Extracorporeal Shockwave Therapy for Spasticity in People With Spinal Cord Injury

NCT05432999 | Completed FDA Device

• 1 other identifier: R-1178-22
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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. 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; Tetraplegia

Keywords

shockwave; extracorporeal shockwave therapy; spinal cord injury; spasticity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• Change in Modified Ashworth Scale scores

  8 weeks

• Change in Modified Tardieu Scale

  4 weeks

• Change in Modified Tardieu Scale

  8 weeks

• Change in Modified Penn Spasticity Frequency Scale

  4 weeks

• Change in Modified Penn Spasticity Frequency Scale

  8 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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

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.

Device: Extracorporeal Shockwave Therapy

Interventions

Extracorporeal Shockwave Therapy DEVICE

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.

Also known as: Storz Medical DUOLITH SD1 Ultra modular system

Control; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kessler Foundation: lead

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Muscle Spasticity; Paraplegia; Quadriplegia

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Paralysis

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Model Details: Randomized, controlled trial with sham control

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: June 27, 2022
• Study Start: September 1, 2022
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 25, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)