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Search / Trial NCT04922983

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

Launched by MANHATTAN PHYSICAL MEDICINE AND REHABILITATION, LLP · Jun 5, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Adolescent Idiopathic Scoliosis Scoliosis Yoga Isometric Botulinum

ClinConnect Summary

This clinical trial is studying the combination of botulinum toxin injections and yoga-like exercises to help improve scoliosis in teenagers. Scoliosis is a condition where the spine curves to the side, and this study focuses on adolescents who have a curve between 25 and 45 degrees. The researchers believe that using both the injections and specific yoga poses could help reduce these curves. While previous studies have shown that yoga poses can be effective, this is the first study to look at how they work together with botulinum toxin.

To participate in this trial, you need to be between 14 and 18 years old and have scoliosis with a curve that meets the criteria. It’s important that you can commit to doing the yoga exercises daily and that you have written consent from a parent or guardian. Participants will have regular check-ins and will receive both the injections and guidance on the yoga-like exercises. If you have certain medical conditions or have previously received botulinum toxin, you may not be eligible. This trial is currently recruiting participants of all genders, and it aims to provide more options for managing scoliosis effectively.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. 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:
  • 1. Neurological, muscular or neuromuscular disease, (e.gs., cerebral palsy, myopathy, stroke),
  • 2. Genetic abnormalities that affect limb growth, proportionality or metabolism, (e.gs., mucopolysaccharidoses, Marfan's syndrome, Refsums disease).
  • 3. Pregnancy and other conditions prohibiting X-rays or minute(s)-long exertion (e.gs., congestive heart failure, great weakness, COPD).
  • 4. Previous exposure to botulinum neurotoxin Type A. Sexually active female subjects must present a recent negative pregnancy test.

About Manhattan Physical Medicine And Rehabilitation, Llp

Manhattan Physical Medicine and Rehabilitation, LLP is a leading clinical trial sponsor dedicated to advancing the field of rehabilitation medicine through innovative research and evidence-based practices. Committed to improving patient outcomes, the organization specializes in conducting high-quality clinical trials that focus on musculoskeletal disorders, pain management, and functional recovery. With a multidisciplinary team of experienced professionals, Manhattan Physical Medicine and Rehabilitation fosters collaboration and rigor in its research efforts, ensuring that new therapies are thoroughly evaluated for safety and efficacy. The organization aims to contribute significantly to the development of effective treatment modalities that enhance the quality of life for patients.

Locations

Manhattan, New York, United States

Patients applied

0 patients applied

Trial Officials

Loren M Fishman

Principal Investigator

Columbia University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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