NCT05823493

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 21, 2023

Completed
Last Updated

April 21, 2023

Status Verified

April 1, 2023

Enrollment Period

1 year

First QC Date

March 19, 2023

Last Update Submit

April 10, 2023

Conditions

Adolescent Idiopathic ScoliosisLaser Acupuncture

Outcome Measures

Primary Outcomes (18)

  • 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

Study Arms (2)

the experimental group

EXPERIMENTAL
Behavioral: Schroth exercise therapyDevice: laser therapy

the control group

ACTIVE COMPARATOR
Behavioral: Schroth exercise therapy

Interventions

Schroth exercise therapyBEHAVIORAL

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.

the control groupthe experimental group
laser therapyDEVICE

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.

the experimental group

Eligibility Criteria

Age125 Months - 200 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Adolescent idiopathic scoliosis patients without history of traumas
  • positive Adam's Forward Bend Test, Cobb Angle\>10°

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dalian Second People's Hospital

Dalian, China

Location

MeSH Terms

Interventions

Laser Therapy

Intervention Hierarchy (Ancestors)

TherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

March 19, 2023

First Posted

April 21, 2023

Study Start

March 1, 2021

Primary Completion

March 1, 2022

Study Completion

March 1, 2023

Last Updated

April 21, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)