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

  • STATUS
    Recruiting
  • End date
    Nov 1, 2023
  • participants needed
    42
  • sponsor
    Manhattan Physical Medicine and Rehabilitation, LLP
Updated on 13 March 2022
Accepts healthy volunteers

Summary

The study uses a yoga-like isometric posture and botulinum injections to reduce the curves in adolescent idiopathic lumbar scoliosis.

Description

The randomized control 5-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 45 degrees. It is open to people between 14 and 18 years of age who are willing to do the pose every day for the study period.

Details
Condition Scoliosis Idiopathic, Scoliosis; Adolescence, Scoliosis; Lumbar Region
Treatment Placebo, Botulinum Toxin Type A, Isometric Yoga-like exercise
Clinical Study IdentifierNCT04922983
SponsorManhattan Physical Medicine and Rehabilitation, LLP
Last Modified on13 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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