42 Participants Needed

Botulinum Toxin + Isometric Exercises for Scoliosis

CM
LM
Overseen ByLoren M Fishman, MD
Age: < 65
Sex: Any
Trial Phase: Phase 2
Sponsor: Manhattan Physical Medicine and Rehabilitation, LLP
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is the combination of Botulinum Toxin and Isometric Exercises safe for humans?

Botulinum toxin type A, including formulations like Xeomin and Dysport, has been used safely for various conditions such as muscle disorders and excessive sweating, with studies showing good tolerability and no significant increase in adverse events like injection site pain compared to placebo.12345

How does the treatment of Botulinum Toxin + Isometric Exercises for Scoliosis differ from other treatments?

This treatment is unique because it combines botulinum toxin type A, which weakens overactive muscles by preventing the release of a chemical that causes muscle contraction, with isometric yoga-like exercises that may help improve posture and muscle strength. This dual approach targets both muscle relaxation and strengthening, which is different from treatments that focus solely on one aspect.678910

What data supports the effectiveness of the drug Botulinum toxin type A for treating scoliosis?

Research shows that Botulinum toxin type A can temporarily paralyze muscles, which has been used to study muscle roles in scoliosis and is effective in treating muscle-related conditions like spasmodic torticollis, suggesting potential benefits for scoliosis treatment.38101112

Who Is on the Research Team?

LM

Loren M Fishman

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My spine curve is between 25 and 45 degrees.
Stated willingness to do the yoga and yoga-like poses daily
Written, signed consent by patient and parent/guardian
See 1 more

Exclusion Criteria

I have a genetic condition affecting my limbs or metabolism.
I am not pregnant and can undergo X-rays or exert myself for a short time without major issues.
I have a condition like cerebral palsy, myopathy, or have had a stroke.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive isometric yoga-like exercises and botulinum injections or placebo for 3 months

3 months
Daily exercises, 1 injection visit

Crossover Treatment

Placebo group receives the actual yoga pose and botulinum injections

3 months
1 injection visit, daily exercises

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months
2 X-ray visits at 3 weeks and 3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Botulinum toxin type A
  • Isometric Yoga-like exercise
  • Placebo
Trial Overview 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.
How Is the Trial Designed?
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.

Botulinum toxin type A is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Xeomin for:
  • Upper limb spasticity (excluding spasticity caused by cerebral palsy)
  • Chronic sialorrhea
🇪🇺
Approved in European Union as Xeomin for:
  • Upper limb spasticity
  • Chronic sialorrhea
  • Blepharospasm
  • Cervical dystonia

Find a Clinic Near You

Who Is Running the Clinical Trial?

Manhattan Physical Medicine and Rehabilitation, LLP

Lead Sponsor

Trials
4
Recruited
1,100+

Published Research Related to This Trial

In a study involving 9 patients with adolescent idiopathic scoliosis (AIS), a single injection of botulinum toxin A into the psoas major muscle resulted in significant radiological improvements in spinal curvature, indicating the muscle's role in scoliosis pathology.
The treatment led to measurable corrective changes in both the thoracic and lumbar spine without any serious adverse events, suggesting that localized muscle paralysis can be a safe and effective intervention for AIS.
The role of the paravertebral muscles in adolescent idiopathic scoliosis evaluated by temporary paralysis.Wong, C., Gosvig, K., Sonne-Holm, S.[2020]
In a study of 20 women with glabellar rhytides that did not respond well to Botox (BTX-A), treatment with Botulinum toxin type B (BTX-B) resulted in significant improvement, with peak effects observed one month after injection.
While BTX-B was effective for patients resistant to BTX-A, its effects lasted shorter (about 4 months) compared to the typical duration of BTX-A, and side effects were generally mild and temporary.
Botulinum toxin type B for dynamic glabellar rhytides refractory to botulinum toxin type A.Alster, TS., Lupton, JR.[2019]
Injections of botulinum toxin into cervical muscles for treating spasmodic torticollis resulted in significant pain reduction and decreased muscle spasms for an average of 2 months.
Out of 36 patients, 25% reported at least a 50% improvement, with 44% experiencing 50-75% improvement, and 17% achieving over 75% improvement after several treatment sessions.
[Treatment of spasmodic torticollis by local injections of botulinum toxin].Jedynak, CP., de Saint Victor, JF.[2011]

Citations

The role of the paravertebral muscles in adolescent idiopathic scoliosis evaluated by temporary paralysis. [2020]
Botulinum toxin type B for dynamic glabellar rhytides refractory to botulinum toxin type A. [2019]
[Treatment of spasmodic torticollis by local injections of botulinum toxin]. [2011]
A mixed treatment comparison to compare the efficacy and safety of botulinum toxin treatments for cervical dystonia. [2018]
Efficacy and Safety of Botulinum Toxin Type A Injection in Patients with Bilateral Trapezius Hypertrophy. [2022]
Cost-Effectiveness of Incobotulinumtoxin-A with Flexible Treatment Intervals Compared to Onabotulinumtoxin-A in the Management of Blepharospasm and Cervical Dystonia. [2018]
Dysport (botulinum toxin type A) in routine therapeutic usage: a telephone needs assessment survey of European physicians to evaluate current awareness and adherence to product labeling changes. [2022]
Clinical and pharmacological properties of incobotulinumtoxinA and its use in neurological disorders. [2018]
Five-year experience with incobotulinumtoxinA (Xeomin(®) ): the first botulinum toxin drug free of complexing proteins. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Use of botulinum toxin type A in the treatment of cervical dystonia. [2006]
[Pharmacology of botulinum toxin drugs]. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
Botulinum toxin treatment of extraocular muscles in rabbits results in increased myofiber remodeling. [2022]
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