Clinical Research Directory

Studying Melatonin and Recovery in Teens

The goal of this feasibility clinical trial is to learn if melatonin can help teens having major musculoskeletal surgery by promoting healthy sleep. Melatonin is available as a dietary supplement that may be effective in promoting longer, higher quality sleep. This study will assess the feasibility and acceptability of melatonin for teens undergoing major musculoskeletal surgery, as well as determine optimal measured outcomes (sleep, pain, health-related quality of life) at short- and long-term follow-up.

Casting vs Bracing for Idiopathic Early-Onset Scoliosis

Comparison of casting and bracing for the treatment of idiopathic early onset scoliosis

Effect of Kinesio Taping Combined With Schroth Therapy in Young Adults With Idiopathic Scoliosis

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.

Exercise Effects on Fascia, Low Back Pain, and Function in Scoliosis

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.

Idiopathic Scoliosis Progression and Sleep-disordered Breathing in Children

This study aimed to investigate the prevalence and clinical significance of sleep-disordered breathing (SDB) in children with new onset and progressive idiopathic scoliosis (IS)

Post-market Clinical Follow-up Study of NEMOST V2

The NEMOST spinal implant is a growth domino intended for the surgical treatment of progressive scoliosis in children. As part of post-market surveillance, EUROS is conducting a retrospective and prospective study to collect clinical and radiological data on the NEMOST growth domino. Retrospective and prospective multicenter post-market surveillance clinical study. This study is interventional, non-randomized, and uncontrolled. The primary objective of this clinical study is to monitor complications related to the NEMOST growth domino during a 5-year postoperative follow-up in patients treated for progressive scoliosis in children. The secondary objective of this clinical study is to monitor the performance of the NEMOST growth domino during a 5-year postoperative follow-up in patients treated for progressive scoliosis in children. The study will include 140 patients.

Yoga for Back Pain in Adolescent Scoliosis

The Problem: Adolescent Idiopathic Scoliosis (AIS), the pre-eminent spinal pathology affecting over 5% of children and adolescents, presents a pronounced spinal curvature exceeding 10 degrees, with prevalence amongst female adolescents at a ratio of 3:1 compared to males. A significant portion of these patients are not immediate candidates for surgical intervention. The acute shortage of viable non-operative management strategies, which is becoming increasingly imperative given the current barriers to physical therapy access and the growing opioid crisis. The investigator's research intends to explore the addition of a structured yoga protocol to standard of care. This research will thus explore the potential for improved relief and quality-of-life improvements for AIS patients not ready for surgery. Significance: AIS is a pervasive condition which correlates with chronic and episodic lower back pain, diminished sleep quality, and depressive symptoms. This extensive comorbid association coupled with the financial pressure to patients and the healthcare system cannot be understated. Needs Statement: There is a lack of sufficient non-operative management options for AIS. Many patients face limited access and require supplementary management strategies to address the patient's conditions effectively, creating a significant unmet need for non-pharmacological pain management interventions. This need is further highlighted in the context of the escalating opioid crisis, a leading cause of death among adolescents and young adults. Hypothesis: The introduction of a structured yoga protocol can serve as a non-inferior or even superior alternative to traditional standard of care i management of AIS, addressing both the physical and psychosocial aspects intertwined with the condition. IMPACT: Change in Problem Significance: This research trial aims to enhance current standard of care for patients grappling with AIS. If the trial demonstrates superiority of yoga, it will delineate a paradigm shift in the current care standards for AIS patients, fostering a move towards a more cost-effective and holistic approach. Yoga could help alleviate the burdens on the healthcare system by reducing costs and enhancing accessibility for patients. Improvement in Pediatric Orthopedics Practice: By paving the way for non-pharmacological interventions, the trial aspires to mitigate the reliance on opioids for pain management in the pediatric demographic, therefore promoting overall well-being. This project not only seeks to develop alternative pain management strategies amidst a growing opioid epidemic but also champions the cause of improving the quality of life for the pediatric population battling chronic conditions like AIS. It echoes the urgent call to innovate and expand upon the current strategies in place, steering the medical community towards a future where integrative approaches are not the exception but the norm. Ultimately, this research aspires to guide the trajectory of pediatric orthopedics towards a healthcare system that is more inclusive, accessible, and holistically oriented, thereby enhancing the quality of life for pediatric patients grappling with conditions like AIS. 2\. Objectives (include all primary and secondary objectives) Goals/Objectives: To create a randomized clinical trial aimed to evaluate the efficacy of yoga in conjunction with standard of care treatments for AIS patients. SPECIFIC AIMS Aim 1: Evaluate the feasibility and challenges of implementing a yoga protocol for AIS patients. Methodology: Online class attendance, survey completions, and follow-up appointments. Anticipated Results: Adequate participant adherence and data reliability. Aim 2: Compare clinical outcomes between patients who receive traditional care modalities versus those who added yoga to treatment plan. Methodology: Utilize validated tools such as the SRS-22 questionnaire and monitor outcomes including depression scale, sleep quality, analgesic usage, activity levels, and Cobb angle. Anticipated Results: Significant physical and psychological improvements in the yoga group.

Apparent Diffusion Coefficient of the Intervertebral Disc in Children: Pilot Study

The pathophysiology of adolescent idiopathic scoliosis is unknown. This pathology develops from 10-11 years of age and progresses until skeletal maturity, or even adulthood for the most severe forms. Current knowledge is limited as to its origin on the one hand and the evolutionary nature of scoliosis on the other. The mechanical parameters of the intervertebral disc are incompletely known from the deep location of this organ, its fragile nature in vivo and its susceptibility to desiccation during ex-vivo analysis. To complete our knowledge of the mechanical parameters of the intervertebral disc of scoliotic and non-scoliotic children, we are proposing an in vivo, non-invasive and non-irradiating study carried out in children who are the main target of this pathology. The objective of this work is to characterize the diffusion parameters (apparent diffusion coefficient ADC) of the intervertebral disc in vivo, in a non-invasive and non-irradiating manner by magnetic resonance imaging in children and adolescents. As this measurement has not been carried out in children and adolescents, we want to perform these MRI scans in children free from scoliosis and carriers of scoliosis.

Reliability of the Scoliosis Caregiver Response and Emotional Scale (SCaRES) Questionnaire

The aim of this study is to examine the psychometric properties of the Turkish version of the Scoliosis Caregiver Response and Emotional Scale (SCaRES) questionnaire; to evaluate the reliability of the Turkish form and to ensure its usability in clinical and research fields.

Inspiratory Muscle Training in Children and Adolescents With Idiopathic Scoliosis Undergoing Schroth Therapy.

This study evaluates the effectiveness of inspiratory muscle training in children and adolescents with idiopathic scoliosis undergoing therapy with the Schroth method. The intervention- inspiratory muscle training- aims to improve respiratory function, increase exercise tolerance, and strengthen core stability in the participants. The proposed training may enhance the effectiveness of therapy conducted using the Schroth method and improve participants' performance in activities of daily living. The project aims to assess the impact of inspiratory muscle training in children and adolescents with idiopathic scoliosis on respiratory system function, exercise tolerance, and core stability.

This Cross-sectional Study Investigates the Relationship Between Different Curve Patterns in Adolescent Idiopathic Scoliosis (AIS) and the Distribution of Foot Pressure. It Aims to Determine Whether Coronal and Sagittal Curve Patterns Are Associated With Asymmetries in Plantar Pressure Distribution

This cross-sectional study investigates the relationship between different curve patterns in Adolescent Idiopathic Scoliosis (AIS) and the distribution of foot pressure. It aims to determine whether coronal and sagittal curve patterns are associated with asymmetries in plantar pressure distribution during static standing.

Paravertebral Muscles Assessment Using High-resolution MRI in Idiopathic or Neuromuscular Scoliosis Children

Scoliosis is a common three-dimensional spinal deformity defined by vertebral rotation. Apart from collapse scoliosis, clinical and radiological similarities have been observed in children with secondary scoliosis of neuromuscular origin and children with idiopathic scoliosis in terms of the location and type of curvature. It seems relevant to study the axial musculature in these children in more detail, particularly the deep muscles (transversospinales muscles) that have a stabilising and rotational function (multifidi and rotatores). MRI is a non-invasive, non-irradiating technique used in the aetiological diagnosis of idiopathic scoliosis before adolescence and in the diagnosis of secondary scoliosis. However, the muscles are not specifically studied during these examinations. They are performed to analyse the spinal cord and rule out hinge deformities, although this technique does provide information on the paravertebral muscles. The muscles of interest should be analysed using the usual sequences, with the addition of a sequence (DTI) specific to the study of deep muscles in children undergoing axial MRI. This adds 5 minutes to the standard MRI procedure. Several morphological muscle parameters would be thus obtained on specific interest areas and then compared between right and left side and between two groups of children, 5 suffering from idiopathic scoliosis and 5 with neuromuscular scoliosis. Idiopathic scoliosis corresponds to a heterogeneous group of patients in terms of the location, number and progression of the curves. The research hypothesis is that there may be a subgroup of patients with idiopathic scoliosis whose progression and/or aetiology is muscular in origin. MRI could then become a routine examination in the assessment of all scoliosis, whether idiopathic or not.

Synergic Effects of Schroth Method With and Without Core Stabilization Exercises in Idiopathic Scoliosis Patients

A randomized controlled trial was conducted on 72 patients diagnosed with idiopathic scoliosis at the University of Lahore Teaching Hospital. The study aimed to explore the synergistic effects of the Schroth method with and without core stabilization exercises. Participants were randomly allocated into two groups: Group A, which received both the Schroth method and core stabilization exercises, and Group B, which received only the Schroth method. The intervention lasted for 10 weeks, with assessments conducted at baseline, the 5th week, and the 10th week. Outcome measures included Cobb angle (spinal curvature), lumbar extensor endurance (Sorensen test), chest mobility, and quality of life (SRS-22 questionnaire). The study found significant improvements in all outcome measures for both groups, with Group A showing superior results. The addition of core stabilization exercises to the Schroth method resulted in better reductions in Cobb angle, enhanced lumbar extensor endurance, and improved chest mobility and quality of life, indicating a synergistic effect of the combined approach. The findings suggest that incorporating core stabilization exercises into scoliosis treatment protocols can lead to superior clinical outcomes.

Comprehensive Study of Post-surgical Pain After Pectus or Spine Surgery

This will be a prospective study to determine the association between specific genotypes, epigenetics, behavioral, social and biological factors, with the phenotypes, defined by pain perception, postoperative pain, analgesic effects, side effects to perioperative analgesics, chronic postoperative pain, and gene expression in patients following pectus excavatum repair.

Zhejiang Adolescent Spine and Vision Health Cohort: A Longitudinal Database Analysis

The aim of study: 1. To investigate the prevalence of scoliosis, other spinal deformities, myopia, and visual impairments in adolescents (aged 6-18) in Zhejiang Province. 2.To track 8-year dynamic changes in spinal curvature and analyze associations between scoliosis, vision disorders, and potential risk factors. 3.To deliver scoliosis health education during screenings. 4.To mitigate scoliosis progression through early detection and intervention.

PMCF (Post-Market Clinical Follow-up) Study on The Tether™ in UK (United Kingdom)

The goal of this observational study is to collect information about The Tether™ device in participants with progressive idiopathic scoliosis, Lenke Type 1 curves. The main purpose is to provide assessment of: * ongoing safety * probable benefits Participants who will receive The Tether™ during spine surgery will have to attend follow-up visits which are part of standard-of-care.

fNIRS-based Analysis and Evaluation of the Effect of Schroth Rehabilitation on Motor Functions in Adolescent Idiopathic Scoliosis (AIS)

This study investigates the effects of Schroth-based rehabilitation on cortical dynamics, body awareness, and quality of life in individuals with Adolescent Idiopathic Scoliosis (AIS). Using fNIRS technology, motor control processes will be monitored, and the impact of rehabilitation on brain activity will be assessed. A total of 30 participants (15 healthy and 15 with AIS), aged 8-16, will be examined, with pre- and post-rehabilitation comparisons. Measurements will include static posture, Y-Balance Test, Schroth walking, and brain activity recordings. SPM analysis will be used to assess brain signals, and quality of life and cosmetic deformity perception will be statistically evaluated. The findings will contribute to the integration of neuroimaging into rehabilitation assessment, helping to develop more effective treatment strategies.

De Tethering Exercises for Scolisis

This study aimed to investigate the effect of Detethering exercises on muscle tone in patients with adolescent idiopathic scoliosis. H1: Detethering exercises affect muscle tone in patients with adolescent idiopathic scoliosis.

Dexmedetomidine for ESPB in Pain Management After Pediatric Idiopathic Scoliosis Surgery

Effect of perineurial dexmedetomidine on erector spinal plane block duration for pediatric, idiopathic scoliosis surgery.

Spinal Bracing in Adults with Painful Degenerative Scoliosis: a Randomized Controlled Open Trial

The purpose of this study is to compare the efficacy on low back pain intensity at 6 months after randomization of a custom-molded lumbar-sacral orthosis as an add-on therapy to usual care in people with painful adult degenerative scoliosis.

A Suggested Rehabilitation Protocol for the Treatment of C-shape Scoliosis

This study aims to compare the effectiveness of mechanical traction and 3D apical vertebral mobilization and active exercises on Cobb's angle, spinal ROM, and function in patients with C-shaped scoliosis.

The Use of DXA in Scoliosis

This is a pilot study to look at image quality of iDXA AP supine spinal images to see if the investigators can accurately measure the size of the curve from iDXA images and to see how patients with scoliosis feel about iDXA imaging compared to normal x-rays. With normal x-rays being taken standing (or sitting if patients are in a wheelchair), it is important that the investigators understand how the lying down images compare to the standing images. Where there may be some clinical benefit, images will be taken standing (normal x-rays) and lying down (iDXA images). The investigators will see if the addition of iDXA images can help in brace design and brace monitoring.

Idiopathic Scoliosis New Onset and Melatonin Phase Delay in Children

This study aimed to investigate the prevalence and clinical significance of melatonin phase delay in children with new onset and progressive idiopathic scoliosis (IS).

Development and Internal Validation of Predicting Models of Idiopathic Scoliosis Natural History and Treatment Outcomes Through the Use of Artificial Intelligence in a Large Clinical Database

Scoliosis is a three-dimensional deformity of the spine. In its most common form (about 70% of cases), the causes are unknown, therefore it is called idiopathic scoliosis. In most cases, it is discovered after 10 years of age, and is defined diagnostically as a curve of at least 10°, measured on a standing x-ray using the Cobb method. If scoliosis exceeds the critical threshold of 30° Cobb at the end of growth, there is a progressively greater risk of health and social problems in adult life. For this reason, the main aim of the treatment is to complete the growth period with a curve less than 30° and good sagittal balance, or at least well below 50°, which represents the surgical threshold. Growth is a factor favouring the evolution of deformities, therefore patients are followed until the end of growth. This is why therapy can last many years, from the discovery of the presence of a deformity until bone maturation is achieved. The early identification of parameters predictive of the outcome of the therapy to direct the least possible aggressiveness towards the result necessary for the patient's future, integrated with the evaluation of its effectiveness (monitoring), is one of the most important objectives in this field to minimize the burden of treatment in a particular phase of growth such as adolescent development, as well as to identify the subjects most at risk of worsening in adulthood. The systematic collection of clinical data during the therapeutic process offers the possibility, through advanced analysis models, applied retrospectively, to identify predisposing factors and protective factors. When the data available is sufficiently large, it is possible to obtain predictive equations that assist clinicians in therapeutic choices and help patients understand the risks and benefits of available therapies. New technologies such as artificial intelligence techniques offer new and interesting ways of estimating risks and calculating the benefits and safety of some therapeutic choices compared to others. This study aims to develop and internally validate data-driven stratification and prediction models to predict multiple end-of-care outcome measures that include curve magnitude, measured in Cobb degrees, measures determining the sagittal balance, and measures of quality of life and function measured through self-completion questionnaires.