Exploring Paraspinal Electromyographic Features in Adolescent Idiopathic Scoliosis Patients

Scoliosis; Adolescence Clinical Trial

Official title:

Paravertebral Electromyographic Characteristics of Adolescent Idiopathic Scoliosis Patients Explored on the Basis of High-density Surface Electromyography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06456333
• Other study ID #: 2023-K-286-01
• Status: Completed
• Start date: August 1, 2022
• Est. completion date: May 31, 2024

Study information

• Verified date: June 2024
• Source: The First Affiliated Hospital of Zhejiang Chinese Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

Inclusion Criteria:

?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.

Exclusion Criteria:

• 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; and (? Subjects with ECOG scores of >2, which may have an effect on the results of the study.

Related Conditions & MeSH terms

• Electromyography
• Scoliosis
• Scoliosis; Adolescence

Intervention

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)

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Zhejiang Chinese Medical University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Zhejiang Chinese Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One collection
Primary	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.	One collection
Primary	fractal dimension(FD)	The complex waveforms were categorized into multiple dimensions, and each dimension was analyzed by typing.	One collection
Primary	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.	One collection