Incobotulinumtoxin A and Yoga-like Isometric Exercise in Adolescent Idiopathic Lumbar Scoliosis
NCT ID: NCT04922983
Last Updated: 2023-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
42 participants
INTERVENTIONAL
2021-07-01
2026-01-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Outcomes assessors will be blinded to the entire procedure (radiologists reading X-rays).
Study Groups
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Group I: Placebo isometric measure, no injection
Group I: no isometric yoga-like exercise, no injection given.
Placebo
Used as placebo
Group II Isometric yoga-like exercise, placebo injection given
Group II isometric yoga-like exercise, injection of preservative-free normal saline.
Isometric Yoga-like exercise
Extended torso and legs held diagonally by one straight arm, back against wall if necessary
Group III: True isometric exercise, botulinum injection
Group III: Isometric yoga-like exercise, botulinum injection given
Botulinum toxin type A
A position similar to the side-plank (Vasisthasana) held for maximal time at least once daily (usual duration: 30 - 90 seconds).
Isometric Yoga-like exercise
Extended torso and legs held diagonally by one straight arm, back against wall if necessary
Crossover
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.
Botulinum toxin type A
A position similar to the side-plank (Vasisthasana) held for maximal time at least once daily (usual duration: 30 - 90 seconds).
Isometric Yoga-like exercise
Extended torso and legs held diagonally by one straight arm, back against wall if necessary
Interventions
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Botulinum toxin type A
A position similar to the side-plank (Vasisthasana) held for maximal time at least once daily (usual duration: 30 - 90 seconds).
Isometric Yoga-like exercise
Extended torso and legs held diagonally by one straight arm, back against wall if necessary
Placebo
Used as placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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.
14 Years
18 Years
ALL
Yes
Sponsors
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Manhattan Physical Medicine and Rehabilitation, LLP
OTHER
Responsible Party
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Principal Investigators
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Loren M Fishman
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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Manhattan Physical Medicine and Rehabilitation, PLLC
Manhattan, New York, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Fishman LM, Groessl EJ, Sherman KJ. Serial case reporting yoga for idiopathic and degenerative scoliosis. Glob Adv Health Med. 2014 Sep;3(5):16-21. doi: 10.7453/gahmj.2013.064.
Fishman LM. Isometric Yoga-Like Maneuvers Improve Adolescent Idiopathic Scoliosis-A Nonrandomized Control Trial. Glob Adv Health Med. 2021 Feb 24;10:2164956120988259. doi: 10.1177/2164956120988259. eCollection 2021.
Fishman LM, Groessl EJ, Bernstein P.Two Isometric Yoga Poses Reduce the Curves in Degenerative and Adolescent Idiopathic Scoliosis. Topics in Geriatric Rehabilitation. 33(4):231-237, October/December, 2017.
Related Links
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Other Identifiers
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Pro00047989
Identifier Type: -
Identifier Source: org_study_id
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