Effect of Schroth Exercises Combined With Laser Acupuncture Therapy in Adolescent Idiopathic Scoliosis

Study Overview
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Brief Summary
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The goal of this clinical trial] is to explore the clinical effect of laser acupuncture combined with Schroth training on adolescent idiopathic scoliosis (AIS) . The main question[s] it aims to answer are: The effects of Schroth exercises on Cobb angles, angle of trunk rotation, spinal mobility, gait parameters and clinical efficacy in patients with AIS. Laser acupuncture combined with Schroth method on Cobb angles, angle of trunk rotation, spinal mobility, gait parameters and clinical efficacy in patients with AIS. Participants will received Schroth exercise therapy and laser acupuncture therapy (MLS laser). If there is a comparison group: Researchers will compare received Schroth exercise therapy to see the effects of Schroth exercises and laser acupuncture combined with Schroth method on Cobb angles, angle of trunk rotation, spinal mobility, gait parameters and clinical efficacy in patients with AIS

Detailed Description
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In this study, the standard control, control group receipts schroth exercise therapy, while trial group receives Schroth exercise therapy and laser therapy. The design of the individual Schroth exercise is carried out according to the c urve patterns of the Schroth classification. The Schroth classification criteria includes four curve patterns that are determined with reference to the location of the curves, the importance of lumbar and thoracic prominences, and the effect of the scoliosis on the pelvis. Laser therapy was performed w ith a dual wavelength, high power IR laser (Multiwave Locked System (MLS®) laser, Mphi, ASA srl, Vicenza, Italy) and the laser acupuncture points include DU2, GB30, DU9, SP6, LR8, DU6, DU4, DU12. Laser puncture acupuncture points had been identified according to Traditional Chinese Medicine (TCM) and treated with handpiece optical group following the detailed treatment parameters: 900Hz, FPW mode, 60 s per point, 29.12J, spot size 3 cm2, energy density 27J/cm2. All treatments are performed five times in a week for 4 consecutive weeks.

Official Title
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Schroth Exercises Combined With Laser Acupuncture Therapy

Conditions
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Adolescent Idiopathic Scoliosis, Laser Acupuncture

Intervention / Treatment
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* Behavioral: Schroth exercise therapy
* Device: laser therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adolescent idiopathic scoliosis patients without history of traumas positive Adam's Forward Bend Test, Cobb Angle>10° Exclusion Criteria: functional scoliosis and other structural scoliosis Previous history of scoliosis surgery Wearing braces and being treated in other ways Unable to complete PSSE training actions as required Complicated with serious heart, liver, kidney and other systemic diseases

Ages Eligible for Study
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Minimum Age: 125 Months
Maximum Age: 200 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: the experimental group<br> | Behavioral: Schroth exercise therapy<br>* The Schroth classification criteria includes four curve patterns that are determined with reference to the location of the curves, the importance of lumbar and thoracic prominences, and the effect of the scoliosis on the pelvis.<br>Device: laser therapy<br>* Laser therapy was performed w ith a dual wavelength, high power IR laser (Multiwave Locked System (MLS®) laser, Mphi, ASA srl, Vicenza, Italy) and the laser acupuncture points include DU2, GB30, DU9, SP6, LR8, DU6, DU4, DU12. Laser puncture acupuncture points had been identified according to Traditional Chinese Medicine (TCM) and treated with handpiece optical group following the detailed treatment parameters: 900Hz, FPW mode, 60 s per point, 29.12J, spot size 3 cm2, energy density 27J/cm2. All treatments are performed five times in a week for 4 consecutive weeks.<br>|
| Active Comparator: the control group<br> | Behavioral: Schroth exercise therapy<br>* The Schroth classification criteria includes four curve patterns that are determined with reference to the location of the curves, the importance of lumbar and thoracic prominences, and the effect of the scoliosis on the pelvis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cobb angle(°) | Draw a line through the spine on the upper surface of the upper vertebra and the lower surface of the lower vertebra on the X-ray film, and make the vertical line of the above two lines, and measure the angle between the two vertical lines. All radiographs are measured three times by a professional physician with the same protractor, and the average value is recorded | before the whole treatment cycle | 
| Cobb angle(°) | Draw a line through the spine on the upper surface of the upper vertebra and the lower surface of the lower vertebra on the X-ray film, and make the vertical line of the above two lines, and measure the angle between the two vertical lines. All radiographs are measured three times by a professional physician with the same protractor, and the average value is recorded | 6 months after treatment | 
| Cobb angle(°) | Draw a line through the spine on the upper surface of the upper vertebra and the lower surface of the lower vertebra on the X-ray film, and make the vertical line of the above two lines, and measure the angle between the two vertical lines. All radiographs are measured three times by a professional physician with the same protractor, and the average value is recorded | 12 months after treatment | 
| Trunk rotation angle(°) | Trunk rotation angle (ATR) is measured with scoliosis instrument to quantitatively evaluate the chest rotation angle and waist rotation angle. | before the whole treatment cycle | 
| Trunk rotation angle(°) | Trunk rotation angle (ATR) is measured with scoliosis instrument to quantitatively evaluate the chest rotation angle and waist rotation angle. | 6 months after treatment | 
| Trunk rotation angle(°) | Trunk rotation angle (ATR) is measured with scoliosis instrument to quantitatively evaluate the chest rotation angle and waist rotation angle. | 12 months after treatment | 
| Musculoskeletal stiffness | Use PulStarG3 system (Sense Technology Inc) to evaluate the musculoskeletal stiffness of each spinal segment. The handheld pulse head presses on the patient and provides a single low-energy pulse to the vertebral layer of interest. The force sensor in the pulse head measures the resistance to the pulse and transmits the analysis results to a digital computer, which can be considered as a computer-assisted spinal palpation in a series of bar graphs (abnormal musculoskeletal hardness is shown in the red bar and normal musculoskeletal hardness is shown in the green bar). | before the whole treatment cycle | 
| Musculoskeletal stiffness | Use PulStarG3 system (Sense Technology Inc) to evaluate the musculoskeletal stiffness of each spinal segment. The handheld pulse head presses on the patient and provides a single low-energy pulse to the vertebral layer of interest. The force sensor in the pulse head measures the resistance to the pulse and transmits the analysis results to a digital computer, which can be considered as a computer-assisted spinal palpation in a series of bar graphs (abnormal musculoskeletal hardness is shown in the red bar and normal musculoskeletal hardness is shown in the green bar). | 6 months after treatment | 
| Musculoskeletal stiffness | Use PulStarG3 system (Sense Technology Inc) to evaluate the musculoskeletal stiffness of each spinal segment. The handheld pulse head presses on the patient and provides a single low-energy pulse to the vertebral layer of interest. The force sensor in the pulse head measures the resistance to the pulse and transmits the analysis results to a digital computer, which can be considered as a computer-assisted spinal palpation in a series of bar graphs (abnormal musculoskeletal hardness is shown in the red bar and normal musculoskeletal hardness is shown in the green bar). | 12 months after treatment | 
| Gait(stride length (m)) | collected by wearable devices (micro-electro-mechanical systems, MEMS), the sampling frequency is set at 20 Hz, and transmitted to the computer server according to the manufacturer's protocol. The collected gait parameters include average pressure distribution, stride length, stride length and walking speed. | before the whole treatment cycle | 
| Gait(stride time(s)) | collected by wearable devices (micro-electro-mechanical systems, MEMS), the sampling frequency is set at 20 Hz, and transmitted to the computer server according to the manufacturer's protocol. The collected gait parameters include average pressure distribution, stride length, stride length and walking speed. | before the whole treatment cycle | 
| Gait(walking speed(m/s)) | collected by wearable devices (micro-electro-mechanical systems, MEMS), the sampling frequency is set at 20 Hz, and transmitted to the computer server according to the manufacturer's protocol. The collected gait parameters include average pressure distribution, stride length, stride length and walking speed. | before the whole treatment cycle | 
| Gait(stride length (m)) | collected by wearable devices (micro-electro-mechanical systems, MEMS), the sampling frequency is set at 20 Hz, and transmitted to the computer server according to the manufacturer's protocol. The collected gait parameters include average pressure distribution, stride length, stride length and walking speed. | 6 months after treatment | 
| Gait(stride time(s)) | collected by wearable devices (micro-electro-mechanical systems, MEMS), the sampling frequency is set at 20 Hz, and transmitted to the computer server according to the manufacturer's protocol. The collected gait parameters include average pressure distribution, stride length, stride length and walking speed. | 6 months after treatment | 
| Gait(walking speed(m/s)) | collected by wearable devices (micro-electro-mechanical systems, MEMS), the sampling frequency is set at 20 Hz, and transmitted to the computer server according to the manufacturer's protocol. The collected gait parameters include average pressure distribution, stride length, stride length and walking speed. | 6 months after treatment | 
| Gait(stride length (m)) | collected by wearable devices (micro-electro-mechanical systems, MEMS), the sampling frequency is set at 20 Hz, and transmitted to the computer server according to the manufacturer's protocol. The collected gait parameters include average pressure distribution, stride length, stride length and walking speed. | 12 months after treatment | 
| Gait(stride time(s)) | collected by wearable devices (micro-electro-mechanical systems, MEMS), the sampling frequency is set at 20 Hz, and transmitted to the computer server according to the manufacturer's protocol. The collected gait parameters include average pressure distribution, stride length, stride length and walking speed. | 12 months after treatment | 
| Gait(walking speed(m/s)) | collected by wearable devices (micro-electro-mechanical systems, MEMS), the sampling frequency is set at 20 Hz, and transmitted to the computer server according to the manufacturer's protocol. The collected gait parameters include average pressure distribution, stride length, stride length and walking speed. | 12 months after treatment |