Extracorporeal Shockwave Therapy for Spasticity in People With Spinal Cord Injury

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries; Spasticity, Muscle; Tetraplegia; Paraplegia; Spastic Tetraplegia; Spastic Paraplegia; Spastic Quadriplegia
• Intervention / Treatment: Device: Extracorporeal Shockwave Therapy

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • West Orange, New Jersey, United States, 07052
      • Kessler Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 18 years of age or older.
2. Have a non-progressive traumatic SCI (complete or incomplete) with residual neurological deficits that occurred greater than 1 year prior to their enrollment.
3. MAS score of 2 or greater in the gastrocnemius of the treated limb.
4. 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
5. No change in antispasmodic medications within the past three months or intended changes over the course of the trial.
6. Participant is able and willing to comply with the protocol.

Exclusion Criteria:

1. History of surgical procedures of the lower extremity.
2. Ankle contracture.
3. Sever, inflammatory arthritic diseases.
4. Thrombosis.
5. Anticoagulant medications.
6. Pregnancy.
7. Cancer.
8. Recent history of local injection of botulinum toxin within 6 months, or phenol/alcohol with 12 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; This group will receive a focused extracorporeal shockwave therapy treatment (three applications over three weeks), applied to the spastic medial gastrocnemius.	Device: Extracorporeal Shockwave Therapy; 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.; Other Names: Storz Medical DUOLITH SD1 Ultra modular system
Sham Comparator: Control; 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.	Device: Extracorporeal Shockwave Therapy; 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.; Other Names: Storz Medical DUOLITH SD1 Ultra modular system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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").	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").	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.	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.	8 weeks
Medial gastrocnemius muscle echogenicity	Average "brightness" of the medial gastrocnemius muscle, measured using quantitative ultrasound techniques.	4 weeks
Medial gastrocnemius muscle echogenicity	Average "brightness" of the medial gastrocnemius muscle, measured using quantitative ultrasound techniques.	8 weeks
Medial gastrocnemius muscle elasticity	Average elasticity of the medial gastrocnemius muscle, measured using shear wave elastography.	4 weeks
Medial gastrocnemius muscle elasticity	Average elasticity of the medial gastrocnemius muscle, measured using shear wave elastography.	8 weeks
Medial gastrocnemius muscle fiber length	Fiber length of the medial gastrocnemius muscle, measured quantitatively using ultrasound.	4 weeks
Medial gastrocnemius muscle fiber length	Fiber length of the medial gastrocnemius muscle, measured quantitatively using ultrasound.	8 weeks
Medial gastrocnemius muscle thickness	Thickness of the medial gastrocnemius muscle, measured quantitatively using ultrasound.	4 weeks
Medial gastrocnemius muscle thickness	Thickness of the medial gastrocnemius muscle, measured quantitatively using ultrasound.	8 weeks
Medial gastrocnemius muscle pennation angle	Pennation angle of the medial gastrocnemius muscle, measured quantitatively using ultrasound.	4 weeks
Medial gastrocnemius muscle pennation angle	Pennation angle of the medial gastrocnemius muscle, measured quantitatively using ultrasound.	8 weeks

Collaborators and Investigators

• Sponsor: Kessler Foundation

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): November 1, 2025
• Study Completion (Actual): December 1, 2025

Study Registration Dates

• First Submitted: June 23, 2022
• First Submitted That Met QC Criteria: June 23, 2022
• First Posted (Actual): June 27, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: spasticity; spinal cord injury; shockwave; extracorporeal shockwave therapy
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Paralysis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Muscle Spasticity; Spinal Cord Injuries; Quadriplegia; Paraplegia; Therapeutics; Physical Therapy Modalities; Rehabilitation; Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Extracorporeal Shockwave Therapy
• Other Study ID Numbers: R-1178-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No