Overview
The study uses a yoga-like isometric posture and botulinum injections to reduce the curves in adolescent idiopathic lumbar scoliosis. Three previous studies show that the yoga pose is effective for reversing scoliotic curves; Botulinum toxin has been approved by the FDA for teenagers. However, no studies using the two of them together have been done until this one.
Description
The randomized control 6-month study employs an isometric yoga-like posture to strengthen the weak side, and one set of botulinum injections to weaken the strong side of adolescent idiopathic lumbar scoliosis between 25 and 60 degrees. It is open to people between 12 and 18 years of age who are willing to do the pose every day for three months.
This is a crossover study: After 3 months, every patient who was placebo will be offered the actual proven yoga pose and botulinum toxin injections. Two additional free X-rays at 3 weeks and 3 months following the botulinum injection will also be available to each placebo patient.
In this way every patient - placebo or not - will receive the full proper treatment within 3 months.
Eligibility
Inclusion Criteria:
- 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:
- Neurological, muscular or neuromuscular disease, (e.gs., cerebral palsy, myopathy, stroke),
- Genetic abnormalities that affect limb growth, proportionality or metabolism, (e.gs., mucopolysaccharidoses, Marfan's syndrome, Refsums disease).
- Pregnancy and other conditions prohibiting X-rays or minute(s)-long exertion (e.gs., congestive heart failure, great weakness, COPD).
- Previous exposure to botulinum neurotoxin Type A. Sexually active female subjects must present a recent negative pregnancy test.
- Exclusion Criteria: