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Scoliosis clinical trials

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NCT ID: NCT03978273 Recruiting - Clinical trials for Idiopathic Scoliosis

Effects of Real-Time Feedback Assisted Self-Correction on the Posture of Scoliotic Patients

COVIRSCOL
Start date: October 11, 2019
Phase: N/A
Study type: Interventional

Scoliosis is a progressive three-dimensional deformation of the spine during growth, with a prevalence of 80% in girls. The treatments currently used are surgery and rigid brace, which aim to stabilize scoliosis evolution. The place of rehabilitation is disputed because the methods are multiple, non-standardized and the sessions are infrequent. In a previous study (MOUVSCO, NTC02134704), researchers have identified systematic postural abnormalities in patients with scoliosis, and developped a virtual-brace (medical device, MD) to allow real-time self-correction of the trunk position. The aim of the present study is to evaluate for the first time the efficacy of the virtual-brace on the correction of the posture of scoliotic patients. The hypothesis is that intensified rehabilitation with the virtual-brace will improve pathological postures related to scoliosis.

NCT ID: NCT03968146 Completed - Clinical trials for Scoliosis Idiopathic

Erector Spinae Plane Block in Scoliotic Adolescents

Start date: June 18, 2019
Phase: Phase 2
Study type: Interventional

For scoliotic surgeries, Erector Spinae Plane Block (ESPB) can add to the multimodal approach for perioperative pain management with decreasing the opioids requirement, improving recovery and decreasing ICU stay.

NCT ID: NCT03935295 Recruiting - Clinical trials for Adolescent Idiopathic Scoliosis

Dysport ® as an Adjunctive Treatment to Bracing in the Management of Adolescent Idiopathic Scoliosis

Start date: September 3, 2020
Phase: Phase 4
Study type: Interventional

This study evaluates the combined effect of botulinum toxin A (administered as Dysport® (Ipsen Pharmaceuticals)) and bracing in children with adolescent idiopathic scoliosis. Two thirds of patients will be treated with Dysport® and bracing, while the remaining patients will be treated with placebo and bracing.

NCT ID: NCT03929614 Recruiting - Clinical trials for Idiopathic Scoliosis

Development and Validation of the MOBI Questionnaire

MOBI
Start date: February 1, 2019
Phase:
Study type: Observational

Scoliosis is a common spinal deformity in adolescents. Orthopedic brace treatment is the only conservative (nonsurgical) treatment effective in limiting the progression of this deformity. It is a difficult treatment for young people (discomfort, self-image, limitation in activities) who must wear this rigid orthosis between 20-23 hrs / day during the growth spurt. Recent studies have shown that the effectiveness of this treatment is related to the wearing time of the corset. However, there is a serious problem of compliance to treatment. On average, the brace is worn only 12 hrs / day. A negative perception of the patient with respect to the brace can lead to treatment failure if the brace is not worn. It is therefore essential to understand the impact of the brace on the quality of psychological life, the daily activities and the comfort of young patients. Unfortunately, there is no valid instrument to evaluate all these dimensions. The objective of this project is to develop a questionnaire that can measure the quality of life of patients wearing a brace and validate it for its clinical use. The investigators have created a questionnaire based on the best knowledge published on the subject, opinions of experts in the field and a group of patient partners. At the end of this project, a questionnaire will be available for the first time to assess in depth the perception that patients have of their braces. It can be used to adjust braces in the clinic, as well as to support and encourage compliance to the treatment

NCT ID: NCT03929042 Recruiting - Clinical trials for Adolescent Idiopathic Scoliosis

Evaluating the Effectiveness of Posture Correction Girdle for Adolescents With Early Scoliosis

Start date: July 17, 2017
Phase: N/A
Study type: Interventional

Through the ITF-Tier 3 project (ITS/ 237/ 11), a prototype of the posture correction girdle based on the clinical, textile science, material and ergonomics engineering analyses has been developed for preteen and teenage girls aged 10 to 13 who have the early stages of scoliosis. The girdle provides a corrective force onto the torso by the warping and elastic extension of the shoulder straps and waistband and the insertion of semi-rigid EVA padding and uses a point-pressure support system to achieve the target of posture improvement and spinal progression control with physical and psychological comfort. In order to evaluate the effectiveness of the posture correction girdle, it is proposed to recruit 10 patients to take low dose x-ray (sterEOS) at QMH at supine position. Then, the patient should wear the girdle for two hours and take another x-ray at standing position. If the Cobb's angle of the patient on girdle at standing position can be same as her supine position. It can prove the effectiveness of the girdle.

NCT ID: NCT03915106 Recruiting - Quality of Life Clinical Trials

Quality of Life (HRQoL) of AIS Patients Who Require Bracing or Surgery Using SRS-22 Questionnaire

QolAISSRS22
Start date: July 1, 2019
Phase:
Study type: Observational

Adolescent Idiopathic Scoliosis (AIS) is an unexpected curvature of spine at teenage. AIS causes mainly unpleasant appearance, and sometime comes with pain and difficult to locate or move around. When the spinal curve, or "Cobb angle", increases with time, the investigators call it severe condition when the Cobb angle is 60 degrees or above. The severe suffering patients need to be operated to correct their spinal curve by using metallic rods and metallic screws (implants) to fix the spine. In order to avoid this surgery, the investigators use "brace", a hard fitting case, trying to control the spinal curve degree by using forces from outside. (bracing) to intervene the spinal curve progression is highly recommended for patients with particular clinical characteristics. However, bracing is not always a present experience apart from function restriction. Clinical recommendation requires the patients to brace over 20 hours everyday, which means the patients have to be "braced" around the clock. Patients' perception on being "braced" all day, apart from discomforts under bracing, self-image and mental health after bracing are also important psycho-social factors which have yet to be addressed. Based on our clinical experience, 1-2% of AIS patients, undergoing bracing or not (i.e. at observation stage), require surgical intervention due to rapid spinal progression in a short period of time. By definition, surgery will be arranged for patients with major spinal curve ≥50. The use of health-related-quality-of-life (HRQoL) questionnaires allow clinical professionals to explore many different kinds of interests on patients, including the patient's feeling on his/her medical condition and satisfaction with provided care. Scoliosis Research Society (SRS) patient outcome tool has been a well-accepted HRQoL questionnaire to look for the perception of patients with spinal problems of their status. The SRS-22 questionnaire that has been well accepted as its trustworthy on the score results and SRS-22 is good to be used in patients under different conditions across the disease. This is very important to obtain and compare the scores over time in order to look for any consistent changes. Apart from AIS patients requiring bracing, surgical cases are also very important group of patients to monitor their quality of life before and after surgery, and every follow-up visit after surgery.

NCT ID: NCT03904914 Recruiting - Clinical trials for Scoliosis; Adolescence

Thumb Ossification Composite Index (TOCI) to Predict Skeletal Maturity and Curve Progression in AIS

TOCI
Start date: September 1, 2016
Phase:
Study type: Observational

Accurate skeletal maturity assessment is important for prediction of curve progression and clinical management of adolescent idiopathic scoliosis (AIS) including bracing decision and counseling for prognosis. Determination of the timing of peak growth height velocity and growth remaining are paramount important.1,2 Commonly used clinical or radiological methods are still inadequate or too complex for rapid clinical use in the outpatient setting.3-5 Risser sign had disadvantages of low visibility in posteroanterior (PA) spinal radiograph, wide variability with maturity level and imprecise representation of peak height velocity (PHV) timing.6 Greulich and Pyle atlas (GP atlas) and Tanner-Whitehouse-III (TWIII) method are more reliable and comprehensive classifications to predict maturity, but they are cumbersome and time consuming to be used clinically.7 Both methods require the usage of an atlas, a learning curve required for exact matching of atlas plate or assignment of scores to bones.8 In this study, the investigators introduce Thumb Ossification Classification Index (TOCI). TOCI employed the measurements of epiphysis of distal phalange, proximal phalange, and adductor sesamoid, and results were analyzed together to form a composite stage (composite score) to predict maturity in patient at their peripubertal period. Ultimately the application of TOCI should not be limited to IS patients only. After the establishment of TOCI classification system, the staging system would be applied to radiographs from patients without spinal deformity or suffering from diseases not related to spine.

NCT ID: NCT03894865 Completed - Scoliosis Clinical Trials

Screening and Prevalence of Adolescent Idiopathic Scoliosis in Selected Urban and Countryside Schools in Egypt

Start date: April 1, 2019
Phase: N/A
Study type: Interventional

Early detection of scoliosis and determination of which areas are more affected urban or countryside will help in early management. Also, this will guide the government and the community for early intervention to decrease the factors that leads to this postural abnormality. This also will guide another clinician to search for the cause of these posture deformities and to concentrate screening for special areas with special cultures.

NCT ID: NCT03867240 Withdrawn - Pain, Postoperative Clinical Trials

Gabapentin and Chronic Post Surgical Pain

CPSP
Start date: June 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the effect of a common pain medication (gabapentin) on chronic postsurgical pain in pediatric patients who require surgery for idiopathic scoliosis.

NCT ID: NCT03863496 Completed - Clinical trials for Neuromuscular Diseases

Efficacy of Surgical Treatment by Different Pedicle Screw Systems in Pediatric Neuromuscular Spinal Deformity

Start date: January 31, 2018
Phase: N/A
Study type: Interventional

This study was sponsored by Federal state budgetary institution "Russian scientific center for traumatology and orthopedics" n.a. acad. G.A. Ilizarov" of the Ministry of Health of Russian Federation. The study will take place at this center. It is expected to enroll 70 patients aged 6-25 years with NMD, all of whom will be subjected to thoracic and lumbar spinal deformity surgery. Patients will be divided into two groups depending on skeletal maturity. The degree of skeletal maturity will be determined on the basis of an X-ray study of spinal and pelvic bones. The type of surgical correction will depend on the group.