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Extracorporeal Shockwave Therapy as an Additional Treatment for Spasticity Secondary to Spinal Cord Injury
Sponsor: Kessler Foundation
Summary
Spasticity is a common consequence of spinal cord injury and can have a profound impact on quality of life. The goal of this study is to learn if an intervention called focused extracorporeal shockwave therapy can enhance the effectiveness of injections received for spasticity, such as Botox. The main questions this study seeks to answer are whether shockwave therapy and toxin injection 1) can improve spasticity symptoms greater than toxin injection alone, and 2) change the structure of the injected muscles. Researchers will compare the group who receives both shockwave therapy and toxin injection to a group who receives only toxin injection. Participants will be asked to visit the clinic five times over the span of three months. The first three visits will occur on three consecutive weeks, during which participants will receive shockwave therapy or the sham therapy. The final two visits will occur four and eight weeks later, during which participants will be asked a series of questions about their spasticity and have ultrasounds and MRIs collected of their leg muscles.
Official title: Randomized, Sham-controlled Trial to Investigate Extracorporeal Shockwave Therapy as an Adjunctive Treatment for Spasticity Secondary to Spinal Cord Injury
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-09-21
Completion Date
2028-08-31
Last Updated
2026-10-28
Healthy Volunteers
No
Conditions
Interventions
Focused extracorporeal shockwave therapy
Participants will receive one session of shockwave therapy applied to the plantar flexors (calf muscles) per week for three consecutive weeks.
Botulinum toxin
Botulinum toxin types A and B injections into the plantar flexors (calf muscles)
Sham
Sham shockwave therapy will applied once per week for three consecutive weeks to the plantar flexors (calf muscles).
Locations (1)
Kessler Foundation
West Orange, New Jersey, United States