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

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Scoliosis Idiopathic, Scoliosis; Adolescence, Scoliosis; Lumbar Region

In brief

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.

Key facts

Study ID

NCT04922983

Run by

Manhattan Physical Medicine and Rehabilitation, LLP

People needed

42

Starts

2021-07-01

Expected to finish

2026-01-01

Last updated by the study team

2023-10-19

Who can join

Age: 14 and older, up to 18. Sex: any. Healthy volunteers: accepted.

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.
• 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.

Where it is running

• Manhattan Physical Medicine and Rehabilitation, PLLC — Manhattan, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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