Safety and Feasibility of the NeurolyserXR for Sacroiliac Joint Pain

Sacroiliitis Clinical Trial

Official title:

Safety and Initial Feasibility of Using the Neurolyser XR Device for the Treatment of Sacroiliac Joint Related Low Back Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05396495
• Other study ID #: SIJ-001
• Status: Recruiting
• Phase: N/A
• Start date: October 24, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: September 2023
• Source: FUSMobile Inc.
• Contact: Glia Pesah
• Phone: +972 52 3213525
• Email: Galia.Pesah[@]sheba.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pilot study to evaluate the safety and the effectiveness of the Neurolyser XR as a treatment for sacroiliitis

Description:

Pilot, Interventional, Prospective, Open label, Single Arm study to evaluate Non-invasive thermal ablation of the posterior sacral nerve branches as a treatment of painful sacroiliac joint (SIJ) using High Intensity Focused Ultrasound delivered by the Neurolyser XR.

Patient would be treated and then followed for up to 6 months. Primary safety endpoint will be measured by the incidence and severity of treatment related adverse events Primary effectiveness endpoint will be measured by the changes in average pain score and Rolland Morris Disability Questionnaire between baseline and 6 and 12 months

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Adult male and females, legally able and willing to participate in the study and come for follow-up visits

2. Able and willing to fill the research questionnaires and to communicate with investigator and research team

3. Patient with bilateral or unilateral sacroiliac joint pain of > 6 months duration

4. Patients presenting with a) a positive (>70% pain relief) to a previous nerve ablation procedure of the sacroiliac joint and / or b) with a positive (>70% pain relief) to a previous nerve block procedure of the sacroiliac joint within the last six months)

5. Average pain score of 4 or higher in the last month, (on 0-10 scale).

Exclusion Criteria:

1. Pregnant or breastfeeding patient

2. Patients younger than 18 or older than 80 years

3. Patients presenting with neurological deficits (including lumbosacral radiculopathy but not solitary radicular pain).

4. Patients with history of lumbar and / or sacral spine surgery

5. Patients with the presence of metal hardware at the lumbosacral spine

6. Patients with history of pelvic pathology that may increase procedural risk and / or influence symptoms and / or generate unrelated adverse event (per the discretion of the study PI)

7. Patients unable to understand and complete the research questionnaires in Hebrew.

8. Patients presenting with any severe medical condition preventing the patient from safely and effectively being treated in the study or reporting study outcome.

9. Patient with extensive scarring in the skin and tissue overlying the treatment area.

10. Patients enrolled in or planned to be enrolled in another clinical trial during the duration of this research project

Related Conditions & MeSH terms

• Sacroiliitis

Intervention

Device:
• NeurolyserXR
Using the NeurolyserXR to non-invasively ablate the posterior sacral branches enervating the sacroiliac joint

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Givatayim

Sponsors (2)

Lead Sponsor	Collaborator
FUSMobile Inc.	Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness per pain score using numerical rating scale of 0 to 10	Pain reduction would be measured using numerical rating scale of 0 to 10 to evaluate pain and brief pain inventory questioner	Baseline throughout the follow-up period of six months
Primary	Safety per adverse events	Measured by the incidence and severity of treatment related adverse events	Baseline throughout the follow-up period of six months
Secondary	Assess self-rated physical disability caused by low back pain	Roland-Morris Disability Questionnaire providing a scale of 0 to 24 when 0 is best and 24 is worst	Baseline throughout the follow-up period of six months
Secondary	Opioid intake dosage using morphine equivalency conversion	Using by recording patient opioid intake using opioid equivalency chart	Baseline throughout the follow-up period of six months