Ignite Creation Date:
2024-05-06 @ 4:14 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04922983
Status:
RECRUITING
Last Update Posted:
2023-10-19
First Post:
2021-04-03
Brief Title:
Incobotulinumtoxin A and Yoga-like Isometric Exercise in Adolescent Idiopathic Lumbar Scoliosis
Sponsor:
Manhattan Physical Medicine and Rehabilitation LLP
Organization:
Manhattan Physical Medicine and Rehabilitation LLP
Study Overview
Official Title:
Incobotulinumtoxin A and Yoga-like Isometric Exercise in Adolescent Idiopathic Lumbar Scoliosis
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None