Spinal Cord InjuriesNCT05432999
Extracorporeal Shockwave Therapy for Spasticity in People With Spinal Cord Injury
A study testing Extracorporeal Shockwave Therapy in people with Spinal Cord Injuries and Spasticity, Muscle, run by Kessler Foundation at 1 site in United States.
Trial summary
People with spinal cord injury (SCI) experience a host of secondary complications that can impact their quality of life and functional independence. One of the more prevalent complications is spasticity, which occurs in response to spinal cord damage and the resulting disruption of motor pathways. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Spasticity, Muscle, Spastic Paraplegia
- What is being tested?
- Extracorporeal Shockwave Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 18 years of age or older.
- Have a non-progressive traumatic SCI (complete or incomplete) with residual neurological deficits that occurred greater than 1 year prior to their enrollment.
- MAS score of 2 or greater in the gastrocnemius of the treated limb.
- Can be treated with shockwaves. Contraindications include current or recent (within the past 3 months) infection at the site of treatment and severe coagulopathies (e.g. hemophilia).164
- No change in antispasmodic medications within the past three months or intended changes over the course of the trial.
- Participant is able and willing to comply with the protocol.
Who cannot join
- History of surgical procedures of the lower extremity.
- Ankle contracture.
- Sever, inflammatory arthritic diseases.
- Thrombosis.
- Anticoagulant medications.
- Pregnancy.
- Cancer.
- Recent history of local injection of botulinum toxin within 6 months, or phenol/alcohol with 12 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Extracorporeal Shockwave Therapy on Spasticity in Chronic SCI: A Pilot Study
People with spinal cord injury (SCI) experience a host of secondary complications that can impact their quality of life and functional independence. One of the more prevalent complications is spasticity, which occurs in response to spinal cord damage and the resulting disruption of motor pathways. Common symptoms include spasms and stiffness, and can occur more than once per hour in many people with SCI. Spasticity can have a negative impact over many quality of life domains, including loss of functional independence, activity limitations, and even employment. Its impact on health domains is also pronounced, with many people who have spasticity reporting mood disorders, depression, pain, sleep disturbances, and contractures. Spasticity can interfere with post-injury rehabilitation and lead to hospitalization. There are many treatments for spasticity in this population. However, many do not have long-term efficacy, and, if they do, they are often pharmacological in nature and carry side effects that could limit function or affect health. The goal of this pilot, randomized-controlled study is to investigate the potential efficacy and safety of a non-invasive treatment with a low side effect profile, extracorporeal shockwave therapy (ESWT). ESWT has shown some benefits in people with post-stroke spasticity with no long term side effects. Thirty individuals with chronic, traumatic SCI will be recruited. Fifteen will be provided with ESWT while the other fifteen will be given a sham treatment. Clinical and self-report measures of spasticity and its impact on quality of life will be collected, as well as quantitative ultrasound measures of muscle architecture and stiffness. The ultimate goal of this pilot project is to collect the data necessary to apply for a larger randomized-controlled trial. Conducting a larger trial will allow for a more powerful estimation of safety and efficacy of ESWT as a treatment for spasticity in people with SCI.
- Conditions
- Spinal Cord Injuries, Spasticity, Muscle, Spastic Paraplegia, Spastic Quadriplegia, Spastic Tetraplegia, Paraplegia
- Being tested
- Extracorporeal Shockwave Therapy
- Keywords
- shockwave, extracorporeal shockwave therapy, spinal cord injury, spasticity
- Medical subject headings
- Spinal Cord Injuries, Muscle Spasticity, Paraplegia, Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Shockwave TherapyDevice
Also called Storz Medical DUOLITH SD1 Ultra modular system
Shockwaves are high pressure sound waves that interact with tissues to elicit a biological response. The shockwave probe will be placed on the skin with ultrasound gel and the muscle will be stimulated for a few minutes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This group will receive a focused extracorporeal shockwave therapy treatment (three applications over three weeks), applied to the spastic medial gastrocnemius. Receives: Device: Extracorporeal Shockwave Therapy |
| Control | Sham comparator | This group will go through the same procedures as the intervention group, but the shockwave device will not touch their skin and thus they will receive no therapeutic effect. Receives: Device: Extracorporeal Shockwave Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Modified Ashworth Scale scores
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.
Measured: 4 weeks
Secondary outcomes (19)
Change in Modified Ashworth Scale scores
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.
Measured: 8 weeks
Change in Modified Tardieu Scale
The Modified Tardieu Scale (MTS) was developed as a more accurate method to measure spasticity by assessing muscle tone at different velocities. Since its development, it has gone through multiple modifications. The MTS is also included in the NINDS CDE recommendations as a measure of spasticity in people with SCI. The MTS includes two measurements, quality and angle of muscle reaction.
Measured: 4 weeks
Change in Modified Tardieu Scale
The Modified Tardieu Scale (MTS) was developed as a more accurate method to measure spasticity by assessing muscle tone at different velocities. Since its development, it has gone through multiple modifications. The MTS is also included in the NINDS CDE recommendations as a measure of spasticity in people with SCI. The MTS includes two measurements, quality and angle of muscle reaction.
Measured: 8 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 that assesses the impact of spasticity on health-related quality of life. It is separated into physical, psychological, and social subdomains, making is possible to investigate how spasticity impacts different aspects of quality of life. Each item is rated using a scale of 0 ("never") to 3 ("often to very often").
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 that assesses the impact of spasticity on health-related quality of life. It is separated into physical, psychological, and social subdomains, making is possible to investigate how spasticity impacts different aspects of quality of life. Each item is rated using a scale of 0 ("never") to 3 ("often to very often").
Measured: 8 weeks
Participant Global Impression of Change
The Participant Global Impression of Change (PGIC, also referred to as the original Guy-Farrar/PGIC scale) is used to measure global treatment effect. It asks the participant to rate, using a 7-point scale (anchored by "very much worse" and "very much improved"), his or her overall impression following treatment as compared to before the treatment. This scale is particularly useful as it provides an indication of clinically important improvement. Although it was designed for and has commonly been used in pain trials, it has been used to assess efficacy of spasticity treatments in people with SCI.
Measured: 4 weeks
Participant Global Impression of Change
The Participant Global Impression of Change (PGIC, also referred to as the original Guy-Farrar/PGIC scale) is used to measure global treatment effect. It asks the participant to rate, using a 7-point scale (anchored by "very much worse" and "very much improved"), his or her overall impression following treatment as compared to before the treatment. This scale is particularly useful as it provides an indication of clinically important improvement. Although it was designed for and has commonly been used in pain trials, it has been used to assess efficacy of spasticity treatments in people with SCI.
Measured: 8 weeks
Medial gastrocnemius muscle echogenicity
Average "brightness" of the medial gastrocnemius muscle, measured using quantitative ultrasound techniques.
Measured: 4 weeks
Medial gastrocnemius muscle echogenicity
Average "brightness" of the medial gastrocnemius muscle, measured using quantitative ultrasound techniques.
Measured: 8 weeks
Medial gastrocnemius muscle elasticity
Average elasticity of the medial gastrocnemius muscle, measured using shear wave elastography.
Measured: 4 weeks
Medial gastrocnemius muscle elasticity
Average elasticity of the medial gastrocnemius muscle, measured using shear wave elastography.
Measured: 8 weeks
Medial gastrocnemius muscle fiber length
Fiber length of the medial gastrocnemius muscle, measured quantitatively using ultrasound.
Measured: 4 weeks
Medial gastrocnemius muscle fiber length
Fiber length of the medial gastrocnemius muscle, measured quantitatively using ultrasound.
Measured: 8 weeks
Medial gastrocnemius muscle thickness
Thickness of the medial gastrocnemius muscle, measured quantitatively using ultrasound.
Measured: 4 weeks
Medial gastrocnemius muscle thickness
Thickness of the medial gastrocnemius muscle, measured quantitatively using ultrasound.
Measured: 8 weeks
Medial gastrocnemius muscle pennation angle
Pennation angle of the medial gastrocnemius muscle, measured quantitatively using ultrasound.
Measured: 4 weeks
Medial gastrocnemius muscle pennation angle
Pennation angle of the medial gastrocnemius muscle, measured quantitatively using ultrasound.
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 posted27 Jun 2022
- Study start1 Sep 2022
- Primary completion1 Nov 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled trial with sham control
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nathan Hogaboom, PhD, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05432999
- Sponsor's protocol ID
- R-1178-22
- Status last verified
- May 2025
- First submitted
- 23 Jun 2022
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Extracorporeal Shockwave Therapy on Spasticity in Chronic SCI: A Pilot Study
- ClinicalTrials.gov ID
- NCT05432999
- Acronym / sponsor ID
- R-1178-22
- Conditions
- Spinal Cord Injuries, Spasticity, Muscle, Spastic Paraplegia, Spastic Quadriplegia, Spastic Tetraplegia, Paraplegia
- Keywords
- shockwave, extracorporeal shockwave therapy, spinal cord injury, spasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 27 Jun 2022 (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.
People with spinal cord injury (SCI) experience a host of secondary complications that can impact their quality of life and functional independence. One of the more prevalent complications is spasticity, which occurs in response to spinal cord damage and the resulting disruption of motor pathways. Common symptoms include spasms and stiffness, and can occur more than once per hour in many people with SCI. Spasticity can have a negative impact over many quality of life domains, including loss of functional independence, activity limitations, and even employment. Its impact on health domains is also pronounced, with many people who have spasticity reporting mood disorders, depression, pain, sleep disturbances, and contractures. Spasticity can interfere with post-injury rehabilitation and lead to hospitalization. There are many treatments for spasticity in this population. However, many do not have long-term efficacy, and, if they do, they are often pharmacological in nature and carry side effects that could limit function or affect health. The goal of this pilot, randomized-controlled study is to investigate the potential efficacy and safety of a non-invasive treatment with a low side effect profile, extracorporeal shockwave therapy (ESWT). ESWT has shown some benefits in people with post-stroke spasticity with no long term side effects. Thirty individuals with chronic, traumatic SCI will be recruited. Fifteen will be provided with ESWT while the other fifteen will be given a sham treatment. Clinical and self-report measures of spasticity and its impact on quality of life will be collected, as well as quantitative ultrasound measures of muscle architecture and stiffness. The ultimate goal of this pilot project is to collect the data necessary to apply for a larger randomized-controlled trial. Conducting a larger trial will allow for a more powerful estimation of safety and efficacy of ESWT as a treatment for spasticity in people with SCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, controlled trial with sham control
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Extracorporeal Shockwave TherapyThis group will receive a focused extracorporeal shockwave therapy treatment (three applications over three weeks), applied to the spastic medial gastrocnemius. |
| Control | Sham comparator | Device: Extracorporeal Shockwave TherapyThis group will go through the same procedures as the intervention group, but the shockwave device will not touch their skin and thus they will receive no therapeutic effect. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older.
- Have a non-progressive traumatic SCI (complete or incomplete) with residual neurological deficits that occurred greater than 1 year prior to their enrollment.
- MAS score of 2 or greater in the gastrocnemius of the treated limb.
- Can be treated with shockwaves. Contraindications include current or recent (within the past 3 months) infection at the site of treatment and severe coagulopathies (e.g. hemophilia).164
- No change in antispasmodic medications within the past three months or intended changes over the course of the trial.
Key exclusion criteria (8 listed)
- History of surgical procedures of the lower extremity.
- Ankle contracture.
- Sever, inflammatory arthritic diseases.
- Thrombosis.
- Anticoagulant medications.
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 |
|---|---|---|
| Extracorporeal Shockwave TherapyAlso: Storz Medical DUOLITH SD1 Ultra modular systemShockwaves are high pressure sound waves that interact with tissues to elicit a biological response. The shockwave probe will be placed on the skin with ultrasound gel and the muscle will be stimulated for a few minutes. | Device | Control, Intervention |
Primary outcome
Change in Modified Ashworth Scale scores
Time frame: 4 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.
19 secondary outcomes
Change in Modified Ashworth Scale scores
Time frame: 8 weeks
Change in Modified Tardieu Scale
Time frame: 4 weeks
Change in Modified Tardieu Scale
Time frame: 8 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
Medial gastrocnemius muscle echogenicity
Time frame: 4 weeks
Medial gastrocnemius muscle echogenicity
Time frame: 8 weeks
Medial gastrocnemius muscle elasticity
Time frame: 4 weeks
Medial gastrocnemius muscle elasticity
Time frame: 8 weeks
Medial gastrocnemius muscle fiber length
Time frame: 4 weeks
Medial gastrocnemius muscle fiber length
Time frame: 8 weeks
Medial gastrocnemius muscle thickness
Time frame: 4 weeks
Medial gastrocnemius muscle thickness
Time frame: 8 weeks
Medial gastrocnemius muscle pennation angle
Time frame: 4 weeks
Medial gastrocnemius muscle pennation angle
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Shockwave Therapy in people with Spinal Cord Injuries and Spasticity, Muscle, 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 8 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: finished, as of the sponsor's last update on 25 Mar 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Modified Ashworth Scale scores (time frame: 4 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 25 Mar 2026.