Focused shockwave treatment for elbow and wrist 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 1 interventional protocol will deliver focused extracorporeal shockwave therapy to the elbow and wrist flexor muscles of adults with chronic, non-progressive spinal cord injury and measurable spasticity. Eligible participants must have had their injury for more than one year and Modified Ashworth Scale scores between 1+ and 3 in the treated muscles, with stable antispasmodic medications. Key exclusions include recent local botulinum toxin or phenol/alcohol injections, anticoagulant use, recent infection at the treatment site, pregnancy, cancer, or severe inflammatory joint disease. The primary focus is early safety and tolerability of the shockwave intervention in this population at a single site.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 18 years of age or older.
2. Have chronic, non-progressive SCI of all levels and severities that occurred greater than 1 year prior to their enrollment.
3. MAS score of between 1+ and 3 in elbow and wrist flexors of the treated upper 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).129
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 in the upper extremity
2. Severe, inflammatory arthritic diseases
3. Thrombosis
4. Anticoagulant medication;
5. Pregnancy
6. Cancer
7. Recent history of local injection of botulinum toxin within 6 months, or phenol/alcohol within the 12 months

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

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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.