No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
10 – 17
Sex
Any
Study type
Observational
Participants needed
500 (estimated)
Sponsor
University of Colorado, Denver · Other
Who this trial is looking for
This trial is looking for young people aged 10-17 with scoliosis, either idiopathic or neuromuscular. Participants will visit a Children's Hospital Colorado location twice, about 6-12 months apart, and give blood samples to help researchers understand scoliosis progression.
Are You a Good Fit for This Trial?
Must not be takingBaclofenPrednisoneAntiepileptic medicationsDiazepamTizanidineDantrolene
I receive care for scoliosis at a Children's Hospital Colorado location.
You may not be able to join if
I have a genetic condition affecting my bones or muscles.
I was diagnosed with scoliosis before I was 9 years old.
My spinal curve is greater than 50 degrees.
I am taking medications that may affect protein levels.
I am pregnant.
I have a neurocognitive disorder that is non-verbal or non-ambulatory.
I have congenital scoliosis.
I have spine surgery scheduled before the study visit.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 prote…
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.
Trial Locations
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Eligibility Criteria
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 t…
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
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