Recruiting
Phase 2

Shockwave Therapy & Botox

Sponsor:

Kessler Foundation

Code:

NCT07894991

Conditions

Spinal Cord Injury

Spasticity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Focused extracorporeal shockwave therapy

Botulinum toxin

Sham

Study Details

Brief 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.

Conditions

Spinal Cord Injury

Spasticity

Study ID

NCT07894991

Start date

Sep 21, 2026

Status verified date

Oct, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Apr 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Shockwave plus toxin

Shockwave therapy plus toxin injection

sham comparator: Sham plus toxin

Toxin injection plus a sham (fake) shockwave therapy

Interventions

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.

Botulinum toxin

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

Sham

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

Primary outcome measure

  • Change in Modified Ashworth Scale score [ Time Frame: 8 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

Oct 26, 2026

Last verified

Oct, 2026

Keywords

  • spinal cord injury
  • spasticity
  • shockwave
  • injection
  • botulinum toxin
  • shockwave therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-27. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2026-10-26. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.