Clinical Research Directory

Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis

Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity that may be associated with misconceptions regarding its causes, symptoms, progression, and treatment. The Scoliosis Misconception Scale (SMS) was developed to assess patients' understanding and misconceptions about AIS. This observational methodological study aims to cross-culturally adapt the SMS into Turkish and evaluate its psychometric properties in adolescents with idiopathic scoliosis. A total of 200 patients aged 10-17 years with AIS will be recruited. The Turkish version of the 17-item SMS will be administered, and test-retest reliability will be assessed in a subgroup of 50 participants approximately two weeks after the initial assessment. The study will examine item-level measurement properties, internal consistency, and test-retest reliability. Item response theory analyses will also be considered, depending on model assumptions and sample adequacy. The findings are expected to provide evidence regarding the suitability of the Turkish SMS for assessing scoliosis-related misconceptions in Turkish-speaking adolescents.

Clinical and Biological Parameters in Adolescent Idiopathic Scoliosis

This single-center, observational, cross-sectional study aims to investigate the association between fecal calprotectin levels and clinical characteristics in adolescents with idiopathic scoliosis. Clinical, radiological, anthropometric, nutritional, and laboratory parameters will be evaluated to explore potential relationships with curve severity.

Protocol for a Randomized Controlled Trial of a Clinician-Supervised Home-School-Hospital-Linked Digital Health Platform-Supported Conservative Management Pathway for AIS

Adolescent idiopathic scoliosis (AIS) brings substantial physical and psychological burden to affected teenagers, and current conservative follow-up management is fragmented under routine clinical settings. This single-center, superiority, parallel-group, 1:1 randomized controlled trial with assessor-blinded outcome evaluation will compare a clinician-supervised, platform-supported collaborative care pathway with routine guideline-based conservative care in 76 adolescents with mild-to-moderate AIS. Participants will be assessed at baseline, 4-month (primary endpoint), 8-month, and 12-month follow-up. The primary outcome is the change in Cobb angle from baseline to 4 months. Secondary outcomes include treatment adherence, mental-health status, medical expenditure, participant and guardian satisfaction, and safety outcomes. The primary analysis will follow the intention-to-treat principle. The first participant was enrolled on 26 March 2025; to date, 35 of the target 76 participants have been recruited.

Construction of a Screening and Precision Intervention System for Adolescent Idiopathic Scoliosis Based on the DIERS Spinal Moiré System

Taking the DIERS Spinal Moiré System as the primary tool, this study intends to establish an early warning model for adolescent scoliosis based on the system, verify the quantitative relationship between different body postures, three-dimensional pelvic parameters (inclination, rotation angle, torsion angle) and Cobb angle progression, analyze the pelvic compensation characteristics of different Lenke classifications, establish a biomechanical prediction model, develop a dynamic risk assessment algorithm suitable for campus screening, formulate personalized rehabilitation programs under the guidance of DIERS parameters, evaluate the inhibitory effect of biofeedback training on scoliosis progression, and form a standardized "screening-diagnosis-intervention-management" process. This project will develop and promote a screening and precision intervention system for adolescent scoliosis based on the DIERS Spinal Moiré System. The research outcomes of this project will assist the clinical diagnosis and treatment of adolescent idiopathic scoliosis, and propose a precision diagnosis and treatment strategy led by a quantitative data platform. The research findings of the project will be mainly submitted in the form of papers, with the plan to publish 1-2 papers indexed in SCI.

Enhancing the Therapeutic Effect of Bracing for Adolescent Idiopathic Scoliosis With a Hybrid Bracing Protocol

This is a prospective randomized controlled trial investigating the therapeutic effect of the Hybrid Bracing Protocol (HyBP) over the Conventional Brace in enhancing In-brace Correction (IBC) for adolescent idiopathic scoliosis(AIS).

Intravenous Dexamethasone for ESP Block Analgesia in Children Undergoing Idiopathic Scoliosis Surgery

This randomized, double-blind, placebo-controlled study will evaluate the effect of intravenous dexamethasone on postoperative analgesia in children and adolescents undergoing surgery for idiopathic scoliosis with bilateral erector spinae plane (ESP) blocks. Participants will be randomly assigned in a 1:1:1 ratio to receive intravenous placebo, dexamethasone 0.1 mg/kg, or dexamethasone 0.2 mg/kg. All participants will receive standardized general anesthesia, bilateral ultrasound-guided ESP blocks, and multimodal postoperative analgesia. The study will evaluate postoperative opioid requirements and the duration and quality of postoperative analgesia. Secondary outcomes will include postoperative pain intensity, time to first rescue opioid administration, the proportion of participants requiring rescue opioid analgesia, postoperative nausea and vomiting, blood glucose concentrations, and adverse events. The study aims to determine whether intravenous dexamethasone improves postoperative analgesia following ESP block and whether the analgesic effect differs between the two studied dexamethasone doses.

Sleep Quality in Adolescents With Idiopathic Scoliosis

This controlled cross-sectional observational study aims to compare sleep quality between adolescents with idiopathic scoliosis and age- and sex-similar healthy controls. Participants aged 10-18 years will complete online questionnaires assessing demographic characteristics and sleep quality. Adolescents with idiopathic scoliosis will also be evaluated for scoliosis-specific quality of life, body image, Cobb angle, curve type, pain, brace use, and daily brace-wearing duration. The study will additionally investigate factors associated with sleep quality in the scoliosis group. The planned enrollment is 100 participants, including 50 adolescents with idiopathic scoliosis and 50 healthy controls.

Real-World Effectiveness of Conservative Treatment in Idiopathic Scoliosis

This retrospective observational study aims to assess the real-world effectiveness of conservative treatment (bracing and specific exercises) in patients with idiopathic scoliosis treated with an Evidence-Based Personalised Approach (EBPA). Clinical records of about 30,000 patients collected in the institutional database of ISICO (Italian Scientific Spine Institute, Milan, Italy) since 2003 will be analysed. For each patient, the expected natural history (risk of progression without treatment) will be estimated with two validated prognostic models, IS-GROWTH and BrAIST-Calc. The outcome observed at skeletal maturity will be compared with the predicted risk to measure treatment effectiveness in preventing the 30°, 45° and 50° Cobb thresholds. Secondary aims include subgroup analyses by age at onset (infantile, juvenile, adolescent), validation of the prognostic models in the Italian population, over- and under-treatment rates, drop-outs and compliance, quality of life of patients and parents, and comparison between treatment tools.

Validation of the Clinical Decision Support Systems (CDSS) Developed in the EU Horizon PREPARE Project in the Rehabilitative Treatment of Idiopathic Scoliosis

The study aims to validate both the predictive capacity and the clinical usability of the Clinical Decision Support System (CDSS) developed within the PREPARE project (European Union Grant Agreement 101080288 PREPARE HORIZON-HLTH-2022-TOOL-12-01) for the management of idiopathic scoliosis (IS). This will be achieved through simulation-based studies.

Hypnosis for Pain and Nausea Reduction in Scoliosis Surgery: An Interventional Study

This study evaluates whether preoperative hypnosis can reduce postoperative pain, nausea, and opioid use in adolescents undergoing scoliosis surgery. Participants aged 12-18 years will receive hypnosis training before surgery. Outcomes include pain scores, nausea severity, opioid consumption, and length of hospital stay. Results will be compared to a historical control group without hypnosis.

Relationship Between Spinopelvic Parameters and Plantar Pressure in Adolescents With Lenke Type I and V Scoliosis

Adolescent idiopathic scoliosis (AIS) affects the alignment of the spine and body posture, which can influence balance and the way body weight is distributed through the feet. This observational study aims to examine how different types of spinal curves, specifically Lenke Type I and Type V, are related to foot pressure patterns during standing and walking. Participants will undergo standard spinal X-rays to measure alignment and a plantar pressure analysis, a simple test performed on a special platform that records how the feet press against the ground. The study will explore the relationship between spinal shape and foot pressure characteristics. The results of this study are expected to improve understanding of how adolescents adapt to scoliosis and may help guide more effective exercise and rehabilitation programs to improve balance and daily function.

Supervised vs. Home Schroth Exercise in AIS

This study aims to compare the effectiveness of supervised Schroth exercises versus a home-based exercise program in adolescents with Adolescent Idiopathic Scoliosis (AIS).

Proprioceptive Neuromuscular Facilitation Combined With Spiral Muscle Chain Training for Adolescent Spinal Curvature Abnormalities

The goal of this clinical trial is to evaluate the clinical effectiveness of proprioceptive neuromuscular facilitation (PNF) combined with spiral muscle chain training in improving spinal function and posture in adolescents aged 13 to 18 years with spinal curvature abnormalities. The main questions it aims to answer are: Does exercise-based intervention improve trunk inclination angle, kyphotic angle, and body balance parameters in adolescents with spinal curvature abnormalities? Researchers will compare a PNF therapy group, a spiral muscle chain training group, and a combined PNF plus spiral muscle chain training group to assess differences in trunk inclination angle, kyphotic angle, and spinal mobility outcomes. Body mass index, fat-to-muscle ratio, and other body-composition-related indicators will be analyzed as exploratory post hoc outcomes. Participants will: Be assigned to one of three intervention groups: PNF therapy alone, spiral muscle chain training alone, or combined PNF plus spiral muscle chain training. Participate in supervised exercise training sessions three times per week for 12 weeks. Undergo pre- and post-intervention assessments, including body composition testing, and electronic spinal measurements. Participants will: Be assigned to one of three intervention groups: PNF therapy alone, spiral muscle chain training alone, or combined PNF plus spiral muscle chain training. Participate in supervised exercise training sessions three times per week for 12 weeks. Undergo pre- and post-intervention assessments, including body composition testing, and electronic spinal measurements.

Wireless EMG-Based Monitoring of Paraspinal Muscle Activation in Adolescent Idiopathic Scoliosis

This study aims to develop and evaluate a wireless, non-invasive, embedded electromyography (EMG) system for monitoring paraspinal muscle activation asymmetries in adolescents with idiopathic scoliosis. Surface EMG electrodes will be placed bilaterally around the apical vertebra of the spinal curve to record muscle activity during static (seated) and dynamic (trunk extension) tasks. Measurements will be taken longitudinally over the course of physiotherapy treatment to evaluate whether the recorded muscle activity patterns can serve as an objective, non-invasive indicator of treatment response, potentially reducing reliance on repeated radiographic (X-ray) follow-up.

Schroth and Pilates for Adolescent Idiopathic Scoliosis

The primary aim of this study is to investigate the effectiveness of Schroth training and the multidimensional effects of adding Pilates-based exercises to Schroth training in individuals with adolescent idiopathic scoliosis. Specifically, the study aims to evaluate the effects of Pilates-based exercises combined with Schroth training on lung capacity, trunk muscle strength, proprioception, trunk rotation, and posture. In addition, it seeks to examine the impact of the intervention on important functional and psychosocial outcomes, including quality of life, perceived cosmetic deformity, and pain threshold. This study is expected to contribute to the existing evidence on the use of Pilates exercises in combination with Schroth exercises for individuals with adolescent idiopathic scoliosis by providing a comprehensive evaluation of the effects of this combined intervention. The findings are intended to provide guidance for clinicians and researchers regarding the combined use of different exercise approaches in the management of adolescent idiopathic scoliosis. Furthermore, the study aims to explore the potential benefits of integrating the Schroth method with Pilates as a holistic treatment approach for scoliosis management.

UNderstanding the Causes Of Idiopathic Scoliosis Through the Longitudinal Analysis of Proteomic Markers: the UNCOIL Study

The goal of this observational study is to find clinical, demographic, and protein biomarkers that scoliosis progression (scoliosis curve increases) and/or differ between participants with scoliosis versus those without scoliosis. The investigators aim to answer the following questions: 1. Are age, sex, skeletal maturity, and family history associated with scoliosis curve progression? 2. Do protein levels differ between progressive and non-progressive cases? 3. Do protein levels change between baseline and follow-up visits in progressive and non-progressive scoliosis cases? 4. Do proteins differ between participants with AIS vs those without AIS? 5. Do proteins or change in proteins differ between participants with AIS vs those with scoliosis secondary to neuromuscular conditions. Participants will: * Participate in two research visits 6-12 months apart at a Children's Hospital Colorado location. * Participate in a blood draw at each study visit to collect about 3 tablespoons of blood. * Fill out surveys yearly regarding new medical visits, pain, physical function, anxiety and depression, medical and family history, and current medications.

Perioperative Steroid Dosing on the APR in AIS

The objective of this study is to perform a prospective, randomized controlled trial investigating the clinical usage of perioperative dexamethasone usage on APR activation, postoperative morphine usage, postoperative nausea, and hospital length of stay. There will be a control control and a Dexamethasone cohort. Participants will be randomized into one of the two cohorts. Patients in the control group will receive one 8mg dose of dexamethasone intraoperatively as per standard of care anesthesia protocols. Patients randomized to the dexamethasone cohort will be administered 8 mg of dexamethasone with 3 additional doses administered at 8-hour intervals following surgery for a total of 4 doses. All study activities will tale place at Egleston during the patient's planned inpatient stay for their posterior spinal fusion. This project has the potential to validate the utility of dexamethasone as a way to optimize postoperative care following PSF for AIS by minimizing the need for opioid medications and enhancing mobility and recovery.

Detection of Scoliosis

This study aims to evaluate whether plantar pressure data collected during standing and walking can be used with machine learning to support early detection of scoliosis in young people. Patients with scoliosis and healthy volunteers aged 10-18 will undergo a short assessment using a pressure mat.

Support System Design for Adolescent Scoliosis Orthosis Wear

This study focuses on improving the daily lives and treatment outcomes of teenagers diagnosed with Adolescent Idiopathic Scoliosis (AIS). For many young patients, wearing a corrective brace for 20+ hours a day is physically uncomfortable and psychologically challenging, leading to low compliance and emotional distress.The investigators have developed an integrated "Product System" designed to transform the bracing experience from a burdensome task into a guided, supportive journey. This system consists of three main components:Smart Sensing: Discrete, thin-film pressure sensors are integrated into the existing brace to monitor real-time wear time and fit quality without compromising comfort.Interactive Desktop Terminal: A dedicated device for the home that uses "narrative-driven" feedback (themed around a journey called "The Spine's Path"). Instead of cold medical data, it provides intuitive progress visualizations and rewards to keep participants engaged.Mobile Support App: A tool for both participants and parents to track long-term trends, access educational resources, and facilitate communication with healthcare providers.The Goal of the Study The primary objective is to evaluate how this digital intervention affects a participant's "Intrinsic Motivation"-the internal drive to adhere to treatment. By focusing on three psychological dimensions-Interest/Enjoyment, Perceived Competence, and Pressure/Tension-the investigators aim to determine if interactive feedback can reduce the "medical feel" of the brace and help teenagers feel more in control of the recovery.What Participation Involves Participants will use the product system during the daily routine in home and school environments. The investigators will collect objective data (brace usage hours) and subjective data (through the Intrinsic Motivation Inventory/IMI scale) to measure changes in behavior and mental well-being.Benefits for Families and ProvidersFor Participants: A more engaging, less stressful way to manage the condition and see real-time progress.For Families: Reduced friction regarding brace-wearing and better visibility into the participant's treatment status.For Healthcare Providers: Access to accurate, objective data on participant compliance, allowing for more personalized and effective clinical adjustments.

The Effect of Erector Spinae Plane Block (ESPB) on Pediatric Pain Management Following Posterior Spinal Fusion (PSF) Surgery

This study is being done to better understand the efficacy of an erector spinae plane block (ESPB) in pain management for children with Adolescent Idiopathic Scoliosis or Neuromuscular Scoliosis undergoing Posterior Spinal Fusion surgery. The study team is trying to find out if receiving the ESPB leads to less pain and less need for pain medication after surgery. The ESPB involves an injection of a local anesthetic, ropivacaine, into your child's back muscles to help block pain signals.

AI-Based Digital Therapeutics vs. Traditional Schroth Exercises for Adolescent Idiopathic Scoliosis

This randomized controlled trial (RCT) evaluates the efficacy of a novel Artificial Intelligence (AI)-based digital therapeutic system compared to traditional outpatient Schroth exercises for the treatment of Adolescent Idiopathic Scoliosis (AIS). The intervention utilizes a smartphone application with computer vision technology to perform remote, personalized posture analysis and generate adaptive exercise prescriptions. The study aims to determine if this "Human-in-the-Loop" AI model demonstrates superior clinical outcomes in controlling spinal curve progression and improving treatment adherence compared to standard conservative care over a 6-month period.

Development of a Conservative Care and Bracing Registry (CCBR)

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.

Pre-op Exercise for AIS Surgery

The goal of this clinical trial is to determine if pre-operative scoliosis-specific exercises have a beneficial effect on the health outcomes of surgery for adolescent idiopathic scoliosis. Adolescent idiopathic scoliosis affects adolescents between the age of 10-18. The main questions this study aims to answer are: * Can pre-operative exercises help reduce curve progression prior to surgery? * Can pre-operative exercises help improve the surgery outcomes, such as a lower number of vertebrae needing fusion, increased curve correction, reduced surgery length, and shorter length of stay in the hospital? * Can a pre-operative exercise intervention result in a reduction of the cost of surgery? Researchers will compare the current standard of care (the control group) to an intervention group (with pre-op exercises) to see if pre-op exercises have an effect on these outcomes. Participants will: * visit the clinic every 3 months to complete ultrasound imaging scans and questionnaires * if given an exercise intervention, aim to complete it for roughly 30 minutes a day

Prospective Opioid-Free AIS Fusion

The purpose of this study is to compare the efficacy of a multimodal opioid-free (OF) pain management protocol with a traditional opioid-containing (OC) protocol in pediatric patients undergoing instrumented PSF for idiopathic scoliosis.