Recruiting
Phase 1

f-ESWT

Sponsor:

Kessler Foundation

Code:

NCT07501429

Conditions

Spinal Cord Injury

Spasticity

Shockwave Therapy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Focused extracorporeal shockwave therapy

Study Details

Brief summary:

Approximately 305,000 people live with a spinal cord injury (SCI) in the United States. Sixty percent of these individuals have tetraplegia, which can cause significant dysfunction of the arms and hands. One of the consequences of SCI is spasticity - involuntary activation of muscles that can hinder bodily functions and negatively affect participation in various aspects of life. Spasticity can lead to loss of functional independence and activity limitations, cause pain, and lead to mood disorders like depression. It can even interfere with rehabilitation and lead to hospitalization. In people with tetraplegia, spasticity of the arms and hands can have a tremendous impact on independence and quality of life, and thus regaining function in these areas remains a top priority. Unfortunately, spasticity is difficult to treat. Common treatments include physical therapy, including exercise or stretching; medications such as Baclofen; and injections with agents like botulinum toxin (also known as Botox). Botox injections are often implemented alongside other modalities like therapy, yet they are invasive, tend to last for only a few months, and carry potential side effects. One potential non-invasive treatment for upper limb spasticity is focused extracorporeal shockwave therapy (f-ESWT), which involves an external application of high-pressure sound waves, similar to ultrasound. An applicator/handpiece is placed on the skin over the spastic muscle and the focused sound waves are applied. f-ESWT carries no long-term side effects with minimal discomfort during application. However, there has been limited research on this treatment option in people with SCI who have arm and hand dysfunction caused by spasticity. The purpose of this study is to fill in that knowledge gap. This will be accomplished by measuring different aspects of spasticity from the perspective of both the clinician and the person with SCI. These will include clinical measures, such as elbow and wrist range of motion, as well as how the treatment impacts the person's functional independence and quality of life. Ultrasound methods will be used to look at the person's muscles to see if any beneficial changes occur in their structure and stiffness. People with SCI who meet eligibility criteria will be invited to the laboratory to receive f-ESWT, which will occur once per week for three consecutive weeks. Treatment will entail application of f-ESWT to the elbow and wrist flexor muscles. Participants will be invited back to the laboratory to have their spasticity measured by a clinician, be asked questions about how their spasticity has impacted their lives, and have their muscles imaged with ultrasound. Findings from this study are expected to generate insight on whether f-ESWT could be a viable treatment option for spasticity of the arms and hands in people with SCI, and if a larger clinical trial is warranted.

Conditions

Spinal Cord Injury

Spasticity

Shockwave Therapy

Study ID

NCT07501429

Start date

Apr, 2026

Status verified date

Mar, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 18 years of age or older.
2. Have chronic, non-progressive SCI of all levels and severities that occurred greater than 1 year prior to their enrollment.
3. MAS score of between 1+ and 3 in elbow and wrist flexors of the treated upper 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).129
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 in the upper extremity
2. Severe, inflammatory arthritic diseases
3. Thrombosis
4. Anticoagulant medication;
5. Pregnancy
6. Cancer
7. Recent history of local injection of botulinum toxin within 6 months, or phenol/alcohol within the 12 months

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

Elbow and Wrist Flexor Focused Extracorporeal Shockwave Therapy

Interventions

Focused extracorporeal shockwave therapy

Three sessions of focused extracorporeal shockwave therapy, applied to forearm and elbow flexor muscles.

Primary outcome measure

  • Change in Modified Ashworth Scale scores [ Time Frame: 4 weeks ]

Central Contacts and Locations

Locations

Kessler Foundation

Recruiting

West Orange, New Jersey, United States, 07052

Contacts

Principal Investigator:

Nathan Hogaboom, PhD

More Information

Sponsor

Kessler Foundation

Last update posted

Mar 30, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2026-03-30.