Health TrialsbyHealthPanel

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

ConditionSacroiliitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFUSMobile Inc.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • High-intensity focused ultrasound for Sacroiliitis using the Neurolyser XR

    Device

    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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: HIFU for SacroiliitisExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Procedure through 6 month follow-up visit

Secondary outcomes

1

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

Time frame
Procedure through 6 month follow-up visit
2

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

Time frame
Procedure through 6 month follow-up visit
3

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.

Time frame
Procedure through 6 month follow-up visit

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

FUSMobile Inc.

Lead sponsor

Focused Ultrasound Foundation

Collaborator

Source ClinicalTrials.gov
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