Use of the Neurolyser XR for the Treatment of Low Back Pain Related to Sacroiliitis
This trial tests a device called the Neurolyser XR that uses focused ultrasound waves to treat lower back pain caused by sacroiliitis (inflammation of the sacroiliac joint). The device works by targeting and disabling specific nerves that carry pain signals from the affected area. This is a new approach to help reduce pain in patients with this condition.
Key Objective:This trial is testing whether the Neurolyser XR can effectively reduce low back pain in patients with sacroiliitis by using ultrasound to disable the nerves responsible for transmitting pain.
Who to Consider:Patients with low back pain caused by sacroiliitis who have not found adequate relief with other treatments should consider enrolling in this trial.
Trial Parameters
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Brief Summary
The Neurolyser XR is a device used to deliver high-intensity focused ultrasound for the ablation of the lateral sacral branch nerve in patients with Sacroiliitis.
Eligibility Criteria
Inclusion Criteria: 1. Men and women aged 18 and older 2. BPI \< 40 3. Patients who are able and willing to give consent and able to attend all study visits. 4. Patients who are able to communicate with the treating physician. 5. Patients must have chronic lower back pain (LBP) attributed to degenerative sacroiliitis diagnosed by a pain physician using the following guidelines: 6. At least 1 positive sacroiliac joint provocation test (Gaeslen's test, FABER (Patrick's test), and pelvic rock) 7. Back pain predominantly below L5 8. 50% relief following either sacroiliac joint (SI) joint injection and/or lateral branch blocks corresponding to the expected duration of the medication utilized. (i.e SI joint injection-expected pain relief duration of steroid, lateral branch blocks-expected pain relief duration of local anesthetic utilized). 9. All other possible sources of low back pain have been ruled out as the primary pain generator, including but not limited to: the intervertebral discs,