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Neurotoxin

Botulinum Toxin + Isometric Exercises for Scoliosis

Phase 2

Recruiting

Led By Loren M Fishman

Research Sponsored by Manhattan Physical Medicine and Rehabilitation, LLP

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Scoliotic curve greater than 25 degrees, less than 45 degrees

Fourteen - 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months after crossover group injections

Awards & highlights

Study Summary

This trial found that the use of a yoga-like isometric posture combined with botulinum toxin injections was effective in reducing curves in adolescent idiopathic lumbar scoliosis.

Who is the study for?

This trial is for teens aged 14-18 with adolescent idiopathic lumbar scoliosis, having a spinal curve between 25 and 45 degrees. They must be willing to do daily yoga-like exercises and have not been treated with botulinum toxin before. Participants need consent from a guardian, recent spine X-rays, and if female and sexually active, a negative pregnancy test.Check my eligibility

What is being tested?

The study tests the combination of Incobotulinumtoxin A injections (a type of Botulinum toxin approved for teenagers) and special yoga-like isometric exercises to see if they can reduce spinal curvature in adolescents with idiopathic lumbar scoliosis more effectively than previous methods.See study design

What are the potential side effects?

Incobotulinumtoxin A may cause muscle weakness, injection site pain or bruising, flu-like symptoms, allergic reactions or spread of toxin effects. The yoga-like exercise might lead to muscle soreness or strain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My spine curve is between 25 and 45 degrees.

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I am between 14 and 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months after crossover group injections

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months after crossover group injections

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months after crossover group injections for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Reduction in lumbar and thoracic scoliotic curve

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: CrossoverActive Control2 Interventions

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.

Group II: Group III: True isometric exercise, botulinum injectionActive Control2 Interventions

Group III: Isometric yoga-like exercise, botulinum injection given

Group III: Group II Isometric yoga-like exercise, placebo injection givenPlacebo Group1 Intervention

Group II isometric yoga-like exercise, injection of preservative-free normal saline.

Group IV: Group I: Placebo isometric measure, no injectionPlacebo Group1 Intervention

Group I: no isometric yoga-like exercise, no injection given.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Manhattan Physical Medicine and Rehabilitation, LLPLead Sponsor

3 Previous Clinical Trials

1,039 Total Patients Enrolled

1 Trials studying Scoliosis

100 Patients Enrolled for Scoliosis

Loren M FishmanPrincipal InvestigatorColumbia University

Media Library

Botulinum toxin type A (Neurotoxin) Clinical Trial Eligibility Overview. Trial Name: NCT04922983 — Phase 2

Scoliosis Research Study Groups: Crossover, Group II Isometric yoga-like exercise, placebo injection given, Group III: True isometric exercise, botulinum injection, Group I: Placebo isometric measure, no injection

Scoliosis Clinical Trial 2023: Botulinum toxin type A Highlights & Side Effects. Trial Name: NCT04922983 — Phase 2

Botulinum toxin type A (Neurotoxin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04922983 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who would be an eligible candidate for this type of research?

"This scoliosis clinical trial is currently looking for 42 patients that have idiopathic scoliosis and are between the ages of 14 to 18."

Answered by AI

What is the target number of enrollees for this research project?

"From what is indicated on clinicaltrials.gov, it seems that this study is still looking for subjects. The posting date was September 1st 2021 and the most recent update was July 17th 2022. They are trying to find 42 individuals total from a single location."

Answered by AI

Are there any available openings for new participants in this experiment?

"The study is currently ongoing, with the most recent update posted on July 17th, 2022. This information can be found by searching for the trial on clinicaltrials.gov; the original posting date was September 1st, 2021."

Answered by AI

Are there other research studies that have looked at the effects of Group III: True isometric exercise, botulinum injection?

"Currently, there are 68 active studies in Group III: True isometric exercise, botulinum injection with 22 trials in Phase 3. While most of the trials for this group are taking place in Farmington Hills, Michigan, there are 766 total locations running trials."

Answered by AI

Does this trial's age limit exclude patients who are middle-aged?

"As per the requirements for this clinical trial, minors aged 14-18 may participate."

Answered by AI

Has the FDA cleared Group III: True isometric exercise, botulinum injection as an effective treatment?

"Group III: True isometric exercise, botulinum injection was given a score of 2. This reflects that while there is data suggesting this intervention is safe, there is currently no evidence to support its efficacy."

Answered by AI

What condition is group three's true isometric exercise usually used to treat with botulinum injections?

"Group III: True isometric exercise, botulinum injection is the most common and effective treatment for urinary incontinence. This same method can be used to treat conditions like spinal cord injury, botox, and overactive bladder syndrome (oabs)."

Answered by AI

Recent research and studies

Global Advances in Health and MedicineJournal

Serial Case Reporting Yoga for Idiopathic and Degenerative Scoliosis

Fishman, Loren M., Erik J. Groessl, and Karen J. Sherman. 2014. “Serial Case Reporting Yoga for Idiopathic and Degenerative Scoliosis”. Global Advances in Health and Medicine. SAGE Publications. doi:10.7453/gahmj.2013.064.

Global Advances in Health and MedicineJournal

Isometric Yoga-like Maneuvers Improve Adolescent Idiopathic Scoliosis—a Nonrandomized Control Trial

Fishman, Loren M. 2021. “Isometric Yoga-like Maneuvers Improve Adolescent Idiopathic Scoliosis—a Nonrandomized Control Trial”. Global Advances in Health and Medicine. SAGE Publications. doi:10.1177/2164956120988259.

clinicaltrials.govStudy

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

2021. "Incobotulinumtoxin A and Yoga-like Isometric Exercise in Adolescent Idiopathic Lumbar Scoliosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04922983.

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