Spinal Cord InjuryPhase 2NCT07894991
Extracorporeal Shockwave Therapy as an Additional Treatment for Spasticity Secondary to Spinal Cord Injury
A Phase 2 study testing Focused extracorporeal shockwave therapy and Botulinum toxin in people with Spinal Cord Injury and Spasticity, run by Kessler Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury, Spasticity
- What is being tested?
- Focused extracorporeal shockwave therapy and Botulinum toxin
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2026to 31 Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of lower limb surgical procedures
- Ankle contracture
- Severe, inflammatory arthritic diseases
- Thrombosis
- Anticoagulant medication
- Pregnancy
Show all 9Show fewer
- Cancer
- Recent (12 months) local phenol/alcohol injection
- MRI contraindications (e.g. claustrophobia, ferromagnetic implants or debris)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Kessler Foundation
West Orange, New Jersey, 07052
Shalaka Paranjpe, MS, 973-327-3572, sparanjpe@kesslerfoundation.org
nhogaboom@kesslerfoundation.org
About this study
Official title: Randomized, Sham-controlled Trial to Investigate Extracorporeal Shockwave Therapy as an Adjunctive Treatment for Spasticity Secondary to Spinal Cord Injury
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.
Read the detailed 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.
- Conditions
- Spinal Cord Injury, Spasticity
- Being tested
- Focused extracorporeal shockwave therapy, Botulinum toxin, Sham
- Keywords
- spinal cord injury, spasticity, shockwave, injection, botulinum toxin, shockwave therapy
- Medical subject headings
- Spinal Cord Injuries, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused extracorporeal shockwave therapyDevice
Participants will receive one session of shockwave therapy applied to the plantar flexors (calf muscles) per week for three consecutive weeks.
Botulinum toxinDrug
Botulinum toxin types A and B injections into the plantar flexors (calf muscles)
ShamOther
Sham shockwave therapy will applied once per week for three consecutive weeks to the plantar flexors (calf muscles).
| Study group | Role | What they receive |
|---|---|---|
| Shockwave plus toxin | Experimental | Shockwave therapy plus toxin injection Receives: Device: Focused extracorporeal shockwave therapy; Drug: Botulinum toxin |
| Sham plus toxin | Sham comparator | Toxin injection plus a sham (fake) shockwave therapy Receives: Drug: Botulinum toxin; Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 8 weeks
Secondary outcomes (9)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start21 Sep 2026
- Primary completion30 Apr 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Nathan Hogaboom, PhD, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07894991
- Sponsor's protocol ID
- R-1332-26
- Other IDs
- 1R21HD123083-01
- Status last verified
- Nov 2026
- First submitted
- 19 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Sham-controlled Trial to Investigate Extracorporeal Shockwave Therapy as an Adjunctive Treatment for Spasticity Secondary to Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07894991
- Acronym / sponsor ID
- R-1332-26
- Conditions
- Spinal Cord Injury, Spasticity
- Keywords
- spinal cord injury, spasticity, shockwave, injection, botulinum toxin, shockwave therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 21 Sep 2026 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shockwave plus toxin | Experimental | Device: Focused extracorporeal shockwave therapy, Drug: Botulinum toxinShockwave therapy plus toxin injection |
| Sham plus toxin | Sham comparator | Drug: Botulinum toxin, Other: ShamToxin injection plus a sham (fake) shockwave therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- History of lower limb surgical procedures
- Ankle contracture
- Severe, inflammatory arthritic diseases
- Thrombosis
- Anticoagulant medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focused extracorporeal shockwave therapyParticipants will receive one session of shockwave therapy applied to the plantar flexors (calf muscles) per week for three consecutive weeks. | Device | Shockwave plus toxin |
| Botulinum toxinBotulinum toxin types A and B injections into the plantar flexors (calf muscles) | Drug | Sham plus toxin, Shockwave plus toxin |
| ShamSham shockwave therapy will applied once per week for three consecutive weeks to the plantar flexors (calf muscles). | Other | Sham plus toxin |
Primary outcome
Change in Modified Ashworth Scale score
Time frame: 8 weeks
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).
9 secondary outcomes
Change in Modified Ashworth Scale score
Time frame: 4 weeks
Change in Modified Penn Spasticity Frequency Scale
Time frame: 4 weeks
Change in Modified Penn Spasticity Frequency Scale
Time frame: 8 weeks
Change in Modified Patient-Reported Impact of Spasticity Measure
Time frame: 4 weeks
Change in Modified Patient-Reported Impact of Spasticity Measure
Time frame: 8 weeks
Participant Global Impression of Change
Time frame: 4 weeks
Participant Global Impression of Change
Time frame: 8 weeks
Change in ankle range of motion
Time frame: 4 weeks
Change in ankle range of motion
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Focused extracorporeal shockwave therapy and Botulinum toxin in people with Spinal Cord Injury and Spasticity, run by Kessler Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shalaka Paranjpe, MS (973-327-3572, sparanjpe@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Modified Ashworth Scale score (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.