Effect of Spinal Manipulative Therapy Combined with Brace in Moderate-severe Grade Adolescent Idiopathic Scoliosis: a Randomized Controlled Trial

Introduction Adolescent idiopathic scoliosis (AIS) is a complex three-dimensional deformity of the spine that primarily affects children and adolescents. It is characterized by coronal scoliosis, sagittal imbalance, and horizontal rotation of the spine. The global prevalence of AIS is estimated to be around 2-3%, with a higher proportion of female patients. Moderate-severe grade AIS may lead to physical deformities including razorback, shoulder imbalance and chest deformity, and even affect cardiopulmonary function and irreversible damage to nerves. In addition, patients with AIS are often associated with moderate to severe psychological disorders. Research has confirmed that if left untreated, approximately 60% of individuals with moderate-severe AIS will experience progression of their scoliosis. Moreover, about 30% moderate-severe AIS will suffer from physical deformities, chronic pain, and psychosocial disorders, such as anxiety and depression, during adulthood.

AIS is classified into three categories based on the extent of spinal curvature, measured by the Cobb angle: mild (<20°), moderate (20-40°), and severe (>40°). Current guidelines, such as the 2016 SOSORT guidelines [8], recommend the primary treatment regimen for moderate AIS to consist of bracing therapy and rehabilitative exercises. This regimen aims to reduce pain, improve posture, and control further progression of scoliosis, ultimately aiming to avoid surgery. However, in clinical practice, prolonged bracing alone can have negative impacts on growth and development, including pressure sores, back pain, decreased respiratory function and potential mental health issues.

It is now generally accepted that severe-grade AIS with skeletally immature need to undergo surgical corrective surgery. But this approach involves relatively high-cost issues and risk of complications due to the invasive, complex nature of the procedure. As a result of these problems, some patients with AIS who are considered to be surgical candidates, as well as their parents, expressly resist surgery and seek more aggressive conservative treatment. In recent years, more and more reports in the literature have shown that conservative treatment still has a certain therapeutic effect on AIS >40° (35%-91%).But this efficacy is affected by a number of risk factors. There is still a need to explore an active conservative treatment for AIS, aims to correct scoliosis, avoid surgery.

Spinal manipulative therapy (SMT), as a complementary and alternative therapy for AIS, is a skilled hand manipulative technique, including massage, chiropractic, osteopathy, and Tuina (traditional Chinese manipulation). Extensive research has demonstrated its effectiveness in reducing pain, decreasing scoliosis angle and improving overall quality of life in patients with AIS. Our team has also observed the corrective effect of SMT on moderate-grade AIS in the clinic beforehand.

However, what needs to be acknowledged is that existing research on the efficacy of SMT for AIS is hampered by the heterogeneity of clinical research protocols and the lack of high-quality randomized controlled trials (RCTs). To ensure consistency in the application of SMT and to obtain more reliable evidence of its efficacy in the clinical management of AIS, our team conducted this RCT to observe the effect of SMT on improving spinal deformity and quality of life in patients with moderate-severe AIS.