Kessler Foundation
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.
Spasticity is experienced by approximately two-thirds of the \~308,620 people living with spinal cord injury (SCI) in the United States. Spasticity can negatively impact quality of life (QOL), including employment, social interactions, and psychological and physical health and well-being, and lead to significant secondary health complications like hospitalizations and chronic pain. Mechanistically, spasticity has both neuronal and rheological components (e.g. infiltration of fatty and connective tissues), which can be targeted for intervention to relieve symptoms. Pharmacological agents are th…
Inclusion criteria: 1. Women and men, age 18 years and older 2. Non-progressive SCI (complete or incomplete) with residual neurological deficits that occurred greater than 1 year prior to enrollment 3. Ankle flexor modified Ashworth scale (MAS) of between 1+ and 3, inclusive 4. No contraindication to f-ESWT, including current or recent infection at the treatment site and severe coagulopathies 5. No change in antispasmodic medications within the past 3 months or intended changes during the trial 6. currently being treated with BoNT in the plantar flexor muscles Exclusion criteria: 1. History…
Participants will receive one session of shockwave therapy applied to the plantar flexors (calf muscles) per week for three consecutive weeks.
Botulinum toxin types A and B injections into the plantar flexors (calf muscles)
Sham shockwave therapy will applied once per week for three consecutive weeks to the plantar flexors (calf muscles).
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