Safety and Efficacy of the Neurolyser XR for the Treatment of Low Back Pain Related to Sacroiliitis

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Men and women aged 18 and older

• BPI \< 40

• Patients who are able and willing to give consent and able to attend all study visits.

• Patients who are able to communicate with the treating physician.

• Patients must have chronic lower back pain (LBP) attributed to degenerative sacroiliitis diagnosed by a pain physician using the following guidelines:

• At least 1 positive sacroiliac joint provocation test (Gaeslen's test, FABER (Patrick's test), and pelvic rock)

• Back pain predominantly below L5

• 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).

• 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, bone fracture, the zygapophyseal joints, the hip joint, symptomatic spondylolisthesis, tumor, and other regional soft tissue structures (this is done by physical exam, medical history, and MRI/CT/X-ray as required)

⁃ Patients with NRS (0-10 scale) LBP average score ≥ 4

⁃ Patients with chronic LBP for at least 12 months.

⁃ Patients with Oswestry Disability Questionnaire (ODQ) for LBP score \> 40%

Locations
United States
Virginia
University of Virginia, Department of Anesthesiology
RECRUITING
Charlottesville
Contact Information
Primary
Alexi Moruza
AM2JT@uvahealth.org
434-243-5676
Time Frame
Start Date: 2024-09-13
Estimated Completion Date: 2026-12-15
Participants
Target number of participants: 10
Treatments
Experimental: HIFU for Sacroiliitis
High-intensity focused ultrasound delivered to the lateral sacral branch nerve for neurolysis.
Related Therapeutic Areas
Sponsors
Collaborators: Focused Ultrasound Foundation
Leads: FUSMobile Inc.

This content was sourced from clinicaltrials.gov