Scoliosis; Adolescence, Scoliosis Idiopathic, Scoliosis; Lumbar Region
Conditions
Keywords
Adolescent idiopathic scoliosis, scoliosis, yoga, isometric, botulinum
Brief summary
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.
Detailed 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.
Interventions
DRUGBotulinum toxin type A
A position similar to the side-plank (Vasisthasana) held for maximal time at least once daily (usual duration: 30 - 90 seconds).
BEHAVIORALIsometric Yoga-like exercise
Extended torso and legs held diagonally by one straight arm, back against wall if necessary
BEHAVIORALPlacebo
Used as placebo
Sponsors
Manhattan Physical Medicine and Rehabilitation, LLP
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants will understand they may receive placebo, and that they will not be told Investigators will know whether they give injections or not, but will not know if injection is placebo. Outcomes assessors will be blinded to the entire procedure (radiologists reading X-rays).
Intervention model description
Three groups: Group I: Placebo isometric measure, no injection Group II True isometric exercise, placebo injection Group III: True isometric exercise, botulinum injection
Eligibility
Sex/Gender
ALL
Age
14 Years to 18 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in lumbar and thoracic scoliotic curve | At study onset | Measured by the Cobb angle in coronal X-rays |
Countries
United States
Contacts
Primary ContactLoren M Fishman, MD
Backup ContactCara M Cipriano, BA
Outcome results
None listed