Botulinum Toxin + Isometric Exercises for Scoliosis
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?
Who Is on the Research Team?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive isometric yoga-like exercises and botulinum injections or placebo for 3 months
Crossover Treatment
Placebo group receives the actual yoga pose and botulinum injections
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Botulinum toxin type A
- Isometric Yoga-like exercise
- Placebo
Botulinum toxin type A is already approved in United States, European Union for the following indications:
- Upper limb spasticity (excluding spasticity caused by cerebral palsy)
- Chronic sialorrhea
- 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