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

University of Colorado, Denver500 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Adolescent Idiopathic Scoliosis (AIS)Neuromuscular Scoliosis

Eligibility

Sex: ALLMin age: 10 YearsMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Patients 10-17 years old with idiopathic or neuromuscular scoliosis with a cobb angle of 10-50° that are currently being seen for their scoliosis at a Children's Hospital Colorado location Exclusion Criteria: * Children diagnosed with certain genetic conditions that affect the bones or muscles (Turner syndrome, down syndrome, Marfan syndrome, osteogenesis imperfecta, muscular dystrophy, Ehlers-Danlos syndrome, VATER/VACTERL syndrome, Rett syndrome, Prader Willi syndrome, or Angelman syndrome) * Patients with congenital scoliosis, early onset scoliosis (diagnosed before 9 years old), or those who have spine surgery scheduled prior to the first study visit * Patients whose spinal curve is \>50 degrees * Those taking medications that may influence protein expression (baclofen, prednisone/corticosteroids, antiepileptic medications, diazepam, tizanidine, and/or dantrolene) * Patients who are pregnant * Patients with neurocognitive disorders who are non-verbal and/or non-ambulatory * Patients who are not receiving care for scoliosis at a Children's Hospital Colorado location

Outcomes

Primary Outcomes

Change in curve severity

The change in Cobb angle of the primary scoliosis curve between the baseline and the 6-12 month visit will be quantified.

Time frame: Baseline and 6-12 months

Curve progression

Curve progression will be defined as an increase in Cobb angle between the baseline and 6-12 month follow-up visit of \>=6 degrees and/or need for spine surgery or other invasive surgical intervention.

Time frame: 6 to 12 months