SacroiliitisNCT06053255
Use of the Neurolyser XR for the Treatment of Low Back Pain Related to Sacroiliitis
A study testing High-intensity focused ultrasound for Sacroiliitis using the Neurolyser XR in people with Sacroiliitis, run by FUSMobile Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sacroiliitis
- What is being tested?
- High-intensity focused ultrasound for Sacroiliitis using the Neurolyser XR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2024to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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%
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Virginia, Department of Anesthesiology
Charlottesville, Virginia, 22903
Sierra B Clark, 434-924-3627, BCSH@uvahealth.org
Lynn R Kohan, MD
About this study
Official title: Safety and Efficacy of the Neurolyser XR for the Treatment of Low Back Pain Related to Sacroiliitis
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.
Read the detailed description
The sacroiliac joint connects the sacrum (a triangle shaped bone) with the iliac bone on both sides of the lower spine. These joints transmit all the forces from the upper body to the pelvis and their respective legs. Repeated trauma and aging affect this joint resulting in inflammation and arthritic changes. These changes result in misalignment of the joint or limitation to normal motion which can create pain typically very low in the back or in the buttocks,
High-Intensity Focused Ultrasound (HIFU) technology uses sound waves. These sound waves are concentrated into a specific spot in order to raise the local tissue temperature causing a burn, this burn is expected to intentionally damage the nerve causing pain.
The HIFU device used in this study is called, the Neurolyser XR. It focuses sound wave energy directly on the nerve of the painful sacroiliac joint, causing an increase in temperature, which is expected to directly damage the nerve fibers which carry pain signals to the brain.
- Conditions
- Sacroiliitis
- Being tested
- High-intensity focused ultrasound for Sacroiliitis using the Neurolyser XR
- Keywords
- neurolysis, high-intensity focused ultrasound, nerve ablation, neurotomy, sacral joint pain
- Medical subject headings
- Sacroiliitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity focused ultrasound for Sacroiliitis using the Neurolyser XRDevice
HIFU is delivered via a non-invasive ultrasonic transducer, through a gel pad for acoustic coupling, into the patients body in a precise manner focused on the lateral sacral branch nerves.
| Study group | Role | What they receive |
|---|---|---|
| HIFU for Sacroiliitis | Experimental | High-intensity focused ultrasound delivered to the lateral sacral branch nerve for neurolysis. Receives: Device: High-intensity focused ultrasound for Sacroiliitis using the Neurolyser XR |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v6.0.
Per the CTCAE assessment, each organ or possible adverse event would be categorized on a scale of 1 to 5 where:
Grade 1 is Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.
Grade 2 is Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL).
Grade 3 is Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL.
Grade 4 is Life-threatening consequences; urgent intervention indicated. Grade 5 is Death related to AE.
Measured: Procedure through 6 month follow-up visit
Secondary outcomes (3)
The participants change in level of pain as assessed by the Numerical Rating Scale (NRS) and any change in analgesic/opiate usage.
The pain scale is 0 to 10 where 0 is no pain at all and 10 is the worst pain imaginable
Measured: Procedure through 6 month follow-up visit
Change in quality of life will be assessed by Oswestry Disability Index (ODI)
ODI scale includes 10 questions, each can score 0 to 5 for a total score of 0 to 50.
scores are interpreted as follows: 0-4: No disability 5-14: Mild disability 15-24: Moderate disability 25-34: Severe disability 35-50: Completely disabled
Measured: Procedure through 6 month follow-up visit
Change in quality of life will be assessed also by Brief Pain Inventory (BPI-QOL)
BPI includes 7 questions on the level the patient pain interferes with their daily activities.
Each question can score 0 to 10 for a total score of 0 to 70.
Measured: Procedure through 6 month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start13 Sep 2024
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SacroiliitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 10 participant feasibility study
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FUSMobile Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Focused Ultrasound Foundation
- Responsible party
- Sponsor
- Investigators
- Lynn Kohan, MD, Principal investigator, University of Virginia Pain Medicine Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06053255
- Sponsor's protocol ID
- SIJ-002
- Status last verified
- May 2025
- First submitted
- 6 Sep 2023
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Perez J, Gofeld M, Leblang S, Hananel A, Aginsky R, Chen J, Aubry JF, Shir Y. Fluoroscopy-Guided High-Intensity Focused Ultrasound Neurotomy of the Lumbar Zygapophyseal Joints: A Clinical Pilot Study. Pain Med. 2022 Jan 3;23(1):67-75. doi: 10.1093/pm/pnab275.
PubMed 34534337
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the Neurolyser XR for the Treatment of Low Back Pain Related to Sacroiliitis
- ClinicalTrials.gov ID
- NCT06053255
- Acronym / sponsor ID
- SIJ-002
- Conditions
- Sacroiliitis
- Keywords
- neurolysis, high-intensity focused ultrasound, nerve ablation, neurotomy, sacral joint pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- FUSMobile Inc.Industry (pharma, biotech, devices)
- Collaborators
- Focused Ultrasound Foundation
- Study start
- 13 Sep 2024 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 25 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The sacroiliac joint connects the sacrum (a triangle shaped bone) with the iliac bone on both sides of the lower spine. These joints transmit all the forces from the upper body to the pelvis and their respective legs. Repeated trauma and aging affect this joint resulting in inflammation and arthritic changes. These changes result in misalignment of the joint or limitation to normal motion which can create pain typically very low in the back or in the buttocks,
High-Intensity Focused Ultrasound (HIFU) technology uses sound waves. These sound waves are concentrated into a specific spot in order to raise the local tissue temperature causing a burn, this burn is expected to intentionally damage the nerve causing pain.
The HIFU device used in this study is called, the Neurolyser XR. It focuses sound wave energy directly on the nerve of the painful sacroiliac joint, causing an increase in temperature, which is expected to directly damage the nerve fibers which carry pain signals to the brain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 10 participant feasibility study
| Arm | Type | Receives |
|---|---|---|
| HIFU for Sacroiliitis | Experimental | Device: High-intensity focused ultrasound for Sacroiliitis using the Neurolyser XRHigh-intensity focused ultrasound delivered to the lateral sacral branch nerve for neurolysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
Key exclusion criteria (29 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-intensity focused ultrasound for Sacroiliitis using the Neurolyser XRHIFU is delivered via a non-invasive ultrasonic transducer, through a gel pad for acoustic coupling, into the patients body in a precise manner focused on the lateral sacral branch nerves. | Device | HIFU for Sacroiliitis |
Primary outcome
The number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v6.0.
Time frame: Procedure through 6 month follow-up visit
Per the CTCAE assessment, each organ or possible adverse event would be categorized on a scale of 1 to 5 where: Grade 1 is Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 is Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 is Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 is Life-threatening consequences; urgent intervention indicated. Grade 5 is Death related to AE.
3 secondary outcomes
The participants change in level of pain as assessed by the Numerical Rating Scale (NRS) and any change in analgesic/opiate usage.
Time frame: Procedure through 6 month follow-up visit
Change in quality of life will be assessed by Oswestry Disability Index (ODI)
Time frame: Procedure through 6 month follow-up visit
Change in quality of life will be assessed also by Brief Pain Inventory (BPI-QOL)
Time frame: Procedure through 6 month follow-up visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Background: PubMed 34534337Perez J, Gofeld M, Leblang S, Hananel A, Aginsky R, Chen J, Aubry JF, Shir Y. Fluoroscopy-Guided High-Intensity Focused Ultrasound Neurotomy of the Lumbar Zygapophyseal Joints: A Clinical Pilot Study. Pain Med. 2022 Jan 3;23(1):67-75. doi: 10.1093/pm/pnab275.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lynn Kohan, MD principal investigator
University of Virginia Pain Medicine Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity focused ultrasound for Sacroiliitis using the Neurolyser XR in people with Sacroiliitis, run by FUSMobile Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexi Moruza (434-243-5676, AM2JT@uvahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v6.0. (time frame: Procedure through 6 month follow-up visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06053255, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.