwan University Hospital
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: