NCT04922983

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Manhattan Physical Medicine and Rehabilitation, LLP · Academic / Other
• Sex: All
• Age: 14 Years – 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Scoliosis Idiopathic
• Scoliosis; Adolescence
• Scoliosis; Lumbar Region

Interventions

Type	Name	Description
DRUG	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).
BEHAVIORAL	Isometric Yoga-like exercise	Extended torso and legs held diagonally by one straight arm, back against wall if necessary
BEHAVIORAL	Placebo	Used as placebo

Timeline

• Start date: 2021-07-01
• Primary completion: 2025-07-01
• Completion: 2026-01-01
• First posted: 2021-06-11
• Last updated: 2023-10-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study