Biomechanical PhenomenaNCT04786717
Lumbopelvic Movement Control: Effect of Injury History, and the Role of Cortical Control and Its Practical Application 1
A study testing core muscle training in people with Biomechanical Phenomena, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
Lumbopelvic movement control is crucial for movement stability during weight loading training, and also an important risk factor for the occurrence and recurrence of low back pain (LBP). Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Biomechanical Phenomena
- What is being tested?
- core muscle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Nov 2021to 1 Jun 2022
- Phase
- Interventional
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Frequency of weight loading squatting training:
- 1. At least 1 time/week, at least 1 year.
- LBP group:
- Present symptoms from T12 to the upper buttock
- Numerical rating scale (NRS) score ≥ 3/10
- Present episode of LBP lasting > 24 hours
Show all 12Show fewer
- LBPH group:
- Previous symptoms from T12 to the upper buttock
- Presently in symptom remission
- At least 2 episodes of LBP in the past 1 year, each lasting > 24 hours, and following a period of at least 2~4 weeks pain-free, OR at least 1 episode of LBP, each lasting 2 months.
- Asymptomatic controls:
- 1. Without any history of LBP that limited their function or required treatment from a health professional in the past 2 years.
Who cannot join
- Inability to perform parallel-squat due to LBP
- Pain and ROM limitation in lower extremities
- LBP due to traumatic injury
- Previous spine surgery
- Spinal deformities: HIVD, spondylosis, scoliosis, spinal stenosis
- Neurological sign, and radiating pain to lower extremities
- Systematic disease: rheumatoid arthritis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Restoration of Lumbopelvic Movement Control: Effect of Injury History, and the Role of Cortical Control and Its Practical Application(1)
Lumbopelvic movement control is crucial for movement stability during weight loading training, and also an important risk factor for the occurrence and recurrence of low back pain (LBP). Previous studies indicated that athletes with LBP had poorer lumbopelvic movement control, and the deficits in lumbopelvic control could be remained after LBP remission. However, there has been no study investigating the effect of LBP history (LBPH) on the performance of the loaded squatting task, and lumbopelvic movement control in people who practice regular weight training.
Therefore, the aims of this study are to examine the differences in lumbopelvic movement control, kinematics and muscle activation during the loaded squatting task in weight training practitioners with LBP, LBPH, and asymptomatic controls, to compare the cortical control mechanisms between 3 types of motor control training strategies, and to investigate the intervention effect of motor control training on restoring the lumbopelvic movement control and squatting performance.
Read the detailed description
Lumbopelvic movement control is crucial for movement stability during high weight loading training, and also an important risk factor for the occurrence and recurrence of low back pain (LBP). Previous studies indicated that athletes with LBP had poorer lumbopelvic movement control, and for those athletes who have recovered from LBP, some research data still showed that poor lumbopelvic control remained. However, there has been no study investigating the effect of LBP history (LBPH) on the performance of the loaded squatting task, and lumbopelvic movement control in people who practice regular weight training.
Therefore, the aims of this study are to examine the differences in lumbopelvic movement control, kinematics and muscle activation during the loaded squatting task in weight training practitioners with LBP, LBPH, and asymptomatic controls. In the next part of the study, investigators will further investigate the intervention effect of motor control training on restoring the lumbopelvic movement control and squatting performance. Methods: This is an exploratory, cross-sectional, and intervention study. First part: investigators plan to recruit 15 participants between 20-40 years old, practicing loaded squatting for 1 day a week for at least one year, and having LBPH; 15 matched participants with current LBP, and 15 controls for the study. All subjects will undergo a series of squatting task (4 X 10 repetitions) and the kinematics and muscle activation of the rectus abdominus, transverse abdominus/internal obliqus, eractor spinae, and gluteus maximus will be recorded and analyzed using Noraxon myoRESEARCH (Noraxon U.S.A., Inc., Scottsdale, AZ, USA). A set of lumbopelvic movement control tests will also be conducted. The kinematics, muscle activation, and movement control test scores will be compared between groups. The second part, investigators plan to recruit 45 weight training practitioners with LBPH, randomized into three groups (core muscle training, movement control training, combined imagery and movement control training), and compare the effect of 4-week training on squatting performance and lumbopelvic movement control. Statistical analysis: Comparisons of all continuous variables are performed using the analysis of variance (ANOVA), and the intervention effect will be assessed using the repeated measures ANOVA. Chi squared test is used to examine the group differences in lumbopelvic movement control testing. The significance level is set at 0.05.
- Conditions
- Biomechanical Phenomena
- Being tested
- core muscle training, movement control training, combined imagery and movement control training
- Keywords
- back pain history, deep squat, movement control, cortical control, imagery training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
core muscle trainingOther
The intervention of this group will focus on training the endurance of the core muscle.
movement control trainingOther
Based from the initial test, the subjects will receive either lumbar flexion control exercise or lumbar extension control exercise. They will perform each lumbar movement control exercise in different position. Starting from the lying position, then progressing to sitting, standing with support, and the last level will be standing without support. Each set of movement will be practiced 10 times, totally 10 sets. It will take approximately 5~8 minutes to finish each movement. The subjects will learn 5~8 types of the movement every week.
combined imagery and movement control trainingOther
The intervention of this group is mostly same as the movement control training group. The different part is that the first 3 times of the movement will be practiced through image training, so the subjects will not have any real movement, and the last 7 times they will perform the lumbar motor control exercise literally. Each set of movement will be practiced 10 times, totally 10 sets. It will take approximately 5~8 minutes to finish each movement. The subjects will learn 5~8 types of the movement every week.
| Study group | Role | What they receive |
|---|---|---|
| core muscle training | Experimental | Training the endurance of the core muscle. Receives: Other: core muscle training |
| movement control training | Experimental | Based from the initial test, the subjects will receive lumbar movement control exercise. They will perform each lumbar movement control exercise in different position. Receives: Other: movement control training |
| combined imagery and movement control training | Experimental | The intervention of this group is mostly same as the movement control training group. The different part is that the first 3 times of the movement will be practiced through image training, and the subjects will practice the real movement in the rest of 7 times. Receives: Other: combined imagery and movement control training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbopelvic kinematics
The investigator will place three markers at subjects' 1st lumbar vertebrae, 2nd sacrum vertebrae, and lateral side of left greater trochanter. The investigator will record the track of each marker through the video system(Noraxon myoVIDEOTM, Noraxon USA Inc., USA) while the subject is squatting. According to the record, the investigator will analyze the angles between 1st lumbar vertebrae and 2nd sacrum vertebrae which are the lumbar flexion angles and the lumbar extension angles.
Measured: pre-intervention
Lumbopelvic kinematics
The investigator will place three markers at subjects' 1st lumbar vertebrae, 2nd sacrum vertebrae, and lateral side of left greater trochanter. The investigator will record the track of each marker through the video system(Noraxon myoVIDEOTM, Noraxon USA Inc., USA) while the subject is squatting. According to the record, the investigator will analyze the angles between 1st lumbar vertebrae and 2nd sacrum vertebrae which are the lumbar flexion angles and the lumbar extension angles.
Measured: after 4 weeks of intervention
Hip kinematics
The investigator will place three markers at subjects' 1st lumbar vertebrae, 2nd sacrum vertebrae, and lateral side of left greater trochanter. The investigator will record the track of each marker through the video system(Noraxon myoVIDEOTM, Noraxon USA Inc., USA) while the subject is squatting. According to the record, the investigator will analyze the angles between 2nd sacrum vertebrae and greater trochanter which are the hip flexion angles and the hip extension angles.
Measured: pre-intervention
Hip kinematics
The investigator will place three markers at subjects' 1st lumbar vertebrae, 2nd sacrum vertebrae, and lateral side of left greater trochanter. The investigator will record the track of each marker through the video system(Noraxon myoVIDEOTM, Noraxon USA Inc., USA) while the subject is squatting. According to the record, the investigator will analyze the angles between 2nd sacrum vertebrae and greater trochanter which are the hip flexion angles and the hip extension angles.
Measured: after 4 weeks of intervention
Muscle activation
The investigator will record the muscle activation of erector spinae, rectus abdominus, internal obliques, and gluteus maximus through the electromyography (Noraxon TeleMyo sEMG System, Noraxon USA Inc., USA)
Measured: pre-intervention
Muscle activation
The investigator will record the muscle activation of erector spinae, rectus abdominus, internal obliques, and gluteus maximus through the electromyography (Noraxon TeleMyo sEMG System, Noraxon USA Inc., USA)
Measured: after 4 weeks of intervention
Lumbopelvic control ability
Using lumbar motor control test battery to test the stability of subjects' lumbar. This test battery is consisted of 10 motor control test based from previous studies. If the subjects complete the test successfully, they will get 1 point in each test, otherwise they may not get any points. Therefore, the minimum of the scale is 0 point, and the maximum is 10 points, and the higher scores mean the subjects can control their lumbar vertebrae much better.
Measured: pre-intervention
Lumbopelvic control ability
Using lumbar motor control test battery to test the stability of subjects' lumbar. This test battery is consisted of 10 motor control test based from previous studies. If the subjects complete the test successfully, they will get 1 point in each test, otherwise they may not get any points. Therefore, the minimum of the scale is 0 point, and the maximum is 10 points, and the higher scores mean the subjects can control their lumbar vertebrae much better.
Measured: after 4 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start14 Nov 2021
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biomechanical PhenomenaStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-Fen Shih, National Yang Ming Chiao Tung University
- Investigators
- Yi-Fen Shih, PhD, Study director, Department of Physical Therapy and Assistive Technology, National Yang-Ming Chiao-Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04786717
- Sponsor's protocol ID
- YM110027E(1)
- Status last verified
- Sep 2022
- First submitted
- 3 Mar 2021
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoration of Lumbopelvic Movement Control: Effect of Injury History, and the Role of Cortical Control and Its Practical Application(1)
- ClinicalTrials.gov ID
- NCT04786717
- Acronym / sponsor ID
- YM110027E(1)
- Conditions
- Biomechanical Phenomena
- Keywords
- back pain history, deep squat, movement control, cortical control, imagery training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 14 Nov 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 8 Mar 2021 (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.
Lumbopelvic movement control is crucial for movement stability during weight loading training, and also an important risk factor for the occurrence and recurrence of low back pain (LBP). Previous studies indicated that athletes with LBP had poorer lumbopelvic movement control, and the deficits in lumbopelvic control could be remained after LBP remission. However, there has been no study investigating the effect of LBP history (LBPH) on the performance of the loaded squatting task, and lumbopelvic movement control in people who practice regular weight training.
Therefore, the aims of this study are to examine the differences in lumbopelvic movement control, kinematics and muscle activation during the loaded squatting task in weight training practitioners with LBP, LBPH, and asymptomatic controls, to compare the cortical control mechanisms between 3 types of motor control training strategies, and to investigate the intervention effect of motor control training on restoring the lumbopelvic movement control and squatting performance.
Detailed description
Lumbopelvic movement control is crucial for movement stability during high weight loading training, and also an important risk factor for the occurrence and recurrence of low back pain (LBP). Previous studies indicated that athletes with LBP had poorer lumbopelvic movement control, and for those athletes who have recovered from LBP, some research data still showed that poor lumbopelvic control remained. However, there has been no study investigating the effect of LBP history (LBPH) on the performance of the loaded squatting task, and lumbopelvic movement control in people who practice regular weight training.
Therefore, the aims of this study are to examine the differences in lumbopelvic movement control, kinematics and muscle activation during the loaded squatting task in weight training practitioners with LBP, LBPH, and asymptomatic controls. In the next part of the study, investigators will further investigate the intervention effect of motor control training on restoring the lumbopelvic movement control and squatting performance. Methods: This is an exploratory, cross-sectional, and intervention study. First part: investigators plan to recruit 15 participants between 20-40 years old, practicing loaded squatting for 1 day a week for at least one year, and having LBPH; 15 matched participants with current LBP, and 15 controls for the study. All subjects will undergo a series of squatting task (4 X 10 repetitions) and the kinematics and muscle activation of the rectus abdominus, transverse abdominus/internal obliqus, eractor spinae, and gluteus maximus will be recorded and analyzed using Noraxon myoRESEARCH (Noraxon U.S.A., Inc., Scottsdale, AZ, USA). A set of lumbopelvic movement control tests will also be conducted. The kinematics, muscle activation, and movement control test scores will be compared between groups. The second part, investigators plan to recruit 45 weight training practitioners with LBPH, randomized into three groups (core muscle training, movement control training, combined imagery and movement control training), and compare the effect of 4-week training on squatting performance and lumbopelvic movement control. Statistical analysis: Comparisons of all continuous variables are performed using the analysis of variance (ANOVA), and the intervention effect will be assessed using the repeated measures ANOVA. Chi squared test is used to examine the group differences in lumbopelvic movement control testing. The significance level is set at 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| core muscle training | Experimental | Other: core muscle trainingTraining the endurance of the core muscle. |
| movement control training | Experimental | Other: movement control trainingBased from the initial test, the subjects will receive lumbar movement control exercise. They will perform each lumbar movement control exercise in different position. |
| combined imagery and movement control training | Experimental | Other: combined imagery and movement control trainingThe intervention of this group is mostly same as the movement control training group. The different part is that the first 3 times of the movement will be practiced through image training, and the subjects will practice the real movement in the rest of 7 times. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 1. At least 1 time/week, at least 1 year.
- Present symptoms from T12 to the upper buttock
- Numerical rating scale (NRS) score ≥ 3/10
- Present episode of LBP lasting > 24 hours
- Previous symptoms from T12 to the upper buttock
Key exclusion criteria (7 listed)
- Inability to perform parallel-squat due to LBP
- Pain and ROM limitation in lower extremities
- LBP due to traumatic injury
- Previous spine surgery
- Spinal deformities: HIVD, spondylosis, scoliosis, spinal stenosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| core muscle trainingThe intervention of this group will focus on training the endurance of the core muscle. | Other | core muscle training |
| movement control trainingBased from the initial test, the subjects will receive either lumbar flexion control exercise or lumbar extension control exercise. They will perform each lumbar movement control exercise in different position. Starting from the lying position, then progressing to sitting, standing with support, and the last level will be standing without support. Each set of movement will be practiced 10 times, totally 10 sets. It will take approximately 5~8 minutes to finish each movement. The subjects will learn 5~8 types of the movement every week. | Other | movement control training |
| combined imagery and movement control trainingThe intervention of this group is mostly same as the movement control training group. The different part is that the first 3 times of the movement will be practiced through image training, so the subjects will not have any real movement, and the last 7 times they will perform the lumbar motor control exercise literally. Each set of movement will be practiced 10 times, totally 10 sets. It will take approximately 5~8 minutes to finish each movement. The subjects will learn 5~8 types of the movement every week. | Other | combined imagery and movement control training |
Primary outcome
Lumbopelvic kinematics
Time frame: pre-intervention
The investigator will place three markers at subjects' 1st lumbar vertebrae, 2nd sacrum vertebrae, and lateral side of left greater trochanter. The investigator will record the track of each marker through the video system(Noraxon myoVIDEOTM, Noraxon USA Inc., USA) while the subject is squatting. According to the record, the investigator will analyze the angles between 1st lumbar vertebrae and 2nd sacrum vertebrae which are the lumbar flexion angles and the lumbar extension angles.
Lumbopelvic kinematics
Time frame: after 4 weeks of intervention
The investigator will place three markers at subjects' 1st lumbar vertebrae, 2nd sacrum vertebrae, and lateral side of left greater trochanter. The investigator will record the track of each marker through the video system(Noraxon myoVIDEOTM, Noraxon USA Inc., USA) while the subject is squatting. According to the record, the investigator will analyze the angles between 1st lumbar vertebrae and 2nd sacrum vertebrae which are the lumbar flexion angles and the lumbar extension angles.
Hip kinematics
Time frame: pre-intervention
The investigator will place three markers at subjects' 1st lumbar vertebrae, 2nd sacrum vertebrae, and lateral side of left greater trochanter. The investigator will record the track of each marker through the video system(Noraxon myoVIDEOTM, Noraxon USA Inc., USA) while the subject is squatting. According to the record, the investigator will analyze the angles between 2nd sacrum vertebrae and greater trochanter which are the hip flexion angles and the hip extension angles.
Hip kinematics
Time frame: after 4 weeks of intervention
The investigator will place three markers at subjects' 1st lumbar vertebrae, 2nd sacrum vertebrae, and lateral side of left greater trochanter. The investigator will record the track of each marker through the video system(Noraxon myoVIDEOTM, Noraxon USA Inc., USA) while the subject is squatting. According to the record, the investigator will analyze the angles between 2nd sacrum vertebrae and greater trochanter which are the hip flexion angles and the hip extension angles.
Muscle activation
Time frame: pre-intervention
The investigator will record the muscle activation of erector spinae, rectus abdominus, internal obliques, and gluteus maximus through the electromyography (Noraxon TeleMyo sEMG System, Noraxon USA Inc., USA)
Muscle activation
Time frame: after 4 weeks of intervention
The investigator will record the muscle activation of erector spinae, rectus abdominus, internal obliques, and gluteus maximus through the electromyography (Noraxon TeleMyo sEMG System, Noraxon USA Inc., USA)
Lumbopelvic control ability
Time frame: pre-intervention
Using lumbar motor control test battery to test the stability of subjects' lumbar. This test battery is consisted of 10 motor control test based from previous studies. If the subjects complete the test successfully, they will get 1 point in each test, otherwise they may not get any points. Therefore, the minimum of the scale is 0 point, and the maximum is 10 points, and the higher scores mean the subjects can control their lumbar vertebrae much better.
Lumbopelvic control ability
Time frame: after 4 weeks of intervention
Using lumbar motor control test battery to test the stability of subjects' lumbar. This test battery is consisted of 10 motor control test based from previous studies. If the subjects complete the test successfully, they will get 1 point in each test, otherwise they may not get any points. Therefore, the minimum of the scale is 0 point, and the maximum is 10 points, and the higher scores mean the subjects can control their lumbar vertebrae much better.
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 30 Sep 2022.
- Individual participant dataSharing planned: No
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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-Fen Shih, PhD study director
Department of Physical Therapy and Assistive Technology, National Yang-Ming Chiao-Tung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing core muscle training in people with Biomechanical Phenomena, run by National Yang Ming Chiao Tung 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 12 inclusion and 7 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 30 Sep 2022. 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?
Lumbopelvic kinematics (time frame: pre-intervention). The study lists 8 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 30 Sep 2022; AzTrials last refreshed its copy on 8 Nov 2026.