Incobotulinumtoxin A and Yoga-like Isometric Exercise in Adolescent Idiopathic Lumbar Scoliosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Incobotulinumtoxin A and Yoga-like Isometric Exercise in Adolescent Idiopathic Lumbar Scoliosis

Conditions
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Scoliosis Idiopathic, Scoliosis; Adolescence, Scoliosis; Lumbar Region

Intervention / Treatment
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* Drug: Botulinum toxin type A
* Behavioral: Isometric Yoga-like exercise
* Behavioral: Placebo


Participation Criteria
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Eligibility Criteria
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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: 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.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Group I: Placebo isometric measure, no injection<br>Group I: no isometric yoga-like exercise, no injection given. | Behavioral: Placebo<br>* Used as placebo<br>* Other names: no active intervention by drug or yoga-like exercise;|
| Placebo Comparator: Group II Isometric yoga-like exercise, placebo injection given<br>Group II isometric yoga-like exercise, injection of preservative-free normal saline. | Behavioral: Isometric Yoga-like exercise<br>* Extended torso and legs held diagonally by one straight arm, back against wall if necessary<br>* Other names: Side-Plank, Vasisthasana;|
| Active Comparator: Group III: True isometric exercise, botulinum injection<br>Group III: Isometric yoga-like exercise, botulinum injection given | Drug: Botulinum toxin type A<br>* A position similar to the side-plank (Vasisthasana) held for maximal time at least once daily (usual duration: 30 - 90 seconds).<br>* Other names: Incobotulinumtoxin A;Behavioral: Isometric Yoga-like exercise<br>* Extended torso and legs held diagonally by one straight arm, back against wall if necessary<br>* Other names: Side-Plank, Vasisthasana;|
| Active Comparator: Crossover<br>After the three months, Arm I and Arm II patients will be given botulinum injections, and Group I will be given the proper yoga-like exercise. These two arms will constitute a further comparator with their own performances in the first 3 months of the study. | Drug: Botulinum toxin type A<br>* A position similar to the side-plank (Vasisthasana) held for maximal time at least once daily (usual duration: 30 - 90 seconds).<br>* Other names: Incobotulinumtoxin A;Behavioral: Isometric Yoga-like exercise<br>* Extended torso and legs held diagonally by one straight arm, back against wall if necessary<br>* Other names: Side-Plank, Vasisthasana;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in lumbar and thoracic scoliotic curve | Measured by the Cobb angle in coronal X-rays | At study onset | 
| Reduction in lumbar and thoracic scoliotic curve | Measured by the Cobb angle in coronal X-rays | 3 weeks after study onset | 
| Reduction in lumbar and thoracic scoliotic curve | Measured by the Cobb angle in coronal X-rays | 3 months after study onset | 
| Reduction in lumbar and thoracic scoliotic curve | Measured by the Cobb angle in coronal X-rays | 3 weeks after crossover group injections | 
| Reduction in lumbar and thoracic scoliotic curve | Measured by the Cobb angle in coronal X-rays | 3 months after crossover group injections | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescent idiopathic scoliosis, scoliosis, yoga, isometric, botulinum