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RECRUITING
NCT07894991
PHASE2

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

Sponsor: Kessler Foundation

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-09-21

Completion Date

2028-08-31

Last Updated

2026-10-28

Healthy Volunteers

No

Interventions

DEVICE

Focused extracorporeal shockwave therapy

Participants will receive one session of shockwave therapy applied to the plantar flexors (calf muscles) per week for three consecutive weeks.

DRUG

Botulinum toxin

Botulinum toxin types A and B injections into the plantar flexors (calf muscles)

OTHER

Sham

Sham shockwave therapy will applied once per week for three consecutive weeks to the plantar flexors (calf muscles).

Locations (1)

Kessler Foundation

West Orange, New Jersey, United States