RecruitingNot Applicable

Use of the Neurolyser XR for the Treatment of Low Back Pain Related to Sacroiliitis

United States10 participantsStarted 2024-09-13

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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).

Exclusion criteria

✕. Patients on dialysis
✕. Patients with evidence of lumbosacral radiculopathy on MRI, CT or physical exam findings, including radicular leg pain (symptomatic moderate or severe foraminal or central canal stenosis).
✕. Spinal pathology that may impede recovery such as spina bifida occulta, grade II or higher.
✕. Spondylolisthesis at L5/S1, or scoliosis
✕. Patients with radiofrequency ablation (RF/RFA) treatment for sacroiliitis LBP
✕. Patients with bilateral sacroiliitis LBP
✕. Patients with previous low back surgery
✕. Patients who are pregnant

What they're measuring

The number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v6.0.

Timeframe: Procedure through 6 month follow-up visit

Trial details

NCT IDNCT06053255

SponsorFUSMobile Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-09-15

Contact for this trial

Alexi Moruza

434-243-5676 AM2JT@uvahealth.org

View on ClinicalTrials.gov More Sacroiliitis trials