An observational study in Scoliosis; Adolescence and Electromyography, sponsored by The First Affiliated Hospital of Zhejiang Chinese Medical University. Completed at 1 site in China. Open to participants aged 10 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by The First Affiliated Hospital of Zhejiang Chinese Medical University · Observational
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.
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..
603 studies on the registry are indexed under Scoliosis; 141 are open to participants now.
This study's enrollment of 70 is below the median of 84 across 236 observational studies indexed under Scoliosis.
Browse Scoliosis studies →The First Affiliated Hospital of Zhejiang Chinese Medical University is the lead sponsor of 38 studies on the registry; 18 are open to participants now.
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AIS patients and healthy control populations
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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.
Device: High-density surface electromyography
Same intervention as the observation group.
Device: High-density surface electromyography
Electromyographic signals were acquired from the paravertebral muscles in apical vertebral in patients with AIS using SAGA High Density Myoelectrics (TMSi International, New Zealand)
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.
Time frame: 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.
Time frame: Day 1
fractal dimension（FD）
The complex waveforms were categorized into multiple dimensions, and each dimension was analyzed by typing.
Time frame: 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.
Time frame: Day 1
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Ran from Aug 2022 to primary completion in Dec 2023, 16 months.
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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital of Zhejiang Chinese Medical University