Key Points
- Participants are now being enrolled in a US clinical trial of FUSMobile’s NeurolyserXR focused ultrasound device for the treatment of sacroiliitis.
- The Foundation is funding this study.
The first few participants have been enrolled in a new clinical trial investigating the safety and efficacy of using FUSMobile’s NeurolyserXR focused ultrasound device for the treatment of low back pain due to sacroiliitis.
Caused by inflammation of the sacroiliac (SI) joint, sacroiliitis is a common cause of pain and stiffness in the buttocks or lower back. It affects up to 27% of people in the United States. The NeurolyserXR uses high-intensity focused ultrasound guided by x-ray fluoroscopy imaging to heat and destroy neural tissue. The device has been used to treat other causes of low back pain, but this is the first study testing its ability to ease SI joint pain.
The trial is being led by Lynn Kohan, MD, an anesthesiologist and division chief of the Pain Management Center at the University of Virginia (UVA). In all, 10 participants will undergo a single noninvasive focused ultrasound treatment.
Participants will be followed for two years after the procedure, and pain relief will be assessed based on the numerical rating scale (1-10) and reduction or change in analgesic or opiate usage. Researchers will also track the participants’ self-reported quality of life.
“SI joint pain is not uncommon and can contribute to significant pain and suffering,” explains Dr. Kohan. Long-lasting procedures to treat the pain can be invasive; thus, there is a great need for an effective procedure that can help patients. Focused ultrasound targeted therapy can treat patients suffering from this painful disorder without using multiple needles. Thus, we hope to find an effective and safe noninvasive treatment option that greatly alleviates pain and suffering.”
The Foundation is funding this clinical trial.
Arik Hananel, MD, FUSMobile’s CEO and co-founder said, “Here at FUSMobile, we feel fortunate and grateful to collaborate with Dr. Kohan, UVA, and the Focused Ultrasound Foundation in this research and provide any needed technical support with the goal of improving patients’ quality of life.”
This year, the device has earned the CE Mark in Europe and Health Canada approval for the treatment of lumbar zygapophyseal joint syndrome, or arthritic low back pain. The company has also completed patient enrollment in a larger, pivotal clinical trial for lumbar zygapophyseal joint syndrome at 10 sites in the US. Similar studies were conducted in Canada and Israel.
For Patients
If you are interested in learning more about this clinical trial at UVA, please contact Alexi Moruza at (434) 243-5676 or AM2JT@uvahealth.org.