To evaluate the effectiveness of a treatment called extracorporeal shockwave therapy (ESWT) as an additional treatment to toxin injection for spasticity or muscle spasms. This therapy involves high intensity sound waves that are delivered to the body using an external device.
The study includes 6 in-person visits over 3 months. The initial screening visit could take up to 2 hours. Three consecutive treatment visits (one per week) could take up to 1 hour 30 minutes each. The two follow up visits could take about 1 hour each.
1. I am 18 years of age or older.
2. I have paralysis from a traumatic or non-traumatic spinal cord injury (complete or incomplete) that occurred greater than 1 year prior to my screening visit.
3. I have moderate spasticity in my calf muscle, as determined by the study physician.
4. I have not had an infection at the treatment site within the past 3 months.
5. I do not have a severe bleeding disorder that I’m aware of (such as hemophilia).
6. I have not changed my spasticity medications within the past 3 months and I do not intend to change them over the course of the study.
7. I am willing to comply with the protocol, including attending all scheduled follow-up visits.
8. I am currently receiving toxin injections for the spasticity in my leg.
Up to $300 for completion of the study.
R-1332-26
