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Sound waves aim to calm spastic muscles in spinal injury patients

NCT ID NCT05432999

Symptom relief Sponsor: Kessler Foundation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tested whether a non-invasive treatment called extracorporeal shockwave therapy (ESWT) can safely reduce spasticity—muscle stiffness and spasms—in people with chronic spinal cord injury. Five participants received ESWT or a sham treatment, and researchers measured changes in muscle tone and quality of life. The goal is to gather data for a larger trial that could confirm if this low-side-effect approach works better than current medications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Extracorporeal shockwave therapy (ESWT) – a device that delivers high-pressure sound waves to muscles through the skin
What this could lead to
If it works, this could offer a non-drug option to reduce muscle stiffness and spasms in people with spinal cord injury, with fewer side effects than medications.
What could go wrong
This is a very small pilot study with only 5 participants completed, so results may not apply to everyone. The treatment may not prove effective in larger trials.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

5 people

The number who actually took part.

Started

Sep 2022

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

hereditary spastic paraplegia Muscle Spasticity paraplegia quadriplegia spastic quadriplegic cerebral palsy spastic triplegia spinal cord injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Paraplegia Spastic paraplegia Spastic quadriplegia Spastic tetraplegia Spasticity, muscle Spinal cord injuries Tetraplegia

Contacts and locations

Locations

  • Kessler Foundation

    West Orange, New Jersey, 07052, United States

More trials for these conditions

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