Clinical trial NCT05259956: 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
Overall status: COMPLETED
Phase: NA
Conditions: Scoliosis; Adolescence
Lead sponsor: Peking University Aerospace Center Hospital
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 42
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change From Baseline in Ratio of Iliac Widths at 24th week
timeFrame: baseline and at 24th week
Secondary outcomes:
measure: Change in Cobb Angle
timeFrame: baseline and at 24th week
measure: Change in Apical Vertebral Translation in Main Curves
timeFrame: baseline and at 24th week
measure: Change in Coronal Pelvic Tilt
timeFrame: baseline and at 24th week
measure: Change in Apical Vertebral Rotation in Main curves
timeFrame: baseline and at 24th week
measure: Change in Angle of Trunk Rotation
timeFrame: baseline and at 24th week
measure: Change in Scoliosis Research Society-22 Questionnaire
timeFrame: baseline and at 24th week
Other outcomes:
Locations:
city: Beijing
country: China
facility: Zhang yafei
Study officials:
affiliation: Aerospace Centre Hospital
name: Zhang Meng
role: STUDY_DIRECTOR
References: