Low Back PainNCT05649150
Influence of Physical Activity Level on Lumbar Movement Control
An observational study of Low Back Pain, run by National Cheng Kung University at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Aug 2022to 12 Apr 2023
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Health adults and adults with LBP
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Self-reported symptoms of dizziness
- Visual, vestibular or balance problems
- Other conditions affecting balance (eg, drug or alcohol consumption)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Physical Activity Level on Lumbar Movement Control and Standing Balance in Adults With and Without Low Back Pain.
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.
Read the detailed 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
- Conditions
- Low Back Pain
- Keywords
- Physical activity, Lumbar movement control, Motor control exercise, Standing balance, Proprioception
- Medical subject headings
- Low Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy group | For healthy group A.K.As adults without LBP are: (1) aged from 20 to 65 years old, (2) no specific low back pain in the past 6 months. | |
| LBP group | The inclusion criteria for adults with LBP are: (1) aged from 20 to 65 years old, (2) persistent LBP for more than 3 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One day
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.
Measured: One day
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
Measured: One day
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.
Measured: One day
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.
Measured: One day
International PA Questionnaire (IPAQ)
IPAQ is a self-reported questionnaire for assessing physical activity. The total MET-mins/week will be recorded for analysis.
Measured: One day
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.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start24 Aug 2022
- Primary completion12 Apr 2023
- Study completion12 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng Kung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YI-JU TSAI, National Cheng Kung University
- Investigators
- Yi-Ju Tsai, Study chair, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649150
- Sponsor's protocol ID
- NCKU-2022
- Status last verified
- May 2023
- First submitted
- 23 Nov 2022
- Last updated
- 3 May 2023
- 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 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Physical Activity Level on Lumbar Movement Control and Standing Balance in Adults With and Without Low Back Pain.
- ClinicalTrials.gov ID
- NCT05649150
- Acronym / sponsor ID
- NCKU-2022
- Conditions
- Low Back Pain
- Keywords
- Physical activity, Lumbar movement control, Motor control exercise, Standing balance, Proprioception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- National Cheng Kung UniversityUniversity, hospital or other
- Study start
- 24 Aug 2022 (actual)
- Primary completion
- 12 Apr 2023 (actual)
- Study completion
- 12 Apr 2023 (actual)
- First posted
- 13 Dec 2022 (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.
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.
Detailed 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
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy group | – | –For healthy group A.K.As adults without LBP are: (1) aged from 20 to 65 years old, (2) no specific low back pain in the past 6 months. |
| LBP group | – | –The inclusion criteria for adults with LBP are: (1) aged from 20 to 65 years old, (2) persistent LBP for more than 3 months. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Health adults and adults with LBP
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
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
Lumbar proprioception (joint repositioning error of lumbar spine)
Time frame: One day
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.
Lumbar movement control ability
Time frame: One day
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-leg standing balance
Time frame: One day
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
Dynamic standing balance
Time frame: One day
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.
Oswestry Disability Index
Time frame: One day
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.
International PA Questionnaire (IPAQ)
Time frame: One day
IPAQ is a self-reported questionnaire for assessing physical activity. The total MET-mins/week will be recorded for analysis.
Fear-Avoidance Beliefs Questionnaire (FABQ)
Time frame: One day
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.
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 3 May 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Low Back Pain
Not yet recruiting
Pilot Study: Clinical Trial of Ultrasound Guiding Pharmacopuncture Therapy for Acute Low Back Pain
Low Back Pain (LBP)
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
RecruitingObservational study
The Hidden Burden of Cerebral Palsy: Exploring the Relationship Between Gross Motor Function of Children, Maternal Low Back Pain, and Quality of Life
Gross Motor
Not yet recruiting
Comparison of Two Patient Education Methods in Women With Chronic Low Back Pain: Online Pain Education vs. AI-Driven Patient Education on Pain Beliefs, Catastrophizing, and Self-Efficacy
Chronic Low Back Pain (CLBP)
Not yet recruiting
Effects of Myofascial Techniques on Chronic Low Back Pain
Chronic Low-back Pain (cLBP)
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.
Yi-Ju Tsai study chair
National Cheng Kung University
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 Low Back Pain, run by National Cheng Kung University 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 9 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 3 May 2023. 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?
Lumbar proprioception (joint repositioning error of lumbar spine) (time frame: One day). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2023.