Facet Syndrome of Lumbar SpineNCT05154448
Double Arm Pivotal Study to Evaluate the Neurolyser XR for the Treatment of Chronic Low Back Pain
A study testing Non-Invasive Thermal Ablation of the Medial Branch Nerves (Neurolyser XR) in people with Facet Syndrome of Lumbar Spine, run by FUSMobile Inc. at 10 sites in United States.
Trial summary
Double arm pivotal study to evaluate the Neurolyser XR as a non-invasive treatment of axial chronic low back pain Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Facet Syndrome of Lumbar Spine
- What is being tested?
- Non-Invasive Thermal Ablation of the Medial Branch Nerves (Neurolyser XR)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 10 sitesUnited States
- Study dates
- 16 May 2022to 16 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
- Individuals with first-degree family member already enrolled in this study
- 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)
- Individuals diagnosed with co-morbid multifocal chronic pain (e.g. fibromyalgia, generalized osteoarthritis)
- Individuals with other chronic pain that is 2 or more points higher on the NRS score than the participants low back pain
- Individuals who have had a steroid injection within the last 2 months from date of enrollment at the location of the planned treatment
- Any individuals with clinical or radiographic evidence of dynamic instability of the lumbar spine
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Emory
Atlanta, Georgia, 30322
The Physicians Spine and Rehabilitation Specialist of GA
Atlanta, Georgia, 30328
Charlie Norwood VA Medical Center
Augusta, Georgia, 30904
University of Virginia Pain Management Center
Charlottesville, Virginia, 22904
Mayo University Jacksonville
Jacksonville, Florida, 32224
Univ of Miami Rehabilitation Medicine
Miami, Florida, 33136
Ainsworth Institute of Pain Management
New York, New York, 10022
Stamford Hospital
Stamford, Connecticut, 06902
Gershon Pain Specialists
Virginia Beach, Virginia, 23454
Center for Clinical Research
Winston-Salem, North Carolina, 27103
About this study
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
Double arm pivotal study to evaluate the Neurolyser XR as a non-invasive treatment of axial chronic low back pain
Read the detailed 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
- Conditions
- Facet Syndrome of Lumbar Spine
- Being tested
- Non-Invasive Thermal Ablation of the Medial Branch Nerves (Neurolyser XR), Sham procedure
- Keywords
- chronic low back pain, zygapophyseal joint syndrome, Facet syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Invasive Thermal Ablation of the Medial Branch Nerves (Neurolyser XR)Device
Thermal ablation of the medial nerve branch using High Intensity Focused Ultrasound
Sham procedureOther
Sham procedure done in an identical manner to the treatment arm, but without deploying acoustical energy
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Sham procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS
Change in average pain score as measured by a numeric rating scale from 0 (no pain) to 10, worst possible pain
Measured: 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
Measured: 6 months after procedure
Secondary outcomes (2)
Oswestry Disability Index (ODI)
Low Back Pain Questionnaire (Range: 0% to 100%)
Measured: Time Frame: Base line, 1, & 4 weeks, 3 & 6 months after procedure
Patient Global Impression of Change (PGIC)
Patient Global Impression of Change (Range: 1 to 7)
Measured: Time Frame: Base line, 1, & 4 weeks, 3 & 6 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start16 May 2022
- Primary completion16 Apr 2024
- Study completion16 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facet Syndrome of Lumbar SpineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double arm randomized study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- FUSMobile Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05154448
- Sponsor's protocol ID
- LBP003
- Status last verified
- Oct 2023
- First submitted
- 16 Nov 2021
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05154448
- Acronym / sponsor ID
- LBP003
- Conditions
- Facet Syndrome of Lumbar Spine
- Keywords
- chronic low back pain, zygapophyseal joint syndrome, Facet syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- FUSMobile Inc.Industry (pharma, biotech, devices)
- Study start
- 16 May 2022 (actual)
- Primary completion
- 16 Apr 2024 (actual)
- Study completion
- 16 Apr 2024 (actual)
- First posted
- 13 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Double arm pivotal study to evaluate the Neurolyser XR as a non-invasive treatment of axial chronic low back pain
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double arm randomized study
| Arm | Type | Receives |
|---|---|---|
| Thermal ablation of the medial nerve branch using High Intensity Focused Ultrasound | Experimental | Device: Non-Invasive Thermal Ablation of the Medial Branch Nerves (Neurolyser XR)Non-Invasive Thermal Ablation of the Medial Branch Nerves using the Neurolyser XR High Intensity Focused Ultrasound device |
| Sham treatment | Sham comparator | Other: Sham procedureThe 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. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Invasive Thermal Ablation of the Medial Branch Nerves (Neurolyser XR)Thermal ablation of the medial nerve branch using High Intensity Focused Ultrasound | Device | Thermal ablation of the medial nerve branch using High Intensity Focused Ultrasound |
| Sham procedureSham procedure done in an identical manner to the treatment arm, but without deploying acoustical energy | Other | Sham treatment |
Primary outcome
NRS
Time frame: Base line, 2 days 1, 2 & 4 weeks, 3 & 6 months after procedure
Change in average pain score as measured by a numeric rating scale from 0 (no pain) to 10, worst possible pain
Procedure and Device Safety up to six months post procedure
Time frame: 6 months after procedure
Safety will be measured by the incidence and severity of treatment related adverse events
2 secondary outcomes
Oswestry Disability Index (ODI)
Time frame: Time Frame: Base line, 1, & 4 weeks, 3 & 6 months after procedure
Patient Global Impression of Change (PGIC)
Time frame: Time Frame: Base line, 1, & 4 weeks, 3 & 6 months after procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Facet Syndrome of Lumbar Spine
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Lumbar Facet Platelet-Rich Plasma Injection Versus Medial Branch Radiofrequency Ablation for Chronic Lumbar Facet-Mediated Pain
Chronic Lower Back Pain (CLBP), Lumbar Facet Joint Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Invasive Thermal Ablation of the Medial Branch Nerves (Neurolyser XR) in people with Facet Syndrome of Lumbar Spine, run by FUSMobile Inc. at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS (time frame: Base line, 2 days 1, 2 & 4 weeks, 3 & 6 months after procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.