Home › Spinal Cord Injuries › NCT07894991

Extracorporeal Shockwave Therapy as an Additional Treatment for Spasticity Secondary to Spinal Cord Injury

Randomized, Sham-controlled Trial to Investigate Extracorporeal Shockwave Therapy as an Adjunctive Treatment for Spasticity Secondary to Spinal Cord Injury

Who can join

Ages 18 and older · All sexes

Inclusion criteria:

1. Women and men, age 18 years and older
2. Non-progressive SCI (complete or incomplete) with residual neurological deficits that occurred greater than 1 year prior to enrollment
3. Ankle flexor modified Ashworth scale (MAS) of between 1+ and 3, inclusive
4. No contraindication to f-ESWT, including current or recent infection at the treatment site and severe coagulopathies
5. No change in antispasmodic medications within the past 3 months or intended changes during the trial
6. currently being treated with BoNT in the plantar flexor muscles

Exclusion criteria:

1. History of lower limb surgical procedures
2. Ankle contracture
3. Severe, inflammatory arthritic diseases
4. Thrombosis
5. Anticoagulant medication
6. Pregnancy
7. Cancer
8. Recent (12 months) local phenol/alcohol injection
9. MRI contraindications (e.g. claustrophobia, ferromagnetic implants or debris)

About the study

Spasticity is a common consequence of spinal cord injury and can have a profound impact on quality of life. The goal of this study is to learn if an intervention called focused extracorporeal shockwave therapy can enhance the effectiveness of injections received for spasticity, such as Botox. The main questions this study seeks to answer are whether shockwave therapy and toxin injection 1) can improve spasticity symptoms greater than toxin injection alone, and 2) change the structure of the injected muscles. Researchers will compare the group who receives both shockwave therapy and toxin injection to a group who receives only toxin injection. Participants will be asked to visit the clinic five times over the span of three months. The first three visits will occur on three consecutive weeks, during which participants will receive shockwave therapy or the sham therapy. The final two visits will occur four and eight weeks later, during which participants will be asked a series of questions about their spasticity and have ultrasounds and MRIs collected of their leg muscles.

What is being tested

• Focused extracorporeal shockwave therapy (device)
• Botulinum toxin (drug)
• Sham (other)

Sponsor: Kessler Foundation · Participants: 30 · Started: Sep 21, 2026

Contact the study team

• Shalaka Paranjpe, MS · Phone: 973-327-3572
• Nathan Hogaboom, PhD · Phone: 973-324-3584

Official record on ClinicalTrials.gov — NCT07894991

Locations in the U.S.

Conditions

• Spinal Cord Injuries
• Muscle Spasticity

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.