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

October 17, 2023 updated by: Manhattan Physical Medicine and Rehabilitation, LLP
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • Manhattan, New York, United States, 10022
        • Recruiting
        • Manhattan Physical Medicine and Rehabilitation, PLLC
        • Contact:
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

10 years to 14 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Group I: Placebo isometric measure, no injection
Group I: no isometric yoga-like exercise, no injection given.
Behavioral: Placebo
Used as placebo
Other Names:
  • no active intervention by drug or yoga-like exercise
Placebo Comparator: Group II Isometric yoga-like exercise, placebo injection given
Group II isometric yoga-like exercise, injection of preservative-free normal saline.
Behavioral: Isometric Yoga-like exercise
Extended torso and legs held diagonally by one straight arm, back against wall if necessary
Other Names:
  • Side-Plank, Vasisthasana
Active Comparator: Group III: True isometric exercise, botulinum injection
Group III: Isometric yoga-like exercise, botulinum injection given
Behavioral: Isometric Yoga-like exercise
Extended torso and legs held diagonally by one straight arm, back against wall if necessary
Other Names:
  • Side-Plank, Vasisthasana
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).
Other Names:
  • Incobotulinumtoxin A
Active Comparator: Crossover
After the three months, Arm I and Arm II patients will be given botulinum injections, and Group I will be given the proper yoga-like exercise. These two arms will constitute a further comparator with their own performances in the first 3 months of the study.
Behavioral: Isometric Yoga-like exercise
Extended torso and legs held diagonally by one straight arm, back against wall if necessary
Other Names:
  • Side-Plank, Vasisthasana
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).
Other Names:
  • Incobotulinumtoxin A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in lumbar and thoracic scoliotic curve
Time Frame: At study onset
Measured by the Cobb angle in coronal X-rays
At study onset
Reduction in lumbar and thoracic scoliotic curve
Time Frame: 3 weeks after study onset
Measured by the Cobb angle in coronal X-rays
3 weeks after study onset
Reduction in lumbar and thoracic scoliotic curve
Time Frame: 3 months after study onset
Measured by the Cobb angle in coronal X-rays
3 months after study onset
Reduction in lumbar and thoracic scoliotic curve
Time Frame: 3 weeks after crossover group injections
Measured by the Cobb angle in coronal X-rays
3 weeks after crossover group injections
Reduction in lumbar and thoracic scoliotic curve
Time Frame: 3 months after crossover group injections
Measured by the Cobb angle in coronal X-rays
3 months after crossover group injections

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Manhattan Physical Medicine and Rehabilitation, LLP

Investigators

  • Principal Investigator: Loren M Fishman, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

April 3, 2021

First Submitted That Met QC Criteria

June 5, 2021

First Posted (Actual)

June 11, 2021

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 17, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00047989

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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