Double Arm Pivotal Study to Evaluate the Neurolyser XR for the Treatment of Chronic Low Back Pain

NCT05154448 | Completed DMC FDA Device

• 1 other identifier: LBP003
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 10

Brief Summary

Double arm pivotal study to evaluate the Neurolyser XR as a non-invasive treatment of axial chronic low back pain

Conditions

Facet Syndrome of Lumbar Spine

Keywords

chronic low back pain; zygapophyseal joint syndrome; Facet syndrome

Outcome Measures

Primary Outcomes (2)

• NRS

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

  Base line, 2 days 1, 2 & 4 weeks, 3 & 6 months after procedure

• Procedure and Device Safety up to six months post procedure

  Safety will be measured by the incidence and severity of treatment related adverse events

  6 months after procedure

Secondary Outcomes (2)

• Oswestry Disability Index (ODI)

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

• Patient Global Impression of Change (PGIC)

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

Study Arms (2)

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

EXPERIMENTAL

Non-Invasive Thermal Ablation of the Medial Branch Nerves using the Neurolyser XR High Intensity Focused Ultrasound device

Device: Non-Invasive Thermal Ablation of the Medial Branch Nerves (Neurolyser XR)

Sham treatment

SHAM COMPARATOR

The procedure would be done in an identical manner to the NeurolyserXR treatment without any person in the procedure room knowing that this is a sham procedure. The only difference is that the acoustic energy would not be output from the system during a sham procedure.

Other: Sham procedure

Interventions

Non-Invasive Thermal Ablation of the Medial Branch Nerves (Neurolyser XR) DEVICE

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

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

Sham procedure OTHER

Sham procedure done in an identical manner to the treatment arm, but without deploying acoustical energy

Sham treatment

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 50 to 85 years old, legally able and willing to participate in the study and all follow-up visits
• Able and willing to complete the research questionnaires and to communicate with investigator and research team
• Individual with current bilateral or unilateral low back pain of \> 6 months duration
• Individual whose back pain is alleviated by recumbency or comfortable sitting position
• Individual presenting with a) a positive (\>80% pain relief) to a previous, double, lumbar medial branch block (within the last 12 months) and/or b) with a positive (\>70% pain relief lasting more than 6 months) to the most recent lumbar facet thermal radiofrequency denervation
• Average low back pain score of 6 or higher in the last month (on 0-10 scale) with activity

You may not qualify if:

• Individuals who are pregnant or breastfeeding
• Individuals younger than 50 or older than 85 years
• BMI greater than 40, or individuals with at least one of the planned targets outside the Neurolyser XR treatment envelope as seen on treatment day on a lateral X-ray scan taken before the treatment.
• Individuals presenting with neurological deficits (including lumbosacral radiculopathy but not solitary radicular pain)
• Individuals with history of lumbar or lumbosacral spine surgery
• Individuals who have had lumbar radiofrequency neurotomy in the past 6 months
• Individuals with history of lumbar spine pathology that may increase procedural risk and/or influence symptoms and/or generate unrelated adverse event (per investigator's discretion)
• Individuals presenting with any severe medical condition preventing them from participation (per investigator's discretion) (Example: inability to lay prone)
• Individuals with extensive scarring of the skin and tissue overlying the treatment area
• Individuals enrolled in or planned to be enrolled in another clinical trial during the duration of this research project
• Any Individuals with an uncontrolled coagulopathy
• Individuals with known osteoporosis with absolute risk of spinal fracture of \> 10% over 10 years
• Any Individuals with a history of malignant disease in the past five years or any individuals with clinical history suggestive of new/previously unknown malignancy and pathological pain who require further work up or is currently undergoing work up
• Individuals with rheumatologic diseases causing spine pain that are currently receiving active treatment including steroids, disease modifying drugs, biological agents or immunosuppressants
• Individuals known for concomitant psychiatric disorders, excluding compensated mood disorders

Sponsors & Collaborators

• FUSMobile Inc.: lead

Study Sites (10)

Stamford Hospital

Stamford, Connecticut, 06902, United States

Location

Mayo University Jacksonville

Jacksonville, Florida, 32224, United States

Location

Univ of Miami Rehabilitation Medicine

Miami, Florida, 33136, United States

Location

Emory

Atlanta, Georgia, 30322, United States

Location

The Physicians Spine and Rehabilitation Specialist of GA

Atlanta, Georgia, 30328, United States

Location

Charlie Norwood VA Medical Center

Augusta, Georgia, 30904, United States

Location

Ainsworth Institute of Pain Management

New York, New York, 10022, United States

Location

Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

University of Virginia Pain Management Center

Charlottesville, Virginia, 22904, United States

Location

Gershon Pain Specialists

Virginia Beach, Virginia, 23454, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The sham procedure would be done using the same system and setup. Randomization would be done using an EDC system and no person at the room would know if the procedure is a treat or sham procedure.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double arm randomized study

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: December 13, 2021
• Study Start: May 16, 2022
• Primary Completion: April 16, 2024
• Study Completion: April 16, 2024
• Last Updated: February 7, 2025

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)