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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05649150
Other study ID # NCKU-2022
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 24, 2022
Est. completion date April 12, 2023

Study information

Verified date May 2023
Source National Cheng Kung University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aims to compare the two groups of low back pain and health adults. To investigate the relationship among lumbar movement control, standing balance and physical activity. Methods used in the study will be clinical tools such as proprioception test, lumbar movement control, timed one-leg- standing balance and Y-balance test according to the Mat.


Description:

Low back pain (LBP) is a leading cause of disability that results in significant health and socioeconomic problems. Most of the LBP is non-specific and altered motor control is one of the possible causes. Motor control exercise (MCE) thus has been recently developed as a non-operative intervention for LBP. Recently, a series of lumbar movement control (LMC) tests have been advocated to evaluate impaired motor control of lumbar. To perform a coordinated movement pattern, normal proprioception (part of neural system) is thought to be essential. Poor proprioception related to delayed muscle response and altered motor control which possibly leading to deficits in postural control and balance in LBP population. Study showed standing balance was related to higher physical activity (PA) which has been promoted in all adults and proper amount is at least 150 to 300 minutes of moderate-intensity aerobic physical activity; or at least 75 to 150 minutes of vigorous-intensity aerobic physical activity per week for substantial health benefits. As we know, there is no specific research about the relationship among PA, LMC and standing balance. Therefore, the purposes of the study are to investigate (1) the influence of different level of PA on LMC tests; (2) the influence of PA on standing balance; (3) the relationship of battery of LMC tests and standing balance in adults with and without LBP. It is expected to recruit total 160 participants with and without LBP. The inclusion criteria for adults with LBP are: (1) aged from 20 to 65 years old, (2) persistent LBP for more than 3 months. For adults without LBP are: (1) aged from 20 to 65 years old, (2) no specific low back pain in the past 6 months. All the participants will fill in International PA Questionnaire (IPAQ), Short form Taiwan Version, perform proprioception test for the lumbar spine, LMC tests, timed one-leg standing balance, and Y-balance test for the lower quarter (YBT-LQ). After finishing the examination, all the data will be analyzed by mix analysis of variance (ANOVA) and Chi-square analysis. Bonferroni post-hoc tests will be used to identify the significance within each analysis. Level of statistical significance was set at p<0.05. Keywords: Physical activity, motor control exercise, lumbar movement control, standing balance, proprioception


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date April 12, 2023
Est. primary completion date April 12, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria: - For adults with LBP are: (1) aged from 20 to 65 years old, (2) persistent LBP for more than 3 months. - For adults without LBP are: (1) aged from 20 to 65 years old, (2) no specific low back pain in the past 6 months. Exclusion Criteria: (for both groups) - Musculoskeletal symptoms of lower extremity in the past 6 months - History of surgeries, fractures, or ruptures to the musculoskeletal structures on the lower limbs and spine - Congenital spinal pathologies and deformities - Sensory and neurological deficits - Pregnancy - Body mass indexes (BMI) >30 kg/m2 - Self-reported symptoms of dizziness - Visual, vestibular or balance problems - Other conditions affecting balance (eg, drug or alcohol consumption)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan National Cheng Kung University Tainan

Sponsors (1)

Lead Sponsor Collaborator
National Cheng Kung University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Lumbar proprioception (joint repositioning error of lumbar spine) Joint repositioning error of lumbar spine will be measured by the difference between starting to the finishing position. Five trials will be tested and the average of the difference will be recored for analysis. One day
Primary Lumbar movement control ability Lumbar motor control is a self-made battery according to the previous studies. The lumbar movement control tests included 10 items. And the passed number of tests will be recorded for analysis. One day
Primary One-leg standing balance Timed balance tests will be exanimated for static one-leg standing balance in four conditions. The subjects will be instructed to one leg standing in barefoot, arm folded across the chest, on solid surface or foam surface with eyes opened and closed. 3 trial for each conditions and the average of the 3 trials will be recored into analysis One day
Primary Dynamic standing balance Y-balance test- lower quarter (YBT-LQ) will be used for assessing dynamic standing balance. Participants stand on one leg in the center of the YBT-LQ and reaching the gesture leg into three different directions (anterior, posterio-lateral, posterior-medial). The reaching distance will be recored in centimeters. Three for each direction, the average will be normalized by leg length and be recorded into analysis. One day
Primary Oswestry Disability Index Oswestry Disability Index is a self-reported questionnaire for assessing disability of LBP group. The sum score of the Oswestry Disability Index will transformed into percentage for analysis. One day
Primary International PA Questionnaire (IPAQ) IPAQ is a self-reported questionnaire for assessing physical activity. The total MET-mins/week will be recorded for analysis. One day
Primary Fear-Avoidance Beliefs Questionnaire (FABQ) FABQ is an self-reported questionnaire for assessing the fear-avoidance in low back pain group. The sum of the score of the 16 questions will be transformed into percentage for analysis. One day
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