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Trial on Two Treatments for Adolescent Idiopathic Scoliosis

Primary Purpose

Scoliosis; Adolescence

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Schroth based scoliosis specific exercise
"3 plus 1" multidimensional exercise therapy
Sponsored by
Peking University Aerospace Centre Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scoliosis; Adolescence

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • A diagnosis of adolescent idiopathic scoliosis; Age from 10 to 18 years; A Cobb angle of 10 to 25 degrees; All maturity levels (Risser sign of 0-5).

Exclusion Criteria:

  • Non-idiopathic scoliosis, which is caused by a neuromuscular, neurological, congenital malformation, or trauma-related comorbidity; Having mental problems or other contraindications to exercise; Previous fractures, rheumatic diseases, or operation history of lower extremities; Previous or current brace or surgical treatments for scoliosis.

Sites / Locations

  • Zhang yafei

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

"3 plus 1" multidimensional exercise therapy

Schroth based scoliosis specific exercise

Arm Description

The intervention consists of a Schroth-based exercise session and a manipulative therapy of pelvic asymmetry.

The intervention consists of the Schroth-based exercise session.

Outcomes

Primary Outcome Measures

Change From Baseline in Ratio of Iliac Widths at 24th week
Rotation in the transverse plane of pelvic seen on a spinal standing full-length posteroanterior radiograph.

Secondary Outcome Measures

Change in Cobb Angle
The largest coronal convex curve is measured by the Cobb method on a spinal standing full-length posteroanterior radiograph.
Change in Apical Vertebral Translation in Main Curves
When an apical vertebra or disc is identified as the apex of the curve, the center of the vertebra or disc is identified by drawing a horizontal line through the vertebra or disc, apical translation of the disc is measured from the disc centroid to the center sacral vertical line (CSVL).
Change in Coronal Pelvic Tilt
The vertical distance between the horizontal tangents of the highest point of the bilateral iliac crest.
Change in Apical Vertebral Rotation in Main curves
The Nash and Moe method is used to determine vertebral rotation. The apical vertebral body is divided into six equal segments longitudinally. When both pedicles are in view, there is no vertebral rotation. It is graded as "0". When the pedicle in the concave side (the right side) starts disappearing, it is graded as "1". When the pedicle disappears, it is graded as "2". When the contralateral pedicle (pedicle in the convex side) is in the midline of the vertebra, it is graded as "3". When it crosses the midline of the vertebra, it is graded as "4".
Change in Angle of Trunk Rotation
The angle of trunk rotation will be measured with a Scoliometer.
Change in Scoliosis Research Society-22 Questionnaire
The SRS-22 contains 22 questions covering 5 domains: function/activity 5 items; pain 5 items; self-perceived image 5 items; mental health 5 items; and satisfaction with treatment 2 items. Each item is scored from 1 (worst) to 5 (best). The sum of the 5 domains is 110.

Full Information

First Posted
February 16, 2022
Last Updated
April 9, 2023
Sponsor
Peking University Aerospace Centre Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05259956
Brief Title
Trial on Two Treatments for Adolescent Idiopathic Scoliosis
Official Title
The Impact of "3+1" Multidimensional Therapeutic Exercises on the Progression of Adolescent Idiopathic Scoliosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 18, 2022 (Actual)
Primary Completion Date
April 7, 2023 (Actual)
Study Completion Date
April 7, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Aerospace Centre Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Adolescent Idiopathic scoliosis is a three-dimensional structural deformity of the spine and pelvic that occurs in children. More evidence has arisen to emphasize the important role played by pelvic asymmetry during the progression of scoliosis. The purpose of this study is to compare the effectiveness of pelvic adjustments accompanied with Schroth-based exercises, with the latter alone in adolescent idiopathic scoliosis, to assess the impact of pelvic asymmetry on the spinal three-dimensional parametric features in scoliosis.
Detailed Description
Adolescent idiopathic scoliosis is the most common three-dimensional structural deformity of the spine among adolescence, the International Society on Scoliosis Orthopaedic and Rehabilitation Treatment recommend specific exercise therapy to delay the progression of scoliosis. Many specific exercise therapies are effective in reducing the angle of coronal scoliosis, but their efficiency in sagittal and axial deformities hasn't been convincing. Recent studies have found that the axial asymmetry of the pelvis may be involved in the pathogenesis of idiopathic scoliosis, but there is no clinical study on the treatment of scoliosis by correcting the axial torsion of the pelvis neither at home nor abroad. So in this study, "3 plus 1" multidimensional exercise therapy was applied to mild adolescent idiopathic scoliosis for the first time. The present study is a single-center randomized controlled trial conducted at the department of rehabilitation medicine, Aerospace Center Hospital. The written Informed consent will be obtained from each patient and one of their parents before inclusion. Eligible subjects will be randomized by a 1:1 allocation ratio either to the experimental group, in which the "3 plus 1" multidimensional exercise therapy will be performed and pelvic correction technique was adopted to correct pelvic axial rotation, or the control group, in which they will receive the Schroth-based exercise therapy. Blinded assessments will be conducted at baseline and 6-month after the intervention, including the differences in three-dimensional structural parameters of pelvis and spine, such as the ratio of the iliac widths, SRS-22 questionnaire, etc, to compare the efficacy of two different groups in improving the three-dimensional balance of the spine and the quality of daily life in adolescent idiopathic scoliosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis; Adolescence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
"3 plus 1" multidimensional exercise therapy
Arm Type
Experimental
Arm Description
The intervention consists of a Schroth-based exercise session and a manipulative therapy of pelvic asymmetry.
Arm Title
Schroth based scoliosis specific exercise
Arm Type
Active Comparator
Arm Description
The intervention consists of the Schroth-based exercise session.
Intervention Type
Behavioral
Intervention Name(s)
Schroth based scoliosis specific exercise
Intervention Description
The intervention is set to be delivered in a one-hour Schroth-based exercise session, with the frequency of twice a week for five weeks. The exercise consists of active auto-correction in 3D, stabilizing the corrected posture, and training in ADL.
Intervention Type
Behavioral
Intervention Name(s)
"3 plus 1" multidimensional exercise therapy
Intervention Description
The intervention is set to be delivered in a 90-minute exercise session, with a frequency of twice a week for five weeks. The exercise consists of a one-hour Schroth-based exercise session and an additional 30-minute manipulative therapy of pelvic asymmetry.
Primary Outcome Measure Information:
Title
Change From Baseline in Ratio of Iliac Widths at 24th week
Description
Rotation in the transverse plane of pelvic seen on a spinal standing full-length posteroanterior radiograph.
Time Frame
baseline and at 24th week
Secondary Outcome Measure Information:
Title
Change in Cobb Angle
Description
The largest coronal convex curve is measured by the Cobb method on a spinal standing full-length posteroanterior radiograph.
Time Frame
baseline and at 24th week
Title
Change in Apical Vertebral Translation in Main Curves
Description
When an apical vertebra or disc is identified as the apex of the curve, the center of the vertebra or disc is identified by drawing a horizontal line through the vertebra or disc, apical translation of the disc is measured from the disc centroid to the center sacral vertical line (CSVL).
Time Frame
baseline and at 24th week
Title
Change in Coronal Pelvic Tilt
Description
The vertical distance between the horizontal tangents of the highest point of the bilateral iliac crest.
Time Frame
baseline and at 24th week
Title
Change in Apical Vertebral Rotation in Main curves
Description
The Nash and Moe method is used to determine vertebral rotation. The apical vertebral body is divided into six equal segments longitudinally. When both pedicles are in view, there is no vertebral rotation. It is graded as "0". When the pedicle in the concave side (the right side) starts disappearing, it is graded as "1". When the pedicle disappears, it is graded as "2". When the contralateral pedicle (pedicle in the convex side) is in the midline of the vertebra, it is graded as "3". When it crosses the midline of the vertebra, it is graded as "4".
Time Frame
baseline and at 24th week
Title
Change in Angle of Trunk Rotation
Description
The angle of trunk rotation will be measured with a Scoliometer.
Time Frame
baseline and at 24th week
Title
Change in Scoliosis Research Society-22 Questionnaire
Description
The SRS-22 contains 22 questions covering 5 domains: function/activity 5 items; pain 5 items; self-perceived image 5 items; mental health 5 items; and satisfaction with treatment 2 items. Each item is scored from 1 (worst) to 5 (best). The sum of the 5 domains is 110.
Time Frame
baseline and at 24th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A diagnosis of adolescent idiopathic scoliosis; Age from 10 to 18 years; A Cobb angle of 10 to 25 degrees; All maturity levels (Risser sign of 0-5). Exclusion Criteria: Non-idiopathic scoliosis, which is caused by a neuromuscular, neurological, congenital malformation, or trauma-related comorbidity; Having mental problems or other contraindications to exercise; Previous fractures, rheumatic diseases, or operation history of lower extremities; Previous or current brace or surgical treatments for scoliosis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhang Meng
Organizational Affiliation
Aerospace Centre Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Zhang yafei
City
Beijing
Country
China

12. IPD Sharing Statement

Learn more about this trial

Trial on Two Treatments for Adolescent Idiopathic Scoliosis

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