RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-07-01
Study Completion:2026-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04922983

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 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.
  2. *
  1. 1. Neurological, muscular or neuromuscular disease, (e.gs., cerebral palsy, myopathy, stroke),
  2. 2. Genetic abnormalities that affect limb growth, proportionality or metabolism, (e.gs., mucopolysaccharidoses, Marfan's syndrome, Refsums disease).
  3. 3. Pregnancy and other conditions prohibiting X-rays or minute(s)-long exertion (e.gs., congestive heart failure, great weakness, COPD).
  4. 4. Previous exposure to botulinum neurotoxin Type A. Sexually active female subjects must present a recent negative pregnancy test.

Contacts and Locations

Study Contact

Loren M Fishman, MD
CONTACT
646-642-0700
lorenmartinfishman@gmail.com
Cara M Cipriano, BA
CONTACT
(2120 472-0077
Cara@sciatica.org

Principal Investigator

Loren M Fishman
PRINCIPAL_INVESTIGATOR
Columbia University

Study Locations (Sites)

Manhattan Physical Medicine and Rehabilitation, PLLC
Manhattan, New York, 10022
United States

Collaborators and Investigators

Sponsor: Manhattan Physical Medicine and Rehabilitation, LLP

  • Loren M Fishman, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-01
Study Completion Date2026-01-01

Study Record Updates

Study Start Date2021-07-01
Study Completion Date2026-01-01

Terms related to this study

Keywords Provided by Researchers

  • Adolescent idiopathic scoliosis
  • scoliosis
  • yoga
  • isometric
  • botulinum

Additional Relevant MeSH Terms

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