12 Participants NeededMy employer runs this trial

Shockwave Therapy for Spasticity in Spinal Cord Injury

SP
NH
Overseen ByNathan Hogaboom, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to treat muscle spasticity in individuals with spinal cord injuries using focused extracorporeal shockwave therapy (f-ESWT). Spasticity causes muscles to contract involuntarily, complicating daily tasks and affecting quality of life. The treatment employs sound waves to relax muscles in the arms and hands, with no long-lasting side effects. Ideal participants have had a spinal cord injury for more than a year and experience muscle tightness in their arms or hands. The trial aims to determine if this therapy can improve movement and independence. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

What prior data suggests that focused extracorporeal shockwave therapy is safe for treating spasticity in spinal cord injury?

Research has shown that focused extracorporeal shockwave therapy (f-ESWT) is generally safe for people with spinal cord injuries. Studies have found that it can reduce muscle stiffness and spasms without causing long-term side effects. Some reports also mention improvements in daily activities and quality of life for those who receive this treatment. Although more research is needed, current evidence suggests that f-ESWT is well-tolerated and has few negative effects.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about focused extracorporeal shockwave therapy for spasticity in spinal cord injury because it offers a new, non-invasive approach. Unlike typical treatments, such as muscle relaxants and physical therapy, this method uses sound waves to target muscle tightness directly. This innovative approach may reduce spasticity more effectively and with fewer side effects, potentially improving quality of life for patients.

What evidence suggests that focused extracorporeal shockwave therapy is effective for spasticity in spinal cord injury?

Research has shown that focused extracorporeal shockwave therapy (f-ESWT), which participants in this trial will receive, can help reduce involuntary muscle tightness, known as spasticity, in people with spinal cord injuries. One study found that f-ESWT improved daily activities and muscle function for many patients. Other studies have shown it can reduce spasticity in both arms and legs, with effects lasting up to 12 weeks. Importantly, f-ESWT has no long-term side effects and causes little discomfort during treatment. Overall, f-ESWT appears to be a promising non-invasive treatment for managing spasticity in individuals with spinal cord injuries.12346

Are You a Good Fit for This Trial?

Inclusion Criteria

I am 18 years old or older.
Participant is able and willing to comply with the protocol
I can receive shockwave treatment and have no recent infections or bleeding disorders.
See 3 more

Exclusion Criteria

Pregnancy
I have a severe inflammatory arthritis condition.
I am currently taking blood-thinning medication.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive focused extracorporeal shockwave therapy (f-ESWT) to the elbow and wrist flexor muscles once per week for three consecutive weeks

3 weeks
3 visits (in-person)

Follow-up

Participants are monitored for changes in spasticity and muscle characteristics using clinical measures and ultrasound imaging

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Focused extracorporeal shockwave therapy

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials
190
Recruited
11,300+

Citations

Shockwave therapy in persons with a spinal cord injury ... - PMC

In this study, ESWT resulted in improved performance of specific ADL items in most persons with SCI. More research is needed to confirm these ...

Preliminary Findings from a Randomized, Sham-controlled ...

Preliminary evidence from our pilot trial suggests f-ESWT may be a promising treatment for lower limb spasticity in people with SCI. However, a larger sample ...

Extracorporeal Shockwave Therapy for Spasticity in People ...

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 ...

Extracorporeal Shock Wave Therapy (eSWT) in Spinal Cord ...

Some reports have shown that eSWT can improve spasticity, walking ability, urological function, quality of life, and independence in daily life.

Extracorporeal Shockwave Therapy on Spasticity after...

Both radial and focus ESWTs could decrease spasticity, regardless of the treatment session. The result could last for 12 weeks after treatment. Moreover, no ...

Effectiveness of Shock Wave Therapy as a Treatment for ...

In recent years, shock waves have been tested on spasticity, and were shown to be safe and effective in reduction [13,18,23], with few observed ...