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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 10 Years and 17 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Scoliosis cases Participants with clinician diagnosed adolescent idiopathic scoliosis, defined as Cobb angle >=10 degrees with rotation.
Controls Participants without adolescent idiopathic scoliosis, described as a spinal curvature (Cobb angle) of <10 degrees.
Neuromuscular scoliosis Participants with physician confirmed scoliosis, defined as Cobb angle >=10 degrees, secondary to a neuromuscular condition.

Recruiting Locations

Children's Hospital Colorado Anschutz
Aurora, Colorado 80045

More Details

Status
Recruiting
Sponsor
University of Colorado, Denver

Study Contact

Siera R Rossi, B.S.
720-777-1050
siera.rossi@cuanschutz.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.