Scoliosis; AdolescenceNCT06456333
Exploring Paraspinal Electromyographic Features in Adolescent Idiopathic Scoliosis Patients
An observational study of Scoliosis; Adolescence and Electromyography, run by The First Affiliated Hospital of Zhejiang Chinese Medical University at 1 site in China.
Trial summary
Adolescent Idiopathic Scoliosis (AIS) is a complex three-dimensional spinal deformity with onset in adolescents between the ages of 10 and 18 years, characterized by coronal curvature, sagittal imbalance and horizontal rotation of the spine. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Scoliosis; Adolescence, Electromyography
- What is being tested?
- High-density surface electromyography
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 31 May 2024
- 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 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: AIS patients and healthy control populations
Who may be able to join
- Patients with a diagnosis of AIS
- Any gender, age 10-18 years old
- Signed informed consent and able to cooperate with follow-up
- Ability to cooperate with electromyography examination and evaluation, and to perform measurements of relevant indexes.
Who cannot join
- Subjects with spine-related diseases such as Marfan's syndrome
- Subjects with previous spine-related diseases such as ankylosing spondylitis, spinal neurofibroma, spinal tuberculosis, spinal trauma, etc
- Subjects with comorbid serious medical diseases and patients with psychiatric disorders
- Subjects with ECOG scores of >2, which may have an effect on the results of the study
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310006
About this study
Official title: Paravertebral Electromyographic Characteristics of Adolescent Idiopathic Scoliosis Patients Explored on the Basis of High-density Surface Electromyography
Adolescent Idiopathic Scoliosis (AIS) is a complex three-dimensional spinal deformity with onset in adolescents between the ages of 10 and 18 years, characterized by coronal curvature, sagittal imbalance and horizontal rotation of the spine. The incidence of AIS is 1-4% globally, with more females than males, and it is a common, frequent and difficult-to-treat disease that seriously jeopardizes the physical and mental health of adolescents.
Previous studies have found significant changes in the morphologic structure and physiologic characteristics of the paraspinal muscles in patients with AIS, including muscle fiber distribution, muscle contraction and relaxation capacity, the convex side of the AIS curve exhibits a higher level of electromyographic activity, and asymmetric changes in the paraspinal muscles are highly correlated with progression of scoliosis. The current single-electrode sEMG technique extracts limited muscle activity signals and is susceptible to interference from random noise. Compared with the single-electrode sEMG technique, HD-sEMG can provide rich spatiotemporal information on paraspinal muscle activity, so it is necessary to use a wide and closely spaced electrode array for signal acquisition to obtain more accurate and detailed characteristics of paraspinal muscle activity.
In summary, this study used high-density surface electromyography to collect muscle parameters of the paraspinal muscles on the concave and convex sides of AIS patients and compared them with those of healthy people to comprehensively summarize the characteristics of their paraspinal muscles, so as to provide scientific basis for the subsequent development of precise treatment plans and improvement of clinical efficacy.
Read the detailed description
Paravertebral muscle EMG signals were acquired from AIS patients and healthy controls under the BST test paradigm.
Acquisition site: paravertebral muscle at the L1-L3 level, with the electrode sheet placed 1.5 cm adjacent to the spinous process.
（Biering-Sorensen test,BST）：The subject was lying prone on the bed, with the upper half of the body poking out of the bed, the anterior superior iliac spine located at the edge of the bed, both lower limbs partially immobilized on the bed with straps, both hands crossed in front of the chest grasping the contralateral shoulder and tightly pressed against the chest wall, and the torso was suspended in the air and parallel to the floor, and the patient stopped the test when he/she maintained this position for 90s.
Observation indicators:
1, the average change (mean) characteristics of each channel signal, including the 32 channels of the root mean square value （RMS）, mean power frequncy（MPF）, fractal dimension（FD）,Slope sign change(SSC), a total of 4 types of indicators-reflecting the strength and fatigue of muscle contractions..
- Conditions
- Scoliosis; Adolescence, Electromyography
- Being tested
- High-density surface electromyography
- Keywords
- Adolescent idiopathic scoliosis, high-density surface electromyography, Cross-sectional study
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-density surface electromyographyDevice
Electromyographic signals were acquired from the paravertebral muscles in apical vertebral in patients with AIS using SAGA High Density Myoelectrics (TMSi International, New Zealand)
| Study group | Role | What they receive |
|---|---|---|
| Adolescent idiopathic scoliosis patients（Observation Group） | Acquisition equipment：SAGA high-density electromyography system (TMSi, New Zealand).Acquisition site: paravertebral muscle at the L1-L3 level, with the electrode sheet placed 1.5 cm adjacent to the spinous process.Acquisition process: ① Place the electrode sheet and fix it. ② The subject was instructed to complete the specified movements according to the experimental paradigm and the EMG signals were recorded simultaneously.Experimental Paradigm:Biering-Sorensen test,BST：The subject was lying prone on the bed, with the upper half of the body poking out of the bed, the anterior superior iliac spine located at the edge of the bed, both lower limbs partially immobilized on the bed with straps, both hands crossed in front of the chest grasping the contralateral shoulder and tightly pressed against the chest wall, and the torso was suspended in the air and parallel to the floor, and the patient stopped the test when he/she maintained this position for 90s. Receives: Device: High-density surface electromyography | |
| Healthy population（Control Group） | Same intervention as the observation group. Receives: Device: High-density surface electromyography |
What is being measured
The primary outcome is the main question the study is designed to answer.
root mean square value （RMS）
The square root of the mean value of the amplitude of the sEMG signal over a certain time window is commonly used to assess the strength of muscle contraction and fatigue.
Measured: Day 1
mean power frequncy（MPF）
The average of the power frequency distribution of the sEMG signals generated during a muscle contraction can be used to assess the force and fatigue of a muscle contraction.
Measured: Day 1
fractal dimension（FD）
The complex waveforms were categorized into multiple dimensions, and each dimension was analyzed by typing.
Measured: Day 1
Slope sign change(SSC)
The number of times the sign of the rate of change of amplitude changes in the waveform of the sEMG signal is commonly used to indicate an impending fluctuating change in the state of the surface EMG signal.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Aug 2022
- Primary completion31 Dec 2023
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis; AdolescenceStudies 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Honggen Du, doctor, Study director, The First Affiliated Hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456333
- Sponsor's protocol ID
- 2023-K-286-01
- Status last verified
- Jun 2024
- First submitted
- 7 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paravertebral Electromyographic Characteristics of Adolescent Idiopathic Scoliosis Patients Explored on the Basis of High-density Surface Electromyography
- ClinicalTrials.gov ID
- NCT06456333
- Acronym / sponsor ID
- 2023-K-286-01
- Conditions
- Scoliosis; Adolescence, Electromyography
- Keywords
- Adolescent idiopathic scoliosis, high-density surface electromyography, Cross-sectional study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 13 Jun 2024 (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.
Adolescent Idiopathic Scoliosis (AIS) is a complex three-dimensional spinal deformity with onset in adolescents between the ages of 10 and 18 years, characterized by coronal curvature, sagittal imbalance and horizontal rotation of the spine. The incidence of AIS is 1-4% globally, with more females than males, and it is a common, frequent and difficult-to-treat disease that seriously jeopardizes the physical and mental health of adolescents.
Previous studies have found significant changes in the morphologic structure and physiologic characteristics of the paraspinal muscles in patients with AIS, including muscle fiber distribution, muscle contraction and relaxation capacity, the convex side of the AIS curve exhibits a higher level of electromyographic activity, and asymmetric changes in the paraspinal muscles are highly correlated with progression of scoliosis. The current single-electrode sEMG technique extracts limited muscle activity signals and is susceptible to interference from random noise. Compared with the single-electrode sEMG technique, HD-sEMG can provide rich spatiotemporal information on paraspinal muscle activity, so it is necessary to use a wide and closely spaced electrode array for signal acquisition to obtain more accurate and detailed characteristics of paraspinal muscle activity.
In summary, this study used high-density surface electromyography to collect muscle parameters of the paraspinal muscles on the concave and convex sides of AIS patients and compared them with those of healthy people to comprehensively summarize the characteristics of their paraspinal muscles, so as to provide scientific basis for the subsequent development of precise treatment plans and improvement of clinical efficacy.
Detailed description
Paravertebral muscle EMG signals were acquired from AIS patients and healthy controls under the BST test paradigm.
Acquisition site: paravertebral muscle at the L1-L3 level, with the electrode sheet placed 1.5 cm adjacent to the spinous process.
（Biering-Sorensen test,BST）：The subject was lying prone on the bed, with the upper half of the body poking out of the bed, the anterior superior iliac spine located at the edge of the bed, both lower limbs partially immobilized on the bed with straps, both hands crossed in front of the chest grasping the contralateral shoulder and tightly pressed against the chest wall, and the torso was suspended in the air and parallel to the floor, and the patient stopped the test when he/she maintained this position for 90s.
Observation indicators:
1, the average change (mean) characteristics of each channel signal, including the 32 channels of the root mean square value （RMS）, mean power frequncy（MPF）, fractal dimension（FD）,Slope sign change(SSC), a total of 4 types of indicators-reflecting the strength and fatigue of muscle contractions..
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adolescent idiopathic scoliosis patients（Observation Group） | – | Device: High-density surface electromyographyAcquisition equipment：SAGA high-density electromyography system (TMSi, New Zealand).Acquisition site: paravertebral muscle at the L1-L3 level, with the electrode sheet placed 1.5 cm adjacent to the spinous process.Acquisition process: ① Place the electrode sheet and fix it. ② The subject was instructed to complete the specified movements according to the experimental paradigm and the EMG signals were recorded simultaneously.Experimental Paradigm:Biering-Sorensen test,BST：The subject was lying prone on the bed, with the upper half of the body poking out of the bed, the anterior superior iliac spine located at the edge of the bed, both lower limbs partially immobilized on the bed with straps, both hands crossed in front of the chest grasping the contralateral shoulder and tightly pressed against the chest wall, and the torso was suspended in the air and parallel to the floor, and the patient stopped the test when he/she maintained this position for 90s. |
| Healthy population（Control Group） | – | Device: High-density surface electromyographySame intervention as the observation group. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- AIS patients and healthy control populations
Key inclusion criteria (4 listed)
- Patients with a diagnosis of AIS
- Any gender, age 10-18 years old
- Signed informed consent and able to cooperate with follow-up
- Ability to cooperate with electromyography examination and evaluation, and to perform measurements of relevant indexes.
Key exclusion criteria (4 listed)
- Subjects with spine-related diseases such as Marfan's syndrome
- Subjects with previous spine-related diseases such as ankylosing spondylitis, spinal neurofibroma, spinal tuberculosis, spinal trauma, etc
- Subjects with comorbid serious medical diseases and patients with psychiatric disorders
- Subjects with ECOG scores of >2, which may have an effect on the results of the study
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 |
|---|---|---|
| High-density surface electromyographyElectromyographic signals were acquired from the paravertebral muscles in apical vertebral in patients with AIS using SAGA High Density Myoelectrics (TMSi International, New Zealand) | Device | Adolescent idiopathic scoliosis patients（Observation Group）, Healthy population（Control Group） |
Primary outcome
root mean square value （RMS）
Time frame: Day 1
The square root of the mean value of the amplitude of the sEMG signal over a certain time window is commonly used to assess the strength of muscle contraction and fatigue.
mean power frequncy（MPF）
Time frame: Day 1
The average of the power frequency distribution of the sEMG signals generated during a muscle contraction can be used to assess the force and fatigue of a muscle contraction.
fractal dimension（FD）
Time frame: Day 1
The complex waveforms were categorized into multiple dimensions, and each dimension was analyzed by typing.
Slope sign change(SSC)
Time frame: Day 1
The number of times the sign of the rate of change of amplitude changes in the waveform of the sEMG signal is commonly used to indicate an impending fluctuating change in the state of the surface EMG signal.
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 Jul 2024.
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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.
Honggen Du, doctor study director
The First Affiliated Hospital of Zhejiang Chinese Medical 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 Scoliosis; Adolescence and Electromyography, run by The First Affiliated Hospital of Zhejiang Chinese Medical University at 1 site in China.
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 4 inclusion and 4 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 Jul 2024. 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 China. 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?
root mean square value （RMS） (time frame: Day 1). The study lists 4 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 Jul 2024; AzTrials last refreshed its copy on 7 Nov 2026.