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

NCT ID: NCT05823493

Last Updated: 2023-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2023-03-01

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

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.

Conditions

Adolescent Idiopathic Scoliosis; Laser Acupuncture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

the experimental group

Group Type: EXPERIMENTAL

Schroth exercise therapy

Intervention Type: BEHAVIORAL

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

Intervention Type: DEVICE

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 control group

Group Type: ACTIVE_COMPARATOR

Schroth exercise therapy

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 125 Months
• Maximum Eligible Age: 200 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dalian Second People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Guangyu Fu

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dalian Second People's Hospital

Dalian, , China

Countries

China

Other Identifiers

DLSP001

Identifier Type: -

Identifier Source: org_study_id