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

Sponsor
Dalian Second People's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05823493
Collaborator
(none)
80
1
2
24
3.3

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Schroth exercise therapy
  • Device: laser therapy
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Schroth Exercises Combined With Laser Acupuncture Therapy
Actual Study Start Date :
Mar 1, 2021
Actual Primary Completion Date :
Mar 1, 2022
Actual Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: the experimental group

Behavioral: Schroth exercise therapy
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.

Device: laser therapy
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.

Active Comparator: the control group

Behavioral: Schroth exercise therapy
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.

Outcome Measures

Primary Outcome Measures

  1. Cobb angle(°) [before the whole treatment cycle]

    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

  2. Cobb angle(°) [6 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

  3. Cobb angle(°) [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

  4. Trunk rotation angle(°) [before the whole treatment cycle]

    Trunk rotation angle (ATR) is measured with scoliosis instrument to quantitatively evaluate the chest rotation angle and waist rotation angle.

  5. Trunk rotation angle(°) [6 months after treatment]

    Trunk rotation angle (ATR) is measured with scoliosis instrument to quantitatively evaluate the chest rotation angle and waist rotation angle.

  6. Trunk rotation angle(°) [12 months after treatment]

    Trunk rotation angle (ATR) is measured with scoliosis instrument to quantitatively evaluate the chest rotation angle and waist rotation angle.

  7. Musculoskeletal stiffness [before the whole treatment cycle]

    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).

  8. Musculoskeletal stiffness [6 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).

  9. Musculoskeletal stiffness [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).

  10. Gait(stride length (m)) [before the whole treatment cycle]

    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.

  11. Gait(stride time(s)) [before the whole treatment cycle]

    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. Gait(walking speed(m/s)) [before the whole treatment cycle]

    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.

  13. Gait(stride length (m)) [6 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.

  14. Gait(stride time(s)) [6 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.

  15. Gait(walking speed(m/s)) [6 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.

  16. Gait(stride length (m)) [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.

  17. Gait(stride time(s)) [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.

  18. Gait(walking speed(m/s)) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
125 Months to 200 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dalian Second People's Hospital Dalian China

Sponsors and Collaborators

  • Dalian Second People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Guangyu Fu, Doctor, Dalian Second People's Hospital
ClinicalTrials.gov Identifier:
NCT05823493
Other Study ID Numbers:
  • DLSP001
First Posted:
Apr 21, 2023
Last Update Posted:
Apr 21, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 21, 2023