Use of the Neurolyser XR for the Treatment of Low Back Pain Related to Sacroiliitis
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ClinicalTrials.gov Identifier: NCT06053255 |
Recruitment Status :
Not yet recruiting
First Posted : September 25, 2023
Last Update Posted : October 5, 2023
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Condition or disease | Intervention/treatment | Phase |
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Sacroiliitis | Device: High-intensity focused ultrasound for Sacroiliitis using the Neurolyser XR | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | 10 participant feasibility study |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Safety and Efficacy of the Neurolyser XR for the Treatment of Low Back Pain Related to Sacroiliitis |
Estimated Study Start Date : | November 15, 2023 |
Estimated Primary Completion Date : | September 15, 2024 |
Estimated Study Completion Date : | December 15, 2024 |
Arm | Intervention/treatment |
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Experimental: HIFU for Sacroiliitis
High-intensity focused ultrasound delivered to the lateral sacral branch nerve for neurolysis.
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Device: High-intensity focused ultrasound for Sacroiliitis using the Neurolyser XR
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. |
- 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.
- 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 ]The pain scale is 0 to 10 where 0 is no pain at all and 10 is the worst pain imaginable
- Change in quality of life will be assessed by Oswestry Disability Index (ODI) [ Time Frame: Procedure through 6 month follow-up visit ]
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
- Change in quality of life will be assessed also by Brief Pain Inventory (BPI-QOL) [ Time Frame: Procedure through 6 month follow-up visit ]
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).
- 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%
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06053255
Contact: Alexi Moruza | 434-243-5676 | AM2JT@uvahealth.org |
Principal Investigator: | Lynn Kohan, MD | University of Virginia Pain Medicine Clinic |
Responsible Party: | FUSMobile Inc. |
ClinicalTrials.gov Identifier: | NCT06053255 |
Other Study ID Numbers: |
SIJ-002 |
First Posted: | September 25, 2023 Key Record Dates |
Last Update Posted: | October 5, 2023 |
Last Verified: | October 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
neurolysis high-intensity focused ultrasound nerve ablation neurotomy sacral joint pain |
Sacroiliitis Back Pain Low Back Pain Pain |
Neurologic Manifestations Arthritis Joint Diseases Musculoskeletal Diseases |