Overview

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

Status:
Not yet recruiting
Trial end date:
2022-05-01
Target enrollment:
0
Participant gender:
All
Summary
The study uses a yoga-like isometric posture and botulinum injections to reduce the curves in adolescent idiopathic lumbar scoliosis.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Manhattan Physical Medicine and Rehabilitation, LLP
Treatments:
abobotulinumtoxinA
Botulinum Toxins
Botulinum Toxins, Type A
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.