Low Back Pain Clinical Trial
Official title:
The Influence of Physical Activity Level on Lumbar Movement Control and Standing Balance in Adults With and Without Low Back Pain.
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 |
Verified date | May 2023 |
Source | National Cheng Kung University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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) |
Country | Name | City | State |
---|---|---|---|
Taiwan | National Cheng Kung University | Tainan |
Lead Sponsor | Collaborator |
---|---|
National Cheng Kung University |
Taiwan,
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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