Incobotulinumtoxin A and Yoga-like Isometric Exercise in Adolescent Idiopathic Lumbar Scoliosis
1 other identifier
interventional
42
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2021
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2021
CompletedFirst Posted
Study publicly available on registry
June 11, 2021
CompletedStudy Start
First participant enrolled
July 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2026
CompletedOctober 19, 2023
August 1, 2023
4 years
April 3, 2021
October 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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
Study Arms (4)
Group I: Placebo isometric measure, no injection
SHAM COMPARATORGroup I: no isometric yoga-like exercise, no injection given.
Group II Isometric yoga-like exercise, placebo injection given
PLACEBO COMPARATORGroup II isometric yoga-like exercise, injection of preservative-free normal saline.
Group III: True isometric exercise, botulinum injection
ACTIVE COMPARATORGroup III: Isometric yoga-like exercise, botulinum injection given
Crossover
ACTIVE COMPARATORAfter 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.
Interventions
A position similar to the side-plank (Vasisthasana) held for maximal time at least once daily (usual duration: 30 - 90 seconds).
Extended torso and legs held diagonally by one straight arm, back against wall if necessary
Used as placebo
Eligibility Criteria
You may qualify if:
- \. 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Manhattan Physical Medicine and Rehabilitation, PLLC
Manhattan, New York, 10022, United States
Related Publications (3)
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.
PMID: 25568820RESULTFishman 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.
PMID: 33717658RESULTFishman 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.
RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Loren M Fishman
Columbia University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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).
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2021
First Posted
June 11, 2021
Study Start
July 1, 2021
Primary Completion
July 1, 2025
Study Completion
January 1, 2026
Last Updated
October 19, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share