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

NCT04922983 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2023-10-19

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Manhattan Physical Medicine and Rehabilitation, LLP

    lead OTHER

Principal Investigators

  • Loren M Fishman · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
14 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2025-07-01
Completion
2026-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04922983 on ClinicalTrials.gov