Effectiveness and Safety of SpineCare Used in Conjunction With Spinal Realignment Therapy in the Treatment of Idiopathic Scoliosis: An Investigator-initiated, Randomized, Single-blind, Pilot Study

1. Introduction Idiopathic scoliosis (IS) is a condition characterized by an abnormal lateral curvature and rotational deformity of the vertebral column, typically presenting as either an S- or C-shaped curve in the vertebral column. IS leads to musculoskeletal asymmetry, culminating in morphological and geometric changes in the torso. It can result in numerous is-sues such as changes in posture, sensory impairment, balance and gait problems, limitations in physical activity, pain, body image disturbances, and challenges in social communication . The treatment approach for IS depends on the severity of the curve measured by Cobb's angle: surgical intervention is considered for angles of 40º or greater, while non-surgical treatments are considered for angles under 40º. Non-surgical modalities include physical therapy, manipulative therapy, braces, and exercise therapy. Traditionally, braces are recommended for Cobb's angles of 20-40º. However, braces often lead to undesirable effects such as psychological stress, discomfort in daily activities, negative selfesteem, and impaired respiratory function , and their effectiveness remains controversial . Manipulative therapy aims to correct the alignment of spinal segments and optimize the mechanical interaction between the spine and torso to facilitate healing and restore spinal mobility. Therefore, manipulative therapy focusing on correcting the position of spinal segments and improving neuromuscular stabilization is needed to manage IS [9]. Such treatments include chiropractic therapy, Chuna manual therapy (CMT), and spinal realignment therapy (SRT).

The difference among these three treatment modalities is the patient's posture during treatment. During chiropractic treatment or CMT, the patient lies in the supine or prone position. During SRT, the patient lies in the prone position, and the lower extremities are placed under traction against gravity using SpineCare. SpineCare (Korea, Dr. Bom, Co., Ltd.) is a modernized traction device inspired by Panseo (攀索), which was introduced in the section on external therapy techniques (正骨心法要旨) in "Yizong Jinjian," a medical treatise compiled by Wu Jia (吳假) and others during the Qing Dynasty. This contraption received medical device certification from the Korean Ministry of Food and Drug Safety in 2020 (License No. 20-5054). The SpineCare device is used by having the patient lying prone with knees bent at 90º and both ankles secured on ankle braces to pull them up-wards against gravity. This posture helps create space between spinal segments, allowing deformed spinal and skeletal structures to return to their normal positions. With-out SpineCare, spinal imbalance may not be adequately addressed and corrected. Administering corrective treatment without spinal segment spacing may actually decrease spacing, increase pressure between the discs and vertebrae, and exacerbate disc abnormalities. Furthermore, it may affect the adjacent muscles and ligaments, thereby increasing pain and restricting movement and function, which, in turn, could cause discomfort and limitations in performing the activities of daily living. Thus, ensuring adequate space be-tween spinal segments using SpineCare is crucial for restoring the normal positions of the spine and skeletal structures.

However, research on the effectiveness of SRT using SpineCare is insufficient. There-fore, this study aimed to assess the effectiveness and safety of the application of SRT in conjunction with SpineCare in patients with IS. In this study, we will elaborate on the specific procedures involved in SRT with SpineCare for patients with IS and report the out-comes using NRS and Cobb's angle. 2. Materials and Methods 2.1. Study Design and Setting This investigator-initiated, randomized controlled, single-blind trial was approved by the Institutional Review Board (Date of approval: Rebom Clinic June 1, 2023). Written informed consent was obtained from all patients before trial commencement.

2.2. Participants Participants were enrolled from among the patients of Rebom Clinic from June 1 to November 30, 2023, by posting a recruitment announcement within the clinic. The inclusion criteria were age ranging from 19-70 years and spinal radiographs obtained in an upright position. Patients with a Cobb's angle of 15-39º on X-rays who consented to participate in the trial were included. The exclusion criteria were spine-related surgery in the past six months, diagnosis of osteoporosis, history of other non-surgical treatments, participation in another interventional clinical trial in the past month (including human studies), and plan to participate in another interventional study after starting this trial.

2.3. Randomization and Allocation Concealment The investigator responsible for data analysis prepared two envelopes marked with odd and even numbers. Participants chose an envelope in the order of arrival. To maintain a 1:1 ratio between the trial and control groups, participants were assigned to the remaining group once one group reached capacity. Participants who chose an odd number were assigned to the SpineCare based SRT group (trial group, TG), and those who chose an even number were assigned to the SRT group without SpineCare (control group, CG).