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RAMBAM 021: Safety and Initial Feasibility of the Neurolyser XR for the Treatment of Chronic Low Back Pain

Primary Purpose

Facet Syndrome of Lumbar Spine

Status

Completed

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Non-Invasive Thermal Ablation of the Medial Branch Nerves using the Neurolyser XR

About this trial

This is an interventional treatment trial for Facet Syndrome of Lumbar Spine

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adult male and females >55 years of age legally able and willing to participate in the study and come for follow-up visits Able and willing to fill the research questionnaires and to communicate with investigator and research team Patient with bilateral or unilateral low back pain of > 6 months duration Patients whose back pain is alleviated by recumbency or comfortable sitting position Patients presenting with a) a positive (>70% pain relief) to a previous, single or double, L1 to L5 lumbar medial branch block (within the last 12 months) and / or b) with a positive (>70% pain relief lasting more than 6 months) to a previous lumbar facet thermal radiofrequency denervation.

Average pain score of 6 or higher in the last month, (on 0-10 scale).

Exclusion Criteria:

Pregnant or breastfeeding patient Patients younger than 55 or older than 85 years Patients presenting with neurological deficits (including lumbosacral radiculopathy but not solitary radicular pain).

Patients with history of lumbosacral spine surgery excluding previous lumbar radiofrequency neurotomy Patients who have had lumbar radiofrequency neurotomy in the past 6 months Patients with the presence of metal hardware or other foreign objects at the lumbosacral spine Patients with history of lumbar spine pathology that may increase procedural risk and / or influence symptoms and / or generate unrelated adverse event, (per the discretion of the study PI) Patients unable to understand and complete the research questionnaires in the official language used within the particular sites' location.

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

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

Patients enrolled in or planned to be enrolled in another clinical trial during the duration of this research project Any patients with an uncontrolled coagulopathy Patients with known osteoporosis with absolute risk of spinal fracture of >10% over 10 years will be excluded Any patients with a history of malignant disease in the past five years Patients with rheumatologic diseases causing spine pain that are currently receiving active treatment including steroids, disease modifying drugs, biological agents or immunosuppressants.

Patients known for concomitant psychiatric disorders, excluding mood disorders. Patients presenting with concomitant mood disorders (deemed severe by the research physician).

Patients with a first-degree family member already enrolled in this study. Patient who is scheduled for any interventional/surgical procedure within 3 months from screening date Patients diagnosed with co-morbid multifocal chronic pain (e.g., fibromyalgia)

Sites / Locations

Rambam

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neurolyser XR treatment

Arm Description

Thermal ablation of the medial nerve branch using High Intensity Focused Ultrasound

Outcomes

Primary Outcome Measures

Numerical rating scale of pain (NRS)

Change in average pain score as measured by a numeric rating scale from 0 (no pain) to 10, worst possible pain

Saftey

Procedure and Device Safety at six months as measured by measured by the number and severity of treatment related adverse events

Secondary Outcome Measures

Lesion Size

Lesion size and location as shown in MRI Image, 2 days post treatment.

Oswestry Disability Index (ODI)

Low Back Pain Questionnaire (Range: 0% to 100%)

Short Form 12 (SF-12)

A multipurpose short form survey with 12 questions (Range: 0 to 100)

Patient Global Impression of Change (PGIC)

Patient Global Impression of Change (Range: 1 to 7)

Full Information

NCT ID

NCT04519541

First Posted

August 17, 2020

Last Updated

September 6, 2023

Sponsor

FUSMobile Inc.

Collaborators

Rambam

1. Study Identification

Unique Protocol Identification Number

NCT04519541

Brief Title

RAMBAM 021: Safety and Initial Feasibility of the Neurolyser XR for the Treatment of Chronic Low Back Pain

Official Title

Safety and Initial Feasibility of Using the Neurolyser XR Device for the Treatment of Axial Chronic Low Back Pain

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

February 3, 2021 (Actual)

Primary Completion Date

September 11, 2022 (Actual)

Study Completion Date

January 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

FUSMobile Inc.

Collaborators

Rambam

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Single arm pilot study to evaluate the safety and initial feasibility of the Neurolyser XR, a high intensity focused ultrasound device, for non-invasive treatment of axial chronic low back pain

Detailed Description

Study design: Prospective, single arm Timeline: six month enrollment period and 12 months follow-up period. Sites: The study will be conducted at five sites in Canada: McGill University, Toronto Western, Silver Medical Group, Precision Sport & Spine, Kinetix Integrated Orthopaedic & Regenerative Medicine Study population: Thirty adult patients diagnosed with facet related low back pain. Primary study objective: Safety and efficacy of the Neurolyser XR for the treatment of chronic low back pain secondary to zygapophyseal joint syndrome. Safety is measured by the incidence and severity of treatment related adverse events. Efficacy is measured by the changes in pain severity at the treatment area, using a numerical rating scale (NRS), of 0 to 10 between baseline and 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Facet Syndrome of Lumbar Spine

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Single arm, non-randomized

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Neurolyser XR treatment

Arm Type

Experimental

Arm Description

Thermal ablation of the medial nerve branch using High Intensity Focused Ultrasound

Intervention Type

Device

Intervention Name(s)

Non-Invasive Thermal Ablation of the Medial Branch Nerves using the Neurolyser XR

Intervention Description

Thermal ablation of the medial nerve branch using High Intensity Focused Ultrasound

Primary Outcome Measure Information:

Title

Numerical rating scale of pain (NRS)

Description

Change in average pain score as measured by a numeric rating scale from 0 (no pain) to 10, worst possible pain

Time Frame

Time Frame: Base line, 2 days 1, 2 & 4 weeks, 3, 6 & 12 months after procedure

Title

Saftey

Description

Procedure and Device Safety at six months as measured by measured by the number and severity of treatment related adverse events

Time Frame

Time Frame: 6 months after procedure

Secondary Outcome Measure Information:

Title

Lesion Size

Description

Lesion size and location as shown in MRI Image, 2 days post treatment.

Time Frame

2 days post procedure

Title

Oswestry Disability Index (ODI)

Description

Low Back Pain Questionnaire (Range: 0% to 100%)

Time Frame

Time Frame: Base line, 1, & 4 weeks, 3, 6 & 12 months after procedure

Title

Short Form 12 (SF-12)

Description

A multipurpose short form survey with 12 questions (Range: 0 to 100)

Time Frame

Time Frame: Base line, 1, & 4 weeks, 3, 6 & 12 months after procedure

Title

Patient Global Impression of Change (PGIC)

Description

Patient Global Impression of Change (Range: 1 to 7)

Time Frame

Time Frame: 1, & 4 weeks, 3, 6 & 12 months after procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult male and females >55 years of age legally able and willing to participate in the study and come for follow-up visits Able and willing to fill the research questionnaires and to communicate with investigator and research team Patient with bilateral or unilateral low back pain of > 6 months duration Patients whose back pain is alleviated by recumbency or comfortable sitting position Patients presenting with a) a positive (>70% pain relief) to a previous, single or double, L1 to L5 lumbar medial branch block (within the last 12 months) and / or b) with a positive (>70% pain relief lasting more than 6 months) to a previous lumbar facet thermal radiofrequency denervation. Average pain score of 6 or higher in the last month, (on 0-10 scale). Exclusion Criteria: Pregnant or breastfeeding patient Patients younger than 55 or older than 85 years Patients presenting with neurological deficits (including lumbosacral radiculopathy but not solitary radicular pain). Patients with history of lumbosacral spine surgery excluding previous lumbar radiofrequency neurotomy Patients who have had lumbar radiofrequency neurotomy in the past 6 months Patients with the presence of metal hardware or other foreign objects at the lumbosacral spine Patients with history of lumbar spine pathology that may increase procedural risk and / or influence symptoms and / or generate unrelated adverse event, (per the discretion of the study PI) Patients unable to understand and complete the research questionnaires in the official language used within the particular sites' location. Patients presenting with any severe medical condition preventing the patient from safely and effectively being treated in the study or reporting study outcome per PI decision. Patient with extensive scarring of the skin and tissue overlying the treatment area. Patients enrolled in or planned to be enrolled in another clinical trial during the duration of this research project Any patients with an uncontrolled coagulopathy Patients with known osteoporosis with absolute risk of spinal fracture of >10% over 10 years will be excluded Any patients with a history of malignant disease in the past five years Patients with rheumatologic diseases causing spine pain that are currently receiving active treatment including steroids, disease modifying drugs, biological agents or immunosuppressants. Patients known for concomitant psychiatric disorders, excluding mood disorders. Patients presenting with concomitant mood disorders (deemed severe by the research physician). Patients with a first-degree family member already enrolled in this study. Patient who is scheduled for any interventional/surgical procedure within 3 months from screening date Patients diagnosed with co-morbid multifocal chronic pain (e.g., fibromyalgia)

Facility Information:

Facility Name

Rambam

City

Haifa

Country

Israel

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

RAMBAM 021: Safety and Initial Feasibility of the Neurolyser XR for the Treatment of Chronic Low Back Pain

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