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Study to Assess the Efficacy and Safety of Iovera®° System in Subjects with Upper Extremity Spasticity

Trial to test Iovera®° for treating upper limb muscle stiffness.

Recruiting
18 years and older
All
Phase 3

Upper extremity spasticity means that the muscles in your arm are too tight, often due to conditions like a stroke or spinal injury. This study checks how well a device called the iovera° system works to help with this problem. The iovera° system uses a special needle to target nerves in your shoulder and elbow. Before using it, doctors will numb the area with a local anesthetic called lidocaine. Randomized means participants will be randomly chosen to either use the iovera° system or a pretend version called a sham treatment. Double-blind means neither you nor the person giving the treatment knows which one you get. The study will last about 13 weeks, with check-ups at 3, 7, and 13 weeks after treatment to see how well it works and if it's safe.

  • The study lasts 13 weeks with three follow-up visits.
  • Participants receive either real or sham treatment.
  • The procedure uses local anesthetic and targets specific nerves.
Study details
    Spasticity
    Cerebral or Spinal Condition

NCT06340451

Pacira Pharmaceuticals, Inc

9 March 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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