Receive one of two nerve-targeting treatments for shoulder spasticity and pain

What is this trial?

This trial compares two treatments for shoulder pain and stiffness caused by spasticity—a condition where muscles become tight and overactive after stroke, traumatic brain injury, or spinal cord injury. One treatment uses onabotulinumtoxinA (a medication that relaxes overactive muscles), while the other uses cryoneurolysis, a procedure that freezes specific nerves to reduce muscle overactivity. Both treatments are guided by ultrasound imaging to target the exact muscles and nerves causing your shoulder problems.

Long-term spasticity can cause permanent muscle shortening, joint stiffness, and severe pain that makes it hard to care for yourself. While botulinum toxin is commonly used, cryoneurolysis (freezing nerves) is a newer approach that may offer similar or better results without needing repeated injections. This trial will help doctors understand which treatment works best for shoulder pain and function.

Do you qualify?

You likely qualify if…

you are 18 years or older
you experienced a stroke, traumatic brain injury, or lack of oxygen to the brain more than 6 months ago
you have significant muscle tightness and overactivity in your shoulder (especially muscles that pull your arm inward and rotate it)
you have shoulder pain rated above 40 on a 0–100 pain scale
your spasticity is making it difficult to care for yourself (washing, dressing, or daily activities)
you have the mental ability to understand the study and make your own decisions about participating

You likely don't qualify if…

you have had any nerve injections or treatments in your upper arm within the last 4 months
you have certain rare blood conditions triggered by cold (cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria) or Raynaud's disease
you have myasthenia gravis or Eaton-Lambert syndrome (conditions that affect muscle strength)
you are pregnant or breastfeeding
you have open wounds or active skin infections on the arm being treated

What participation looks like

You will be randomly assigned to receive either botulinum toxin injections or cryoneurolysis treatment, both guided by ultrasound. The procedure itself is a one-time or single-session intervention performed by a trained doctor. You will then attend multiple follow-up evaluation sessions and participate in a rehabilitation program at the study center to track improvements in your shoulder pain, muscle tightness, and ability to perform daily activities. The study team will monitor your progress over time to see which treatment works best.

AI-generated summary from trial data · Jun 10, 2026 · Not medical advice

Key details

Sponsor

Centre National de Rééducation Fonctionnelle et de Réadaptation

Enrollment target

~50 participants

Started

December 2024

Primary completion

December 2028

Age range

18 Years and older

Last updated on clinicaltrials.gov in March 2026.

Contact the research team directly

Reach out to the team running this trial. Response times vary — some teams are faster than others.

Central contact

José A Carvalho Pereira, M.D.

Centre National de Rééducation Fonctionnelle et de Réadaptation

Interested in joining?

Tell us you're interested and we'll help connect you with the research team. We'll walk you through what to expect first — no email needed to get started.

Freezing Nerves vs. Botox for Shoulder Pain After Stroke or Brain Injury

What is this trial?

Do you qualify?

What participation looks like

Trial locations(1 site)