A Phase 2 interventional study of Focused extracorporeal shockwave therapy and Botulinum toxin in Spinal Cord Injury and Spasticity, sponsored by Kessler Foundation. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Kessler Foundation · Phase 2, Interventional, and Treatment
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 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. We recently concluded a pilot, randomized, sham-controlled trial to establish the effectiveness of f-ESWT. Results were promising, yet recruitment issues limited sample size and study power. 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.
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Exclusion criteria:
Shockwave therapy plus toxin injection
Device: Focused extracorporeal shockwave therapy · Drug: Botulinum toxin
Toxin injection plus a sham (fake) shockwave therapy
Drug: Botulinum toxin · Other: Sham
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).
Change in Modified Ashworth Scale score
The Modified Ashworth Scale (MAS) is a physical exam maneuver used frequently both clinically and for research purposes to assess the increase in velocity-dependent muscle tone after neurologic disorders. We will be focusing on the MAS score of the ankle plantar flexors. This measure is included in the NINDS list of CDE recommendations for SCI. Specifically, it evaluates the resistance to passive stretch of the ankle joint through full range of motion. Scores range from 0 (no spasticity) to 4 (severe spasticity).
Time frame: 8 weeks
Change in Modified Ashworth Scale score
The Modified Ashworth Scale (MAS) is a physical exam maneuver used frequently both clinically and for research purposes to assess the increase in velocity-dependent muscle tone after neurologic disorders. We will be focusing on the MAS score of the ankle plantar flexors. This measure is included in the NINDS list of CDE recommendations for SCI. Specifically, it evaluates the resistance to passive stretch of the ankle joint through full range of motion. Scores range from 0 (no spasticity) to 4 (severe spasticity).
Time frame: 4 weeks
Change in Modified Penn Spasticity Frequency Scale
The Modified Penn Spasticity Frequency Scale (mPSFS) is a self-report scale with two components, which is meant to provide a more complete understanding of an individual's spasticity status. The first component is comprised of a five-point scale, which assesses spasm frequency between 0 ("no spasms") and 4 ("spontaneous spasms occurring more than 10 times per hour"). The second component includes a three-point scale, which assesses spasm severity between 1 ("mild") and 3 ("severe"); this component is not answered if the individual reports no spasms in part one.
Time frame: 4 weeks
Change in Modified Penn Spasticity Frequency Scale
The Modified Penn Spasticity Frequency Scale (mPSFS) is a self-report scale with two components, which is meant to provide a more complete understanding of an individual's spasticity status. The first component is comprised of a five-point scale, which assesses spasm frequency between 0 ("no spasms") and 4 ("spontaneous spasms occurring more than 10 times per hour"). The second component includes a three-point scale, which assesses spasm severity between 1 ("mild") and 3 ("severe"); this component is not answered if the individual reports no spasms in part one.
Time frame: 8 weeks
Change in Modified Patient-Reported Impact of Spasticity Measure
The Modified Patient-Reported Impact of Spasticity Measure (mPRISM) is a self-reported instrument with 37 items to quantify the impact of spasticity on physical, psychological, and social health-related QOL domains. Each item is rated using a scale of 0 ("never") to 3 ("often/very often"). The scale's psychometric properties have been well-established, including floor and ceiling effects for the various subscales, and it has been shown to be both valid and reliable.
Time frame: 4 weeks
Change in Modified Patient-Reported Impact of Spasticity Measure
The Modified Patient-Reported Impact of Spasticity Measure (mPRISM) is a self-reported instrument with 37 items to quantify the impact of spasticity on physical, psychological, and social health-related QOL domains. Each item is rated using a scale of 0 ("never") to 3 ("often/very often"). The scale's psychometric properties have been well-established, including floor and ceiling effects for the various subscales, and it has been shown to be both valid and reliable.
Time frame: 8 weeks
Participant Global Impression of Change
The Participant Global Impression of Change (PGIC) measures global treatment effect by asking the participant to rate with a 7-point scale (anchored by 1 \["very much worse"\] and 7 \["very much improved"\]) their overall impression following treatment as compared to prior. This scale provides an indication of clinically important improvement and has been used to assess efficacy of spasticity treatments in SCI. 11-week scores will be considered a primary outcome.
Time frame: 4 weeks
Participant Global Impression of Change
The Participant Global Impression of Change (PGIC) measures global treatment effect by asking the participant to rate with a 7-point scale (anchored by 1 \["very much worse"\] and 7 \["very much improved"\]) their overall impression following treatment as compared to prior. This scale provides an indication of clinically important improvement and has been used to assess efficacy of spasticity treatments in SCI. 11-week scores will be considered a primary outcome.
Time frame: 8 weeks
Change in ankle range of motion
Passive plantar flexion and dorsiflexion ROM will be measured using a goniometer during the MAS assessment by the same blinded clinician. The participant will assume a supine position. Use of a universal goniometer is generally considered a reliable method of measuring passive ankle ROM in a clinical setting among patients with neurological conditions.
Time frame: 4 weeks
Change in ankle range of motion
Passive plantar flexion and dorsiflexion ROM will be measured using a goniometer during the MAS assessment by the same blinded clinician. The participant will assume a supine position. Use of a universal goniometer is generally considered a reliable method of measuring passive ankle ROM in a clinical setting among patients with neurological conditions.
Time frame: 8 weeks
Change in medial gastrocnemius muscle echogenicity
Echogenicity is a measure of a tissue's "brightness." In muscle, this reflects the concentration of connective tissue and thus is a marker of muscle health. We will apply quantitative ultrasound image collection and analysis techniques to quantify the average echogenicity of the treated medial gastrocnemius muscle in longitudinal view.
Time frame: 4 weeks
Change in medial gastrocnemius muscle echogenicity
Echogenicity is a measure of a tissue's "brightness." In muscle, this reflects the concentration of connective tissue and thus is a marker of muscle health. We will apply quantitative ultrasound image collection and analysis techniques to quantify the average echogenicity of the treated medial gastrocnemius muscle in longitudinal view.
Time frame: 8 weeks
Change in medial gastrocnemius fat fraction
Using quantitative MRI techniques, the percentage of fat within the medial gastrocnemius will be calculated. MRI images of the calf will be collected. A custom image analysis program will allow for manual segmentation of the muscle and calculation of its fat percentage in each slice. Fat percentages will be averaged across each slice.
Time frame: 4 weeks
Change in medial gastrocnemius fat fraction
Using quantitative MRI techniques, the percentage of fat within the medial gastrocnemius will be calculated. MRI images of the calf will be collected. A custom image analysis program will allow for manual segmentation of the muscle and calculation of its fat percentage in each slice. Fat percentages will be averaged across each slice.
Time frame: 8 weeks
Change in lateral gastrocnemius fat fraction
Using quantitative MRI techniques, the percentage of fat within the lateral gastrocnemius will be calculated. MRI images of the calf will be collected. A custom image analysis program will allow for manual segmentation of the muscle and calculation of its fat percentage in each slice. Fat percentages will be averaged across each slice.
Time frame: 4 weeks
Change in lateral gastrocnemius fat fraction
Using quantitative MRI techniques, the percentage of fat within the lateral gastrocnemius will be calculated. MRI images of the calf will be collected. A custom image analysis program will allow for manual segmentation of the muscle and calculation of its fat percentage in each slice. Fat percentages will be averaged across each slice.
Time frame: 8 weeks
Change in medial gastrocnemius muscle volume
Using quantitative MRI techniques, the percentage of fat within the medial gastrocnemius will be calculated. MRI images of the calf will be collected. A custom image analysis program will allow for manual segmentation of the muscle and calculation of its cross sectional area. Cross sectional areas of each slice will be summed for total volume.
Time frame: 4 weeks
Change in medial gastrocnemius muscle volume
Using quantitative MRI techniques, the percentage of fat within the medial gastrocnemius will be calculated. MRI images of the calf will be collected. A custom image analysis program will allow for manual segmentation of the muscle and calculation of its cross sectional area. Cross sectional areas of each slice will be summed for total volume.
Time frame: 8 weeks
Change in lateral gastrocnemius muscle volume
Using quantitative MRI techniques, the percentage of fat within the lateral gastrocnemius will be calculated. MRI images of the calf will be collected. A custom image analysis program will allow for manual segmentation of the muscle and calculation of its cross sectional area. Cross sectional areas of each slice will be summed for total volume.
Time frame: 4 weeks
Change in lateral gastrocnemius muscle volume
Using quantitative MRI techniques, the percentage of fat within the lateral gastrocnemius will be calculated. MRI images of the calf will be collected. A custom image analysis program will allow for manual segmentation of the muscle and calculation of its cross sectional area. Cross sectional areas of each slice will be summed for total volume.
Time frame: 8 weeks
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
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