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NCT07418983
The use of various muscle energy techniques to address fascial restrictions, in addition to three-dimensional correction within scoliosis-specific exercise approaches, suggests that these exercises may have different effects on thoracolumbar fascia thickness. This may, in turn, lead to varying impacts on low back pain and functional improvement. Therefore, the aim of this study is to investigate the effects of different scoliosis-specific exercise approaches on thoracolumbar fascia thickness, low back pain, and function in individuals with idiopathic lumbar scoliosis and chronic low back pain.
NCT07593560
Scoliosis is a sideways curvature of the spine that often develops during childhood and adolescence. When detected early, scoliosis can be managed effectively with non-invasive approaches such as bracing and physiotherapy, while late detection frequently leads to surgical intervention. Current screening methods rely on physical examination and X-ray imaging, which exposes children to ionizing radiation and may miss early-stage cases. This observational study investigates whether millimeter-wave (mmWave) radar, combined with deep learning (a type of artificial intelligence), can detect early signs of scoliosis by analyzing how a child walks. The radar sensor records subtle movement patterns during walking without using cameras and without producing any identifiable images, fully preserving the participant's privacy. No ionizing radiation is involved. Pediatric participants attending the orthopedic clinic for routine scoliosis evaluation are invited to walk a short distance in front of a mmWave radar sensor. The collected gait recordings are then analyzed using deep learning models, and the results are compared with the participant's standard clinical scoliosis assessment performed by a pediatric orthopedic specialist. The diagnostic performance of the deep learning model is evaluated using sensitivity, specificity, and overall accuracy. If the approach proves accurate, it could offer a radiation-free, privacy-preserving, and low-cost alternative for early scoliosis screening in schools, primary healthcare centers, and pediatric orthopedic clinics, ultimately supporting earlier diagnosis and reducing the long-term clinical burden of untreated scoliosis.
NCT06258161
Adult spinal deformity (ASD) is a common spinal condition that often impacts an individual's ability to stand and maintain an upright posture. Poor balance often limits an individual's ability to perform basic activities of daily life (ADL) and can lead to disability. Current considerations of correcting ASD to improve balance focus on the amount of sway that one exhibits during normal standing. However, current tests do not provide insight into the limits of balance during normal ADL. The goal of this research is to develop a new balance assessment that includes a functional reach test (FRT) to provide numerical data on the limits of one's ability to maintain balance. The study will include both ASD patients and matched healthy adults and will compare postural sway measures between them. Wearable motion tracking sensors and a force plate will be used to monitor body movement and changes in the center of pressure under foot during normal standing and during a FRT. Data from this study will inform spine surgeons of ASD patient's risk of balance loss in daily life and enable further research on the effects of surgical techniques to restore balance among ASD surgery patients.
NCT05866419
The primary objective of the clinical investigation is to demonstrate successful clinical use of the ThecaFlex DRx™ System in delivering nusinersen in subjects with spinal muscular atrophy (SMA). All enrolled subjects will undergo implantation of the investigational device (ThecaFlex DRx™ System) and will be followed for 12 months after receiving the implant. The 12-month data will be used to assess the primary endpoint support a Pre-Market Approval (PMA) application.
NCT07527611
Idiopathic scoliosis (IS) is a common problem affecting approximately 3% of the population; its progression can lead to significant health problems. The BrAIST study proved brace effectiveness, which increased bracing interest and utilization globally. There is a lack of evidence-based guidelines for brace treatment. There is significant variability in the brace literature with little consistency in indications for brace treatment goals, brace types, use of monitors, timing of radiographs, and evaluation of skeletal maturity. This lack of evidence demonstrates a clear need for a multi-center brace registry. The first aim of this proposal is to develop a comprehensive retrospective brace registry. This project involves expert clinicians, researchers and an orthotist, each with broad clinical and research experience in the field of bracing for scoliosis. The retrospective registry will function as a pilot, providing strategies to optimize variables, streamline data collection and minimize missing data. The next step will be to develop and launch a multicenter, prospective brace registry and Quality Improvement registry.
NCT06062550
Scoliosis correction surgery is associated with severe pain. Patients after scoliosis correction surgery usually require high dose opioids and long duration analgesia, which may increase side effects and drug tolerance. In a recent trial, mini-dose esketamine and dexmedetomidine combination as a supplement to sufentanil significantly improved analgesia and subjective sleep quality after spinal correction surgery without increasing adverse events; however, the proportion of patients with moderate-to-severe pain remained high. The authors speculate that increasing esketamine dose in the combination may further improve analgesic effects.
NCT06789016
Effect of perineurial dexmedetomidine on erector spinal plane block duration for pediatric, idiopathic scoliosis surgery.
NCT05051254
Respiratory muscle testing allows a quantitative assessment of inspiratory and expiratory muscles in children of any age with primary or secondary respiratory muscle impairment, in order to better understand the pathophysiology of respiratory impairment and guide therapeutic management. The use of an invasive technique (esogastric probe) makes it possible to specifically explore the diaphragm, the accessory inspiratory muscles and the expiratory muscles in order to detect dysfunction or paralysis of these muscles, and to estimate the work of breathing in order to better guide the respiratory management. The primary objective of the study is to evaluate the respiratory effort in children with primary or secondary impairment of the respiratory muscles during spontaneous breathing or during mechanical ventilation.
NCT06828068
In the scoliosis screening program of the Student Health Service (SHS), Department of Health (DH), in Hong Kong, more than 50% of screened school children prescribed with x-ray examination basing on the screening protocol did not have Cobb angle greater than the referral threshold of 20°; ie they did not need specialist referral and thus were subjected to unnecessary x-ray exposure. Our primary objective is to determine whether a new radiation-free ultrasound system could identify subjects with Cobb angle greater than the referral threshold of 20° thus avoiding unnecessary x-rays in the referral workflow. The secondary objective is to evaluate if Angle of Trunk Rotation (ATR) can further increase the accuracy of ultrasound assessment. This study is an extension of the registered project entitled "Using Radiation-free Ultrasound for Screening Scoliosis Among School Children in Hong Kong to Reduce Unnecessary X-ray Exposure", (ClinicalTrials.gov Identifier: NCT03135665), however focusing on validity of ultrasound measurement for immature female subjects aged around ten with year since menarche equal to or less than 9 months, who are prone to curve progression, and thus are among the most critical group in clinical management of scoliosis for regular monitoring, treatment decision, and brace indication.
NCT07490886
Introduction Scoliosis is a three dimensional spinal deformity, in the coronal plane, sagittal and transverse planes. The conventional method for assessment of severity of scoliosis is by measuring the Cobb angle on x-ray radiographs of the whole spine. The drawback with x-ray radiography is that it involves radiation. In light of this, a radiation-free ultrasound imaging system, the Scolioscan, has been developed for quantitative assessment of spinal deformity. This study aims at evaluating the effectiveness of Scolioscan for screening scoliosis among school children in Hong Kong. Benefit and harm The results of this study will carry significant impacts in that if Scolioscan is proven to be accurate for screening scoliosis among school children, it can be incorporated in the algorithm for screening scoliosis with the intention of reducing unnecessary x-ray exposure. Scolioscan is a radiation-free ultrasound system. Procedures 1. This is a longitudinal study on school children screened for scoliosis at the Student Health Service Centres of Department of Health. If the subject and the guardians agree to participate in the study, ultrasound scanning of the spine using the Scolioscan will be performed. No additional visit is required beyond the routine practice. Clinical assessment of apical rotation of the spine with the subjects bending forward will also be measured using a Scoliometer at the first clinic visit and subsequent clinic follow- up visits at Prince of Wales Hospital. Specialist care for the back problem and scoliosis will be continued at Prince of Wales Hospital as needed. 2. Subjects will be identified at the Student Health Service Centres of Department of Health, Hong Kong. Those who fulfill the recruitment criteria and their guardians will be given full explanation of the study and be invited to participate in the study. During the scanning procedure with the Scolioscan, clients will be asked to stand steadily in different postures, namely erect, right side-bending and left side-bending within the comfort level of the clients. Ultrasound gel will be applied on the back and ultrasound images will be taken along the spine. The scanning itself may last for 1 minute for each posture.
NCT04929678
The purpose of this study was to establish probable benefits and evaluate the safety and preliminary effectiveness of the Braive™ GMS when used in the treatment of pediatric progressive scoliosis.
NCT07470567
Posterior scoliosis correction surgery is associated with sever postoperative pain that necessitate high perioperative opioid doses to alleviate pain . Regional anesthesia techniques such as ultrasound-guided erector spinae plane (ESP) block have emerged as promising strategies for improving postoperative analgesia and reducing opioid consumption. This secondary analysis evaluates the cost-utility of ESP block compared with total intravenous anesthesia (TIVA) alone in patients scheduled for posterior scoliosis correction surgery. The analysis assesses postoperative quality of life using the EQ-5D-5L instrument value sets from Egyptian population alongside healthcare costs within the early postoperative period. The study aims to determine whether ESP block provides improved patient outcomes and represents a cost-effective strategy for perioperative pain management in scoliosis surgery
NCT06365892
This study aims to investigate the effects of conditioning with open-label placebos on standard postoperative treatment for patients undergoing surgery for idiopathic scoliosis in a randomized controlled, 6-week trial with 64 AIS patients randomly assigned to one of two arms: Open-label Placebo (COLP) + treatment as usual TAU / TAU control. The study involves collecting data from your child's medical record. At each regular clinic visit, the patient clinical data will be collected by the research coordinator. Surveys will be collected including:• PROMIS for the age group 10 to 18 years.
NCT04761549
Adolescent Idiopathic Scoliosis (AIS) is a growth defect of the spine that primarily occurs in prepubertal children between the age of 10 to 14 years, affecting approximately 3% of these otherwise normal children. AIS has been associated with problems related to posture, load-related back pain, as well as aesthetic problems, e.g. the induced asymmetry of the shoulder. Therefore, early diagnosis followed by the appropriate treatment is vital to prevent further curve progression of AIS and minimize the health-related complications of these patients. The current treatment recommendation to stop curve progression for an immature patient with a scoliosis curve between 25 and 40 degrees is to wear a brace. If the curve in the skeletally immature patient is not responding to the brace treatment, dynamic scoliosis correction by vertebral body tethering can be considered when there is still some growth potential left. State-of-the-art guidelines for the selection of fusion levels are currently mainly based on two-dimensional (2D) static radiographic parameters (such as, the Cobb angle and Shoulder balance) and a qualitative assessment of 2D bending or traction radiographs. Several classification systems and algorithms that are based on the 2D static radiographic (X-ray) parameters exist to assist surgeons in determining the appropriate levels to be instrumented. Despite this wide range of classification systems and detailed guidelines available in the literature, spinal fusion does not always yield satisfying 2D radiographic clinical outcome, with revision rates ranging from 3.9% to 22%. Overall, the surgeon is presently not provided with 3D dynamic and mechanical information regarding the deformity of the AIS to guide the decision-making. Obtaining this vital 3D dynamic information regarding the curvature and mechanical behavior of the spine will allow the surgeon to make an evidence-based and well-informed decisions in the treatment of the AIS patient. Consequently, realizing these objectives has the potential to improve patient satisfaction, reduce the postoperative complications and accordingly reduce socio-economic costs associated with AIS treatment. Recent advances in the use of subject specific musculoskeletal models will form the basis to realize this shift from 2D to 3D dynamic in AIS care.
NCT07459400
Scoliosis is a musculoskeletal disorder defined by a three-dimensional spinal deformity that can result in substantial clinical and functional limitations, particularly during adolescence and young adulthood. Affected individuals commonly experience postural asymmetry, muscular imbalance, pain, and diminished quality of life. In conservative management, Physiotherapeutic Scoliosis-Specific Exercises (PSSE) have gained recognition as a fundamental intervention. The primary objectives of PSSE include optimizing spinal alignment, facilitating rotational breathing, and restoring muscular symmetry to improve functional capacity. Evidence from systematic reviews suggests that PSSE, especially the Schroth method, are superior to general exercise programs in improving both radiographic parameters and health-related quality of life.Meta-analytic findings further support the effectiveness of PSSE in reducing curve magnitude and enhancing quality of life outcomes. Among the various PSSE approaches, the Schroth method is one of the most extensively investigated and widely applied in clinical settings. This method incorporates three-dimensional postural correction, targeted breathing techniques, and the development of postural awareness. Randomized controlled trials have demonstrated that Schroth exercises significantly improve SRS-22 quality of life scores and positively influence pain, body image, and overall well-being.Despite these established benefits, pain and muscle tension occurring during exercise sessions may negatively influence adherence to rehabilitation programs. In young adults, pain is a critical factor limiting treatment compliance and restricting engagement in daily activities. Accordingly, adjunctive interventions implemented prior to exercise may enhance exercise tolerance and optimize therapeutic outcomes.Peloidotherapy, which involves the therapeutic application of natural medicinal mud, is commonly used in musculoskeletal rehabilitation due to its analgesic, muscle-relaxant, and circulation-enhancing effects. By alleviating pain and reducing muscular tension, peloidotherapy may facilitate greater participation in exercise programs and support improved clinical outcomes.This study aims to investigate the effects of adjunctive peloidotherapy administered before Schroth-based PSSE in young adults with scoliosis, focusing on pain, exercise adherence, and quality of life, with particular emphasis on SRS-22 measures..
NCT07285551
The aim of this study is to assess how physiotherapy based on the Rigo Concept, combined with WBV, affects sagittal spinal curvatures, the angle of trunk rotation (ATR), and trunk symmetry in girls with AIS. Participants undergo a 5-day individualized physiotherapy program. The exercises follow the four general principles of the Rigo Concept: three-dimensional postural correction, expansion technique, muscle activation, and integration. Therapy is delivered for 3 hours per day, with three 15-minute breaks. Additionally, participants in the Rigo Concept with WBV group perform exercises in a standing position using two poles while exposed to WBV on a Galileo Med 35 platform (Novotec Medical GmbH, Pforzheim, Germany) at a frequency of 25 Hz, with a peak-to-peak displacement of 2 mm. Each session includes three 3-minute bouts of vibration, with 3-minute rests between them. During WBV, participants perform exercises according to the principles of the Rigo Concept.
NCT07321600
This prospective randomized controlled trial will evaluate whether adding resisted inspiratory muscle training (IMT) to Physiotherapeutic Scoliosis-Specific Exercises (PSSE)-Schroth exercises provides additional benefits on clinical outcomes in individuals with adolescent idiopathic scoliosis. Participants will be randomly assigned to either PSSE-Schroth plus IMT or PSSE-Schroth alone. Both groups will receive supervised exercise sessions three times per week for 8 weeks (24 sessions). Outcomes will be assessed before and after the intervention and will include clinical measures (e.g., Cobb angle, angle of trunk rotation, Posterior Trunk Symmetry Index, The Walter Reed Visual Assessment Scale), respiratory muscle performance (maximal inspiratory pressure/maximal expiratory pressure, six-minute walk test) and related physiological parameters, functional performance (balance, 3D kinematics, plantar pressure analysis, isokinetic strength), sleep quality, and health-related quality of life (Scoliosis Research Society- 22, Italian Spine Youth Quality of Life). The study is expected to enroll approximately 45 participants.
NCT07447193
The aim of this study is to evaluate whether pain perception under spinal pressure created on a physiotherapy roller differs according to gender in individuals diagnosed with scoliosis.
NCT00448448
Adolescent idiopathic scoliosis (AIS) is a structural curve of the spine with no clear underlying cause. Bracing is currently the standard of care for preventing curve progression and treating AIS. However, the effectiveness of bracing remains unclear. The purpose of this study is to compare the risk of curve progression in adolescents with AIS who wear a brace versus those who do not and to determine whether there are reliable factors that can predict the usefulness of bracing for a particular individual with AIS.
NCT07428083
In this study, the effects of Kinesio Taping methods applied in combination with Schroth therapy on pain and functional capacity in young adults diagnosed with idiopathic scoliosis will be evaluated. This study is designed as a randomized controlled trial. Participants will be randomly assigned to one of three groups: Group 1: Schroth therapy combined with Kinesio Taping Group 2: Schroth therapy alone Group 3: Schroth therapy combined with sham Kinesio Taping Kinesio Taping will be applied for 4 weeks. The tape will remain in place for 5 consecutive days, followed by a 2-day rest period for the skin, and this cycle will be repeated throughout the intervention period. Schroth therapy will be administered 3 times per week for 4 weeks. Assessments will be conducted at baseline (Week 0), during treatment (Week 2), at the end of treatment (Week 4), and at follow-up (Week 8). The primary outcome measures will be pain intensity assessed by the Numeric Rating Scale (NRS) and functional disability assessed by the Oswestry Disability Index (ODI). Secondary outcome measures will include the Scoliosis Research Society-22 (SRS-22) questionnaire and the Patient Global Impression of Change (PGIC) scale.