Overview
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.
Description
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 the most commonly utilized treatments for post-SCI spasticity, including the injectable botulinum toxin type-A (e.g. Botox \[onabotulinumtoxinA\]).36 Botox acts by inhibiting the release of acetylcholine at the neuromuscular junction and, while effective, it can carry side effects like atrophy of the injected muscles and does not impact rheological effects of spasticity. Focused extracorporeal shockwave therapy (f-ESWT) has emerged as a treatment option for spasticity. Several studies have demonstrated its effectiveness and safety profile in people with stroke,61 including as an adjunctive treatment to Botox. However, there have been no published studies in individuals with SCI, and clinical trials are needed to establish its effectiveness and safety in this population prior implementation in clinical practice. The investigators recently concluded a pilot, randomized, sham-controlled trial to establish the effectiveness of f-ESWT. Results were promising. The proposed trial builds upon our pilot work by seeking to investigate f-ESWT as an adjunctive treatment to Botox using a randomized, controlled design. Thirty subjects will be enrolled and randomized to receive either Botox and f-ESWT (n=15) or Botox and a sham f-ESWT treatment (n=15). All subjects will receive a single Botox injection into three plantar flexor muscles: medial gastrocnemius, later gastrocnemius, and soleus. Participants in the active treatment group will receive 3 sessions of f-ESWT (1 per week for 3 consecutive weeks) following an evidence-based protocol. The same protocol will be applied to those in the sham control group, only the shockwave probe will not touch the skin to eliminate a therapeutic effect. Clinical and self-report outcomes of spasticity will be collected at all 5 timepoints (3 treatment visits, 4 and 8 weeks post-treatment). Medial gastrocnemius muscle echogenicity and elasticity will be determined via quantitative ultrasound and shear wave elastography, respectively, to investigate effects of the combined treatment on muscle composition and biomechanical properties; these outcomes will be collected at all timepoints. Magnetic resonance imaging of the lower limb will assist the quantification of muscle volumes, collected at baseline and 4 and 8 weeks post-treatment.
Eligibility
Inclusion criteria:
- Women and men, age 18 years and older
- Non-progressive SCI (complete or incomplete) with residual neurological deficits that occurred greater than 1 year prior to enrollment
- Ankle flexor modified Ashworth scale (MAS) of between 1+ and 3, inclusive
- No contraindication to f-ESWT, including current or recent infection at the treatment site and severe coagulopathies
- No change in antispasmodic medications within the past 3 months or intended changes during the trial
- currently being treated with BoNT in the plantar flexor muscles
Exclusion criteria:
- History of lower limb surgical procedures
- Ankle contracture
- Severe, inflammatory arthritic diseases
- Thrombosis
- Anticoagulant medication
- Pregnancy
- Cancer
- Recent (12 months) local phenol/alcohol injection
- MRI contraindications (e.g. claustrophobia, ferromagnetic implants or debris)
