Schroth Exercises Combined With Laser Acupuncture Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Cobb angle(°)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 125 Months 至 200 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescent idiopathic scoliosis patients without history of traumas
- •positive Adam's Forward Bend Test, Cobb Angle>10°
排除标准
- •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
结局指标
主要结局
Cobb angle(°)
时间窗: 12 months after treatment
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
Gait(stride time(s))
时间窗: 12 months after treatment
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.
Gait(walking speed(m/s))
时间窗: 12 months after treatment
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.
Trunk rotation angle(°)
时间窗: 12 months after treatment
Trunk rotation angle (ATR) is measured with scoliosis instrument to quantitatively evaluate the chest rotation angle and waist rotation angle.
Musculoskeletal stiffness
时间窗: 12 months after treatment
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).
Gait(stride length (m))
时间窗: 12 months after treatment
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.
次要结局
未报告次要终点
研究者
Guangyu Fu
Doctor
Dalian Second People's Hospital