Shockwave therapy added to toxin injections to help spasticity after spinal cord injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 trial tests whether adding focused extracorporeal shockwave therapy to botulinum toxin injections yields greater improvement in spasticity for people with non-progressive spinal cord injury. Participants will be randomized to receive either real shockwave therapy with toxin injections or sham therapy with toxin injections, over five visits in about three months. The study also looks at potential changes in the structure of the injected muscles. Outcomes will be measured through spasticity assessments and patient-reported experiences. The investigation is conducted at the Kessler Foundation with NICHD collaboration.

Why it matters

Who can join: the full rules

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)

Where it's running

• Kessler Foundation
  West Orange, New Jersey, United States Recruiting

Study contacts

• Study coordinator: Shalaka Paranjpe, MS
• Email: sparanjpe@kesslerfoundation.org
• Phone: 973-327-3572

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.