What side effects are associated with this type of intervention?

The common treatments for scoliosis, such as yoga-like isometric exercises and botulinum toxin injections, have specific side effects. Yoga-like isometric exercises are generally safe but may cause muscle soreness or strain if not performed correctly. Botulinum toxin injections can lead to side effects such as injection site pain, stiffness, cramping, hematoma, and paresthesias. Additionally, there is a risk of muscle weakness, which can interfere with motor tasks and functional abilities.

What prior FDA approvals exist?

Botulinum toxin, specifically approved by the FDA for teenagers, is used in the treatment of scoliosis to help relax muscles and potentially correct posture. This treatment involves injections of botulinum toxin, which includes various preparations such as abobotulinumtoxinA, incobotulinumtoxinA, onabotulinumtoxinA, and rimabotulinumtoxinB. These injections are aimed at reducing muscle spasticity and improving the alignment of the spine. The combination of botulinum toxin injections with yoga-like isometric exercises is being studied to enhance the effectiveness of posture correction and muscle relaxation in scoliosis treatment.

What other types of research exist?

Promising novel alternatives for scoliosis treatment in 2024 include: 1) Advanced bracing techniques such as dynamic braces that adapt to body movements, providing continuous correction. 2) Genetic and molecular therapies targeting the underlying causes of scoliosis. 3) Robotic-assisted physical therapy to enhance precision in posture correction exercises. 4) Non-invasive neuromuscular electrical stimulation to strengthen spinal muscles and improve alignment. 5) Virtual reality (VR)-based rehabilitation programs that offer immersive and engaging exercises tailored to individual needs.

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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

Must not have

Genetic abnormalities that affect limb growth, proportionality or metabolism (e.g., mucopolysaccharidoses, Marfan's syndrome, Refsums disease)

Neurological, muscular or neuromuscular disease (e.g., cerebral palsy, myopathy, stroke)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months after crossover group injections

Summary

This trial uses a specific yoga pose to treat adolescents with curved spines. The yoga pose strengthens weaker back muscles and helps relax stronger ones. It targets teens aged 12-18 with moderate scoliosis who may not benefit from other treatments.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a genetic condition affecting my limbs or metabolism.

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I have a condition like cerebral palsy, myopathy, or have had a stroke.

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I have been treated with Botox before.

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I am a sexually active woman and have a recent negative pregnancy test.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for scoliosis, such as posture correction and muscle relaxation, aim to address the spinal curvature and associated muscle imbalances. Yoga-like isometric exercises help strengthen and stabilize the spine by promoting proper alignment and enhancing muscle endurance. This can reduce the progression of the spinal curve and improve overall posture. Botulinum toxin injections, on the other hand, work by temporarily paralyzing overactive muscles, reducing muscle spasms and pain, and allowing for better alignment and function. These treatments are crucial for scoliosis patients as they can alleviate discomfort, improve mobility, and potentially slow the progression of the spinal curvature, enhancing the patient's quality of life.