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Scoliosis clinical trials

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NCT ID: NCT04153994 Recruiting - Clinical trials for Scoliosis; Adolescence

Erector Spinae Plane Blockade in Pediatric Scoliosis Surgery Patients

Start date: August 28, 2020
Phase: N/A
Study type: Interventional

Providing effective analgesia after spinal fusion for idiopathic scoliosis remains a challenge with significant practice variation existing among high volume spine surgery centers. Even in the era of multimodal analgesia, opioids are the primary analgesics used for pain control after pediatric scoliosis surgery, but have multiple known adverse effects. The erector spinae plane block (ESPB) is a newly described fascial plane block performed by injecting local anesthetic between the erector spinae muscle and the transverse process. Additionally, there are case reports describing the ESPB as part of a multi-modal analgesic plan in adult degenerative spine surgery as well as adult spinal deformity surgery, demonstrating effective analgesia and no clinical motor blockade. Although it is known that the inflammatory reaction plays a crucial role in the mechanism of acute pain after major surgery, the effectiveness of the current regional approach on inflammatory response is not well studied.

NCT ID: NCT04117334 Recruiting - Clinical trials for Adolescent Idiopathic Scoliosis

Determining Best Indications for Bracing for Adolescent Idiopathic Scoliosis

Start date: December 1, 2016
Phase:
Study type: Observational

This is a prospective study for Investigating the cost-effectiveness of current bracing protocols for adolescent idiopathic scoliosis (AIS). It is hypothesized that aggressive management of adolescent idiopathic scoliosis (AIS) including early bracing at mild curve magnitudes and surgery at 40 degrees is more cost-effective while maintaining similar health quality of life. Scoliosis Research Society 22-item and EuroQol- 5 dimension questionnaires and direct/indirect medical costs will be utilized for the cost-effectiveness analysis and health related quality of life assessment. The findings of this study have the potential to improve decision-making and revolutionize care of AIS patients in Hong Kong and globally. Clinicians will be able to utilize our results to provide the best and most cost-effective timing for initiating brace treatment.

NCT ID: NCT04116723 Recruiting - Scoliosis Clinical Trials

Trial of Flexible Bracing Treatment of Adolescents Idiopathic Scoliosis

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

Scoliosis is the three-dimensional (3D) deformity of the spine and trunk. The majority or 80% of the scoliosis cases are idiopathic which means that the cause is unknown. The progression of scoliosis is much more frequently seen in females and severely scoliotic patients face a higher risk of different health problems in their adult life Bracing is the most commonly used non-invasive treatment for patients with smaller spinal curves which are usually between 21 and 40 degrees at Risser stage 0, 1 or 2. However, scoliosis braces are traditionally constructed based on the experience of orthotists. Since 3D spinal deformities are complex, the design and evaluation of braces are challenging with no consensus on an optimal brace design. AI and ML methods therefore constitute a new approach to address the difficulties in designing braces.

NCT ID: NCT04081896 Recruiting - Low Back Pain Clinical Trials

Evaluation of the Effects of a Rehabilitation Program in Individuals With Spine Pain

Start date: April 15, 2019
Phase:
Study type: Observational [Patient Registry]

SpineZone is an innovative physical therapy program with its focus on treatment of cervical, thoracic, and lumbar conditions through the use of a multi-disciplinary, technology enabled platform. Standard physical therapy modalities including psychologically informed physical therapy are employed in addition to online coaching with a fundamental tenant of core strengthening. Treatments are tracked and modified in a multi-disciplinary format taking all radiographic studies into direct consideration. The goal of this study is to utilize a registry of participants undergoing either in-clinic or online rehabilitation treatment for spine pain at the SpineZone clinical in order to understand the clinical outcomes and costs of different rehabilitation modalities in this patient population.

NCT ID: NCT04071665 Recruiting - Spinal Deformity Clinical Trials

A Modified Lateral Lumbar Interbody Fusion VS. Transforaminal Lumbar Interbody Fusion for Adult Degenerative Scoliosis

Start date: May 1, 2020
Phase: N/A
Study type: Interventional

A modified lateral lumbar interbody fusion VS. transforaminal lumbar interbody fusion for the treatment of adult degenerative scoliosis with 2 year follow-up with a multiple center, randomized case-control study

NCT ID: NCT04058561 Recruiting - Clinical trials for Early-Onset Scoliosis Deformity of Spine

Hospital-Based Cluster Trial: Magnetically Controlled Growing Rods Using Distraction Intervals

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

A hospital-based cluster stratified randomization control study will be conducted to investigate spinal growth in Early Onset Scoliosis patients between 5 and 9 years of age. Patients must have a major coronal curve measuring over 50 degrees and be undergoing Magnetically Controlled Growing Rod treatment. We will be studying 6-week lengthening intervals compared to 16-week lengthening intervals on spinal growth within 3 years.

NCT ID: NCT04047225 Recruiting - Clinical trials for Scoliosis Idiopathic

POSTOPERATIVE OPIOID-SPARING EFFECT OF INTRAOPERATIVE PAIN MONITORING USING THE ANALGESIA NOCICEPTIVE INDEX (ANI) DURING IDIOPATHIC SCOLIOSIS CORRECTION IN CHILDREN.

OpiSpANI
Start date: October 26, 2020
Phase: N/A
Study type: Interventional

Anaesthesia is often performed using a balanced technique by administering both opioids and anaesthetics agents. Intraoperative opioid administration is still relying on simple parameters such as heart rate and blood pressure variations. However, many studies in both adults and children have shown the poor accuracy of those parameters in predicting pain because of their sensibility to other intraoperative events such as depth of anaesthesia and volaemic variations. Consequently, intraoperative analgesia is still inadequately managed with periods of under dosage or over dosage of opioid agents. This has been hypothesized to cause postoperative hyperalgesia related to both intraoperative pain (in case of under dosage) or to opioid agents (in case of over dosage). The main resulting effect is an increase of postoperative opioid consumption and the inadequate postoperative rehabilitation because of adverse effects of opioids. During the last decade, many pain-monitors have been investigated. Most of these devices are relying on the determination of the sympathetic-to the parasympathetic systems balance. Among those monitors, the Analgesia Nociceptive Index (ANI) quantifies the parasympathetic system. The ANI device can produce two parameters the instantaneous ANI (ANIi), derived from 60 seconds analysis and the mean ANI (ANIm) derived from 4 minutes analysis. Studies have shown the accuracy of ANIi to detect both experimental and clinical pain in various populations. Moreover, a recent randomized controlled trial during spine surgery in adults has found ANIi to decrease the intraoperative and postoperative opioid consumption when used intraoperatively for guiding the administration of opioid agents

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: 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