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Shockwave for Elbow and Wrist Spasticity in People With Spinal Cord Injury

RecruitingPhase 1Ages 18 Years - anyAllKessler Foundation
NCT07501429 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Approximately 305,000 people live with a spinal cord injury (SCI) in the United States. Sixty percent of these individuals have tetraplegia, which can cause significant dysfunction of the arms and hands. One of the consequences of SCI is spasticity - involuntary activation of muscles that can hinder bodily functions and negatively affect participation in various aspects of life. Spasticity can lead to loss of functional independence and activity limitations, cause pain, and lead to mood disorders like depression. It can even interfere with rehabilitation and lead to hospitalization. In people with tetraplegia, spasticity of the arms and hands can have a tremendous impact on independence and quality of life, and thus regaining function in these areas remains a top priority. Unfortunately, spasticity is difficult to treat. Common treatments include physical therapy, including exercise or s

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📋 Eligibility rules (as published)
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
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What it tests

  • Focused extracorporeal shockwave therapy
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Where

1 site
Kessler Foundation
West Orange, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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