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New treatment option for Sacroiliitis
Official title Use of the Neurolyser XR for the Treatment of Low Back Pain Related to Sacroiliitis
ClinicalTrials.gov ID: NCT06053255
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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:
You likely can't join if
- Patients on dialysis
- Patients with evidence of lumbosacral radiculopathy on MRI, CT or physical exam findings, including radicular leg pain (symptomatic moderate or...
- 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
See the full eligibility 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...
- 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...
- 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%
- 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
- Patients with existing malignancy
- Patients with allergies to relevant anesthetics
- Patients with motor deficit or any other indication for surgical intervention
- Patients with contraindications for MRI
- Patients with an acute medical condition (e.g., pneumonia, sepsis, systemic infection, uncontrolled immunosuppression-AIDS, cancer, DM) that is expected to hinder them from completing this study.
- Patients with unstable cardiac status including:
- Unstable angina pectoris on medication
- Patients with documented myocardial infarction less than 40 days prior to protocol enrolment
- Patients with Severe Congestive Heart Failure, New York Heart Association (NYHA) class 4.
- Patients on anti-arrhythmic drugs or with uncontrolled and/or untreated arrhythmia status
- Patients with severe cerebrovascular disease (CVA within last 6 months)
- Patients with severe hypertension (diastolic BP \> 100 on medication)
- Patient Body Mass Index \> 45 or \<20
- Patients with known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) including advanced kidney disease
- Patients with an active infection or severe hematological, neurological, or other uncontrolled disease.
- The patient is unable to communicate with the investigator and staff.
- Patients who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 2 hours)
- Patient with acute pelvic inflammatory conditions
- Ongoing/ unresolved Worker's compensation, injury litigation, military medical board, or disability remuneration claims
- Morphine Milligram Equivalents (MME) \> 60 per 24 hrs.
- Patients with platelets \< 100.
The study team makes the final eligibility decision.
Where it's taking place
- Charlottesville, Virginia, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charlottesville, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.