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

Facet Syndrome of Lumbar Spine Clinical Trial

Official title:

High-Intensity Focused Ultrasound Ablation With the Neurolyser XR Device for the Treatment of Chronic Low Back Pain: a Prospective Randomized Double-Blind Sham-Controlled Multicenter Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05154448
• Other study ID #: LBP003
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 16, 2022
• Est. completion date: April 1, 2024

Study information

• Verified date: September 2023
• Source: FUSMobile Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Study design: Prospective, Double Arm Timeline: Twelve months enrollment period and 6 months follow-up period. Sites: The study will be conducted at 10 sites in the USA Study population: 80 adult subjects diagnosed with facet related low back pain with an additional 10 roll in subjects.

Arms: 40 patients would be treated by the NeurolyserXR and 40 would get a sham treatment Crossover: blinded crossover between the two arms could be done between 1 and 3 months 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 pain numerical rating scale

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Age 50 to 85 years old, legally able and willing to participate in the study and all follow-up visits

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

3. Individual with current bilateral or unilateral low back pain of > 6 months duration

4. Individual whose back pain is alleviated by recumbency or comfortable sitting position

5. 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

6. Average low back pain score of 6 or higher in the last month (on 0-10 scale) with activity

Exclusion Criteria:

1. Individuals who are pregnant or breastfeeding

2. Individuals younger than 50 or older than 85 years

3. 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.

4. Individuals presenting with neurological deficits (including lumbosacral radiculopathy but not solitary radicular pain)

5. Individuals with history of lumbar or lumbosacral spine surgery

6. Individuals who have had lumbar radiofrequency neurotomy in the past 6 months

7. 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)

8. Individuals presenting with any severe medical condition preventing them from participation (per investigator's discretion) (Example: inability to lay prone)

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

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

11. Any Individuals with an uncontrolled coagulopathy

12. Individuals with known osteoporosis with absolute risk of spinal fracture of > 10% over 10 years

13. 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

14. Individuals with rheumatologic diseases causing spine pain that are currently receiving active treatment including steroids, disease modifying drugs, biological agents or immunosuppressants

15. Individuals known for concomitant psychiatric disorders, excluding compensated mood disorders

16. Individuals with first-degree family member already enrolled in this study

17. Individual who is scheduled for any interventional/surgical procedure within 6 months from the treatment date excluding trivial surgeries (e.g., cataract, carpal tunnel release)

18. Individuals diagnosed with co-morbid multifocal chronic pain (e.g. fibromyalgia, generalized osteoarthritis)

19. Individuals with other chronic pain that is 2 or more points higher on the NRS score than the participants low back pain

20. Individuals who have had a steroid injection within the last 2 months from date of enrollment at the location of the planned treatment

21. Any individuals with clinical or radiographic evidence of dynamic instability of the lumbar spine

Related Conditions & MeSH terms

• Back Pain
• Facet Syndrome of Lumbar Spine
• Low Back Pain
• Syndrome

Intervention

Device:
• Non-Invasive Thermal Ablation of the Medial Branch Nerves (Neurolyser XR)
Thermal ablation of the medial nerve branch using High Intensity Focused Ultrasound

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

Locations

Country	Name	City	State
United States	Emory	Atlanta	Georgia
United States	The Physicians Spine and Rehabilitation Specialist of GA	Atlanta	Georgia
United States	Charlie Norwood VA Medical Center	Augusta	Georgia
United States	University of Virginia Pain Management Center	Charlottesville	Virginia
United States	Mayo University Jacksonville	Jacksonville	Florida
United States	Univ of Miami Rehabilitation Medicine	Miami	Florida
United States	Ainsworth Institute of Pain Management	New York	New York
United States	Stamford Hospital	Stamford	Connecticut
United States	Gershon Pain Specialists	Virginia Beach	Virginia
United States	Center for Clinical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
FUSMobile Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Oswestry Disability Index (ODI)	Low Back Pain Questionnaire (Range: 0% to 100%)	Time Frame: Base line, 1, & 4 weeks, 3 & 6 months after procedure
Secondary	Patient Global Impression of Change (PGIC)	Patient Global Impression of Change (Range: 1 to 7)	Time Frame: Base line, 1, & 4 weeks, 3 & 6 months after procedure