Using botulinum toxin and yoga-like exercises to treat scoliosis in adolescents
Incobotulinumtoxin A and Yoga-like Isometric Exercise in Adolescent Idiopathic Lumbar Scoliosis
This study is testing if combining botulinum toxin injections with yoga-like exercises can help teenagers with scoliosis improve their spinal curvature and strength.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 14 Years to 18 Years |
| Sex | All |
| Sponsor | Manhattan Physical Medicine and Rehabilitation, LLP Academic / other |
| Locations | 1 site (Manhattan, New York) |
| Trial ID | NCT04922983 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the combined effects of botulinum toxin injections and a yoga-like isometric exercise regimen on adolescents with idiopathic lumbar scoliosis. The study involves a randomized control design over six months, where participants aged 12 to 18 with scoliotic curves between 25 and 60 degrees will perform daily yoga poses to strengthen the weak side of their spine. After three months, those in the placebo group will receive the actual treatment, ensuring all participants benefit from the intervention. The study also includes follow-up X-rays to monitor changes in spinal curvature.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 12 to 18 with a scoliotic curve between 25 and 60 degrees who are willing to commit to daily yoga exercises.
Not a fit: Patients with neurological or muscular diseases, genetic abnormalities affecting growth, or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive treatment option to reduce scoliosis curvature in adolescents.
How similar studies have performed: Previous studies have shown that yoga poses can effectively reverse scoliotic curves, but this combined approach with botulinum toxin is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Fourteen - 18 years of age, 2. Scoliotic curve greater than 25 degrees, less than 45 degrees, 3. Stated willingness to do the yoga and yoga-like poses daily, 4. Written, signed consent by patient and parent/guardian 5. Pre-test Cobb films no less than 3 months old read by independent radiologists. * Exclusion Criteria: 1. Neurological, muscular or neuromuscular disease, (e.gs., cerebral palsy, myopathy, stroke), 2. Genetic abnormalities that affect limb growth, proportionality or metabolism, (e.gs., mucopolysaccharidoses, Marfan's syndrome, Refsums disease). 3. Pregnancy and other conditions prohibiting X-rays or minute(s)-long exertion (e.gs., congestive heart failure, great weakness, COPD). 4. Previous exposure to botulinum neurotoxin Type A. Sexually active female subjects must present a recent negative pregnancy test.
Where this trial is running
Manhattan, New York
- Manhattan Physical Medicine and Rehabilitation, PLLC — Manhattan, New York, United States (Recruiting)
Study contacts
- Principal investigator: Loren M Fishman — Columbia University
- Study coordinator: Loren M Fishman, MD
- Email: lorenmartinfishman@gmail.com
- Phone: 646-642-0700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.